Importation of Prescription Drugs: A Side-by-Side Comparison of Current Law, S. 109/H.R. 328, S. 184/H.R. 753, and S. 334/H.R. 700

CRS Report for Congress
Importation of Prescription Drugs: A Side-by-Side
Comparison of Current Law, S. 109/H.R. 328,
S. 184/H.R. 753, and S. 334/H.R. 700
December 6, 2005
Susan Thaul and Donna U. Vogt
Specialists in Social Legislation
Domestic Social Policy Division


Congressional Research Service ˜ The Library of Congress

Importation of Prescription Drugs: A Side-by-Side
Comparison of Current Law, S. 109/H.R. 328,
S. 184/H.R. 753, and S. 334/H.R. 700
Summary
As prices of prescription drugs have risen, many in Congress have sponsored
legislation to permit the importation of FDA-approved drugs from less expensive
foreign sources. In the 109th Congress, three pairs of bills have been introduced to
repeal the existing import restrictions and provide for limited forms of importation
of prescription drugs. Current law and the bills all seek to balance the availability of
imported prescription drugs — both for commercial and personal use — and the
assurance that those imports would be safe and effective. An underlying goal is to
reduce or restrain the growth of the financial burden that prescription drugs place on
U.S. consumers.
The drug importation provisions in the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA, P.L. 108-173) effectively do
not allow the commercial or personal-use importation of prescription drugs.
Congress, with the MMA, continued the major legal obstacle to importation: the
requirement that the Secretary of Health and Human Services first certify that imports
are safe and offer cost savings to U.S. consumers — something no Secretary has been
willing to do. This report, which will be updated, briefly discusses major differences
among current law and the introduced bills, and presents a side-by-side comparison
of their provisions. The bills are the Pharmaceutical Market Access Act of 2005 (S.
109, H.R. 328), the Safe Importation of Medical Products and Other Rx Therapies
Act of 2005 (the Safe IMPORT Act of 2005; S. 184, H.R. 753), and the
Pharmaceutical Market Access and Drug Safety Act of 2005 (S. 334, H.R. 700).
Although all three pairs of bills seek to make lower-priced prescription drugs
available to U.S. consumers by allowing importation while also ensuring that the
drugs are safe and effective, they take different approaches. The proposed bills use
extensive registration, licensing, facility inspection, and records requirements to
document an imported shipment’s chain-of-custody requirements, rather than the
MMA’s use of mandated laboratory testing of imported drugs to verify their content,
potency, and labeling. Current law and the bills each have different lists of countries
from which imports could be imported, and they provide the Secretary with different
time frames and criteria for determining whether to permit commercial or personal-
use importation. Secretarial reporting requirements vary as do mechanisms to fund
the import activities: current law relies on appropriations alone, while the proposed
bills each create specific user-fee provisions. The proposed bills also address the
regulation of Internet pharmacies. S. 109/H.R. 328 and S. 334/H.R. 700 propose
links to patent law to influence industry behavior. While current law does not specify
when importation could begin, S. 109/H.R. 328 requires regulations to allow
personal-use and commercial imports 180 days after enactment. S. 184/H.R. 753
provides for personal-use imports at enactment and commercial imports one year
later. S. 334/H.R. 7000 begins imports from registered exporters 90 days after
enactment and by registered importers one year after enactment.



Contents
In troduction ......................................................1
Safe and Effective Drugs............................................2
Relationship to FDA Approval...................................2
Permitted Countries............................................3
Ensuring Drug Identity..........................................3
Registration ..............................................3
Monitoring, Inspecting, and Testing...........................3
Packaging and Labeling.....................................4
Internet Pharmacies........................................4
Cost Savings to U.S. Consumers......................................5
Discrimination and Unfair Acts...................................5
Drug Differences..............................................5
Patent Law...................................................5
Administration of Importation Provisions...............................5
Funding .....................................................5
Effective Dates................................................6
Side-by-Side Comparison...........................................6
Legislation ...................................................7
Direction to regulate............................................7
Commencem ent of program.....................................0
Permitted countries...........................................11
Definitions ..................................................14
Qualifying drug..............................................15
Relationship to FDA approval...................................20
Manufacturer requirements.....................................25
Testing .....................................................36
Monitoring and inspections.....................................37
Records of chain of custody.....................................38
Registration of exporters and importers............................45
Secretary’s approval or disapproval of registration...................51
Licensing as pharmacist........................................58
Appropriations ...............................................58
Importer and exporter fees......................................59
Packaging and anti-counterfeiting programs........................65
Suspension and termination of importation
of a product or by an importer...............................75
Prior notice of shipments.......................................77
Enforcement .................................................79
Warning notices..............................................82
Unfair and discriminatory acts and practices........................84
Drugs refused admission.......................................95
Drugs recalled..............................................100
Personal use................................................101
Rulemaking deadlines........................................103



Internet pharmacies..........................................104
Prohibition of port shopping...................................119
Patents ....................................................120
Charitable contributions.......................................121
Controlled substances exemption...............................122
List of Tables
Table 1. Comparison of Prescription Drug Importation Provisions
in Current Law, S. 109/H.R. 328, S. 184/H.R. 753,
and S. 334/H.R. 700............................................7



Importation of Prescription Drugs:
A Side-by-Side Comparison of Current Law,
S. 109/H.R. 328, S. 184/H.R. 753,
and S. 334/H.R. 700
Introduction
In recent years, as prices of prescription drugs have risen, many in Congress
have sponsored legislation to permit the importation of Food and Drug
Administration (FDA) approved drugs from less expensive foreign sources. In the
109th Congress, three pairs of bills have been introduced to repeal the existing import
restrictions and provide for limited forms of importation of prescription drugs.
Current law and the bills all seek to balance the availability of imported prescription
drugs — both for commercial and personal use — and the assurance that those
imports would be safe and effective. An underlying goal is to reduce or restrain the
growth of the financial burden that prescription drugs place on U.S. consumers.
Current law bars importation unless the Secretary of Health and Human Services
(HHS) certifies that imports are safe and offers cost savings to U.S. consumers.
Congress reaffirmed this requirement, first established by the Medicine Equity and
Drug Safety (MEDS) Act of 2000, most recently in the Medicare Prescription Drug,
Improvement, and Modernization Act (MMA, P.L. 108-173) in December 2003. The
three bill pairs each would eliminate this requirement and, instead, include other
potential safeguards regarding drug safety and effectiveness. They all would act
primarily by replacing or amending Section 804 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), which had been initially added to the FFDCA by the
Medicine Equity and Drug Safety (MEDS) Act of 2000; individual bills would
amend other laws.
This report compares the provisions of three approaches to prescription drug
importation (represented by three Senate and three House bills) with provisions on1
the subject in current law. The three bill pairs are:


1 For a detailed comparison of changes in Section 804 made by the MMA to the preexisting
law (as established by the 2000 MEDS Act), see CRS Report RL32271, Importation of
Prescription Drugs Provisions in P.L. 108-173, the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, by Susan Thaul and Donna U. Vogt. For an
analysis of the issues involved in drug importation, see CRS Report RL32511, Importing
Prescription Drugs: Objectives, Options, and Outlook, by Susan Thaul and Donna U. Vogt.

!The Pharmaceutical Market Access Act of 2005:
S. 109, introduced by Senator Vitter on January 24, 2005, and
H.R. 328, introduced by Representative Gutknecht on January 25,
2005; referred to in this report as the Vitter-Gutknecht bills. No
action has been taken.
!The Safe Importation of Medical Products and Other Rx
Therapies Act of 2005, or the Safe IMPORT Act of 2005:
S. 184, introduced by Senator Gregg on January 26, 2005, and
H.R. 753, introduced by Representative Bradley on February 10,
2005; referred to in this report as the Gregg-Bradley bills. No action
has been taken.
!The Pharmaceutical Market Access and Drug Safety
Act of 2005:
S. 334, introduced by Senator Dorgan on February 9, 2005, and
H.R. 700, introduced the same day by Representative Emerson;
referred to in this report as the Dorgan-Emerson bills. In July 2005,
Senator Dorgan successfully offered the drug importation provisions
as an amendment to the Federal Trade Commission reauthorization
bill (S. 1392) ordered to be reported by the Senate Commerce,
Science and Transportation Committee.2
The differences in approach across the bills fall into three areas: attempts to
ensure that imported drugs are safe and effective; attempts to influence industry
behavior so drugs are available for import by U.S. consumers at cost savings to
current domestic prices; and administrative arrangements.
Safe and Effective Drugs
Relationship to FDA Approval
Current law and language proposed by the Vitter-Gutknecht and Gregg-Bradley
bills explicitly require that an imported drug be approved for U.S. sale by the FDA.
The Dorgan-Emerson bills would allow different administrative requirements for
importation while maintaining the substantive elements of FDA approval. The
Dorgan-Emerson bills require that a manufacturer notify the HHS Secretary when a
drug that could be imported differs from the version FDA had approved for sale in
the United States (the “U.S. label drug”). The bills require extensive information
about whether the difference, if it were to be made to a U.S. label drug, would require
a supplemental application to FDA and whether FDA would require that the
application be processed before the drug could be marketed.


2 Elaine S. Povich, “Drug Importation Tacked to FTC Bill,” July 21, 2005, at
[http://nationalj ournal.com] .

Permitted Countries
The three bills and current law vary in the countries from which they would
permit drug importation. The most inclusive are the Vitter-Gutknecht bills,3 which
include Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa,
members of the European Union, Iceland, Liechtenstein, and Norway. These bills
also would allow the Secretary to designate additional countries that have equivalent
regulatory requirements regarding safety and effectiveness, or to remove a country
that does not. The Dorgan-Emerson bills differ from the Vitter-Gutknecht bills by
excluding Israel, South Africa, and members of the European Economic Area that are
not also members of the European Union (excluded are Iceland, Liechtenstein, and
Norway), and, for European Union countries, by adding a reference to their Annex
to the Treaty of Accession that essentially disqualifies the 10 countries admitted to
membership in May 2004 (excluded are Cyprus, the Czech Republic, Estonia, Latvia,
Lithuania, Hungary, Malta, Poland, Slovenia, and the Slovak Republic). The Gregg-
Bradley bills would include Canada and allow the Secretary, three years after
enactment, to designate as eligible any members of the European Union as of
December 2003. Current law includes only Canada, although it allows the Secretary
to grant waivers permitting personal-use importation from other countries.
Ensuring Drug Identity
Sponsors of all three pairs of bills are concerned about the potential for entry of
adulterated or counterfeit drugs into the U.S. market. Consequently, they call for a
variety of procedures covering the registration of exporters or importers;
chain-of-custody documentation; inspections of manufacturing, storage, and shipping
facilities; laboratory testing of drug samples; packaging; and labeling of shipping
containers and consumer products.
Registration. Current law requires that a Canadian establishment involved
in importing prescription drugs to the United States register its name and place of
business and the name of its U.S. agent with the Secretary. All three bills have
extensive registration requirements. The specifics vary and cover extensive
recordkeeping, monitoring, inspections, and fees. The Vitter-Gutknecht bills would
require all exporters to register; the Gregg-Bradley and Dorgan-Emerson bills require
all exporters and all commercial importers to register.
Monitoring, Inspecting, and Testing. While current law relies on
laboratory testing of samples of every shipment of imported drugs to verify their
content, potency, and labeling, the three proposed bills focus on documentation of a
monitored, uninterrupted chain of custody from manufacturing facility to importer.
The requirements related to registration involve ongoing and onsite physical
monitoring of the facilities of a drug’s manufacturer, exporter, or importer. If the
Secretary determines it necessary, these would include the inspection of any facility
(and its records) that handles the product along the chain of custody.


3 In one of the very few differences between S. 109 and H.R. 328, the Gutknecht bill restricts
European Union members to those included as of Dec. 31, 2003.

Packaging and Labeling. In addressing counterfeiting and product
tampering, all three bills promote measures intended to ensure that the drug
dispensed to the individual consumer is the same product that was tested, monitored,
or inspected at the manufacturing, shipping, or storage facility. The Vitter-Gutknecht
bills would require that the packaging of all prescription drugs (not just those being
imported) incorporate overt optically variable counterfeit-resistant technologies that
provide visible identification of the product, and be similar to those used to secure
U.S. currency. In addition, manufacturers must incorporate the technologies into
multiple elements of the packaging (including blister packs, shrink wrap, package
labels, package seals, bottles, and boxes). Also, shipping containers of prescription
drugs must have labels that incorporate technologies that enable inspectors to verify
the authenticity of the shipment. The Gregg-Bradley bills would direct the Secretary
to require the use of electronic track-and-trace technology at the case and pallet level
that would identify each sale, purchase, or trade of each case or pallet. The
Dorgan-Emerson bills require that the exporter and importer agree to mark each
shipping container to identify its compliance with all registration conditions. The
markings must include anti-counterfeiting or track-and-trace technology, taking into
account their economic and technical feasibility, and must be designed to prevent
unauthorized affixation.
Internet Pharmacies. Current law does not address use of the Internet to sell
or purchase imported prescription drugs. The Vitter-Gutknecht bills have no
provisions specifically related to Internet pharmacy procedures, but include qualified
Internet pharmacies among other registered exporters and the extensive associated
requirements. The Gregg-Bradley and Dorgan-Emerson bills do address Internet
sales. Their provisions address registration, posted information, prescriptions, and
relationship to medical care.
The Gregg-Bradley bills present an extensive statutory and regulatory structure
for Internet pharmacies, placing it in the FFDCA but set apart from the importation
sections. In addition to registration, the bills would require that Internet pharmacies
provide specific professional services, including confidential patient medication
profiles, “interactive and meaningful consultation by a licensed pharmacist,” and
verification of prescription validity. They require advance notice of commercial
shipments of prescription drugs and include a licensing fee. Providers of interactive
computer services would be liable if they accept advertising for a prescription drug
from an unlicensed Internet pharmacy or accept advertising stating that a physician’s
prescription is not needed to obtain a prescription drug. The Gregg-Bradley bills also
require policies and procedures to prevent payments for unlawful Internet pharmacy
requests.
The Dorgan-Emerson bills would require that detailed information be accessible
on the Internet site, covering pharmacist credentials, address and telephone contacts,
and the name and professional licensure information of the person, if any, who
provides for medical consultations through the site for purposes of providing
prescriptions. No one could dispense or sell a drug if the purchaser or patient who
communicated through the Internet did not have a valid U.S. prescription. The
dispenser of the prescription drug must have a “qualifying medical relationship with
the patient.”



Cost Savings to U.S. Consumers
Impetus to amend current law goes beyond the concern with drug safety. Even
were the Secretary to issue the certification necessary to begin the drug importation
section in the FFDCA, many analysts and Members of Congress anticipate
manufacturer resistance. The Vitter-Gutknecht and Dorgan-Emerson bills contain
specific provisions designed to influence industry behavior; the Gregg-Bradley bills
do not.
Discrimination and Unfair Acts
The Vitter-Gutknecht bills and the Dorgan-Emerson bills would make it
“unlawful for a manufacturer, directly or indirectly (including being a party to a
licensing or other agreement),” to discriminate or act unfairly against an exporter,
importer, or person who distributes, sells, or uses an imported prescription drug by
charging a higher price; denying, restricting, or delaying supplies; or refusing to do
business.
Drug Differences
The Vitter-Gutknecht and Dorgan-Emerson bills would make it unlawful for a
manufacturer to make a drug for distribution in a permitted country so that it differs
from the drug made for U.S. distribution “for the purpose of restricting importation
of the drug.... ” Provisions describe involvement of the Federal Trade Commission
and the state attorneys general. The extensive notification requirements in the
Dorgan-Emerson bills regarding differences between a drug a manufacturer produces
for sale in a permitted country and the drug it produces for U.S. distribution could
serve, in addition to addressing safety, to influence industry decisions.
Patent Law
The Vitter-Gutknecht and Dorgan-Emerson bills would insert a new subsection
in the Patent and Trademark Act that would reverse judicial precedent holding that
sales of patented goods outside the United States do not exhaust the U.S. patent.
Under this provision, goods that were the subject of authorized foreign sales by the
U.S. patent holder may be imported into the United States without regard to the U.S.
patent.
Administration of Importation Provisions
The timing and funding of importation activities vary across current law and the
proposed bills.
Funding
Current law includes no explicit funding mechanism other than authorizing
appropriations of such sums as necessary to implement the prescription drug



importation provisions. The Vitter-Gutknecht bills would not only authorize
appropriations but also provide for exporter fees to cover the cost of administering
the import provisions. The Gregg-Bradley and Dorgan-Emerson bills provide for
both exporter and commercial importer fees designed to cover all costs of the
program.
All three bills link the aggregate total of all fees to the estimated costs of the
importation program, setting a limit of 1% of the total price of drugs imported. The
Secretary would collect from each exporter (and importer, except in the Vitter-
Gutknecht bills) both a flat registration fee and a proportional registration fee. Each
individual importer or exporter would pay the latter fee based on the extent of its own
activity and calculated to estimate its proportion of the aggregate amount. The bills
would require that these fees be used only for the administration of the importation
provisions that the bills would add.
Effective Dates
Current law does not specify when importation could begin, other than linking
it to the required safety and cost certification by the Secretary. It directs the Secretary
to exercise discretion to permit importation by an individual for personal use, if it
does not appear to present an unreasonable risk to the individual. The three proposed
bills stipulate various time frames for commercial and personal-use importation, with
varying times for different countries.
The Vitter-Gutknecht bills would require that the HHS Secretary, in
consultation with the United States Trade Representative and the Commissioner of
Customs, issue regulations not later than 180 days after enactment, permitting
pharmacists, pharmacies, wholesalers, and individuals to import qualifying drugs
from permitted countries. The Gregg-Bradley bills’ section on personal importation
would take effect on the date of enactment, and their section on commercial
importation would take effect one year after enactment, both “without regard to
whether the Secretary … has promulgated regulations…. ” The Dorgan-Emerson
bills would require that the Secretary promulgate a final rule for implementing the
importation provisions not later than one year after promulgating an interim rule. It
also states that the importation provisions shall “permit the importation of qualifying
drugs … without regard to the status of the issuance of implementing regulations”
from registered exporters 90 days after enactment and from permitted countries by
registered importers one year after enactment.
Side-by-Side Comparison
The following table arrays the prescription drug importation provisions of
current law and the three pairs of proposed bills, with the columns ordered
chronologically based on the date of enactment or introduction. Organized by topic,
the rows do not directly follow the order of provisions in any of the compared
documents.



CRS-7
Table 1. Comparison of Prescription Drug Importation Provisions
in Current Law, S. 109/H.R. 328, S. 184/H.R. 753, and S. 334/H.R. 700
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
gislationSection 804 of the Federal[Section 4]a Amends Section[Section 2] Adds a new[Sections 3 and 4] Amends
Food, Drug, and Cosmetic Act804 of the FFDCA [21 USCSubchapter B — “ImportationChapter VIII of the FFDCA by
(FFDCA) was first established384].of Prescription Drugs” — toreplacing Section 804.
iki/CRS-RL33175under the Medicine Equity andChapter VIII of the FFDCA,
g/wDrug Safety Act of 2000 (P.L.Also amends or adds provisionsadding Sections 811-817.Also amends, deletes, or adds
s.or106-387) as Importation ofin other sections of the FFDCA,provisions in other sections of
leak
Covered Products. Sectionand in 35 USC 271[Section 16] Repeals Sectionthe FFDCA, and in the
://wiki1121(a) of the Medicare[Infringement of Patent].804 of the FFDCA.Controlled Substances Import
httpPrescription Drug,and Export Act [21 USC
Improvement, andAlso amends, deletes, or adds956(a)(2)], and in 35 USC 271
Modernization Act of 2003provisions in other sections of[Infringement of Patent].
(P.L. 108-173) replacedthe FFDCA, and in the
Section 804 entirely, renamingControlled Substances Import
it Importation of Prescriptionand Export Act [21 USC 956].
Drugs [21 USC 384].
aTo distinguish between the section numbers of the bills pending in the 109th Congress and the section numbers they would change
in the law, this table notes the former in brackets.
ction to804(b). Regulations. Section804(b). Regulations. Similar[Section 2(b)] Regulations.804(a)(1-3). Importation of
gulate801(d)(1) of the FFDCAto current law, but (1) addsAuthorizes the HHS Secretaryprescription drugs. Waives
allows only a drug’srequirement to publishto promulgate regulations toSection 801(d)(1), which
manufacturer to import thatregulations within 180 days ofcarry out Section 812 [personalprohibits a drug’s importation by
drug. Section 804(b) requiresenactment, (2) would allowimportation] and directs theany entity other than its



CRS-8
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
the Secretary of HHS, afterpharmacies and individuals toSecretary to promulgate interimmanufacturer, as long as the
consultation with the Unitedimport in addition tofinal regulations to carry outdrug complies with the standards
States Trade Representativepharmacists and wholesalers,Section 813 [pharmacy andof Section 801(a), which allow
and the Commissioner ofand (3) would allow importswholesaler importation ofonly certain drugs to be
Customs, to promulgatefrom other permitted countries,prescription drugs] of theimported. A qualifying drug
regulations permittingnot just Canada.FFDCA (as added by thismay not be imported unless the
iki/CRS-RL33175pharmacists and wholesalers tosection). Even if the Secretarydrug is imported by a pharmacy,
g/wimport prescription drugs fromhas not promulgateda group of pharmacies, or a
s.orCanada into the United States.regulations, Section 812 shallwholesaler that is a registered
leaktake effect on the date ofimporter, or by an individual for
://wiki804(j)(2). Waiver authority.enactment of this act, andpersonal or family member use
httpThe Secretary is authorized toSection 813 shall take effect(and not for resale) from a
grant waivers, either throughone year after enactment.registered exporter.
rule-making or on a case-by-
case basis, of the law that813. Pharmacy and wholesaler
allows only manufacturers toimportation of prescription
import FDA-approved drugs,drugs. A drug importation
to allow individuals to bring infacility, pharmacy, Internet
pharmaceuticals underpharmacy, or wholesaler may
conditions the Secretaryimport a prescription drug from
determines appropriate. TheCanada or a permitted country
Secretary must publishinto the United States.
guidance describing the
consistent circumstances in
which waivers would be
granted to individuals.

804(l)(1). Commencement ofNo provision.No provision.No provision.



CRS-9
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
ofprogram. The drug import
ramprogram can begin only if the
Secretary first certifies to
Congress that its
implementation would pose no
additional risk to public health
iki/CRS-RL33175and safety, and would result in
g/wa significant reduction in the
s.orcost of covered products to
leakAmerican consumers.
://wikirmination804(l)(2). Termination ofNo provision.No provision.No provision.


httpramprogram. The authority of the
Secretary to terminate the
program is restricted to the
procedure in this section.
Between 12 and 18 months
after the regulations are
implemented, if the Secretary
certifies to Congress that,
based on substantial evidence,
in the opinion of the Secretary,
the benefits of the
implementation of the import
program do not outweigh any
detriment, drug imports under
the section would cease 30
days after the certification is

CRS-10
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
submitted. However, the
certification may not be
submitted unless, after a public
hearing, the Secretary finds it
is more likely than not that
implementation will result in
iki/CRS-RL33175an increased risk to the public
g/whealth; identifies, in qualitative
s.orand quantitative terms, the
leaknature and causes of the
://wikiincreased risk; considers
httpwhether measures can be taken
to avoid, reduce, or mitigate
the increased risk and, if those
measures would require
additional statutory authority,
to report to Congress
describing needed legislation;
identifies, in qualitative and
quantitative terms, the benefits
that would result from the
program, including reductions
in the cost of drugs to U.S.
consumers, which would allow
them to obtain needed
medications without foregoing
other necessities of life; and, in
specific terms, compares the



CRS-11
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
detriment with those benefits
and determines the benefits do
not outweigh the detriment.
rmittedStipulates that the Secretary’s804(a)(2). The term “permitted811*(4)(A). [Note: Section 811804(a)(4)(E). A “permitted
regulations would include onlycountry” means a country listeddoes not have a lettercountry” means Australia,
iki/CRS-RL33175Canada for imports byin FFDCA Sectiondesignating the beginning ofCanada, Japan, New Zealand,
g/wpharmacists and wholesalers;802(b)(1)(A); these arethis subsection, which anSwitzerland, or a memberb
s.ordoes not specify country forAustralia, Canada, Israel, Japan,asterisk notes here.] Definescountry of the European Union.
leakindividual imports.New Zealand, Switzerland,“permitted country” as aDoes not include a country
://wikiSouth Africa, and a membercountry of the European Unionbmember of the European Unionas of December 31, 2003,b thatwhose Annex to the Treaty ofAccession to the EU 2003
httpor a country in the Europeanis designated by the Secretaryincludes a non-expired
Economic Area if the drug isbased on a report due to thetransitional measure for the
marketed in that country orSenate HELP Committee andregulation of pharmaceuticals, or
authorized for generalthe House Energy anda country that does not meet the
marketing in the EuropeanCommerce Committee threecriteria the Secretary may use to
Economic Area. The Secretaryyears after enactment (seeadd a country not listed here.
may add a country, union, orunder “Study and report,”Those criteria relate to the
economic area to the list if itbelow).country’s having statutory or
has a pharmaceuticalregulatory requirements that
infrastructure equivalent or811*(4)(B). Report. Requiresrequire the governmental review
superior to that in the Unitedthat the Secretary, three yearsof the drug’s safety and
States; or remove from the listafter enactment, submit to theeffectiveness; authorize approval
if it does not. In this decision,Senate HELP Committee andof only those drugs that have
the Secretary should considerthe House Committee onbeen determined to be safe and
pharmacist qualifications,Energy and Commerce a reporteffective by experts qualified to
pharmacy storage procedures,that includes a list of permittedjudge the safety and



CRS-12
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
drug distribution andcountries and why the Secretaryeffectiveness of the drugs based
dispensing systems, and marketdetermined that drug importson adequate and well-controlled
regulation.from such countries would notinvestigations, including clinical
increase risk to the publicinvestigations conducted by
health.experts qualified by scientific
training to evaluate the drug;
iki/CRS-RL33175Requires the Secretary to listrequire the methods used in and
g/wthose countries from whichthe facilities and controls used
s.orprescription drug imports arefor manufacturing, processing,
leaknot permitted and why, andand packing of drugs be
://wikiwhat possible actions thoseadequate to preserve their
httpcountries might take to avoid,identity, quality, purity, and
reduce, or mitigate increasedstrength; require reporting of
risk. Authorizes the Secretaryadverse reactions to drugs and
to determine whether toprocedures to withdraw or
designate as permitted otherremove unsafe or ineffective
countries at any time afterdrugs; and require the labeling
submission of the report.and promotion of drugs to be in
accordance with the drug’s
813(d). Prohibits theapproval. The marketing
importation of a prescriptionauthorization system must be
drug that had entered anyequivalent to systems in the
country other than Canada orcountries that have qualified, and
anotherthe import of drugs into the
permitted country after leavingUnited States from the country
the control of the manufacturer.will not adversely affect U.S.
Even when a drug comes frompublic health.


a permitted country, if it had

CRS-13
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
been outside the manufacturer’s
control, the Secretary may
prohibit its import if the
Secretary determines that
allowing it would present a risk
to the public health.
iki/CRS-RL33175
g/wEuropean Union (EU), as of January 1, 2003, consisted of the following 15 member states: Austria, Belgium, Denmark, Finland, France, Germany,
s.orIreland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. On May 1, 2004, 10 countries joined the EU:
leakprus, the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia, and the Slovak Republic. [Note: S. 109 refers to EU; H.R.
://wiki The European Economic Area consists of the European Union plus Iceland, Liechtenstein, and Norway. (Theree Trade Association consists of Iceland, Liechtenstein, Norway, Switzerland, and the member states of the European Union.)


http

CRS-14
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005

804(a). Definitions. Defines804(a). “Pharmacist,”811. Definitions. Defines804(a)(4). Definitions.


“importer” to mean a“wholesaler,” and “qualifying“drug importation facility” as a“Pharmacist” and “wholesaler”
pharmacist or a wholesaler;laboratory” are defined as inperson, other than an individualare defined as in current law.
“pharmacist” to mean a personcurrent law. Definesimporting a prescription drugDefines “registered exporter” to
licensed by a state to practice“importer” to include not onlyunder Section 812, locatedmean an exporter with an
pharmacy, including thea pharmacist and wholesaler butoutside the United States (otherapproved registration in effect;
iki/CRS-RL33175dispensing and selling ofalso a pharmacy, and group ofthan a transporter) that engages“registered importer” to mean a
g/wprescription drugs; andpharmacies. The termin the distribution or dispensingpharmacy, a group of
s.or“wholesaler” to mean a person“pharmacy” means a personof a prescription drug that ispharmacies, or a wholesaler with
leaklicensed as a wholesaler orlicensed by a state to sellimported or offered foran approved and in effect
://wikidistributor of prescriptionprescription drugs at retail whoimportation into the Unitedregistration; and a “registration
httpdrugs in the United States, butemploys 1 or more pharmacists.States. Defines “Internetcondition” to mean a condition
does not include thepharmacy” as a person thatthat must exist for a registration
manufacturer of the drug beingA “qualifying Internetoffers to dispense a prescriptionto be approved.
imported. “Qualifyingpharmacy” means a registereddrug through an Internet
laboratory” is defined as aexporter that dispenseswebsite in interstate commerce,Defines “exporter” to mean a
laboratory in the United Statesqualifying drugs to individualsregardless of whether itsperson who is in the business of
that has been approved by theover the Internet.physical location is in theexporting a drug to individuals
Secretary for the purposes ofUnited States. Definesin the United States from
this section.Defines “registered exporter”“pharmacy” as a personCanada or from a permitted
to mean an exporter that islicensed by a state to dispensecountry designated by the
exporting or seeking to export aprescription drugs or to provideSecretary, or that seeks to be in
drug to individuals in thepharmaceutical care. Definessuch a business pursuant to
United States with an approved“treating provider” as asubmitting a registration. The
registration in effect.licensed health care providerSecretary shall designate
that (A) performs a documentedcountries (other than Canada)
patient evaluation (including athat have statutory or regulatory
patient history and physicalstandards equivalent to U.S. and



CRS-15
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
examination) of an individual toCanadian standards for
establish the diagnosis forpharmacist training and practice,
which a prescription drug isprotection of personal medical
prescribed; discusses with theinformation privacy, and whose
individual the treatment optionsimports will not adversely affect
of the individual and the riskspublic health. The term
iki/CRS-RL33175and benefits of treatment; and“importer” to mean a pharmacy,
g/wmaintains contemporaneousa group of pharmacies, or a
s.ormedical records concerning thewholesaler that is in the drug
leakindividual; or (B) provides careimporting business or that seeks
://wikito an individual as part of anan approved registration to do
httpon-call or cross-coverageso; “pharmacy” means a person
arrangement with a health carelicensed by a state to engage in
provider. Defines “wholesaler”the business of selling
as a person licensed as aprescription drugs at retail and
wholesaler or distributor ofemploys one or more
prescription drugs in the Unitedpharmacists.
States, but does not include the
manufacturer of the drug being
imported or an individual
importing for personal use.
lifying804(a). Defines “prescription804(a)(5). Same as current law.811*(5). Defines “prescription804(a)(4)(B,C). Defines
drug” as a drug subject todrug” similarly to current law“prescription drug” as a drug
Section 503(b) [a drug804(a)(6). A “qualifying drug”[i.e., an FDA-approved drug],described in current law
intended for use by man that isis a drug approved underwith additional exceptions: a(FFDCA Section 503(b)(1)).
not safe for use except underSection 505(b)(1) and is not adrug manufactured through any
the supervision of a licenseddrug manufactured through 1 orbiotechnology process,A “qualifying drug” means a



CRS-16
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
practitioner (as approved undermore biotechnology processes,including a therapeutic DNAdrug for which there is a U.S.
Section 505)] other than anot required to be refrigerated,plasmid product, a therapeuticlabel drug.
controlled substance, aand not a photoreactive drug.synthetic peptide product of not
biological product, an infusedmore than 40 amino acids, aA “U.S. label drug” means a
drug, an intravenously injected[Section 4(c)] Amends 804(c)monoclonal antibody productdrug that has the same active
drug, a drug that is inhaledby replacing “prescriptionfor in vivo use, and aingredient(s), route of
iki/CRS-RL33175during surgery, or a parenteraldrug” with “qualifying drug”therapeutic recombinant DNA-administration, dosage form, and
g/wdrug that the Secretarythroughout.derived product; a drugstrength as the qualifying drug;
s.ordetermines poses a threat torequiring refrigeration at anyis manufactured by or for the
leakthe public health.time; or a photoreactive drug.person manufacturing the
://wikiqualifying drug; is approved
httpunder Section 505(c) of the
FFDCA; and is not a controlled
substance, a biological product
(including a therapeutic DNA
plasmid product, a therapeutic
synthetic peptide product, a
monoclonal antibody product for
in vivo use, and a therapeutic
recombinant DNA-derived
product), an infused drug, an
injected drug, a drug inhaled
during surgery, or a drug that is
the listed drug referred to in two
or more abbreviated new drug
applications (ANDAs) under
which the drug is commercially
marketed.



CRS-17
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
804(c). Sources of qualifying
drugs. An exporter or importer
may export or import a drug
only if there is compliance with
the following: the drug must
have been manufactured in an
iki/CRS-RL33175FDA-registered establishment
g/w[registered under Sections
s.or510(h) or 510(i)], and the
leakestablishment has been inspected
://wikieither by the Secretary or by a
httppermitted country whose
regulatory system is recognized
as equivalent under a mutual
recognition agreement as
provided in Section 510(i)(3)
[cooperative agreements
between Secretary and foreign
countries regarding means to
determine whether a drug shall
be refused admission into the
United States], Section 803
[agreements between the
Secretary and foreign countries
regarding mutual recognition of
good manufacturing practice
regulations], or 21 CFR 26
[mutual recognition of



CRS-18
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
pharmaceutical good
manufacturing practice reports,
medical device quality system
audit reports, and certain
medical device product
evaluation reports: United
iki/CRS-RL33175States and the European
g/wCommunity] or a successor rule
s.oror regulation.
leak
://wiki
httpThe establishment, located in
any country, manufactured the
drug for distribution in the
United States or a permitted
country.
In addition, the exporter or
importer must obtain the drug
directly from the manufacturing
establishment or directly from an
entity that, by contract with the
exporter or importer, provides a
chain of custody statement from
the manufacturing
establishment, identifying each
prior sale, purchase, or trade
with dates and names and



CRS-19
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
addresses of all parties to the
transaction; agrees to permit the
Secretary to inspect the
statements and related records to
determine accuracy; and agrees
to allow the Secretary to inspect
iki/CRS-RL33175warehouses and other facilities
g/wand records involved, including
s.orthose of all contracting chain of
leakcustody parties, through
://wikicontracts as necessary, to
httpdetermine whether facilities are
in compliance with any FFDCA
standards that are applicable to
facilities of that type in the
United States.
The foreign country from which
the exporter will export the drug
is the permitted country in which
the exporter is located, or the
foreign country from which the
importer will import the drug is
a permitted country. The
exporter or importer ensures that
during any period in which the
drug was not in the drug
manufacturer’s control, the drug



CRS-20
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
did not enter a non-permitted
country. The exporter or
importer must retain a sample of
each lot of the drug, sufficient
for testing by the Secretary.
iki/CRS-RL33175804(c). Limitation.804(a)(6). A qualifying drug813(b)(1,2). Requirements.804(g)(1). Compliance with
g/wDARegulations must ensure thatmust be FDA-approved underRequires that each importedsection 801(a) [Imports and
s.orall imported prescription drugsSection 505(b)(1).prescription drug be FDA-Exports]. For each exported or
leakmeet the same safety andapproved [Section 505] andimported qualifying drug, the
://wikiefficacy standards as drugsapproved in the United Statescomply with FDA requirementsregarding adulteration [Sectionexporter or importer mustcomply with FFDCA Section
httpand that the importer comply501] and misbranding [Section801(a) standards subject to
with all information, reporting,502].FFDCA Sections 505 [approval
and testing requirements. Thestatus], 502 [labeling], and 501
Secretary is permitted to adopt[adulteration].
such rules as necessary to
safeguard public health or as a804(g)(2)(A). Approval status.
means to facilitate theA qualifying drug imported or
importation of prescriptionoffered for import must comply
drugs.with conditions of the approved
FDA new drug application under
FFDCA Section 505(b) for the
U.S. label drug.

804(g)(2)(B)(i). Approval



CRS-21
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
status; Notice by manufacturer;
General provisions. The
manufacturer of the drug for
commercial distribution in a
permitted country shall submit
notice to the Secretary that
iki/CRS-RL33175includes either (a) each
g/wdifference between the
s.orqualifying drug and the U.S.
leaklabel drug beyond variations
://wikiprovided for in the application
httpand any difference in labeling
(other than ingredient labeling),
or (b) a statement of no such
difference.
804(g)(2)(B)(ii). The notice
must include information that
the Secretary may require under
FFDCA Section 506A
[manufacturing changes]; any
additional information (which
may include data on
bioequivalence if not otherwise
required under 506A); the date
that the qualifying drug with



CRS-22
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
such a difference will be (or
was) introduced for commercial
distribution in the permitted
country; demonstration that the
manufacturer also notified the
permitted country in writing that
iki/CRS-RL33175it is submitting this notice to the
g/wSecretary; and copies, with
s.orcertified English translation, of
leakall materials the manufacturer
://wikisubmitted to the permitted
httpcountry for marketing approval
in the permitted country.
804(g)(2)(B)(iii). The chief
executive officer and the chief
medical officer of the
manufacturer must certify that
the information in the notice is
complete and true and has been
provided also to the FTC and the
state attorneys general.
[Section 4(e)(4-5)] For the 100
prescription drugs with the
highest dollar volume of sales in



CRS-23
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
the United States in the
preceding year (as defined), sets
varying time limits for providing
notice based on whether drug is
for import from Canada (30
days) or from other countries
iki/CRS-RL33175(180 days).
g/w
s.or[Section 4(e)(6)] Notice for
leakother drugs for import. Requires
://wikithe Secretary to establish a series
httpof notice submission dates for
drugs not among the top 100
(see subparagraphs 4-5) in a
manner allowing the consistent
and efficient use of available
resources and staff but to be
completed not later than five
years after enactment. The
Secretary must establish these
dates to allow review of notices
regarding qualifying drugs with
higher dollar volume of sales in
the United States before review
of notices regarding drugs with
lower U.S. sales.



CRS-24
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
[Section 4(e)(7)] Notices for
drugs approved after effective
date. Subparagraphs 4(e)(4-6)
do not apply to a qualifying drug
first introduced for commercial
distribution in a permitted
iki/CRS-RL33175country after enactment of this
g/w act .
s.or
leak[Section 4(e)(8)] Report. The
://wikiSecretary must submit a report
httpto Congress within 90 days of
the end of each fiscal year,
beginning with FY2006,
concerning the FDA’s progress
in reviewing notices referred to
in paragraphs (4-6) of Section

4(e).


804(g)(4). Section 501;


Adulteration. A qualified drug
imported or offered for import
shall be considered in
compliance with Section 501
[adulterated drugs] if the drug
complies with subsection (c)



CRS-25
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
[sources of qualifying drugs].
No provision.804(l)(8). Amends section soNo provision.804(g)(2)(B)(iv). Fee. If a
that the term “manufacturer” innotice submitted shows that the
this subsection means anydifference would require the
entity, including any affiliate orsubmission of a supplemental
iki/CRS-RL33175licensee of that entity, that isapplication if made as a change
g/wengaged in: (A) the production,to the U.S. label drug, the
s.orpreparation, propagation,manufacturer submitting the
leakcompounding, conversion, ornotice must pay to the Secretary
://wikiprocessing of a prescriptiondrug, either directly ora fee in the same amount aswould apply if the person were
httpindirectly, by extraction frompaying a Prescription Drug User
substances of natural origin, orFee Act (PDUFA) fee for a
independently by means ofsupplemental application.
chemical synthesis, or by aSubject to Appropriations Acts,
combination of extraction andsuch fees collected by the
chemical synthesis; or (B) theSecretary are available only to
packaging, repackaging,the Secretary and are for the sole
labeling, relabeling, orpurpose of paying the costs of
distribution of a prescriptionreviewing notices.
drug.
804(g)(2)(B)(v). Timing of
submission of notices. For a
notice regarding drug differences
that would require approval



CRS-26
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
before being marketed, the
notice must be submitted to the
Secretary at least 120 days
before the changed drug is
introduced for commercial
distribution in a permitted
iki/CRS-RL33175country, unless the country
g/wrequires earlier distribution.
s.or
leakFor a drug difference that would
://wikinot require prior approval under
httpSection 506A, the manufacturer
must submit notice no later than
the day its commercial
distribution begins in the
permitted country.
804(g)(2)(B)(vi). Review by the
Secretary: The Secretary must
review the difference between
the qualifying drug and the U.S.
label drug as if it were a
manufacturing change to the
U.S. label drug under Section
506A, using the same safe and
effective standard for approving



CRS-27
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
or disapproving a change.
If the Secretary would approve
the difference under 506A and
the qualifying drug is not
bioequivalent to the U.S. label
iki/CRS-RL33175drug, the Secretary may either:
g/w(1) include in the labeling a
s.orprominent advisory stating that
leakthe qualifying drug is safe and
://wikieffective but is not bioequivalent
httpto the U.S. label drug, if the
Secretary decides an advisory is
necessary for health care
practitioners and patients to use
the qualifying drug safely and
effectively; or (2) decline to
approve the difference if the
Secretary decides that the
availability of both the
qualifying drug and the U.S.
label drug would pose a threat to
the public health.
The Secretary must review and
approve or disapprove the notice



CRS-28
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
of a difference in the qualifying
drug that would require prior
approval under 506A within 120
days of its submission. If the
review would require an
inspection by the Secretary of
iki/CRS-RL33175the manufacturing
g/westablishment, such inspection
s.orshall be authorized. The
leakSecretary may rely on a
://wikisatisfactory report from a
httppermitted country of a good
manufacturing practice (GMP)
inspection of the establishment if
the Secretary recognizes such
inspections as equivalent under a
mutual recognition agreement as
provided under Section
510(i)(3), Section 803, or 21
CFR 26.
804(g)(2)(B)(vii). Through
FDA’s Internet website and a
toll-free telephone number, the
Secretary shall readily make
available to the public a list of
notices submitted, dates of



CRS-29
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
submissions, and the status of
the Secretary’s review, including
determinations of whether the
import was allowed in. The
Secretary shall promptly update
the Internet website with any
iki/CRS-RL33175changes to the list.
g/w
s.or804(g)(2)(C). Notice; Drug
leakdifference requiring prior
://wikiapproval. If the notice regardingan imported drug shows that the
httpdifference, if made to a U.S.
label drug, would require the
approval of a supplemental
application to FDA, the
Secretary must notify registered
exporters, registered importers,
the Federal Trade Commission
(FTC), and the state attorneys
general that the notice has been
submitted.
If, by the date on which the drug
involved is to be introduced for
commercial distribution in a



CRS-30
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
permitted country, the Secretary
has not made a determination
whether such a supplemental
application would be approved,
the Secretary must order that the
importation of the involved drug
iki/CRS-RL33175not begin until the Secretary
g/wcompletes review of the notice.
s.orThe Secretary must also
leakpromptly notify registered
://wikiexporters, registered importers,
httpthe FTC, and the state attorneys
general.
If the Secretary decides that such
a supplemental application
regarding the U.S. label drug
would not be approved, the
Secretary shall stop its
importation or continue the
earlier order, if any, to hold until
the review had been completed;
notify the permitted country that
approved the drug for
commercial distribution of the
determination; and promptly



CRS-31
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
notify registered exporters,
registered importers, the FTC,
and the state attorneys general of
the determination.
If the Secretary determines that
iki/CRS-RL33175the supplemental application
g/wregarding the U.S. label drug
s.orwould be approved, the
leakSecretary must vacate the hold
://wikiorder, if any, that had been
httpplaced on the import pending
completion of the review;
consider the difference to be a
variation provided for in the
approved application for the
U.S. label drug; permit
importation of the drug; and
promptly notify registered
exporters, registered importers,
the FTC, and the state attorneys
general of the determination.
804(g)(2)(D). Notice; Drug
difference not requiring prior
approval. If, under Section



CRS-32
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
506(A)(3)(B), the difference
described in the notice would
not require prior approval before
it could be made to the U.S.
label drug, the following shall
occur: During the period in
iki/CRS-RL33175which the notice is being
g/wreviewed by the Secretary, the
s.orauthority under this subsection
leakto import the drug involved
://wikicontinues in effect.
http
If the Secretary determines that
such a supplemental application
regarding the U.S. label drug
would not be approved, the
Secretary shall order that the
importation of the drug involved
from the permitted country
cease; notify the permitted
country that approved the drug
for commercial distribution of
the determination; and promptly
notify registered exporters,
registered importers, the FTC,
and the state attorneys general of



CRS-33
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
the determination.
If the Secretary decides that a
supplemental application
concerning the U.S. label drug
would be approved, the
iki/CRS-RL33175difference shall be considered a
g/wvariation provided for in the
s.orapproved application for the
leakU.S. label drug.
://wiki804(g)(2)(E). Notice; Drug
httpdifference not requiring
approval; No difference. If the
difference between the U.S.
label drug and the drug to be
commercially distributed in a
permitted country would not
require a supplemental
application for the U.S. label
drug under Section
506(A)(d)(1)(A), or if the notice
states that there is no difference,
the Secretary shall consider such
difference to be a variation
provided for in the approved



CRS-34
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
application for the U.S. label
drug, may not stop the
importation, and must promptly
notify registered exporters and
importers.
iki/CRS-RL33175804(g)(2)(F). Differences in
g/wactive ingredient, route of
s.oradministration, dosage form, or
leakstrength. A manufacturer of a
://wikidrug approved under Section505(b) [new drug approval] must
httpsubmit an application under that
section of the FFDCA for
approval of a drug that it
manufactures for distribution in
a permitted country if: “there is
no qualifying drug in
commercial distribution in
permitted countries whose
combined population represents
at least 50 percent of the total
population of all permitted
countries with the same active
ingredient or ingredients, route
of administration, dosage form,



CRS-35
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
and strength as the drug
approved under Section 505(b)”;
and “each active ingredient of
the other drug is related to an
active ingredient of the drug
approved under section
iki/CRS-RL33175505(b)....” [For purposes of this
g/wparagraph, active ingredients are
s.orrelated if they are “the same; or
leakdifferent salts, esters, or
://wikicomplexes of the same moiety.”]
http
The application under Section
505(b) must request approval of
the drug for the indication(s) for
which the U.S. label drug is
approved and include the
information [with a verified
English translation, if necessary]
that the manufacturer submitted
to the government of the
permitted country for purposes
of obtaining approval for that
drug’s commercial distribution;
include a right of reference to
the application under Section

505(b) for the U.S. label drug;



CRS-36
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
and include such additional
information as the Secretary may
require. This application shall
be submitted to the Secretary not
later than the day on which the
previous information is
iki/CRS-RL33175submitted to the government of
g/wthe permitted country. The
s.orSecretary shall promptly notify
leakregistered exporters and
://wikiimporters, the FTC, and the state
httpattorneys general of a
determination to approve or to
disapprove an application.

804(e). Testing. The importer804(e). Testing. The importerNo provision.No provision.


or the manufacturer must(not the manufacturer) must
conduct the requiredconduct the testing of
authenticity testing at aqualifying drugs unless the drug
qualified laboratory. If theis subject to the counterfeit-
importer conducts these tests,resistant technologies
the manufacturer must give therequirement. (Mention is not
importing pharmacist ormade to a qualified laboratory.
wholesaler the informationNor is mention made here to
needed to authenticate themanufacturer’s labeling or
product and confirm itsprotecting trade secrets and
labeling. Also, testinginformation.)

CRS-37
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
information must be kept in
confidence and used only for
testing or to otherwise comply
with this act. The Secretary
may adopt rules to protect
trade secrets and commercial
iki/CRS-RL33175or financial information that is
g/wprivileged or confidential.
s.or
leakNo provision.804(f)(5). Registration of[Section 13] Authority to804(d)(1). Inspection of
://wikictionsexporters; Inspection ofimporters and registeredcommission other federal andstate officials to conductfacilities. To assist the Secretaryto determine exporter
httpexporters. The Secretary shallinspections. Amends thecompliance with all required
inspect warehouses, otherFFDCA to permit the Secretaryconditions, the exporter must
facilities, and records ofto sign a memorandum ofagree to permit the Secretary: to
importers and registeredunderstanding with anotherconduct on-site inspections
exporters as often as thefederal agency or a state for its(including monitoring on a day-
Secretary determines necessaryemployees to conductto-day basis) of facilities that are
to ensure compliance.examinations and investigationsexporter owned, controlled or
for the purposes of enforcingoperated that relate to qualifying
compliance with this act. Thedrugs; to have day-to-day access
memorandum is to includeto records, including financial
provisions for ensuringrecords, and drug samples; to
adequate training andverify the chain of custody of a
reimbursement. Reporting tostatistically significant sample of
the Senate HELP Committeequalifying drugs, monitor
and the House Committee onmarkings, and sample the



CRS-38
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
Energy and Commerce isexported drugs to assure
required on the joint activities.compliance; and to carry out
The Secretary may contractother functions that the Secretary
with a state to use State Boarddetermines necessary regarding
of Pharmacy personnel tocompliance. The Secretary is to
conduct examinations andassign (on a continuous basis)
iki/CRS-RL33175inspections required by this act.one or more employees to
g/wAgreements with a state areperform these functions
s.oreffective only in that state andrandomly, but at least 12 times a
leakfor facilities located in thatyear at the exporter’s places of
://wikistate, and agreements arebusiness.
httpeffective only at facilities that
are jointly regulated by the
Secretary and the other agency.
ecords of804(d)(1). Information and804(d)(1). Information and[Section 15(a)]804(d)(3). Certain duties
n ofrecords. Drug importers mustrecords. Eliminates section ofAnticounterfeiting provisions;relating to exporters. The
provide information thatthe law referring to a drugRequired records. AmendsSecretary shall: randomly
includes the name and amountbeing imported directly fromSection 503(e) of the FFDCAinspect at least 12 times annually
of the active ingredient of thethe first foreign recipient;by requiring the wholesalean exporter’s places of business
drug; the dosage form of thecorrespondingly renames thedistributor of record, for eachwhere qualifying drugs are
drug; the date the drug islist items; and deletesdistribution, to provide to thestored and from where they are
shipped; the quantity shipped;requirement that importerrecipient the identity of theshipped; and verify the chain of
information about its originprovide the Secretary with itsimmediately previouscustody of a statistically
and destination; the price paidprofessional license number.distributor of record fromsignificant sample of qualifying
by the importer; the originalwhich the prescription drug wasdrugs from the manufacturing
source of the drug; the amountpurchased; and, for eachestablishment, which may be



CRS-39
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
of each lot received from thatwholesale distribution of anaccomplished or supplemented
source; the manufacturer’s lotimported drug, to provide theby the use of anti-counterfeiting
or control number; and thepurchaser with identifyingor track-and-trace technologies,
importer’s name, address, andinformation, such as dates andtaking into account the economic
license number.the names and addresses of alland technical feasibility of these
parties to each transaction.technologies, except that no drug
iki/CRS-RL33175For a prescription drugRequires the distributor to keepshall be excluded if it lacks the
g/wimported directly from the firstthe records available for twotechnologies.
s.orforeign recipient from theyears for Secretarial inspection,
leakmanufacturer, there must beincluding the immediatelyIf exports are made to
://wikidocumentation indicating thatprevious and subsequentindividuals for personal use, the
httpthe drug came directly fromdistributors of all distributions,Secretary is directed to randomly
the manufacturer and wasand, for imports, each previousreview records of those exports
subsequently shipped by thatand subsequent distributor, toto determine whether the
recipient to the importer; thatthe extent feasible.conditions required for
the amount being imported isindividual imports are being
not greater than the quantity[Section 9] Adds to themet. That review process must
that was originally received;FFDCA a new Section 815,allow a statistically significant
and verification that eachMaintenance and Inspection ofdetermination of compliance.
batch of the drug has beenRecords for PrescriptionThe Secretary is directed to
statistically sampled and testedDrugs. Authorizes themonitor the required markings of
for authenticity andSecretary to establish, byexports. The inspectors shall
degradation prior toregulation, requirementsinspect, as the Secretary
importation. Samples ofrelating to the establishmentdetermines is necessary, the
subsequent shipments of theseand maintenance, for not longerwarehouses and other facilities
drugs must also be tested forthan two years, of records by: aof other parties in the chain of
authenticity and degradation.drug importation facility,custody of qualifying drugs, and



CRS-40
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
For a prescription drug notpharmacy, Internet pharmacy,determine whether the exporter
imported directly from the firstor wholesaler engaged in theis in compliance with all other
recipient in the foreignimportation of prescriptionregistration conditions.


country, there must bedrugs into the United States, or
documentation demonstratingin the dispensing of such drugs;
that each batch in eachand any person that processes,
iki/CRS-RL33175shipment of the drug has beenpackages, distributes, receives,
g/wstatistically sampled and testedholds, or transports a
s.orfor authenticity andprescription drug imported
leakdegradation prior tounder this subchapter. If the
://wikiimportation.Secretary has reason to believe
httpthat an imported prescription
Also, the importer ordrug presents a risk to the
manufacturer must certify thatpublic health, requires that the
the drug is FDA-approved,drug importation facility,
properly labeled, notpharmacy, Internet pharmacy,
adulterated, and notor wholesaler that imports the
misbranded; and provideprescription drug, and each
laboratory records ofperson that processes, packages,
authenticity testing, includingdistributes, receives, holds, or
data, and evidence that testingtransports the prescription drug
was conducted in an approvedpermit the Secretary’s officer or
U.S. laboratory. The importeremployee, with appropriate
is required to provide anycredentials and a written notice,
other information that theat reasonable times, within
Secretary determines isreasonable limits and in a
necessary to ensure the publicreasonable manner, to have

CRS-41
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
health.access to and copy all records,
in any format, at any location,
needed to determine whether
the prescription drug presents a
risk to the public health.
Requires the Secretary to
iki/CRS-RL33175prevent the unauthorized
g/wdisclosure of any trade secret,
s.orconfidential, or privileged
leakinformation. The Secretary’s
://wikirequirements do not apply to
httppersonal-use imports.
804(d)(6). Certain duties
relating to importers. The
Secretary shall randomly inspect
at least 12 times annually an
importer’s places of business
where the qualifying drugs are
initially received after
importation. During these
inspections, the Secretary shall:
(1) verify the chain of custody of
a statistically significant sample
of qualifying drugs from the
establishment in which the drug
was manufactured to the



CRS-42
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
importer, which shall be
accomplished by the use of
anticounterfeiting or
track-and-trace technologies,
taking into account the economic
and technical feasibility of those
iki/CRS-RL33175technologies, except a drug that
g/wlacks these technologies from
s.orthe point of manufacture shall
leaknot be excluded from
://wikiimportation by an importer; (2)
httpreview prior notices of
shipments and inspect, if
necessary, the warehouses and
other facilities, including
records, of other parties in the
chain of custody of qualifying
drugs; and (3) determine
whether the importer is in
compliance with all other
registration conditions.
503(e)(1)(A) requires that[Section 7(a)] Wholesale
anyone engaged in thedistribution of drugs: Statements
wholesale distribution of aregarding prior sale, purchase,
drug and who is not theor trade; Striking of exemptions;
manufacturer or an authorizedApplicability to registered



CRS-43
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
distributor of record of suchexporters. Amends FFDCA
drug must, before eachSection 503(e) to include an
wholesale distribution of suchauthorized distributor of record
drug, provide to the personalong with all wholesale
who receives the drug adistributors to retail pharmacies
statement identifying eachto provide to the person who
iki/CRS-RL33175prior sale, purchase, or trade ofreceives the drug a statement
g/wsuch drug (including the dateidentifying each prior sale,
s.orof the transaction and thepurchase, or trade of such drugs.
leaknames and addresses of allAlso, requires the Secretary by
://wikiparties to the transaction).regulation to establish
httpalternative requirements to
identify the chain of custody
through all transactions, which
could include standardized
anticounterfeiting or track-and-
trace technologies that would
identify chain-of-custody or the
identity of the discrete package
of the drug at least as well as the
statements required by current
law, and be economically and
technically feasible.
[Section 7(b)] Amends FFDCA
Section 503(c) to require that
each manufacturer of a



CRS-44
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
prescription drug maintain a list
of authorized distributors of
record, defining “authorized
distributors of record” to mean
those with whom a manufacturer
has established an ongoing
iki/CRS-RL33175relationship to distribute such
g/wmanufacturer’s products.
s.or
leak[Section 7(c)] Provides effective
://wikidates, including a distinction for
httpdrugs at high risk of being
counterfeited.
804(d)(2). Maintenance by theImporters of drugs are to804(j). Maintenance of records
Secretary. Records regardingmaintain records for two years.and samples. Both importers
an imported prescription drugand exporters must maintain
must be provided to therecords and samples of each lot
Secretary, and then kept forof a drug required under this
such time as the Secretarysection for not less than two
determines to be appropriate.years. The importer shall keep
the records at the place of
business at which the importer
initially received the drug after
importation. The exporter shall
keep the records at the facility
from which the exporter ships



CRS-45
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
the qualifying drug to the United
States.
gistration804(f). Registration of foreign804(f). Registration of[Section 8] Registration of804(b)(1). Registration of
porterssellers. Requires anyexporters; Inspections. Toprescription drug importationimporters and exporters. To
Canadian establishmentregister, an exporter mustfacilities. Adds to the FFDCAregister, the importer or the
iki/CRS-RL33175engaged in the distribution of asubmit to the Secretary thea new Section 814, Registrationexporter (referred to as the
g/wprescription drug imported orname and addresses of everyof certain importers, to requireregistrant) must submit to the
s.oroffered for importation into theplace of business of thea drug importation facility,Secretary:
leakUnited States to register itsexporter that relates topharmacy, Internet pharmacy,
://wikiname and place of businesswith the Secretary. Alsoqualifying drugs, includingeach warehouse or other facilityor wholesaler engaged in theimportation or offering forfor exporters, the name andidentification of all places of
httprequires that the Canadianowned or controlled by, orimportation of prescriptionbusiness of the registrant,
establishment register theoperated for, the registrant.drugs into the United States, orincluding each warehouse or
name of its U.S. agent.in the dispensing of such drugs,other facility owned or
to register with the Secretary.controlled by, or operated for,
the exporter; and
To register, the person must
submit:for importers, the name and
identification of up to three
[814(b)(1)(A)] the name andplaces of business (more with
address of each drugpermission of the Secretary) at
importation facility, pharmacy,which the importer initially
Internet pharmacy, orreceives the qualifying drug after
wholesaler at which, and allimportation.


trade names under which, the
registrant conducts business;

CRS-46
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
[814(b)(1)(B)] the name of each
prescription drug to be
imported into the United States;
[814(b)(1)(C)] the name and
address of an agent for service
iki/CRS-RL33175of process in the United States;
g/w and
s.or
leak[814(b)(2)] timely notification
://wikiof any change in the
http information.
The registrant agrees: toSuch information as is necessary
make its places of businessto demonstrate that the importer
and records available to theis in compliance with
Secretary for onsiteregistration conditions relating
inspections, without priorto the sources of exported drugs;
notice, for the purpose ofthe inspection of facilities of the
determining whether theimporter; the payment of fees;
registrant is in compliancecompliance with the standards
with this act’s requirements;referred to in Section 801(a); and
maintenance of records and
samples. Such information is
necessary to demonstrate that the
exporter is in compliance with
registration conditions relating



CRS-47
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
to the sources of exported drugs;
the inspection of facilities of the
exporter and the marking of
compliant shipments; the
payment of fees; compliance
with Section 801(a) standards;
iki/CRS-RL33175being licensed as a pharmacist;
g/wconditions for individual
s.orimportation from Canada; and
leakmaintenance of records and
://wiki samples.
httpto export only qualifyingThe importer or the exporter
drugs;must agree not to import or
export any nonqualifying drug.
to export only to personsThe exporter must agree not to
authorized to import theexport a qualifying drug to
drugs;anyone who is not a registered
importer or an individual
importing the drug for personal
use or the use of a family
member.
to notify the Secretary of aThe registrant must agree: to
recall or withdrawal of anotify the Secretary of a recall or
qualifying drug in a permittedwithdrawal of a drug distributed
country to or from which thein a permitted country that the



CRS-48
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
drug will be imported orregistrant has or intends to
exported;export or import; provide for the
return to the registrant of such a
drug; and cease or not begin the
exportation or importation of
such a drug unless the Secretary
iki/CRS-RL33175has notified the registrant that
g/wimports may proceed.
s.or
leakto monitor compliance withThe registrant agrees to ensure
://wikiconditions of registration andreport any noncomplianceand monitor compliance witheach registration condition, to
httppromptly;promptly correct any
noncompliance, to promptly
report to the Secretary any such
noncompliance;
to submit a compliance planand to submit a plan as to how
showing how the registrantthe registrant will comply with
will correct violations, if any;this compliance agreement.
and to notify the SecretaryThe registrant must agree to
promptly of any changes inupdate any information provided
the registration information.in the registration or in the
compliance plan; to notify the
Secretary not more than 30 days
before the registrant acts to make
a change;



CRS-49
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
and to post a bond payable to the
Treasury of the United States if,
after opportunity for an informal
hearing, the Secretary decides
that the exporter has exported a
drug to the United States that is
iki/CRS-RL33175not a qualifying drug or that is
g/wnot in compliance with
s.orsubsection (g). The bond
leakamount is the lesser of the value
://wikiof drugs exported by the
httpexporter to the United States in a
typical four-week period over
the course of a year under this
section, or $1,000,000.
The Secretary may require other
conditions for registration that
would protect the public health
while permitting imports of
qualifying drugs by pharmacies,
groups of pharmacies,
wholesalers as registered
importers, and individuals.
The registrant must agree to
enforce a contract under



CRS-50
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
subsection (c)(3)(B) (records of
chain of custody of a drug)
against a party in the chain of
custody of a qualifying drug and
under the authority of the
Secretary to permit the Secretary
iki/CRS-RL33175to inspect chain-of-custody
g/wstatements to determine their
s.oraccuracy and agree to facility
leakand record inspections.
://wikiThe exporter agrees to comply
httpwith applicable provisions of
Canadian law or the laws of the
permitted countries that protect
the privacy of personal
information of each person
importing from that exporter.
804(b)(1)(I) and (J). The
exporter and importer agree to
report to the Secretary not later
than August 1 of each fiscal
year, the total price and volume
of drugs exported/imported by
the exporter/importer during
January through June of that



CRS-51
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
year; and not later than January
1 of each fiscal year the total
price and volume of drugs
exported/imported the previous
fiscal year.
iki/CRS-RL33175ary’sNo provision.804(f)(2). Notice of approval814(b)(3). Requires the804(b)(2). Approval or
g/wor disapproval. Within 90Secretary, not later than 60 daysdisapproval of registration. The
s.ordays after receiving aafter receipt of a completedSecretary must approve or
leakistrationcomplete registration, theregistration, to assign adisapprove a registration within
://wikiSecretary must notify theregistrant of the receipt of theregistration number to eachregistered drug importation90 days of its submission andnotify the registrant. If the
httpregistration, assign afacility, pharmacy, Internetregistration is disapproved, the
registration number to thepharmacy, and wholesaler, andSecretary must notify the
registrant, and approve ornotify the registrant of theregistrant as to why. After a
disapprove the application.receipt of the registration.registration has been denied, if
The Secretary can disapproveand when the registrant is in
a registration if the registrant814(c). Requires that thecompliance, the Secretary must
is not in compliance with aSecretary provide for andnotify the registrant. Within 30
registration condition, andrequire electronic filing ofdays of receiving a registrant’s
may reverse the decision if heregistrations, with adequatecompliance plan, described
or she later finds that theauthentication protocols toabove, the Secretary must decide
registrant does comply.allow identification of theif the change affects the
registrant and validation of theregistrant’s registration approval

804(f)(3). List. The Secretarydata.and inform the registrant.


shall maintain and update
promptly a list of registeredRequires that the Secretary804(b)(3). Publication of



CRS-52
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
exporters, includingkeep an up-to-date list ofcontact information for
qualifying Internetregistrants and make itregistered exporters. The
pharmacies, and make the listavailable to the public on anSecretary shall post publicly on
available to the public on theInternet website and through athe FDA website and via a toll-
FDA’s website and via a toll-toll-free telephone number.free telephone number a list of
free telephone number.registered exporters, including
iki/CRS-RL33175the exporters’ contact
g/w804(f)(4). Education ofinformation, and update this
s.orconsumers. The Secretaryinformation promptly.
leakshall carry out activities
://wiki(through the website and toll-[Section 4(g)] Consumer
httpfree telephone number) thateducation. The Secretary must
educate consumers about theact to educate consumers
availability of qualifyingregarding the availability of
drugs for import for personalqualifying drugs for import for
use, including how to verifypersonal use from a registered
whether an exporter isexporter, including information
registered.on how to verify whether an
exporter is registered and
approved by use of the FDA
website and toll-free telephone
number. The Secretary must
educate consumers that the
United States Customs Service
(and Border Protection) may
seize and destroy drugs



CRS-53
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
otherwise imported, and that
drugs from unregistered
exporters may be counterfeit,
unapproved, unsafe, or
ineffective. The Secretary must
also educate consumers about
iki/CRS-RL33175the availability of qualifying
g/wdrugs at registered domestic
s.orretail pharmacies.
leak
://wiki[Section 4(e)(2)] Review of
httpregistration by certain exporters.
In the review of registration
submissions, the Secretary must
set as a priority within the first
90 days after enactment
Canadian entities that are
significant exporters of
prescription drugs to individuals
in the United States as of the
date of enactment, allowing a

30-day (rather than a 90-day)


review period to approve or
disapprove a registration.
Whether the Canadian entity
exported drugs to U.S.



CRS-54
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
individuals on or before 90-days
post enactment shall not serve as
a basis for disapproving a
registration.
During the first year after
iki/CRS-RL33175enactment, the Secretary may
g/wlimit the number of registered
s.orexporters to not less than 50, if
leakthe Secretary gives priority to
://wikithose exporters with
httpdemonstrated ability to process a
high volume of shipments of
drugs to individuals in the
United States. During the
second year, the allowed limit is
not less than 100. After two
years, the Secretary may ask
Congress for authority to limit
the number of registered
exporters if the limitation is
necessary for the effective and
efficient enforcement of
requirements and the limitation
will not restrict the ability of
individuals to import



CRS-55
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
prescription drugs for personal
use from registered exporters.
[Section 4(e)(3)] Limits on
number of importers. During the
first year after enactment, the
iki/CRS-RL33175Secretary may limit the number
g/wof registered importers to not
s.orless than 100 (of which at least a
leaksignificant number shall be
://wikigroups of pharmacies, as
httpfeasible), giving priority to those
importers with demonstrated
ability to process a high volume
of shipments of drugs imported
into the United States. The
allowed limit for the second year
is not less than 200, giving
priority to importers with
demonstrated ability to process a
high volume of shipments of
drugs to individuals in the
United States. After three years,
the Secretary may ask Congress
for authority to limit the number
of registered importers if the



CRS-56
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
limitation is necessary for the
effective and efficient
enforcement of requirements,
and the limitation will not
restrict the ability of individuals
to purchase qualifying imported
iki/CRS-RL33175drugs or restrict the savings
g/wavailable to individuals from
s.orthose purchases.
leak
://wiki814(d)(1). Authority. Nothingin this section authorizes the
httpSecretary to require an
application, review, or licensing
process for a drug importation
facility, pharmacy, or
wholesaler.
814(d)(2). Importation by
individuals. This section does
not apply to a prescription drug
imported by an individual for
personal use or to a commercial
transaction conducted between
an Internet pharmacy and an
individual.



CRS-57
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
813(h). Jurisdiction. The
district courts of the United
States shall have jurisdiction in
an action brought by the United
States against a person
importing or offering for
iki/CRS-RL33175importation a prescription drug
g/win violation of the requirements
s.orof this section.
leak
://wiki[Section 8(c)] Amends Section
http801 by adding 801(t), Failure
to register. Prohibits delivery
of a prescription drug until the
drug importation facility,
pharmacy, Internet pharmacy,
or wholesaler is registered.
Requires that the drug be held
in a secure facility and not be
transferred; does not authorize
the delivery of the prescription
drug pursuant to the execution
of a bond while the prescription
drug is held under this
subsection.



CRS-58
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
censing asNo provision.No provision.No provision.804(h). Licensing as
pharmacist. A condition of
registration is that the exporter
agrees that a qualifying drug will
be exported to an individual only
if the Secretary has verified that
iki/CRS-RL33175the exporter is authorized under
g/wthe law of the permitted country
s.orin which the exporter is located
leakto dispense prescription drugs;
://wikiand the exporter employs
httpenough persons licensed under
the law of the permitted country
in which the exporter is located
to dispense safely prescription
drugs to individuals, and the
exporter assigns to those persons
responsibility for dispensing
such qualifying drugs to
individuals.

804(m). Authorization ofSame as current law.No provision.No provision.


appropriations. Authorizes to
be appropriated such sums as
are necessary to carry out this
section.

CRS-59
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
porter andNo provision.[No importer fee provision.][Section 14] Adds to the804(e). Importer fees.
porter feesFFDCA a new Section 740A,
[Section 5] Adds a new SectionFees relating to prescription804(e)(1-2). Registration fee
740A to the FFDCA, Feesdrug importation. Requiresand inspection fee. With its
relating to prescription drugthe Secretary to establish a userregistration submission, an
importation.fee program under which a drugimporter must pay the Secretary
iki/CRS-RL33175importation facility, pharmacy,a $10,000 fee. In addition, the
g/w740A(a-c). Requires theInternet pharmacy, orimporter must pay the Secretary
s.orSecretary to establish awholesaler registering with thea semiannual inspection fee not
leakregistration fee program. ForSecretary under Section 814later than October 1 and April 1
://wikithe fiscal year in which theshall be required to pay theof each fiscal year.
httpregistered exporter first submitsSecretary a fee beginning for
a registration under Section 804FY2005. Directs the Secretary804(e)(3)(A). Aggregate total of
(or resubmits a registration), theto determine the amountfees. The Secretary, in
registered exporter will pay aannually based on anticipatedconsultation with the Secretaries
fee of $10,000, payable whencosts of enforcing this act,of Homeland Security and the
the exporter submits thepublish the fee 60 days inTreasury and not later than 30
registration. In subsequentadvance of each fiscal year,days before the start of each
years, the fee shall be payablehold a public meeting, andfiscal year, shall establish an
on or before October 1 eachprovide time for publicaggregate total of fees to be
year and shall be paid only oncecomment. Directs the Secretarycollected for a fiscal year from
for each registered exporter.to use the collected fees,all importers that is sufficient,
The Secretary will determinewithout further appropriation,and no more than necessary, to
annually the amount of the feeto enforce the act. The fee shallpay the costs of administering
based on the anticipated costsbe payable annually and onlythis section with respect to
of enforcement of the importonce for each facility. From 30registered importers for a fiscal



CRS-60
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
program. The total aggregatedays after the due date, ayear. These are costs for
fee collected shall not exceedregistered facility may notinspecting the facilities of
1% of the total price of theimport a prescription drug untilimporters and others in the chain
drugs exported annually to theall fees are paid. Requires theof custody of the drug;
U.S. by registered exporters.Secretary, 60 days after the enddeveloping, implementing, and
An exporter’s fee shall be basedof FY2006 and annuallyoperating an electronic system
iki/CRS-RL33175on the Secretary’s reasonablethereafter, to submit a report tofor the submission and review of
g/westimate of the exporter’sthe Senate HELP Committeeprior notices of drug shipments;
s.orannual share of the volume ofand the House Committee onand inspecting shipments, as
leakdrugs exported.Energy and Commercenecessary, to determine whether
://wikidescribing implementation ofa shipment should be refused
http740A(d). Requires fees be usedthe user fee authority during theadmission.
only for: administering thisfiscal year and the use of the
section, including the costsfees by the Secretary.804(e)(3)(B). Amount of
associated with inspecting theinspection fee; Limitation. The
registered exporter facilities andaggregate total of fees collected
other entities in the chain offor a fiscal year shall not exceed
custody of a qualifying drug;1% of the total price of drugs
and developing, implementing,imported that year by registered
and maintaining a system toimporters under this section.
decide if the registered
exporters are complying with804(e)(3)(C). Total price of
the registration conditions anddrugs. To estimate the total
when shipments of qualifyingprice of qualifying drugs
drugs are offered for import.imported in the United States by
The fees shall also pay forregistered importers, the



CRS-61
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
inspecting shipments, whenSecretary shall add the total
necessary, to determine if anyprice of qualifying drugs
should be refused admission.imported by each registered
importer from January 1 to June

740A(e). The Secretary, 6030 of the previous fiscal year.


days prior to each fiscal yearBy March 1 of the following
iki/CRS-RL33175(beginning after Sept. 30,fiscal year, the Secretary shall
g/w2005), must establishcalculate the total by adding the
s.orregistration fees.totals as reported to the
leakSecretary. If the total price as
://wiki740A(f). If a fee is not paidcalculated is less than the
httpwithin 30 days after it is due,aggregate total of fees collected
the Secretary will not permitfor that fiscal year, the Secretary
the registered exporter to exportmust, on April 1, provide a pro-
to the United States or offerrata adjustment to each
drugs for exportation until allregistered importer of the
fees are paid.subsequent fiscal year.
740A(g). Reports. Within 60804(e)(3)(D). Individual
days of the start of the fiscalimporter fee. The fee to be paid
year, the Secretary must publishon October 1 and April 1 by an
the registration fees, hold aindividual importer must be
meeting where the public canproportional to a reasonable
comment on theestimate by the Secretary of the
recommendation, and provide asemiannual share of the importer

30-day period for writtenof the volume of drugs imported



CRS-62
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
comments. Within 60 daysby all U.S. importers.
after the end of the fiscal year
when fees are collected, the804(e)(4). Use of fees. Subject
Secretary shall submit to theto appropriations acts, the fees
Senate HELP Committee andcollected by the Secretary must
the House Energy andbe credited to the appropriations
iki/CRS-RL33175Commerce Committee a reportaccount for FDA’s salaries and
g/wthat describes how theexpenses until expended without
s.orregistration fee authority wasfiscal year limitation. The
leakimplemented and how the feesSecretary may, in consultation
://wikiwere used.with the Secretaries of
httpHomeland Security and the
Treasury, transfer some portion
of the fees to the appropriation
account for salaries and
expenses of the Bureau of
Customs and Border Protection
until expended. Fees collected
by the Secretary are available
only to the Secretary (and, if
transferred, to the Secretary of
Homeland Security) and are for
the sole purpose of paying the
costs of activities outlined in

804(e)(3)(A).



CRS-63
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
804(e)(5). Collection of fees. If
the fees are not paid within 30
days after they are due, the fee
shall be a claim of the U.S.
Government (subject to
subchapter II of Chapter 37,
iki/CRS-RL33175Title 31 USC).
g/w
s.or804(f). Exporter fees.
leakRequirements for exporters are
://wikisimilar to the requirements for
httpimporters, as above, except that
the aggregate total of exporter
fees must cover the costs of
inspecting facilities of registered
exporters and others in the chain
of custody, as necessary;
developing, implementing, and
operating a system to screen
marked shipments offered for
import into the United States to
indicate compliance with all
registration conditions; and
screening the markings and
inspecting, as necessary, to
determine if shipment should be



CRS-64
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
refused admission.
[Section 4(e)(9)] User fees. To
establish the aggregate total of
fees from exporters for FY2006,
directs the Secretary to estimate
iki/CRS-RL33175the total price of drugs imported
g/wby registered exporters that year
s.oras $1 billion. To establish the
leakaggregate total of fees from
://wikiimporters, directs the Secretary
httpto estimate the total price of
drugs imported by registered
importers as $1 billion for
FY2006 and $10 billion for
FY2007.
Directs the Secretary to allow for
reestimates and adjustments for
FY2007; and to prepare and
submit an annual report on the
implementation of the fee
authority and the use, by FDA,
of those fees.
Also directs the Secretary of



CRS-65
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
Homeland Security, in
consultation with the Secretary
of the Treasury, beginning in
FY2006, to prepare and submit a
report to Congress on the use of
the fees transferred to the Bureau
iki/CRS-RL33175of Customs and Border
g/w Protection.
s.or
leakingRequires that all imported[Section 6(a)] Counterfeit-[Section 3] Protection against804(d)(2). Marking of
://wikidrugs be FDA-approved andcarry the FDA-approvedresistant technology. Amendsthe FFDCA by adding a newadulterated prescription drugs. Amends Section 801(h) of thecompliant shipments. Theexporter must agree to mark
httpramslabeling.subsection 502(v), stating thatFFDCA [as added by P.L. 107-each shipping container of drugs
if a drug is subject to section188] to include prescriptionidentifying that the shipment is
503(b), it shall be deemed to bedrugs along with food, asin compliance with all
misbranded unless the drug’sfollows. Directs the Secretaryregistration conditions. The
packaging complies withto give high priority tomarkings shall be designed to
requirements of section 505Cimproving FDA informationprevent unauthorized affixation,
for counterfeit-resistantmanagement systems to allowand shall include anti-
technologies.the Secretary to better allocatecounterfeiting or track-and-trace
resources, detect the intentionaltechnologies, taking into account
[Section 6(b)] Amends theadulteration, and facilitate thethe economic and technical
FFDCA by establishing a newimportation of prescriptionfeasibility of those technologies.
Section 505C, Counterfeit-drugs. Also requires the
Resistant Technologies. TheSecretary to improve linkages804(d)(5). The importer must
Secretary must require that thewith other federal regulatorycomply with similar marking



CRS-66
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
packaging of all prescriptionagencies, states, and Indianrequirements, before wholesale
drugs (not just those beingtribes to ensure the safety ofdistribution, except the markings
imported) incorporate overtimported prescription drugs.or other technology shall not be
optically variable counterfeit-required on a drug that bears
resistant technologies (as[Section 15(b)]comparable, compatible
described in (b) according toAnticounterfeiting provisions;markings or technology from the
iki/CRS-RL33175standards in (c)) or technologiesElectronic track and tracemanufacturer of the drug.


g/wthat the Secretary determines totechnology. Directs the
s.orhave an equivalent function ofSecretary to require, no later
leaksecurity.than December 31, 2007, the
://wikiadoption and use of electronic
httpThe technologies employedtrack-and-trace technology for a
must provide visibleprescription drug at the case
identification of the productand pallet level that will
(without the need for readers,identify each sale, purchase, or
microscopes, lighting devices,trade of that case or pallet
or scanners); be similar to those(including the date of
used by the Bureau oftransmission and the names and
Engraving and Printing toaddresses of all parties to the
secure U.S. currency; be madetransaction).
and distributed in a secure
environment; and should[Section 15(c)]
integrate non-visible securityAnticounterfeiting provisions;
features with forensicDistributors of record.
capability.Amends Section 503(e) of the
FFDCA as follows. Defines

CRS-67
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
Manufacturers must incorporate“distributor of record” as a
the technologies into multipleperson that takes title to or
elements of the packaging forpossession of a drug from
prescription drugs (includingmanufacture; this includes a
blister packs, shrink wrap,person that manufactures,
package labels, package seals,processes, packs, distributes,
iki/CRS-RL33175bottles, and boxes). Also,receives, holds, imports, or
g/wshipping containers for drugsoffers for importation, and this
s.ormust have labels thatdoes not include a transporter.
leakincorporate technologies thatDefines “transporter” as the
://wikienable inspectors to verify theUnited States Postal Service,
httpauthenticity of the shipment.foreign government postal
The labels must have: chain-of-service, or a private carrier in
custody procedures accordingthe business of transporting
to contractual agreements forpackages. Defines “wholesale
the use and distribution ofdistribution” as the distribution
labels; audit methods; andof a drug to other than the
access to databases forconsumer or patient but not
government agencies to audit orincluding an intracompany sale
verify the use of the labels.or distribution by a transporter.
This section shall take effect

180 days after this act’s[Section 15(d)]


enactment.Anticounterfeiting programs.
Requires the Secretary to
establish a Counterfeit Alert
Network to notify health



CRS-68
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
professionals and the public of
counterfeit drugs; and to
develop, publish, and keep up-
to-date (quarterly) an Internet-
accessible reference document
to identify prescription drugs
iki/CRS-RL33175marketed in the United States,
g/wCanada, and other countries as
s.orthe Secretary permits. Directs
leakthe Secretary to develop and
://wikipublish a range of materials,
httpincluding those to help the
identification and reporting of
counterfeit drugs, practice
guidelines (in cooperation with
drug supply chain members) for
the sale and distribution of
drugs, and revised model rules
(in cooperation with the
National Association of Boards
of Pharmacy) for state licensure
of wholesalers.
beling804(h). Approved labeling.813(b)(3,4). Requires that the804(g)(3)(A). Labeling;
Requires a drug manufacturercontainer have a prominent andImportation by registered
to give the importer writtenconspicuous label with theimporter. To be considered as



CRS-69
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
authorization to use, at no cost,following items: the lotcomplying with FFDCA Section
the approved labeling for thenumber; the name, address, and502 and the labeling
prescription drug.phone number of the drugrequirements under the U.S.
importation facility; a statementlabel drug’s approved
that the drug was imported,application, a qualifying drug
naming the country from whichthat an importer imports or
iki/CRS-RL33175it came; and a unique identifier,offers for import must bear: the
g/windicating that the drug haslabeling approved for the U.S.
s.orbeen imported, based on thelabel drug by FDA according to
leaknational drug code of theFFDCA Section 505, without
://wikiprescription drug. Requiresregard to whether the copy bears
httpthat the drug comply with anythe trademark; the name and
other FFDCA requirements.location of the manufacturer; the
lot number assigned by the

813(c). Approved labeling.manufacturer; the name,


Requires that a druglocation, and registration number
importation facility demonstrateof the importer; and the National
to the Secretary that theDrug Code number that the
labeling of the prescription drugSecretary assigned to the
to be imported into the Unitedqualifying drug.
States complies with the
requirements of Sections 502The Secretary shall provide a
[adulteration] and 503copy of the label to the
[misbranding]. Requires thatregistered importer involved,
the Secretary approve or denyupon request of the importer.
the application within 60 daysThis labeling shall: (1) include



CRS-70
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
of receipt and notify thethe established name (as defined
applicant of the decision and, ifin Section 502(e)(3)) of each
the application is denied,active ingredient; (2) not include
provide the reason for thethe brand or proprietary name of
denial. Requires the Secretarythe U.S. label drug or its active
to maintain an up-to-date list ofingredient(s); (3) if required,
iki/CRS-RL33175application status.include a prominent advisory
g/wnotice that the qualifying drug is
s.or813(e). Prohibition ofsafe and effective but not
leakcommingling. Prohibits a drugbioequivalent to the U.S. label
://wikiimportation facility, pharmacy,drug; and (4) if the inactive
httpInternet pharmacy, oringredients are different from
wholesaler from comminglingthose in the U.S. label drug,
imported and not importedinclude a prominent notice that
prescription drugs. Requiresthe ingredients differ. A
that a pharmacy or Internetqualifying drug with different
pharmacy that dispenses ainactive ingredients must be
prescription drug importeddispensed with an advisory to
from Canada or a permittedpeople with allergies about this
country affix on each dispenseddifference and with a list of the
container of the drug the labelingredients of the qualifying
required by FDA, unless such adrug as would be required under
label is already affixed to theSection 502(e).
container.

804(g)(3)(B). Labeling;



CRS-71
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
Importation by individual. A
drug imported or offered for
import by a registered exporter
to an individual shall be
considered to be in compliance
with Section 502 and labeling
iki/CRS-RL33175requirements under the U.S.
g/wlabel drug’s approved
s.orapplication if the packaging and
leaklabeling comply with the
://wikiregulations promulgated under
httpSections 3 and 4 of the Poison
Prevention Packaging Act of
1970 and the labeling includes
directions for use by the
consumer; the lot number
assigned by the manufacturer;
the name and registration
number of the exporter; if
required, a prominent advisory
that the drug is safe and effective
but not bioequivalent to the U.S.
label drug; a prominent advisory
for persons with allergies if the
inactive ingredients differ from
those of the U.S. label drug, and



CRS-72
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
a list of the drug’s ingredients as
would be required under Section
502(e); and bear a copy of any
special labeling that would be
required by the Secretary had the
drug been dispensed by a
iki/CRS-RL33175pharmacist in the United States,
g/wwithout regard to whether the
s.orspecial labeling bears any
leaktrademark involved.
://wiki
httpThe Secretary shall provide to
the registered exporter involved
a copy of the special labeling,
the advisory, and the ingredient
list of the drug, upon request of
the exporter. The requested
labeling and ingredient list shall
include the established name for
each active ingredient and not
include the proprietary name of
the U.S. drug or any of its active
ingredients.
804(l). Drug labeling. When an
imported drug is dispensed by a



CRS-73
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
pharmacist to an individual, the
pharmacist must provide
packaging and labeling that
comply with all applicable
regulations promulgated under
Sections 3 and 4 of the Poison
iki/CRS-RL33175Prevention Packaging Act of
g/w1970 and include with any other
s.orlabeling to the individual the lot
leaknumber assigned by the
://wikimanufacturer, and the name and
httpregistration number of the
importer. If the inactive
ingredients differ from those of
the U.S. label drug, the
pharmacist must provide a
prominent advisory that persons
with allergies should check the
ingredients, and also provide a
list of the ingredients as would
be required under FFDCA
Section 502(e). If the Secretary
had determined that the
difference(s) in the qualifying
drug would have been treated as
a manufacturing change to the



CRS-74
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
U.S. label drug under FFDCA
Section 506A, the pharmacist
must provide a prominent
advisory that the drug is safe and
effective but not bioequivalent to
the U.S. label drug.


iki/CRS-RL33175
g/w
s.or
leak
://wiki
http

CRS-75
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
804(g). Suspension of804(g)(A). Suspension of[Section 6] Adds new Section804(b)(4). Suspension and
importations. At the time ofimportation. Authorizes the817, Suspension of importation.termination.
rmination ofdiscovering a pattern ofSecretary to suspend anAllows the Secretary to
counterfeit or violativeexporter’s registration, afterimmediately order the804(b)(4)(A). Suspension. The
products, the Secretary mustnotice and opportunity for asuspension of the importationSecretary may suspend a
ansuspend importation of thathearing, for failing to maintainof a particular prescription drugregistration if, after notice and
iki/CRS-RL33175rspecific prescription drug orcompliance with registrationor a particular dosage form by aopportunity for a hearing, the
g/wby that specific importer. Theconditions. No prior notice isdrug importation facility,exporter or importer fails to
s.orsuspension must stay in effectrequired if the Secretarypharmacy, Internet pharmacy,maintain substantial compliance
leakuntil the Secretary investigatesdetermines the exporter hasor wholesaler, or a country (butwith registration conditions. In
://wikiand determines whether theexported a non-qualifying drugnot an individual importing foraddition, the Secretary shall
httppublic is being adequatelyor exported a qualifying drug topersonal use or an individualsuspend immediately, without
protected from counterfeit andan individual in violation of thisengaged in an Internetprior notice, the registrant’s
violative drug products undersection. Allows the Secretarypharmacy transaction) if theregistration if the
existing importationto reinstate a suspendedSecretary determines it presentsexporter/importer has
regulations.registration if the Secretarya risk to the public health.exported/imported a non-
determines that the registeredAllows this action to bequalifying drug, not met the

804(k). Construction.exporter has demonstrated thatappealed; requires that therequirements relating to a U.S.


Nothing in this section limitsfurther violations of registrationSecretary, after providinglabel drug, or exported a drug to
the Secretary’s authorityconditions will not occur.opportunity for an informalan individual who did not meet
relating to the importation ofhearing, confirm or terminatethe conditions under law.
prescription drugs, other than804(g)(2)(B). Termination.the order within 30 days. An
with respect to SectionAfter notice and the opportunityorder under this section shallThe Secretary must give the
801(d)(1), which allows onlyfor a hearing, the Secretary maynot be subject to judicialexporter a hearing within 10
the manufacturer to import aterminate a registration if thereview.days of the suspension. If the
prescription drug.exporter has a pattern orSecretary determines that there



CRS-76
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
practice of violating one orIf the Secretary determines thatwould be no further violations,
more registration conditions, ora drug importation facility,the Secretary may reinstate the
if the exporter has had itspharmacy, Internet pharmacy,suspended registration.
registration suspended on oneor wholesaler, or a country (but
or more occasions. During thenot an individual importing for804(b)(4)(B). Termination.
period in which a registration ispersonal use or an individualSame as S. 109.
iki/CRS-RL33175terminated, any registration willengaged in an Internet
g/whave no legal effect if thepharmacy transaction) is804(b)(5). Default of bond.
s.orexporter or a partner orengaged in a pattern ofAfter opportunity for an
leakprincipal officer of theimportation that violates theinformal hearing, the exporter’s
://wikienterprise assisted in theact’s requirements, thebond shall be defaulted and paid
httppreparation of the registration.Secretary may immediatelyto the U.S. Treasury if the
order suspension of importationexporter: shipped a non-
of prescription drugs from thatqualifying drug or a drug not in
804(g). Suspension ofperson or country.compliance with FFDCA
importation. Rather thanSection 505(b) for the U.S. label
basing reinstatement on thedrug [new drug applications], or
Secretary’s determination thatAllows that this action beSection 501 [adulteration];
the public is adequatelyappealed; and requires therequired conditions for shipment
protected, the decision wouldSecretary, after providingto an individual; or failed to
be based on the Secretary’sopportunity for an informalpermit an inspection.


determination that the violationhearing, to confirm or terminate
has been corrected and that thethe order within 30 days. An
importer has demonstrated thatorder under this section shall
further violations will notnot be subject to judicial
occur. It also specifies that thisreview.

CRS-77
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
subsection does not apply to a813(i). Effect of section.
drug imported by an individualSimilar to current law. Nothing
or shipped to an individual by ain this section [Pharmacy and
qualifying Internet pharmacy.wholesaler importation of
prescription drugs] limits the
authority of the Secretary
iki/CRS-RL33175relating to the importation of
g/wprescription drugs (including
s.orthe interdiction of prescription
leakdrugs that are unapproved,
://wikiadulterated, or misbranded),
httpother than with respect to the
banning of anyone other than
the manufacturer from
importing a prescription drug
that had been supplied as a
charitable contribution.
eNo provision.No provision.[Section 10] Advance notice of804(d)(4). Prior notice of
imported prescription drugshipments. A condition of
shipments. Amends FFDCAregistration is that the importer
Section 801 to allow theof the prescription drug must
Secretary to inspect druggive the Secretary advance
imports at ports of entry. The(between 8 hours and five days)
person importing or offering fornotice of the name and contact
importation the prescriptionperson submitting the notice and



CRS-78
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
drug must give the Secretarythe importer; the established
advance (between 24 hours andname of the drug, its quantity,
five days) notice of: themanufacturer lot number, name
established name, dosage form,of manufacturer and production
and quantity of the prescriptionfacility; country from which
drug; the name of the shipper;drug will be shipped and
iki/CRS-RL33175the name of the country fromshipper’s contact information;
g/wwhich the prescription druganticipated arrival information
s.ororiginates; the country fromincluding port of arrival,
leakwhich it is shipped; the name ofcrossing location, and the date
://wikithe port of entry;and time; a summary of the
httpdocumentation of the originalchain of custody of the drug
source of the prescription drug;from the establishment where
the quantity of each lot of themanufactured to the importer;
prescription drug originallyand declaration whether the
received by the facility fromSecretary has ordered that
that source; the lot or controlimports cease from the permitted
number assigned to thecountry as a result of review or
prescription drug by thepending review of differences
manufacturer of the prescriptionfrom the U.S. label drug; and
drug; the name, address,other information that the
telephone number, andSecretary may require by
professional license number ofregulation.


the drug importation facility
located in Canada or a
permitted country; and

CRS-79
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
certification from the drug
importation facility located in a
foreign country or from the
manufacturer of the prescription
drug that the prescription drug
is approved for marketing in the
iki/CRS-RL33175United States and is not
g/wadulterated or misbranded and
s.ormeets all labeling requirements
leakunder this act. Failure to
://wikiprovide notice results in
httpholding of the drug at the point
of entry.
forcementFFDCA Section 301(aa)[Section 7] Prohibited acts.[Section 2(c)] Prohibited act.[Section 4(b)] Prohibited acts.
prohibits the importation of aAmends the FFDCA to insertAmends Section 301 of theAmends FFDCA by replacing
prescription drug in violationnew subsection 301(l), addingFFDCA by prohibiting theSection 301(aa) to prohibit the
of Section 804, thefailure to register in accordancedispensing or offering tosale or trade by a pharmacist, or
falsification of any recordwith Section 804(f) or to importdispense a prescription drugby a business organization of
required to be maintained oror offer to import a drug inimported into the United Stateswhich the pharmacist is a part, of
provided to the Secretaryviolation of a suspension orderin violation of the requirementsa qualifying drug that the
under such section, or anyunder Section 804(g) (relatingof the new Section 813 (relatingpharmacist imported unless the
other violation of regulationsto being suspended fromto pharmacy and wholesalerdrug sold at retail is dispensed to
under such section.importation).importation).a customer of the pharmacist or
organization or is sold or traded
to a pharmacy or wholesaler



CRS-80
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
registered to import drugs;
prohibit an individual who
imports a drug for personal use
from selling or trading that drug;
prohibit the making of false,
fictitious, or fraudulent
iki/CRS-RL33175statements in filing a notice or
g/wapplication regarding differences
s.orbetween the qualifying and the
leakU.S. label drug, or to fail to
://wikisubmit such notice; and prohibit
httpthe falsification of any record
required by the Secretary or any
registration conditions.
Amends FFDCA Section 303(a),
by requiring violators of
301(i)(2-3) or 301(aa)(4) to be
imprisoned not more than 10
years, fined, or both.
[Section 7] Debarment for
repeated or serious drug
importation violations.
Amends Section 306(b) of the
FFDCA to allow the Secretary



CRS-81
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
to debar a person (other than an
individual importing for
personal use or an individual
engaged in an Internet
pharmacy transaction) from
importing a prescription drug
iki/CRS-RL33175for up to five years if the person
g/whas been convicted of a felony
s.orfor conduct relating to the
leakimportation into the United
://wikiStates of any prescription drug;
httpor has engaged in a pattern of
importing or offering for import
a prescription drug that presents
a risk to the public health.
Allows the Secretary to
withdraw the debarment if the
conviction on which it was
based is reversed or if it serves
the interests of justice and
adequately protects the integrity
of the prescription drug
importation process.
Amends FFDCA by adding
Section 801(s), Importation of



CRS-82
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
prescription drugs by debarred
persons. Requires that a
prescription drug imported by a
debarred person be held at its
port of entry or moved to a
secure facility, if appropriate,
iki/CRS-RL33175and not otherwise be
g/wtransferred. While the
s.orprescription drug is held under
leaka bond, it may not be delivered.
://wikiWhile the drug is being held,
httpprohibits its transfer by any
person from the port of entry or
the secure facility where it is
held. Allows for the delivery of
a prescription drug to a non-
debarred person if that person
shows, at their own expense,
that the drug complies with
FFDCA requirements.
rning801(g). Prohibits the[Section 4(c)] Amendment of
icesSecretary from sending acertain provisions. Replaces
warning notice (i.e., aFFDCA Section 801(g).
communication from theRequires that, if a drug is
Secretary notifying or clearlyimported or offered for import



CRS-83
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
suggesting to a person thatby an individual not in the
importing the drug forbusiness of such importation, not
personal use is or appears to beshipped by a registered exporter,
a violation of this act) to anand refused admission, the
individual not in the businessSecretary notify the individual
of importation with respect tothat the drug was refused
iki/CRS-RL33175a drug being imported oradmission because it was not a
g/woffered for import into thelawful import and is not
s.orUnited States unless theotherwise subject to a waiver;
leakimport is or appears to be: inand that the individual may
://wikiviolation of Section 801(a)lawfully import from a
http[Imports and Exports] if theregistered exporter and can find
drug is or appears to beinformation, including a list of
adulterated, misbranded, or inregistered exporters, on the
violation of FFDCA SectionFDA’s website or toll-free

505 [New Drugs]; forbidden ortelephone number.


restricted in sale in the country
in which it was produced and
from which it was exported; in
violation of Section 801(d)(1)
[regarding insulin]; or
otherwise in violation of
federal law. The notice must
state the reasons underlying
the determination made by the
Secretary, including a brief

CRS-84
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
application of the principal
facts involved in the provision
of law that is the basis of the
determination.
[Section 9(a)] Adds subsection804(n)(1). Unfair and
iki/CRS-RL33175riminator804(l), Unfair ordiscriminatory acts and
g/ws anddiscriminatory acts andpractices. Makes it unlawful for
s.oricespractices, to make it unlawfula manufacturer, directly or
leakfor a manufacturer, directly orindirectly (including by being a
://wikiindirectly (including being aparty to a licensing or otherparty to a licensing or otheragreement) to:
httpagreement) to discriminate or
act unfairly against an exporter,discriminate against a registered
importer, or person whoexporter or other person in a
distributes, sells, or usespermitted country that exports a
prescription drugs imported toqualifying drug to the United
the United States under SectionStates, a registered importer or

804 by: charging a higher price;other person that distributes,


denying, restricting, or delayingsells, or uses a qualifying drug
supplies; or refusing to doimported into the United States
business. It is also unlawful toby charging a higher price;
cause there to be a differencedenying, restricting, or delaying
(including a difference in activesupplies; publicly, privately, or
ingredient, route ofotherwise refusing to do
administration, dosage form,business with a registered



CRS-85
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
strength, formulation,exporter, registered importer, or
manufacturing establishment,other person that distributes,
manufacturing process, orsells, or uses a qualifying
person that manufactures theimported drug;
drug) between the drug for
distribution in the United Statesto knowingly fail to submit
iki/CRS-RL33175and the prescription drug fornotices required by this act
g/wdistribution in a permittedregarding differences between
s.orcountry for the purpose ofthe qualifying drug and the U.S.
leakrestricting importation of thelabel drug; to fail to submit them
://wikidrug into the United States; toby required dates; or to
httprefuse to allow a requiredknowingly submit false
inspection or fail to conform tostatements to fail to provide
good manufacturing practice; orpromptly information the
to become a party to a licensingSecretary requests to review the
or other agreement that fails tonotice;
provide for compliance with all
requirements of this section, orto cause there to be a difference
that would have the effect of(including a difference in active
prohibiting the drug’singredient, route of
importation; or to engage in anyadministration, dosage form,
other action that the FTCstrength, formulation,
determines to discriminatemanufacturing establishment or
against a person that engagesprocess, or person that
in, or to impede, delay, or blockmanufactures the drug) between
the process for, the importationa drug for distribution in the US



CRS-86
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
of the drug under this section.and in the permitted country;
to refuse to allow authorized
inspection of an establishment
that manufactures the drug for
commercial distribution in a
iki/CRS-RL33175permitted country;
g/w
s.orto fail to conform to good
leakmanufacturing practice of
://wikimethods or facilities used for
httpmanufacturing, processing,
packing, or holding a drug to be
commercially distributed in a
permitted country;
to be a party to a licensing or
other agreement related to a
qualifying drug that fails to
provide for compliance with all
requirements of this section; to
enter into a contract that
restricts, prohibits, or delays the
importation of a qualifying drug;
to engage in any other action to
restrict, prohibit, or delay the



CRS-87
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
importation of a qualifying drug;
or to engage in any other action
that the FTC determines to
discriminate against a person
that engages or attempts to
engage in the importation of a
iki/CRS-RL33175qualifying drug under this
g/w section.
s.or
leak[Section 9(a)] The new804(n)(2) addresses Affirmative
://wikisubsection 804(l)(2,3)addresses Affirmative defense,defense; Discrimination anddrug differences. Similar to S.
httpand Presumption and109 in that the presumption of
affirmative defense. An entityaffirmative defense is based on
charged with any of the unfairthe same language. But in
or discriminatory acts andaddition, the drug differences
practices listed in this sectioncan also be used as an
has a defense to these charges ifaffirmative defense if the person
its actions are based at least inmanufacturing the drug for U.S.
part on any reason other than adistribution has notified the
reason relating to the personSecretary that the drug for U.S.
exporting, importing,distribution is not different from
distributing, selling, or using ana drug for distribution in
imported drug. An affirmativepermitted countries whose
defense can also be based oncombined population represents
the presumption that theat least 50% of the total



CRS-88
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
difference in active ingredient,population of all permitted
route of administration, dosagecountries; or if the difference
form, strength, formulation,was not caused, in whole or in
manufacturing establishment,part, for the purpose of
manufacturing process, isrestricting importation of the
required by the country indrug into the United States.
iki/CRS-RL33175which the drug is distributed; or
g/wthe Secretary has determined
s.orthat the difference was
leaknecessary to improve the safety
://wikior effectiveness of the drug.
http804(l)(4)(A). Sales in other804(n)(3)(A). Sales in other
countries. Specifies that thecountries. Same as S. 109.
subsection applies only to the
sale or distribution of a
prescription drug in a country if
the manufacturer of the drug
chooses to sell or distribute the
drug in the country. Does not
compel the manufacturer of a
drug to distribute or sell the
drug in a country.
804(l)(4)(B). Discounts to804(n)(3)(B). Discounts to
insurers, health plans,insurers, health plans, pharmacy
pharmacy benefit managers,benefit managers, and covered



CRS-89
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
and covered entities. This actentities. Same as S. 109.
does not: (i) prevent or restrict
a drug manufacturer from
providing discounts to an
insurer, health plan, pharmacy
benefit manager in the U.S., or
iki/CRS-RL33175a covered entity in the drug
g/wdiscount program under drug
s.orpricing agreements authorized
leakin the Public Health Service
://wikiAct in return for inclusion of
httpthe drug on a formulary; (ii)
require that such discounts be
made available to other
prescription drug purchasers; or
(iii) prevent or restrict any other
measures taken by an insurer,
health plan, or pharmacy
benefit manager to encourage
consumption of a prescription
drug.
804(l)(5). Enforcement; Unfair804(n)(4). Same as S. 109. In
or discriminatory act oraddition to allowing the FTC to
practice; and Actions by theseek monetary relief threefold
commission. A violation of thisthe damages sustained, allows



CRS-90
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
new subsection shall be treatedany other remedy available to
as a violation of a rule definingthe FTC under the FTC Act.
an unfair or deceptive act or
practice prescribed under
Section 18(a)(1)(B) of the
Federal Trade Commission
iki/CRS-RL33175(FTC) Act. The FTC must
g/wenforce this section as if the
s.orsame terms and jurisdiction,
leakpowers and duties of the FTC
://wikiunder Section 18(a)(1)(B) were
httpincorporated into this section.
The FTC may seek threefold
damages as monetary relief.

804(l)(6). Unfair or804(n)(5-7). Actions by States.


discriminatory acts andSimilar to S. 109.


practices; Actions by states. A
state attorney general may bring
a civil action in an appropriate
U.S. district court to enjoin an
unfair or discriminatory act or
practice; enforce compliance;
obtain damages, restitution, or
other compensation on behalf
of residents and persons doing

CRS-91
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
business in the state, including
three-fold damages; or obtain
further relief as the court may
deem appropriate.
The state must provide a
iki/CRS-RL33175written prior notice to the FTC
g/wof the civil action and provide
s.orthe FTC with a copy of the
leakcomplaint except if it is not
://wikifeasible to provide prior notice,
httpthen the state can serve the
notice immediately upon
instituting such an action and
provide a notice and complaint
copy to the FTC at the same
time as the attorney general
files the action. Once it
receives the notice, the FTC has
the right to intervene, to be
heard on all matters, and to file
petitions for appeal. Nothing in
this chapter shall prevent a state
attorney general from
exercising the powers conferred
on the attorney general by the



CRS-92
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
laws of the state to conduct
investigations or administer
oaths or affirmations or to
compel witnesses to attend or to
produce documentary or other
evidence.
iki/CRS-RL33175
g/wA state may not institute an
s.oraction against the same
leakdefendant named in a complaint
://wikiinstituted by or on behalf of the
httpFTC for a violation during the
pendency. However, a state
attorney general may intervene
on behalf of the state’s
residents in an FTC action and,
if so, the attorney general must
be heard with respect to any
matter that arises in that action
and to file a petition for appeal.
All civil actions brought before
a U.S. district court may be
brought where venue is proper
under 28 USC §1391. The
process may be served in any



CRS-93
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
district in which the defendant
lives or may be found. Any
enforcement action taken by the
FTC or a state attorney general
will be forever barred unless it
begins within five years after
iki/CRS-RL33175the FTC or the state attorney
g/wgeneral knew that the cause of
s.oraction accrued. No barred
leakaction under the existing law on
://wikithe effective date of this act
httpshall be revived by this act.
If a defendant has been found to
have violated a provision,
damages may be assessed in the
aggregate by statistical or
sampling methods, by
computing illegal overcharges,
or by other systems of
estimating aggregate damages
as the court may deem
appropriate without separately
proving the individual claim of
or amount of damage to persons
on whose behalf the suit was



CRS-94
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
brought. The district court
must exclude from the
monetary award any monetary
relief that duplicates the
amounts already awarded for
the same injury.
iki/CRS-RL33175
g/w804(l)(6)(G). Limitation of
s.or actions.
leak
://wiki804(l)(7). Effect of antitrust
httplaws. Nothing in this new
subsection shall be construed to
modify, impair, or supercede
the operation of federal antitrust
laws.
[Section 9(b)] Regulations.
The FTC shall promulgate
regulations to carry out the
enforcement program under
new Section 804(1) of the
FFDCA.
[Section 6] Civil actions
regarding property. Amends
FFDCA Section 303 by adding



CRS-95
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
Section 303(g) that allows the
Attorney General to commence
civil action in any federal court
to stop a person from alienating
or disposing of property relating
to a drug imported in violation
iki/CRS-RL33175of Section 801(a or d), with
g/wproceedings in a manner as
s.orapplies under 18 USC 1345 and
leakto take effect 90 days after
://wiki enact m ent .
https refusedFFDCA Section 801 prohibits740A(d). In listing the allowed[Section 11] Authority to mark804(g)(5). Standards for
the importation of auses of collected fees, includesprescription drugs refusedrefusing admission. A drug
prescription drug by anyoneinspections necessary toadmission into the Unitedfrom a registered exporter may
other than its manufacturer.determine whether a shipmentStates. Further amends Sectionbe refused entry into the United
The Secretary works with theshould be refused admission.801 of the FFDCA (as amendedStates if one or more of the
Secretary of the Treasury toby Section 10(a) of this act) tofollowing applies: the drug is
refuse admission of all otherallow the Secretary to requirenot a qualifying drug; a notice
drugs. [Note: The U.S.the owner or consignee of thefor the drug has not been
Customs Service had been partdrug to label any prescriptionsubmitted to the Secretary; the
of the Dept. of the Treasurydrug refused admissionSecretary has ordered that
until Congress created the“UNITED STATES:imports of the drug from the
Dept. of Homeland Security,REFUSED ADMISSION” untilpermitted country cease because
which includes customsthe Secretary determines thatdifferences from the U.S. label
functions in its U.S. Customsthe prescription drug has beendrug would not have been



CRS-96
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
and Border Protectionbrought into compliance withapproved in a supplemental
component.]this act. The owner orapplication; the drug does not
consignee shall be responsiblecomply with the labeling
for all labeling expenses.requirements; the shipping
Amends Section 502 of thecontainer appears damaged in a
FFDCA so that if theway that could affect the
iki/CRS-RL33175prescription drug does not carrystrength, quality, or purity of the
g/wthe label after the Secretary hasdrug; the Secretary becomes
s.orinformed the owner, it shall beaware that the drug may be
leakconsidered misbranded. Thiscounterfeit, may have been
://wikidoes not apply to a personal-useprepared, packed, or held under
httpimport or a commercialinsanitary conditions, or the
transaction between an Internetmethods used in or the facilities
pharmacy and an individual.or controls used for the
This section does not limit themanufacturing processing,
authority of the HHS Secretarypacking, or holding do not
or the Secretary of the Treasuryconform to good manufacturing
to require the marking ofprocesses; the Secretary has
prescription drugs refusedobtained an injunction under
admission under any otherSection 302 prohibiting the
provision of law.drug’s distribution in interstate
commerce or has withdrawn the
approval of the drug under
Section 505(e); the manufacturer
has instituted a recall of the
drug; the drug is imported or



CRS-97
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
offered for import by a
registered importer without
submission of a prior notice of
shipment; or the drug is
imported or offered for import
from a registered exporter to an
iki/CRS-RL33175individual and the shipping
g/wcontainer does not bear the
s.orrequired markings, the
leakcontainer’s markings appear to
://wikibe counterfeit, or the shipping
httpcontainer or markings appear to
have been tampered with.
804(i)(2). Notice regarding
drug refused admission. If a
registered exporter ships a drug
to an individual and the drug is
refused admission to the United
States, a written notice shall be
sent to the individual and to the
exporter that informs them of the
refusal and the reason for the
refusal.
[Section 5(a)] Creates in the[Section 5] Disposition of



CRS-98
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
FFDCA a new Section 816,certain drugs denied admission
Administrative detention. Aninto United States. Adds a new
officer or qualified employee ofFFDCA Section 805.
the FDA may order the
detention of any prescription805(a-c). The Secretary of
drug that it believes to present aHomeland Security shall deliver
iki/CRS-RL33175risk to the public health. If theto the HHS Secretary a drug
g/wSecretary approves, requiresshipment (1) that has a declared
s.orthat the drug be detained for upvalue less than $10,000 and
leakto 30 days, labeled as detainedwhose shipping container does
://wikiand placed in a secure facility.not bear required markings [of
httpUntil the Secretary releases thecompliance], or (2) of which the
drug or the detention periodHHS Secretary has requested
expires, prohibits the transfer ofdelivery. The new section does
the drug from detention,not authorize delivery pursuant
including delivery pursuant toto a bond, nor may the drugs be
the execution of a bond.exported. The HHS Secretary
Allows the claimant to appealmust destroy these shipments if
the detention and the Secretarythe drugs violate any standard
must confirm within five daysdescribed in Sections 804(g)(5)
or the order will be terminated.[standards for refusing
admission], 801(a) [imports and
[Section 5(b)] Amends Sectionexports], or 801(d)(1)
801 of the FFDCA by adding a[prohibition of importation of an
paragraph (r), Temporary holdinsulin product by other than its
at port of entry. With approvalmanufacturer].



CRS-99
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
by the Secretary or a designated805(d-f). Sets out procedures to
official (director of the districtidentify and destroy a substantial
in which the drug is located, ormajority of violative shipments,
a senior official of the director),allowing for preservation of
directs an FDA officer orpotential evidence, while
qualified employee whoefficiently using federal
iki/CRS-RL33175believes there is a risk to publicresources.
g/whealth and was unable to
s.orinspect to request the Secretary[Section 5(b-c)] Requires that
leakof the Treasury to detain theprocedures to carry out Section
://wikiprescription drug for 24 hours805 be established not later than
httpto allow inspection. [Note:90 days after enactment at which
The U.S. Customs Service hadtime they would take effect.


been part of the Dept. of the
Treasury until Congress created
the Dept. of Homeland
Security, which includes
customs functions in its U.S.
Customs and Border Protection
component.] Directs FDA,
when detaining a drug, to notify
the state of the port of entry.
Prohibits the transfer of a
detained drug or its removal or
alteration of the detention label.
Prohibits delivery of the

CRS-100
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
prescription drug being held
pursuant to the execution of a
bond. This subsection does not
apply to a drug imported by an
individual for personal use or to
a commercial transaction
iki/CRS-RL33175between an Internet pharmacy
g/wand an individual.
s.or
leaksNo provision.No provision.813(f). Drug recalls. Requires804(k). Drug recalls. A
://wikiledthat a drug importation facilitypromptly provide the Secretarymanufacturer of a drug importedfrom a permitted country shall
httpand any person to whom thepromptly inform the Secretary if
prescription drug wasthe drug is recalled or withdrawn
distributed a notice that thefrom the market in a permitted
drug has been recalled orcountry; how the drug may be
withdrawn from the market.identified, including lot number;
Requires that the notificationand the reason for the recall or
include identifying informationwithdrawal.
(including the lot number) and
the reason for the recall orThe Secretary shall enter into an
withdrawal.agreement with the government
of each permitted country to
receive information about recalls
and withdrawals of qualifying
prescription drugs in the



CRS-101
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
country; or monitor recalls and
withdrawals of prescription
drugs in permitted countries
using any information that is
available to the public.
iki/CRS-RL33175The Secretary may notify
g/wregistered exporters, registered
s.orimporters, wholesalers,
leakpharmacies, or the public of a
://wikirecall or withdrawal of a
httpqualified drug in a permitted
country.

804(j). Waiver authority for[Section 4(h)] Amends FFDCA812. Personal importation.804(i)(1). Individuals;


importation by individuals.Section 804(j), WaiverAllows an individual to importConditions for importation. An
804(j)(1). Declaration.authority for individuals.a prescription drug fromindividual may import a
Congress declares that theWithin 180 days of enactment,Canada or a permitted countryqualifying drug if: the drug is
Secretary should use discretionthe Secretary shall byinto the United States foraccompanied by a copy of a
when enforcing the currentregulation permit an individualpersonal use (not for resale) if:prescription that is valid under
legal prohibition againstto import a drug from athe prescription drug isfederal and state laws and was
persons importing drugs orpermitted country if it is apurchased from a licensedissued by a practitioner who,
devices. The Secretary shouldqualifying drug; imported frompharmacy in Canada or aunder the state law of which the
focus enforcement on casesa licensed pharmacy orpermitted country andindividual resides or receives
where the importing may posequalifying Internet pharmacy;dispensed in compliance withcare from the practitioner, is
a significant threat to publicfor personal use by anthat country’s applicable laws;authorized to administer



CRS-102
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
health. When the importationindividual or family memberit is imported for personal useprescription drugs; the drug is
is clearly for personal use andand not for resale; does not(not for resale) by theaccompanied by documentation
the prescription drug or deviceexceed a 90-day supply duringindividual; it is importedrequired by the permitted
does not appear to present anany 90-day period; and has withphysically by the individual; itcountry in which the exporter is
unreasonable risk to theit a copy of a prescription, validdoes not exceed a 90-daylocated to dispense the drug to
individual, the Secretaryunder state and federal laws,supply during any 90-daythe individual; copies of the U.S.
iki/CRS-RL33175should exercise discretion tothat was issued by a practitionerperiod; and the prescriptionprescription and the permitted
g/wpermit the importation by theauthorized to administerdrug is accompanied by a copycountry’s documentation must
s.orindividual.prescription drugs.of a prescription valid in a statebe marked to indicate the
leakand cosigned by a prescribingprescription has been filled and
://wiki804(j)(3). The Secretary isAn individual may import aphysician in Canada or theto prevent duplicative filling by
httprequired to grant waivers, bydrug from a non-permittedpermitted country or, if theanother pharmacist; the
regulation, so persons cancountry if the individual whileprescription drug is available inindividual must have given the
import for personal use up to atraveling in the countryCanada or the permittedregistered exporter a complete
90-day supply of an FDA-received the drug with a validcountry without a prescription,list of all drugs used by the
approved prescription drugprescription under thata copy of the valid prescriptionindividual for review by those
from a licensed pharmacy incountry’s laws and regulations,signed by a pharmacist licensedwho dispense the drug; and the
Canada, so long as the drug’senters the United States within that country.quantity of the drug does not
final dosage form was made inthe drug, and the drug isexceed a 90-day supply.
an FDA-registered facility,approved for commercialCompassionate use. AuthorizesIneligible for importation is a
came from a registereddistribution in the countrythe Secretary to permit andrug approved under accelerated
Canadian seller, waswhere it was obtained, does notindividual to import up to aprocedures for serious or life-
accompanied by a validappear to be adulterated, and90-day supply of a drug that isthreatening illness with
prescription, and was importeddoes not exceed a 14-daynot approved by the Secretaryrestrictions to assure safe use (21
under conditions the Secretarysupply.under FFDCA Section 505 ifCFR 314 subpart H) and for
determines were necessary tothe importation is forwhich the Secretary has



CRS-103
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
ensure public safety.continuation of personal use bypublished a Federal Register
the individual for treatment,notice stating there is good cause
begun in a foreign country, of ato refuse the import of this drug.
serious medical condition.
makingNo provision.No provision.[Section 8(b)] Requires that the[Section 4(e)(f)] The Secretary
iki/CRS-RL33175inesSecretary, not later than onemay promulgate an interim rule
g/wyear after enactment,for implementing Section 804
s.orpromulgate regulations to carryand may do so without providing
leakout Section 814 [to registergeneral notice of proposed
://wikiprescription drug importationfacilities].rulemaking. The Secretary mustpromulgate a final rule not later
httpthan one year after promulgation
date of interim rule.
ctiveNo provision.804(b). Directs the Secretary to[Section 2(b)(1)(B)] Directs[Section 4(e)(1)] Section 804
promulgate regulationsthat personal-use importationshall permit the importation of
permitting commercialbe allowed from enactment ofqualifying drugs without regard
importation of qualifying drugsthis act, even if the Secretaryto the issuance of implementing
from permitted countries nothas not issued regulations.regulations (1) from registered
later than 180 days afterexporters 90 days after the act’s
enactment.[Section 2(b)(2)(B)] Directsenactment, and (2) from
that pharmacy and wholesalerpermitted countries by registered
804(j). Directs the Secretary toimportation be allowed oneimporters one year after the date
permit, by regulation, personal-year after enactment of this actof enactment.


use importation not later thaneven if the Secretary has not

180 days after enactment.issued regulations.



CRS-104
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
[Section 8(b)] Directs that
registration of prescription drug
importation facilities
requirements take effect on the
effective date of the final
regulations or, if the final
iki/CRS-RL33175regulations have not been made
g/weffective, one year after
s.or enact m ent .
leak
://wikiternetaciesNo provision.[Section 4] Includes variousreferences to Internet[Section 4] Adds to theFFDCA a new Section 511,[Section 8] Internet sales ofprescription drugs. Adds to the
httppharmacies.Internet pharmacies.FFDCA a new Section 503B.

804(a)(7). Defines “qualifying511(a). Definitions. Defines503B(e). Defines “practitioner”


Internet pharmacy” as athe terms “advertising serviceand “prescription drug” as in
registered exporter thatprovider,” “designated paymentSection 503(b)(1), and
dispenses qualifying drugs tosystem,” “federal functional“qualifying medical
individuals over an Internetregulator,” “restrictedrelationship” as in new Section
website.transaction,” “unlawful Internet503B(b).
pharmacy request,” “credit,”
“creditor,” “credit card,”503B(f). Defines “Internet,”
“electronic fund transfer,”“link,” “page,” “site” and
“financial institution,” “money“address,” “domain name,” and
transmitting business,” and“Internet Protocol numbers” and
“money transmitting service.”allows the Secretary to modify



CRS-105
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
any definition to account for
changes in technology.
804(f)(3). Includes qualifyingIn particular, defines “Internet503B(a). Requirements
Internet pharmacies amongpharmacy” as a person thatregarding information on
registered exporters that thedispenses or offers to dispenseInternet site. Makes it illegal, in
iki/CRS-RL33175Secretary must list.a prescription drug through angeneral, for anyone to “dispense
g/wInternet website in interstatea prescription drug pursuant to a
s.or804(g)(2). Excludes acommerce in the United Statessale of the drug by such person”
leakprescription drug shipped to anregardless of whether theunless the person provides
://wikiindividual by a qualifyingInternet pharmacy from certainphysical location of theprincipal place of business ofcertain required information oneach page of the site or a link to
httpimportation suspensionthe Internet pharmacy is in thea page with that information.
authority of the Secretary.United States or in anotherThese items are: the name of the
country. Defines “unlawfuldispensing person; each state in
804(j)(1)(B). IncludesInternet pharmacy request” aswhich that person is authorized
qualifying Internet pharmaciesthe request, or transmittal of aby law to dispense drugs; the
in directing the Secretary torequest for a prescription drugaddress and telephone number of
permit by regulation anmade to an unlicensed Interneteach place of business of the
individual to import a drugpharmacy by mail (including aperson that sells drugs through
from a permitted country.private carrier), facsimile,the Internet; the name of each
phone, or electronic mail, or byperson who serves as a
a means that involves the use,pharmacist for drugs mailed or
in whole or in part, of theshipped from that site’s business
Internet.and each state in which that
person is authorized by law to



CRS-106
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
511(b,c). Licensing of Internetdispense drugs; and, if the
pharmacies. To dispense aperson provides for medical
prescription drug to a person inconsultations through the site for
the United States, requires thatpurposes of providing
an Internet pharmacy beprescriptions, then the name of
licensed with the Secretary andthe person doing the
iki/CRS-RL33175have its principal place ofconsultations, each state in
g/wbusiness in the United States,which that person is authorized
s.orCanada, or a permitted country.by law to do so or practice
leakmedicine, and the types of health
://wikiIn each state in which anprofessions for which the person
httpInternet pharmacy seeks toholds a license or other
dispense prescription drugs,authorization. The site shall also
requires that the licensehave the words “licensing and
application include verificationcontact information” with a link
of compliance with all federaldisplayed in a clear and
and state laws regarding theprominent place and manner.
practice of pharmacy and the
manufacturing and distribution503B(d). Excludes a registered
of controlled substances and,exporter from this section.


for an Internet pharmacy in
Canada or a permitted country,
requires verification regarding
compliance with applicable
laws of that country. Also
requires the application to

CRS-107
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
include verification that the
Secretary has not terminated a
previous Internet pharmacy
license of the owner, that the
owner will permit inspections
by the Secretary, and that any
iki/CRS-RL33175agreement between the Internet
g/wpharmacy and a patient
s.orreleasing liability for
leaknegligence is null and void.
://wiki
httpIdentification requirements.
Requires that the Internet
pharmacy website include the
street address and telephone
number of each place of
business; the names of the
supervising and Internet-service
pharmacists; the names of all
states or countries where the
pharmacy and pharmacists are
licensed or otherwise
authorized to dispense
prescription drugs; the name,
address, telephone number, and
state of licensure of any health



CRS-108
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
care practitioner to whom the
Internet pharmacy makes
referrals; and a statement that it
will dispense prescription drugs
only after receipt of a valid
prescription.
iki/CRS-RL33175
g/wLicensure procedure. Requires
s.orthat the Secretary assign an ID
leaknumber, notify the applicant of
://wikilicense application receipt, and
httpissue a license within 60 days,
if pharmacy complies with all
required conditions. Directs the
Secretary to require electronic
submission of application and
to ensure adequate
authentication protocols.
Requires that the Secretary
keep an up-to-date list of
licensees and make the list
available to the public by an
Internet website and a toll-free
telephone number.



CRS-109
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
511(c)(5). Licensing fee. The
licensing fee for the year in
which an Internet pharmacy
first submits an application is
$5,000. Requires that the
Secretary publish, at least 60
iki/CRS-RL33175days before the start of each
g/wfiscal year, and allow 30 days
s.orfor comment, the licensing fee
leakbased on anticipated costs of
://wikienforcing requirements of this
httpsection in the subsequent year.
Requires that the Secretary use,
without further appropriation,
the fees to carry out this
section. The fee is due October
1 of each year and payable only
once for each Internet
pharmacy. If the Internet
pharmacy has not paid the fee

30 days after the due date,


prohibits it from dispensing
drugs until it pays. Requires
the Secretary, in 2005 and each
subsequent year, to submit a
report to Congress describing



CRS-110
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
the implementation of the
licensing fee authority and the
use of the collected fees.
Allows the Secretary to
terminate a license if the
Internet pharmacy has a pattern
iki/CRS-RL33175of noncompliance, made an
g/wuntrue statement in the license
s.orapplication, or is in violation of
leakan applicable federal or state
://wikilaw. Requires that, before
httprenewing a license, the
Secretary conduct an evaluation
of compliance that may include
testing of the website and other
systems and a physical
inspection of the records and
premises. Authorizes the
Secretary to award a renewable
five-year contract to operate the
licensing program, with annual
performance reviews.
Professional services503B(b). Internet sales without
requirements. Requires anappropriate medical
Internet pharmacy to maintainrelationships. No one can



CRS-111
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
patient medication profiles,dispense or sell a drug if: the
conduct prospective drug usepurchaser or patient
reviews, ensure patientcommunicated through the
confidentiality in accordanceInternet and did not, when
with the Health Insurancecommunications began, have a
Portability and Accountabilityvalid U.S. prescription; the
iki/CRS-RL33175Act of 1996, offer interactivedispensing person provided for a
g/wand meaningful consultation bypractitioner’s involvement, or
s.ora licensed pharmacist, establishfor someone the person
leaka mechanism to report errorsrepresented as a practitioner and
://wikiand suspected adverse reactionsthat person issued a prescription
httpand to document responses,for the drug that was purchased;
develop a system to informand the dispenser knew or had
about drug recalls, educatereason to know that the
about disposal of medications,individual referred to as the
assure the sale is in accordancepractitioner did not have a
with a prescription from thequalifying medical relationship
treating provider of thewith the patient and the
individual, and verifydispenser received payment for
prescription validity by mail ordispensing the drug.
electronic mail receipt from the
treating provider. If theSuch conditions do not apply to
prescription is for a controlleddispensing or selling a drug
substance, the Internetpursuant to telemedicine
pharmacy must confirm withpractices sponsored by a hospital
the treating provider that theor certain group practices of at



CRS-112
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
prescription is accurate andleast 100 physicians with
must provide the individual’sprovider agreements under
name and address, identity andMedicare, or if the Secretary
quantity of the drug, datedetermines the practice promotes
prescription was presented tothe public health.
the Internet pharmacy, date and
iki/CRS-RL33175time of the verification request,To have a “qualifying medical
g/wand the name, telephone, fax,relationship with the patient,”
s.orand e-mail contacts of thethe practitioner must have
leakInternet pharmacy contactconducted at least one in-person
://wikiperson. If the treating providermedical evaluation of the
httpdoes not respond within 72patient, or the practitioner
hours or informs the pharmacyconducts an evaluation as a
that the prescription iscovering practitioner. An “in-
inaccurate or expired, theperson medical examination”
Internet pharmacy may not fillrequires the physical presence of
the prescription. The Internetthe patient as part of the
pharmacy must maintainevaluation, without regard to
records of directwhether other health
communications with treatingprofessionals conduct other
providers.portions of the evaluation.
Covering practitioners are
practitioners who conduct a
medical evaluation of the patient
at the request of a practitioner
who previously has conducted



CRS-113
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
an in-person medical evaluation
but is temporarily unavailable to
conduct the evaluation of the
patient.
Someone who is not a
iki/CRS-RL33175practitioner lacks the legal
g/wcapacity to have a qualifying
s.ormedical relationship with any
leakpatient. This section does not
://wikiprohibit conduct that is a
httpstandard practice of pharmacy.
The qualifying medical
relationship requirement applies
only to this section and does not
affect interpretation of state law
concerning the practice of
medicine.
511(d). Providers of503B(g). Interactive computer
interactive computer servicesservice; Advertising. If the
or advertising services.provider of an interactive
Establishes that these providerscomputer service (as defined in
are liable if they acceptCommunications Act of 1934
advertising for a prescription[47 USC 230(f)(2)]) or of
drug from an unlicensedadvertising services does not



CRS-114
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
Internet pharmacy, or acceptown or exercise corporate
advertising stating a physician’scontrol over a person selling or
prescription is not needed todispensing drugs in violation of
obtain a prescription drug.this section, the provider shall
not be held liable for that selling
or dispensing.
iki/CRS-RL33175
g/w511(e). Policies and[Section 8] Lists dispensing or
s.orprocedures required to preventselling a drug in violation of
leakpayments for unlawful InternetSection 503B as a prohibited act.
://wikipharmacy requests. Requiresregulations within a year ofIt also directs the Secretary toconsider practices and
httpenactment regarding designprocedures of public and private
(using, for example,entities that certify as legitimate
authorization codes) of thebusinesses selling prescription
payment system (with systemdrugs through Internet sites,
participant participation, ifincluding practices and
feasible) to prevent or blockprocedures regarding disclosure
restricted transactions.formats and verification
Establishes that there be noprograms.
liability for blocking or refusing
to honor a restrictedAuthorizing appropriations of
transaction. Requires that the$100,000 for each of FY2005-
FTC and other federalFY2007, directs the Secretary to
functional regulators (asmake an award or contract to the
defined in the Gramm-Leach-National Clearinghouse on



CRS-115
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
Bliley Act, 15 USC 6809)Internet Prescribing (operated by
enforce this section taking intothe Federation of State Medical
consideration the person’sBoards) to identify (and report to
history and extent ofstate licensing boards, the
compliance, the extent to whichAttorney General, and the
the person knew the transactionSecretary) Internet sites that
iki/CRS-RL33175was related to an unlawfulappear to violate laws
g/wInternet pharmacy request, andconcerning drug dispensing, and
s.orthe feasibility of any specificto report annually to the
leakremedy.Secretary describing
://wiki investigations.


http511(f). Reports regarding
Internet-related violations of
federal and state laws on
dispensing of drugs. Directs
the Secretary to award a grant
or contract to develop and
maintain a system of:
identifying unlicensed Internet
pharmacy websites or those in
violation of federal or state
laws; reporting these to state
medical and pharmacy
licensing boards, the Attorney
General, and the Secretary; and
submitting reports each fiscal

CRS-116
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
year to the Secretary.
[Section 4(b)] Prohibited acts.
Amends FFDCA Section 301,
adding violations of Section
511 including drug sale or
iki/CRS-RL33175Internet pharmacy ownership,
g/wrepresenting that a prescription
s.ordrug may be obtained without a
leakprescription, or accepting
://wikiadvertising from an Internet
httppharmacy without having a
copy of the pharmacy’s license
on file.
[Section 4(c)] Links to illegal
Internet pharmacies. Amends
FFDCA Section 302, stating
that U.S. district courts and
courts of the territories shall
have jurisdiction to order an
interactive computer service to
remove or disable access to a
website that violates this
section. States that relief shall
be available after notice and



CRS-117
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
opportunity to appear; shall not
oblige the provider to actively
or passively monitory activity
for violations; and shall specify
the provider to which the relief
applies.
iki/CRS-RL33175
g/w[Section 4(d)] Requires that the
s.orSecretary, within one year of
leakenactment, promulgate interim
://wikifinal regulations consistent with
httpthe Verified Internet Pharmacy
Sites certification program
developed by the National
Association of Boards of
Pharmacy. States that the
licensure requirement will take
effect no later than 90 days
after the publication of interim
regulations.
[Section 4(e)] Return to
sender. Requires that a
shipment of a prescription drug
from an unlicensed Internet
pharmacy be refused admission



CRS-118
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
and that the Secretary return it
at the pharmacy’s expense.
Directs the Secretary to return
to the pharmacy at the
pharmacy’s expense a refused
shipment from a licensed
iki/CRS-RL33175Internet pharmacy and to notify
g/wthe individual and the Internet
s.orpharmacy of the reason.
leakProhibits the return of a
://wikiprescription drug that is
httprequired to be destroyed.

503B(c). Actions by states.


State attorney general can bring
a civil action on if he or she
believes that the state’s residents
have been or were threatened or
adversely affected by someone
engaging in a pattern or practice
that violates Section 301(l), and
may obtain reasonable attorneys
fees and costs if the state
prevails in the civil action or
obtain further relief as the court
may deem appropriate. The



CRS-119
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
state must serve prior written
notice upon the Secretary and
provide a copy of the complaint.
The Secretary then shall have the
right to intervene. Does not
prohibit an authorized state
iki/CRS-RL33175official from proceeding in state
g/w court.
s.or
leakNo provision.No provision.813(a)(2). Limitation to certainNo provision.


://wikiports. Allows the Secretary tolimit to a reasonable number
httpthe ports of entry in the United
States through which a
prescription drug may be
imported under this section.

813(c)(3)(B). Lists; Ports.


Requires the Secretary to
maintain an updated list of
ports through which a
prescription drug may be
imported under this section and
to make the list available to the
public on an Internet website.

CRS-120
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
[Section 12] Prohibition of
port shopping. Prohibits entry
of the prescription drug if it has
previously been refused
admission under Section
801(a), unless the person
iki/CRS-RL33175reoffering the prescription drug
g/waffirmatively establishes, at the
s.orexpense of the owner or
leakconsignee of the prescription
://wikidrug, that the prescription drug
httpcomplies with the applicable
requirements of this act, as
determined by the Secretary.
This section does not apply to a
personal-use import or to a
commercial transaction
between an Internet pharmacy
and an individual.
No provision.[Section 8] Patents. AmendsNo provision.[Section 4(d)] Exhaustion.
the Patent and Trademark Act,Same as S. 109 Section 8.
Patents and Protection of PatentPatents. [Amends Section 271 of
Rights [35 U.S.C. Section 271],Title 35 USC by inserting a new
which defines the protection ofsubsection (h) that would reverse
patent rights and infringementjudicial precedent holding that



CRS-121
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
of a patent, by insertingsales of patented goods outside
subsection 271(h), stating that itthe United States do not exhaust
would not be an act ofthe U.S. patent. Under this
infringement to use, sell, orprovision, goods that were the
offer to sell a patentedsubject of authorized foreign
prescription drug under Sectionsales by the U.S. patent holder
iki/CRS-RL33175804 of the FFDCA if the drugmay be imported into the United
g/wwere first sold abroad by orStates without regard to the U.S.
s.orunder the authority of thepatent.]
leakowner or licensee of such
://wiki patent.
httpritable804(i). Charitable[Section 9(a)] Adds Section813(g). Charitable804(m) and 804(n)(3)(C).
contributions. Section804(l)(4)(C), Charitablecontributions. Same as currentCharitable contributions. Same

801(d)(1) of the act, whichcontributions. Amends currentlaw.as S. 109.


allows only the U.S.law to include a drug supplied
manufacturer of a drug toat nominal cost by a
import it into the Unitedmanufacturer. Also specifies
States, will continue to applythat this subsection should not
to a prescription drug donatedprevent a manufacturer from
or otherwise supplied at nomaking these transactions.
charge by the manufacturer to
a charitable or humanitarian
organization or foreign
government.

CRS-122
S. 184 (Gregg 1/26/2005)
and H.R. 753 (Bradley
Current law:2/10/2005)S. 334 (Dorgan 2/9/2005)
Medicare PrescriptionS. 109 (Vitter 1/24/2005) andSafe Importation ofand H.R. 700 (Emerson
Drug, Improvement, andH.R. 328 (GutknechtMedical Products and2/9/2005)
Modernization Act of 2003,1/25/2005)Other Rx Therapies Act ofPharmaceutical Market
enacted 12/8/2003 as P.L.Pharmaceutical Market2005 or the Safe IMPORTAccess and Drug Safety Act
Topic108-173 [117 Stat. 2464]Access Act of 2005Act of 2005of 2005
No provision.No provision.[Section 16(a)] Conforming[Section 9] Importation
amendments. Repeals Sectionexemption under Controlled
emption1006 of the ControlledSubstances Import and Export
Substances Import and ExportAct. Amends Section 1006(a)(2)
Act.of the Controlled Substances
Import and Export Act by
iki/CRS-RL33175substituting a 10 dosage unit
g/wlimit for the current 50 dosage
s.orunit limit for importation.


leak
://wiki
http