Senate Prescription Drug Importation Legislation: A Side-by-Side Comparison of Current Law, S. 2307, S. 2328, and S. 2493

CRS Report for Congress
Senate Prescription Drug Importation Legislation:
A Side-by-Side Comparison of Current Law,
S. 2307, S. 2328, and S. 2493
September 7, 2004
Susan Thaul and Donna U. Vogt
Specialists in Social Legislation
Domestic Social Policy Division


Congressional Research Service ˜ The Library of Congress

Senate Prescription Drug Importation Legislation:
A Side-by-Side Comparison of Current Law,
S. 2307, S. 2328, and S. 2493
Summary
Senators Grassley, Dorgan, and Gregg have each introduced bills that address
Congressional concerns with prescription drug importation that were not resolved by
the provisions in the Medicare Prescription Drug, Improvement, and Modernization
Act (the MMA, P.L. 108-173).
!S. 2307, the Reliable Entry for Medicines at Everyday Discounts
through Importation with Effective Safeguards Act of 2004,
introduced by Senator Grassley on April 8, 2004 [the Grassley bill];
!S. 2328, the Pharmaceutical Market Access and Drug Safety Act of
2004, introduced by Senator Dorgan on April 21, 2004 [the Dorgan
bill]; and
!S. 2493, the Safe Importation of Medical Products and Other Rx
Therapies Act of 2004, introduced by Senator Gregg on June 2, 2004
[the Gregg bill].
By continuing 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
— the MMA effectively does not allow the commercial or personal-use importation
of prescription drugs. This report briefly discusses major differences among current
law and the bills introduced in April and June 2004 and presents a side-by-side
comparison of the provisions.
Although all three 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 three Senate 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
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: the MMA relies on appropriations, and the Senate bills each create
specific user fee provisions. Only the Gregg bill requires the regulation of Internet
pharmacies. The Grassley and Dorgan bills propose links to antitrust, patent, and
internal revenue titles of the U.S. Code to influence industry behavior. The MMA
does not specify when importation could begin. For commercial imports from
Canada, the Grassley and Dorgan bills start 90 days from enactment, later for other
countries; the Gregg bill allows imports from Canada only, beginning one year from
enactment. The Grassley and Gregg bills allow personal-use imports from Canada
upon enactment, with the Grassley bill’s allowing other countries later; the Dorgan
bill allows personal-use imports from Canada only, beginning 90 days after
enactment.



Contents
In troduction ......................................................1
Differences Among the Bills.........................................2
Monitoring ...................................................2
FDA Approval................................................2
Permitted Countries............................................3
Logistics .....................................................3
Reports ......................................................3
Funding .....................................................4
Incentives ....................................................4
Internet Pharmacies............................................4
Effective Dates................................................5
Side-by-Side Comparison...........................................5
Legislation ...................................................6
Findings .....................................................6
Direction to regulate............................................6
Permitted countries............................................7
Definitions ...................................................8
Qualifying drugs..............................................11
Relationship to FDA approval...................................12
Testing .....................................................12
Monitoring and inspections.....................................13
Records of chain of custody.....................................15
Charitable contributions........................................17
Repeal of controlled substances exemption.........................18
Registration of importers and exporters............................18
Licensing as pharmacies and pharmacists..........................22
Fees .......................................................23
Packaging ...................................................24
Records ....................................................26
Manufacturer requirements.....................................28
Secretary’s actions............................................35
Studies and reports............................................39
Enforcement .................................................39
Personal use.................................................50
Rulemaking deadlines.........................................53
Effective dates...............................................53
Appropriations ...............................................55
Protection against adulterated prescription drugs....................55
Internet pharmacies...........................................55
Prohibition of port shopping....................................63
Anti-counterfeiting programs....................................64
List of Tables
Comparison of Prescription Drug Importation Provisions
in Current Law, S. 2307, S. 2328, and S. 2493.......................6



Senate Prescription Drug Importation
Legislation: A Side-by-Side Comparison of
Current Law, S. 2307, S. 2328, and S. 2493
Introduction
This report compares the provisions of three Senate prescription drug
importation bills with current law provisions on the subject.1 The law on the
importation of prescription drugs was recently amended by the Medicare Prescription
Drug, Improvement, and Modernization Act (MMA, P.L. 108-173). The three bills2
with provisions compared to current law are:
!S. 2307, introduced by Senator Grassley on April 8, 2004 [the
Grassley bill];
!S. 2328, introduced by Senator Dorgan3 on April 21, 2004 [the
Dorgan bill]; and
!S. 2493, introduced by Senator Gregg4 on June 2, 2004 [the Gregg
bill].
The new law and the three 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. The underlying goal is to reduce or
restrain the growth of the financial burden that prescription drugs place on U.S.
consumers. They all would act primarily by replacing or amending Section 804 of


1 This report replaces the CRS Congressional Distribution Memorandum, Senate
Prescription Drug Importation Legislation [updated], by Susan Thaul and Donna U. Vogt,
dated June 25, 2004. 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.
2 The House passed H.R. 2427 (introduced by Rep. Gil Gutknecht) on July 25, 2003, before
passage of the MMA. The conferees did not, however, include its provisions in their final
agreement. No Senate version was introduced.
3 Co-sponsors of S. 2328 at its introduction were Sens. Snowe, Kennedy, McCain, Daschle,
Lott, Stabenow, Chafee, Johnson, Pryor, and Feingold; by Sept. 1, 2004, it had 30 co-
sponsors.
4 Co-sponsors of S. 2493 at its introduction were Sens. Smith, Collins, Coleman, Sessions,
Lott, and Enzi; by Sept. 1, 2004, Sen. Voinovich had joined as a co-sponsor.

the Federal Food, Drug, and Cosmetic Act (FFDCA) that had been initially added to
the FFDCA by the Medicine Equity and Drug Safety (MEDS) Act of 2000.
Individual bills would amend other laws.
Impetus for developing new importation legislation so soon after enactment of
the MMA is the result of the new law’s retaining the MEDS Act provision that
importation not be allowed unless the Secretary of Health and Human Services
(HHS) certifies that imports are safe and offer cost savings to U.S. consumers. The
three bills each eliminate this requirement and, instead, include other potential
safeguards regarding drug safety and effectiveness.
Differences Among the Bills
Some of the major areas of difference among the bills are the following:
Monitoring
While the MMA relies on laboratory testing of samples of every shipment of
imported drugs to verify their content, potency, and labeling, the three proposed
Senate bills focus on documentation of a monitored, uninterrupted chain of custody
from manufacturing facility to importer. The MMA requires Canadian exporters to
register with the Secretary. The Grassley and Dorgan bills specify extensive
requirements for that registration, and the Dorgan bill extends similar registration
requirements to importers as well as exporters. To do so, they require ongoing and
onsite physical monitoring of the facilities of a drug’s manufacturer, registered
exporter, and registered importer, including inspection, if the Secretary determines
it necessary, of any facility that handles the product along the chain of custody. The
Gregg bill has extensive registration requirements for importers and dispensers of
imported prescription drugs, including providing to the commercial purchaser
identifying information on all preceding transactions that transferred the drug since
it left the manufacturer’s control.
FDA Approval
The MMA and the Gregg bill explicitly require that an imported drug be
approved for U.S. sale by the Food and Drug Administration (FDA). The Grassley
and Dorgan bills allow different administrative requirements for importation while
maintaining the substantive elements of FDA approval. The Grassley bill also
requires that the imported drug be manufactured in the same facility as the equivalent
FDA-approved drug.



Permitted Countries
The three Senate bills5 and current law vary in the countries from which they
would permit drug importation. The Grassley bill includes Australia, Canada, Japan,
New Zealand, Switzerland, members of the European Union, Iceland, Liechtenstein,
and Norway; it also allows the Secretary to designate additional countries that have
equivalent regulatory requirements regarding safety and effectiveness. For
commercial imports, the Dorgan bill differs in that it excludes Iceland, Liechtenstein,
and Norway, and specifies European Union countries as of January 2003, thereby
excluding the 10 admitted to membership in May 2004. The Dorgan bill, alone,
distinguishes between commercial and personal-use imports regarding permitted
countries, allowing only Canada for the latter. The Gregg bill includes Canada and
allows the Secretary, three years after enactment, to designate as eligible any
members of the European Union as of December 2003. Current law, the MMA,
includes only Canada, although it allows the Secretary to grant waivers permitting
personal-use importation from other countries.
Logistics
The Grassley bill would allow the manufacturer of an FDA-approved drug
distributed in the United States to petition the Secretary to stop the importation of
that drug when it has been manufactured in or exported to another country. The
petition would have to assert that the imported drug differs from the U.S. drug
enough that it would require a supplemental application to FDA if the manufacturer
wanted to introduce it to the U.S. market. The manufacturer would, through fees
similar to those established for supplemental applications under the Prescription
Drug User Fee Act (PDUFA, P.L. 102-571), pay the expense of the Secretary’s
review. The Dorgan bill would require the manufacturer of any drug that “may be
imported” to submit a notice with extensive documentation of the differences, if any,
between a drug it produces for commercial marketing in a permitted country and the
drug it produces for the U.S. market. Here, too, the manufacturer would pay for the
review of these materials with fees similar to those required for supplemental or new
drug applications under PDUFA. The Gregg bill does not require the manufacturer
to document differences between its U.S.-marketed and foreign-marketed products.
Reports
The MMA and the Grassley bills require the HHS Secretary to submit reports
to Congress. The MMA also requires a report from the Commerce Secretary and
others. The Dorgan bill requires no report. The Gregg bill requires three reports to
Congress, covering which countries the Secretary has designated as permitted for
imports and the reasons why, the implementation of registration fees and the use of
those fees, and the commissioning of federal and state officials to conduct
inspections.


5 The most inclusive list is in H.R. 2427 [not included in this report’s table], the Gutknecht
bill, which follows the language in the MEDS Act of 2000. Permitted countries would be
Australia, Canada, Israel, Japan, New Zealand, South Africa, Switzerland, members of the
European Union, Iceland, Liechtenstein, and Norway.

Funding
The MMA includes no explicit funding mechanism other than authorizing
appropriations of such sums as necessary to implement the provisions. The Grassley
bill calls for exporter fees that, in the aggregate, would cover the cost of
administering the import provisions. The Dorgan bill includes exporter and importer
fees based on the share of volume of imports, adjusted annually, to not exceed 1%
of the price of drug imports. The Gregg bill sets a $5,000 first-time registration fee
and requires the Secretary to set annually a fee, based on anticipated costs, to enforce
the Act without further appropriation.
Incentives
Implementation of the MMA is restricted by the requirement that the Secretary
certify safety and cost savings. Criticism of the MMA cites anticipated manufacturer
resistance. The Grassley and Dorgan bills propose links to antitrust, patent, and
internal revenue titles of the U.S. Code to influence industry behavior. The Grassley
bill includes tax incentives and penalties to minimize manufacturer interference. The
Dorgan bill creates an antitrust provision to compel manufacturer participation and
amends patent law to remove obstacles to importation. The Gregg bill includes
neither positive nor negative incentives to influence manufacturer behavior.
Internet Pharmacies
Neither current law, the MMA, nor the Grassley and Dorgan bills, as introduced,
address Internet sales.6 The Gregg bill presents an extensive statutory and regulatory
structure for Internet pharmacies, placing it in the FFDCA, although set apart from
the importation sections. In addition to registration, the bill requires 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. It requires advance notice of
commercial shipments of prescription drug shipments and includes a licensing fee.
Providers of interactive computer services are liable if they accept advertising for a
prescription drug from an unlicensed Internet pharmacy or accept advertising stating
a physician’s prescription is not needed to obtain a prescription drug; the bill requires
policies and procedures to prevent payments for unlawful Internet pharmacy requests.


6 Pending bills in the 108th Congress that address Internet pharmacies include H.R. 4598,
H.R. 4612, H.R. 3880, H.R. 3870, H.R. 2652, H.R. 725, S. 2464, and S. 2288. The July 21,
2004 online newsletter, Inside Health Policy, reported that the Dorgan bill sponsors have
added an Internet sales provision that covers U.S. Internet pharmacies. The report adds that
the addition is based on a bill that Sens. Feinstein and Coleman introduced (S. 2464) as a
companion bill to H.R. 3880, introduced by Reps. Davis and Waxman (“Dorgan Rx Import
Bill Guards Against Fake U.S. Internet Pharmacies,” July 21, 2004 at
[http://insidehealthpolicy.com] .

Effective Dates
The MMA does not specify when importation could begin other than linking it
to the required safety and cost certification by the Secretary. The three Senate bills
stipulate various time frames for commercial and personal-use importation, with
varying times for different countries.
Commercial Imports. The Grassley bill requires that the Secretary promulgate
and make effective an interim final rule not later than 90 days after enactment for
commercial imports from Canada; it allows imports from other countries,
approximately two years later, if the Secretary designates them based on a report
required by the bill. The Dorgan bill would allow registered importers to import
from Canada beginning when the Secretary promulgates an interim rule, which is
required within 90 days of enactment; the Secretary could add other countries one
year later. The Gregg bill would allow pharmacy and wholesaler importation from
Canada one year after enactment, even if the Secretary has not issued regulations; the
Secretary could allow imports from pre-2004 members of the European Union in
three years, following a required study.
Personal-Use Imports. The Grassley bill would allow a 90-day supply from
Canada immediately until 45-days after promulgation of an interim final rule, which
is required within 90 days of enactment. Following a report to Congress due 18
months after enactment, the Secretary may designate other countries from which to
allow personal-use imports. The Dorgan bill allows personal-use imports from
Canada beginning when the interim rule is promulgated, which is 90 days after
enactment; it does not provide for personal-use imports from any other country. The
Gregg bill allows personal-use imports from enactment, even if the Secretary has not
issued regulations. It also requires the Secretary to promulgate interim final
regulations regarding Internet pharmacy certification within one year of enactment,
with licensing to take effect 90 days after that promulgation.
Side-by-Side Comparison
The following table arrays the prescription drug importation provisions of
current law and the three Senate bills, with the columns ordered chronologically
based on date of enactment or introduction. Organized by topic, the rows do not
directly follow the order of provisions in any one of the compared documents.



CRS-6
Comparison of Prescription Drug Importation Provisions in Current Law, S. 2307, S. 2328, and S. 2493
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
gislationSection 804 of the Federal Food,Section 2. Repeals Section 804 of theSection 3. Repeals Section 804 of theSection 2. Adds a new Subchapter B
Drug, and Cosmetic Act Federal Food, Drug, and CosmeticFederal Food, Drug, and Cosmetic— “Importation of Prescription
Importation of Covered ProductsAct (FFDCA) as amended by SectionAct (FFDCA) as amended by SectionDrugs” — to Chapter VIII of the
was first established under the1121(a) of P.L. 108-173.1121(a) of P.L. 108-173.Federal Food, Drug, and Cosmetic
Medicine Equity and Drug Safety ActAct (FFDCA), adding Sections 811-
of 2000 (P.L. 106-387). SectionSection 3. Inserts a new Section 804.Section 4. Inserts a new Section 804.817.
1121(a) of the Medicare Prescription
Drug, Improvement, andAlso amends, deletes, or addsAlso amends, deletes, or addsSection 16. Repeals Section 804 of
Modernization Act of 2003 (P.L. 108-provisions in other sections of theprovisions in other sections of thethe FFDCA.
iki/CRS-RL32568173) replaced Section 804 entirely.FFDCA; and the Internal RevenueFFDCA; and the Clayton Antitrust
g/wCode of 1986 [31 USC 26]; and theAct [15 USC 12 et seq.]; theAlso amends, deletes, or adds
s.orControlled Substances Import andControlled Substances Import andprovisions in other sections of the
leakExport Act [21 USC 956].Export Act [21 USC 956]; SectionFFDCA; and the Controlled
271 [Infringement of Patent] of TitleSubstances Import and Export Act [21
://wiki35 [Patents]; and Section 351 of theUSC 956].
httpPublic Health Service Act [42 USC
262].
dingsNo provision.No provision.Section 2. Findings. IncludesNo provision.
findings that, although the United
States is the largest market for
prescription drugs, U.S. prices are
“unjustly higher than in other
countries, and that allowing the
importation of prescription drugs
would save American consumers
money and ensure access to safe and
effective FDA-approved drugs.
ection to804(b). Regulations. Section 801 of804(a). Waivers Regarding804(a). Importation of PrescriptionSection 2(b). Regulations.
atethe FFDCA allows only a drugsCommercial and PersonalDrugs. The HHS Secretary shallAuthorizes the HHS Secretary to
manufacturer to import that drug.Importation of Prescription Drugs.provide, in regulations for importingpromulgate regulations to carry out
Section 804(b) requires the SecretaryThe HHS Secretary shall provide, inqualifying drugs by registeredSection 812 [personal importation]
of Health and Human Servicesregulations, a waiver of Sectionimporters or from registeredand directs the Secretary to



CRS-7
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
(HHS), after consultation with the801(d)(1) as long as the drugexporters, a waiver of Sectionpromulgate interim final regulations
United States Trade Representativecomplies with the standards of801(d)(1) as long as the drugto carry out Section 813 [pharmacy
and the Commissioner of Customs, toSection 801(a), which allows onlycomplies with the standards ofand wholesaler importation of
promulgate regulations permittingcertain drugs to be imported. ASection 801(a), which allows onlyprescription drugs] of the FFDCA (as
pharmacists and wholesalers to importqualifying drug may not be importedcertain drugs to be imported. Aadded by this section). Even if the
prescription drugs from Canada intounless the drug meets certainqualifying drug may not be importedSecretary has not promulgated
the United States.conditions [stated in 804(h)] or theunless the drug is imported by aregulations, Section 812 shall take
imported drug is for personal use orpharmacy or a wholesaler who is aeffect on the date of enactment of this
804(j)(2). Waiver Authority. Thefor use by a family member and notregistered importer, or a by anAct and Section 813 shall take effect
Secretary is authorized to grantfor resale and meets the conditions inindividual for personal or family-one year after enactment.
waivers, either through rule-makingSection 804(i), as below.member use (and not for resale) from
iki/CRS-RL32568or on a case-by-case basis, of the lawa registered exporter.813. Pharmacy and Wholesaler
g/wthat allows only manufacturers toImportation of Prescription Drugs. A
s.orimport FDA-approved drugs, to allowdrug importation facility, pharmacy,
leakindividuals to bring inInternet pharmacy, or wholesaler may
pharmaceuticals under conditions theimport a prescription drug from
://wikiSecretary determines appropriate.Canada or a permitted country into
httpThe Secretary must publish guidancedescribing the consistentthe United States.
circumstances in which waivers
would be granted to individuals.
rmittedStipulates that the Secretarys804(a)(4)(B). Apermitted country804(a)(4)(D). [For commercial811*(4)(A). [Note: Section 811 does
ntriesregulations would include onlyis Canada and, 180 days after theimportation,] Apermitted countrynot have a letter designating the
Canada for imports by pharmacistspublication of a report (see below),means Australia, Canada, a memberbeginning of this subsection, which an
and wholesalers; does not specifyAustralia, a member country of the*country of the European Union as of*asterisk notes here.] Defines
country for individual imports.European Union or the European***January 1, 2003, Japan, New“permitted country” as a member of
Free Trade Association, Japan, andZealand, and Switzerland.the European Union as of December*
New Zealand. The Secretary may31, 2003, that is designated by the
designate any additional country that804(i)(1). For personal-useSecretary based on a report due to the
has equivalent regulatoryimportation, includes Canada only.Senate HELP Committee and the
requirements to ensure the safety andHouse Energy and Commerce
effectiveness of drugs.Committee three years after
enactment (see under “Study and
report,” below).



CRS-8
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
813(d). Prohibits the importation of a
prescription drug that had entered any
country other than Canada or another
permitted country after leaving the
control of the manufacturer. Even
when a drug comes from a permitted
country, if it had 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
iki/CRS-RL32568 health.
g/w
s.orhe European Union as of January 1, 2003 consisted of the following 15 member states: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg,etherlands, Portugal, Spain, Sweden, and the United Kingdom. On May 1, 2004, 10 countries joined the European Union: Cyprus, the Czech Republic, Estonia, Latvia,
leakthuania, Hungary, Malta, Poland, Slovenia, and the Slovak Republic.**The European Economic Area consists of the European Union plus Iceland, Liechtenstein, and Norway.
://wikiThe European Free Trade Association consists of Iceland, Liechtenstein, Norway, Switzerland, and the member states of the European Union.
httpinitions804(a). Definitions. Defines804(a)(4). Definitions.804(a)(4). Definitions.811. Definitions.
importer” to mean a pharmacist or aDefines “importer,” “pharmacist,”Defines “registered exporter,”Defines “drug importation facility” as
wholesaler; “pharmacist” to mean aand “wholesalerthe same as currentregistration condition,”aperson, other than an individual
person licensed by a state to practicelaw.pharmacist,” and “wholesaler” theimporting a prescription drug under
pharmacy, including the dispensingsame as S. 2307.Section 812, located outside the
and selling of prescription drugs; andDefines “exporter” to mean a personUnited States (other than a
wholesaler” to mean a personwho is (or seeks to be) in the businessDefines “exporter” to mean a persontransporter) that engages in the
licensed as a wholesaler or distributorof exporting a drug to the Unitedwho is in the business of exporting adistribution or dispensing of a
of prescription drugs in the UnitedStates after submitting a registration;drug from Canada to individuals inprescription drug that is imported or
States, but does not include theregistered exporter” to mean anthe United States or that seeks to be inoffered for importation into the
manufacturer of the drug beingexporter with an approved registrationsuch a business pursuant to submittingUnited States.” DefinesInternet
imported.in effect; andregistration conditiona registration;pharmacy” to mean apharmacy” as a person that offers to
to mean a condition that must exist forperson licensed by a state to engage indispense a prescription drug through
a registration to be approved.the business of selling prescriptionan Internet website in interstate
drugs at retail and employs 1 or morecommerce, regardless of whether its
pharmacists;importer” to mean aphysical location is in the United
pharmacy, a group of pharmacies, orStates. Definespharmacy” as a
a wholesaler that is in drug importingperson licensed by a state to dispense
business or that seeks an approvedprescription drugs or to provide
registration to do so; andregisteredpharmaceutical care. Defines



CRS-9
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
importer” to mean a pharmacy, atreating provider” asa licensed
group of pharmacies, or a wholesalerhealth care provider that (A) performs
with an approved and in effecta documented patient evaluation
registration.(including a patient history and
physical examination) of an
individual to establish the diagnosis
for which a prescription drug is
prescribed; discusses with the
individual the treatment options of the
individual and the risks and benefits
of treatment; and maintains
iki/CRS-RL32568contemporaneous medical records
g/wconcerning the individual; or (B)
s.orprovides care to an individual as part
leakof an on-call or cross-coverage
arrangement with a health care
://wikiprovider described in subparagraph
http(A).” Defineswholesaler” as aperson licensed as a wholesaler or
distributor of prescription drugs in the
United States, but does not include the
manufacturer of the drug being
imported or an individual importing
for personal use.
Section 15(c). Anticounterfeiting
Provisions; Distributors of Record.
Amends Section 503(e) of the
FFDCA as follows. Defines
distributor of record” as a person
that takes title to or possession of a
drug from manufacture; this includes
a person that manufacturers,
processes, packs, distributes, receives,
holds, imports, or offers for
importation, and this does not include
a transporter. Definestransporter



CRS-10
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
as the United States Postal Service,
foreign government postal service, or
a private carrier in the business of
transporting packages. Defines
wholesale distribution” as the
distribution of a drug to other than the
consumer or patient but not including
an intracompany sale or distribution
by a transporter.
Defines “prescription drugas a drugDefines “covered prescription drugDefines “prescription drug” as a drug811*(5). Definesprescription drug
iki/CRS-RL32568subject to Section 503(b) [a drugas an approved drug under Sectiondescribed in FFDCA Sectionsimilarly to current law [an FDA-
g/wintended for use by man that is not505(b)(1) [an FDA-approved drug]503(b)(1). Has the same definitionapproved drug], with additional
s.orsafe for use except under thesupervision of a licensed practitioner]that is subject to Section 503(b)(1) [adrug requiring a prescription].forqualifying drug” as S. 2307.exceptions: a drug manufacturedthrough any biotechnology process,
leakother than a controlled substance, aDefines “qualifying drug” as aincluding a therapeutic DNA plasmid
://wikibiological product, an infused drug,an intravenously injected drug, a drugcovered prescription drug other than acontrolled substance, a biologicalproduct, a therapeutic syntheticpeptide product of not more than 40
httpthat is inhaled during surgery, or aproduct, an infused drug, anamino acids, a monoclonal antibody
parenteral drug that the Secretaryintravenously injected drug, or a drugproduct for in vivo use, and a
determines poses a threat to the publicthat is inhaled during surgery.therapeutic recombinant DNA-
health.derived product; a drug requiring
804(g)(2)(A). AU.S. label drug” isrefrigeration at any time; or a
a drug approved for commercialphotoreactive drug.
distribution in the United States.
804(g)(2)(B)(i, iii). A petition drug
is a drug named in a manufacturer’s
petition to the Secretary to stop its
import. [See 804(g), below, regarding
p e titio ns.]
Qualifying laboratory” is defined as
a laboratory in the United States that
has been approved by the Secretary
for the purposes of this section.



CRS-11
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
alifying804(c). Limitation. Regulations must804(c). Sources of Exporting804(c). Sources of Qualifying Drugs.No explicitly comparable provision;
ugsensure that all imported prescriptionQualifying Drugs. An exporter mustSame as S. 2307 except that thehowever, requires that an imported
drugs meet the same safety andonly export a drug that has a verifiedmanufacturing establishment must beprescription drug must be FDA-
efficacy standards as drugs approvedchain of custody from theeither inspected by the Secretary orapproved.


in the United States and that themanufacturer to the exporter. Theregistered under Section 510. The
importer comply with all information,exporter must comply with themanufacturing establishment can be
reporting, and testing requirements.following: the drug must have beenin the United States or any foreign
The Secretary is permitted to adoptmanufactured in an FDA-registeredcountry, as in S. 2307, but the
such rules as necessary to safeguardestablishment [registered under (h) orestablishment can manufacture the
public health or as a means to(i) of Section 510], which is located indrug either for distribution in the US
facilitate the importation ofthe U.S. or any foreign country, andor for distribution in a permitted
iki/CRS-RL32568prescription drugs.the establishment manufactured thecountry. Canada is the only foreign
g/wdrug for distribution in the U.S. andcountry from which the exporter can
s.orfor distribution in a permittedexport the drug; the importer can
leakcountry; the drug came directly fromimport from a permitted country only.
the manufacturing establishment orThe exporter or importer must retain
://wikifrom an entity that, by contract witha sample of each lot of the drug
httpthe exporter, provides the exporter achain of custody statement from thesufficient for testing by the Secretary.
manufacturing establishment,
identifying each prior sale, purchase,
or trade with dates, names and
addresses of all parties to the
transaction; exporter agrees to permit
the Secretary to inspect the statements
and related records to determine
accuracy; and agrees to allow the
Secretary to inspect all facilities
involved and all the contracting chain
of custody parties; the foreign country
from which the exporter will export
the drug is a permitted country, and
exporter ensures that during any
period in which the drug was not in
the drug manufacturer’s control, the
drug did not enter a non-permitted
c o unt r y.

CRS-12
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
nship toNo explicitly comparable provision;804(g)(1). Compliance with Section804(g)(1). Compliance with Section813(b). Requirements. Requires that
A approvalhowever, the law requires that all801(a) [Imports and Exports]. For801(a). Similar to S. 2307. Eacheach imported prescription drug be
imported drugs be FDA-approved.each exported qualifying drug, thequalifying drug exported or importedFDA-approved [Section 505] and
exporter must comply with Sectionby the registered exporter or importercomply with FDA requirements
801(a) FFDCA standards subject tomust be in compliance with Sectionregarding adulteration [Section 501]
the import approval status, labeling,801(a) standards regarding admissionand misbranding [Section 502].
and standards for refused admissionof the drug into the United States,Requires that the container have a
criteria under this Act [Sectionssubject to paragraphs (2), (3), and (4)prominent and conspicuous label with
804(g)(2,3) and 804(j)].[see below].the following items: the lot number;
the name, address, and phone number
804(g)(2)(A). Approval Status;804(g)(2)(A,B). Section 505;of the drug importation facility; a
iki/CRS-RL32568Importation. A drug may be importedApproval Status. There is a generalstatement that the drug was imported,
g/winto the United States if (1) thepresumption that a drug proposed fornaming the country from which it
s.orSecretary has verified the source ofexport or import is an FDA-approvedcame; and a unique identifier,
leakthe exported drug, including that thedrug if it complies with 804(c) and ifindicating that the drug has been
drug is approved for commercialit has the same active ingredient orimported, based on the national drug
://wikidistribution in a specified foreigningredients, route of administration,code of the prescription drug.
httpcountry and that the establishmentthat manufactures the drug alsodosage form, and strength, accordingto the labeling information (referredRequires that the drug comply withany other FFDCA requirements.
manufactures the drug for distributionto in this subsection as a ‘U.S. label
in the United States (referred to as adrug) as an FDA-approved drug that
U.S. label drug); and (2) it has theis manufactured by or for the person
same active ingredients, route ofthat manufactures the drug proposed
administration, dosage form, andfor export or import. A drug that
strength as the U.S. label drug,meets the criteria stated above may be
according to the label of the drug.imported into the United States.
[Section 804(g)(2)(B) is described
later in this document.]
sting804(e). Testing. The importer or theNo provision.No provision.No provision.


manufacturer must conduct the
required authenticity testing at a
qualified laboratory. If the importer
conducts these tests, the manufacturer
must give the importing pharmacist or

CRS-13
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
wholesaler the information needed to
authenticate the product and confirm
its labeling. Also, testing 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 or financial
information that is privileged or
co nfid ential.
iki/CRS-RL32568onitoring andNo provision.804(d)(1). Monitoring of Facilities.804(d)(1). Inspection of Facilities.Section 10. Advance Notice of
g/wectionsThe exporter must agree to assist theSimilar to S. 2307 except it alsoImported Prescription Drug
s.orSecretary to determine exportercompliance with all requiredallows the Secretary to have on-site,day-to-day access to samples of suchShipments. Amends FFDCA Section801 to allow the Secretary to inspect
leakconditions. The exporter must permitdrugs. Also, any employee assigneddrug imports at ports of entry. The
://wikithe Secretary to assign one or moreemployees to conduct day-to-day on-by the Secretary must carry out thefunctions of the section not less thanperson importing or offering forimportation the prescription drug
httpsite continuous monitoring ofevery three weeks and that such anmust give the Secretary advance
warehouses or other exporter owned,assignment remains in effect on a(between 24 hours and five days)
controlled, or operated facility thatcontinuous basis.notice of: the established name,
relate to qualifying drugs; to havedosage form, and quantity of the
day-to-day access to records includingprescription drug; the name of the
financial records; to verify the chainshipper; the name of the country from
of custody of each qualifying drug,which the prescription drug
monitor markings, and sample theoriginates; the country from which it
exported drugs to assure compliance;is shipped; the name of the port of
and to carry out other functions thatentry; documentation of the original
the Secretary determines necessarysource of the prescription drug; the
regarding compliance. The Secretaryquantity of each lot of the prescription
may allow periodic, rather than day-drug originally received by the
to-day, inspections of a business withfacility from that source; the lot or
sufficient history of compliance.control number assigned to the
prescription drug by the manufacturer
of the prescription drug; the name,



CRS-14
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
address, telephone number, and
professional license number of the
drug importation facility located in
Canada or a permitted country; and
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 United States and
is not adulterated or misbranded and
iki/CRS-RL32568meets all labeling requirements under
g/wthis Act. Failure to provide notice
s.orresults in holding of drug at the point
leakof entry.
://wikiSection 13. Authority to Commission
httpOther Federal and State Officials toConduct Inspections. Amends the
FFDCA to permit the Secretary to
sign a memorandum of understanding
with another federal agency or a state
for its employees to conduct
examinations and investigations for
the purposes of enforcing compliance
with this Act. The memorandum is to
include provisions for ensuring
adequate training and reimbursement.
Reporting to the Senate Committee on
Health, Education, Labor, and
Pensions and the House Committee
on Energy and Commerce is required
on the joint activities. The Secretary
may contract with a state to use State
Board of Pharmacy personnel to



CRS-15
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
conduct examinations and inspections
required by this Act. Agreements
with a state are effective only in that
state and for facilities located in that
state; and agreements are effective
only at facilities that are jointly
regulated by the Secretary and the
other agency.
ofNo provision.804(d)(3). Certain Duties. The804(d)(3). Certain Duties Relating toSection 15(a). Anticounterfeiting
ain ofSecretary shall verify the chain ofExporters. Similar to S. 2307 exceptProvisions; Required Records.
iki/CRS-RL32568stodycustody of each qualifying drug fromthat these duties involve verifying theAmends Section 503(e) of the
g/wthe drug manufacturer to the exporter.chain of custody of a statisticallyFFDCA by requiring the wholesale
s.orIf the qualifying drug is exported toindividuals for personal use, thesignificant sample of qualifying drugsfrom the manufacturingdistributor of record, for eachdistribution, to provide to the
leakSecretary is directed to randomlyestablishment, which may berecipient the identity of the
://wikiselect samples of the exports todetermine whether the conditionsaccomplished by the use of anti-counterfeiting or track-and-traceimmediately previous distributor ofrecord from which the prescription
httprequired for individual imports aretechnologies, if available. Recorddrug was purchased; and, for each
being met. The sampling processreview is the same as S. 2307.wholesale distribution of an imported
must allow a statistically significantHowever, the employees shall inspect,drug, to provide the purchaser with
determination of compliance. Theas the Secretary determines isidentifying information, such as dates
Secretary is directed to monitor thenecessary, the warehouses and otherand the names and addresses of all
required markings of exports.facilities of other parties in the chainparties to each transaction. Requires
of custody of qualifying drugs, andthe distributor to keep the records
determine whether the exporter is inavailable for two years for Secretarial
compliance with all other registrationinspection, including the immediately
conditions.previous and subsequent distributors
of all distributions, and, for imports,
each previous and subsequent
distributor, to the extent feasible.
804(h). Importers; Conditions for804(d)(4). Certain Duties Relating to
Importation. An importer may importImporters. The Secretary must
a drug if it receives the drug directlyinspect not less than every three
from the mail, a common carrier, or aweeks the importer’s places of



CRS-16
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
vehicle or aircraft owned by thebusiness that relate to the receipt and
importer or a business organization ofdistribution of a qualifying drug,
which the importer is a part. Theincluding each warehouse or other
personnel of the transporting entitiesfacility owned or controlled by, or
must have had exclusive custody ofoperated for, the importer at which
the drug without the involvement ofqualifying drugs are received or from
any other entity including a wholesalewhich they are distributed to
distributor. Although the wholesalepharmacies. During these
distributor, or any entity not theinspections, the Secretary (1) shall
importer, cannot at any point haveverify the chain of custody of a
custody of the drug, the wholesalerstatistically significant sample of
iki/CRS-RL32568could negotiate price and otherqualifying drugs from the
g/wprocesses for purchasing drugs fromestablishment in which the drug was
s.orexporters.manufactured to the importer, which
leakmay be accomplished by the use of
anticounterfeiting or track-and-trace
://wikitechnologies; (2) may inspect, if
httpnecessary, the warehouses and otherfacilities of other parties in the chain
of custody of qualifying drugs; and
shall determine whether the importer
is in compliance with all other
registration conditions.
Section 7. Wholesale Distribution ofSection 8. Wholesale Distribution of
Drugs; Statements Regarding PriorDrugs; Statements Regarding Prior
Sale, Purchase, or Trade. SectionSale, Purchase, or Trade. Same as S.
503(e) of the FFDCA gives2307. It also removes the reference to
requirements of wholesale distributorsmanufacturer and authorized
(guidelines). This bill would changedistributor, but does not insert
the exclusion of the manufacturer andregistered exporter.


authorized distributor to an exclusion
of a registered exporter. It would also
insert the requirement that a
wholesale distributor is not exempt

CRS-17
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
from providing to the person who
receives the drug after export a
statement identifying each prior sale,
purchase, or trade of such drug
including the date of the transaction
and the names and addresses of all
parties to the transaction. The
Secretary may establishalternative
requirements” to identify the chain of
custody of the drug through the
wholesale distribution chain if the
iki/CRS-RL32568alternatives provide greater certainty
g/wand alternatives are economically and
s.ortechnically feasible. If the Secretary
leakdoes promulgate final rules for
alternative requirements” then other
://wikiconditions are amended. Each
httpmanufacturer distributing FDAapproved drugs shall maintain records
of authorized distributors who are
distributors with an ongoing
relationship with them to distribute
the manufacturer’s products.
aritable804(i). Charitable Contributions.804(k). Charitable Contributions. No provision.813(g). Charitable Contributions.
ntributionsSection 801(d)(1) of the Act, whichSimilar to MMA.Similar to current law.


allows only the U.S. manufacturer of
a drug to import it into the United
States, will continue to apply to a
product donated by a manufacturer of
a drug to a charitable or humanitarian
organization or foreign government.

CRS-18
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
peal ofNo provision.Section 8. Repeal of ImportationSection 9. Repeal of ImportationSection 16(a). Conforming
ntrolledExemption Under ControlledExemption Under ControlledAmendments. Repeals Section 1006
bstancesSubstances Import and Export Act.Substances Import and Export Act.of the Controlled Substances Import
emptionThis section repeals the exemptionSame as S. 2307.and Export Act. (Same as S. 2307.)
authority of the Attorney General to
allow imports of controlled
substances for personal use under
certain conditions.
gistration of804(f). Registration of Foreign804(b)(1). Registration of Foreign804(b)(1). Registration of ImportersSection 8. Registration of
porters andSellers. Requires any CanadianExporters. To register, an exporterand Exporters. To register, thePrescription Drug Importation
iki/CRS-RL32568portersestablishment engaged in themust submit to the Secretary:importer or the exporter (referred toFacilities. Adds to the FFDCA a new
g/wdistribution of a prescription drugas the registrant) must submit to theSection 814, Registration of Certain
s.orimported or offered for importationinto the United States to register itsthe name and addresses of every placeof business of the exporter that relatesSecretary:Importers, to require a drugimportation facility, pharmacy,
leakname and place of business with theto qualifying drugs, including eachthe name and addresses of every placeInternet pharmacy, or wholesaler
://wikiSecretary. Also requires that theCanadian establishment register thewarehouse or other facility owned orcontrolled by, or operated for, theof business of the registrant includingeach warehouse or other facilityengaged in the importation or offeringfor importation of prescription drugs
httpname of its U.S. agent.exporter; andowned or controlled by, or operatedinto the United States, or in the
for, the registrant; anddispensing of such drugs, to register
with the Secretary.
To register, the person must submit:
[814(b)(1)(A)] the name and address
of each drug importation facility,
pharmacy, Internet pharmacy, or
wholesaler at which, and all trade
names under which, the registrant
conducts business; and
[814(b)(1)(B)] the name of each
prescription drug to be imported into
the United States.



CRS-19
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
information necessary to demonstrateinformation necessary to demonstrate
compliance with the conditionsthat the importer is in compliance
relating to the sources of exportedwith registration conditions relating to
drug; the monitoring of foreignthe sources of exported drugs; the
facilities; the marking of compliantinspection of facilities of the importer;
shipments; fee payment; beingthe payment of fees; compliance with
licensed as a pharmacy; andthe standards referred to in Section
compliance with Section 801(a)801(a); and maintenance of records
standards [federal government canand samples; and information
sample and inspect to prevent thenecessary to demonstrate that the
importation of adulterated,exporter is in compliance with
iki/CRS-RL32568misbranded, or non-FDA-approvedregistration conditions relating to the
g/wdrugs];sources of exported drugs; the
s.orinspection of facilities of the exporter
leakand the marking of compliant
shipments; the payment of fees;
://wikicompliance with Section 801(a)
httpstandards; being licensed as apharmacist; conditions for individual
importation from Canada; and
maintenance of records and samples.
The exporter must agree to exportThe importer or the exporter must
only qualified drugs;agree to not import or export any
nonqualifying drug.
to export only to persons authorizedThe exporter must agree to not export
to import the drug;a qualifying drug to anyone who is
not a registered importer, 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 not
a qualifying drug or that is not in
compliance with subsections (g). The



CRS-20
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
bond amount is the lesser of the value
of drugs exported by the exporter to
the United States in a typical
four-week period over the course of a
year under this section; or $1,000,000.
to submit to the jurisdiction of U.S.[814(b)(1)(C)] the name and address
courts and supply the name andof an agent for service of process in
address of its U.S. agent for service ofthe United States.
process;
iki/CRS-RL32568to monitor compliance with allregistration conditions, and correctThe registrant agrees to ensure andmonitor compliance with each
g/wand promptly report anyregistration condition, to promptly
s.ornoncompliance conditions to thecorrect any noncompliance, and to
leakSecretary;promptly report to the Secretary any
://wikisuch noncompliance; and
httpto submit a compliance plan thatto submit a plan as to how the
shows how the exporter will correctregistrant will comply with this
any violation;agreement.
to notify the Secretary of any changesThe exporter must agree to update any[814(b)(2)] timely notification of any
in information provided in theinformation provided in thechange in the information.
registration or in the compliance plan;registration or in the compliance plan.
and
to comply with any other conditionsThe Secretary may require other
for registration that the Secretaryconditions for registration that would
requires to protect the public healthprotect the public health while
while permitting imports.permitting imports of qualifying drugs
by pharmacies, groups of pharmacies,
wholesalers as registered importers,
and individuals.



CRS-21
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
The registrant must agree to notify the
Secretary of a recall or withdrawal of
a drug distributed in a permitted
country that the registrant has or
intends to 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 has notified
the registrant that imports may
proceed; and
iki/CRS-RL32568
g/wto enforce a contract under subsection
s.or(c)(3)(B) (records of chain-of-custodyof a drug) against a party in the chain
leakof custody of a qualifying drug and
://wikiunder the authority of the Secretary toinspect such statements to determine
httptheir accuracy and agree to
insp ectio ns.
814(d)(1). Authority. “Nothing in
this section authorizes the Secretary 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-22
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
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 importation
a prescription drug in violation of the
requirements of this section.
Section 8(c). Importation; Failure to
Register. Prohibits delivery of a
prescription drug until the drug
iki/CRS-RL32568importation facility, pharmacy,
g/wInternet pharmacy, or wholesaler is
s.orregistered. Requires that the drug be
leakheld in a secure facility and not be
transferred.
://wikicensing asNo provision.804(f). Licensing as a Pharmacy.804(h). Licensing as Pharmacist. ANo provision.


httparmacies andThe Secretary must determine that thecondition of registration is that the
armacistsexporter intending to export aexporter agrees that a qualifying drug
qualifying drug for personal use is (1)will be exported to an individual only
authorized under foreign law toif the Secretary has verified that the
dispense prescription drugs, and (2)exporter is authorized under Canadian
that the foreign countrys programs tolaw to dispense prescription drugs;
regulate pharmacists are comparableand the exporter employs enough
to U.S. state programs; or, if thepersons licensed under Canadian law
exporter is not a licensed pharmacist,to dispense prescription drugs to
that the exporter employs a sufficientdispense safely the qualifying drugs
number of pharmacists licensed byexported by the exporter to
one of the states and assigns to thoseindividuals, and the exporter assigns
pharmacists responsibility forto those persons responsibility for
dispensing drugs that individuals willdispensing such qualifying drugs to
import into the United States forindividuals.
personal use.

CRS-23
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
esNo provision.804(e). Fees. As a condition of804(e). Importer Fees. An importerSection 14. Adds to the FFDCA a
registration, an exporter must pay amust pay the Secretary a $10,000 feenew Section 740A, Fees Relating to
semi-annual fee with the first paymentalong with the registrationPrescription Drug Importation.
included with the registration. Thesubmission. In addition, the importerRequires the Secretary to establish a
aggregate fee total for each fiscal yearmust pay the Secretary a semiannualuser fee program under which a drug
must cover the costs of administeringfee.importation facility, pharmacy,
this program. These costs are forInternet pharmacy, or wholesaler
monitoring foreign facilities;The Secretary shall ensure that theregistering with the Secretary under
developing, implementing, andaggregate total of fees collected for aSection 814 shall be required to pay
maintaining a system to markfiscal year from all importers isthe Secretary a fee beginning for
shipments to indicate registrationsufficient, and no more thanFY2005. Directs the Secretary to
iki/CRS-RL32568compliance; and conductingnecessary, to pay the costs ofdetermine the amount annually based
g/winspections within the United States toadministering this section with respecton anticipated costs of enforcing this
s.ordetermine compliance with requiredto registered importers for a fiscalAct, publish the fee 60 days in
leakconditions for importers and foryear. These are costs for inspectingadvance of each fiscal year, hold a
imports for personal use. Thethe facilities of importers; reviewingpublic meeting and provide time for
://wikiSecretary may use these fees only forqualifying drugs offered for import topublic comment. Directs the
httpthese costs. For the first year,however, the Secretary may collect aimporters; and determining thecompliance of importers withSecretary to use the collected fees,without further appropriation, to
lesser aggregate total of fees takingregistration conditions. The aggregateenforce the Act.
into account the lesser number oftotal of fees collected shall not exceed
registered exporters and the capacity1% of the total price of drugsThe fee shall be payable annually and
of that group to pay the administrativeimported annually to the United Statesonly once for each facility. From 30
costs. Authorizes the collection of aby registered importers under thisdays after the due date, a registered
semi-annual fee from each exportersection.facility may not import a prescription
set by the Secretary as a pro rata sharedrug until all fees are paid.
of the aggregate costs, including theThe fee for an individual importer
number of employees that theshall be a reasonable estimate by theRequires the Secretary, 60 days after
Secretary has assigned to thatSecretary of the semiannual share ofthe end of FY2005 and annually
exporter.the importer of the volume of drugsthereafter, to submit a report to the
imported by importers. The SecretarySenate Committee on Health,
must annually adjust the fees toEducation, Labor, and Pensions and
accurately reflect the actual costs, andthe House Committee on Energy and
to not exceed, in the aggregate, 1% ofCommerce describing implementation
the total price of drugs importedof the user fee authority during the



CRS-24
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
annually to the United States byfiscal year and the use by the
registered importers under thisSecretary of the fees.
section. Subject to appropriations
acts, the fees collected by the
Secretary are available only to the
Secretary and are for the sole purpose
of paying the costs of administering
this program.
804(f). Exporter Fees. Requirements
for exporters are similar to the
iki/CRS-RL32568requirements for importers, as above,
g/wexcept that the aggregate exporter fees
s.ormust cover the cost of monitoring
leakforeign facilities; developing,
implementing, and sustaining a
://wikisystem to mark shipments to indicate
httpcompliance with all registrationconditions; and conducting
inspections within the United States to
determine compliance with conditions
for licensing exporting pharmacists
and for importation from Canada.
agingNo explicitly comparable provision;804(d)(2). Marking of Compliant804(d)(2). Marking of CompliantSection 15(b). Anticounterfeiting
however, the law requires that allShipments. The exporter must agreeShipments. Same as S. 2307.Provisions; Electronic Track and
imported drugs be FDA-approved andto mark each shipping container ofTrace Technology. Directs the
carry the FDA-approved labeling.drugs identifying that the shipment isSecretary to require, no later than
in compliance with all registrationDecember 31, 2007, the adoption and
conditions. The markings mayuse of electronic track and trace
include anti-counterfeiting or track-technology for a prescription drug at
and-trace technologies and shall bethe case and pallet level that will
designed to prevent unauthorizedidentify each sale, purchase, or trade
affixation.of that case or pallet (including the
date of transmission and the names



CRS-25
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
and addresses of all parties to the
tr ansactio n) .
804(h). Approved Labeling. Requires804(g)(3)(A). Labeling; Importation804(g)(3)(A). Section 502; Labeling;813(c). Approved Labeling. Requires
a drug manufacturer to give theby Importer. If a qualifying drug isImportation by Registered Importer.that a drug importation facility
importer written authorization to use,offered to a pharmacist or wholesalerIf an importer imports a qualifyingdemonstrate to the Secretary that the
at no cost, the approved labeling forfor import or is imported, it must beardrug, the drug must bear the labelinglabeling of the prescription drug to be
the prescription drug.a copy of the labeling approved byapproved for the drug by FDA,imported into the United States
FDA, whether or not the copy bearswithout regard to whether the copycomplies with the requirements of
the trademark involved. Thebears the trademark. The label mustSections 502 [adulteration] and 503
Secretary shall provide a copy of theinclude the name and location of the[misbranding]. Requires that the
iki/CRS-RL32568approved labeling to the registeredmanufacturer, the lot number assignedSecretary approve or deny the
g/wexporters upon request.by the manufacturer; and the name,application within 60 days of receipt
s.orlocation, and registration number ofthe importer. The Secretary shalland notify the applicant of thedecision and, if the application is
leakprovide a copy to the registereddenied, provide the reason for the
://wikiimporter involved, upon request of theimporter.denial. Requires the Secretary tomaintain an up-to-date list of
httpapplication status.
813(e). Prohibition of Commingling.
Prohibits a drug importation facility,
pharmacy, Internet pharmacy, or
wholesaler from commingling
imported and not imported
prescription drugs. Requires that a
pharmacy or Internet pharmacy that
dispenses a prescription drug
imported from Canada or a permitted
country affix on each dispensed
container of the drug the label
required by FDA unless such a label
is already affixed to the container.
804(g)(3)(B). Labeling; Importation804(g)(3)(B). Section 502; Labeling;
by Individual. If a drug is importedImportation by Individual. If a drug



CRS-26
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
by an individual, it must bear a labelis imported by a registered exporter to
providing the directions for use by thean individual, the drug must bear a
consumer, and a copy of any speciallabel providing the directions for use
labeling that would be required by theby the consumer, and bear a copy of
Secretary had the drug been dispensedany special labeling that would be
by a pharmacist in the United States,required by the Secretary had the drug
without regard to whether the specialbeen dispensed by a pharmacist in the
labeling bears the trademark involved.United States, without regard to
The Secretary shall provide to thewhether the special labeling bears the
registered exporter involved a copy oftrademark involved. The Secretary
the special labeling, upon request ofshall provide to the registered
iki/CRS-RL32568the exporter.exporter involved a copy of the
g/wspecial labeling, upon request of the
s.or exporter.
leak804(d)(1). Information and Records.Section 804(c) requires, among other804(j). Maintenance of Records andSection 15(a). Anticounterfeiting
://wikiDrug importers must provideinformation that includes: the namecriteria, the manufacturer to provide achain-of-custody statement to theSamples. Both importers andexporters must maintain recordsProvisions; Required Records.Requires the wholesale distributor to
httpand amount of the active ingredient ofexporter.required under this section for not lesscreate and maintain for two years
the drug, the dosage form of the drug,than two years; and maintain samplesavailable to the Secretary, for each
the date the drug is shipped, theof each lot of a drug required underwholesale distribution, records of the
quantity shipped, information aboutthis section for not less than twoimmediately previous and
its origin and destination, the priceyears.immediately subsequent distributors
paid by the importer, the originalof record; and, for each imported
source of the drug, the amount of eachdrug, records of each previous and
lot received from that source, theeach subsequent distributor, as
manufacturer’s lot or control number,feasible.
and the importer’s name, address, and
license number.Section 9. Adds to the FFDCA a new
Section 815, Maintenance and
For a prescription drug importedInspection of Records for Prescription
directly from the first foreignDrugs. Authorizes the Secretary to
recipient from the manufacturer, thereestablish, by regulation, requirements
must be documentation indicating thatrelating to the establishment and
the drug came directly from themaintenance, for not longer than two
manufacturer and was subsequentlyyears, of records by a drug



CRS-27
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
shipped by that recipient to theimportation facility, pharmacy,
importer; that the amount beingInternet pharmacy, or wholesaler
imported is not greater than theengaged in the importation of
quantity that was originally received;prescription drugs into the United
and verification that each batch of theStates, or in the dispensing of such
drug has been statistically sampleddrugs; and any person that processes,
and tested for authenticity andpackages, distributes, receives, holds,
degradation prior to importation.or transports a prescription drug
Samples of subsequent shipments ofimported under this subchapter.
these drugs must also be tested for
authenticity and degradation.If the Secretary has reason to believe
iki/CRS-RL32568that an imported prescription drug
g/wFor a prescription drug not importedpresents a risk to the public health,
s.ordirectly from the first recipient in therequires that the drug importation
leakforeign country, there must befacility, pharmacy, Internet pharmacy,
documentation demonstrating thator wholesaler that imports the
://wikieach batch in each shipment of theprescription drug, and each person
httpdrug has been statistically sampledand tested for authenticity andthat processes, packages, distributes,receives, holds, or transports the
degradation prior to importation.prescription drug permit the
Secretarys officer or employee, with
Also, the importer or manufacturerappropriate credentials and a written
must certify that the drug is FDA-notice, “at reasonable times, within
approved, properly labeled, notreasonable limits and in a reasonable
adulterated, and not misbranded,manner,” to have access to and copy
provide laboratory records ofall records, in any format, at any
authenticity testing, including data,location, needed to determine whether
and evidence that testing wasthe prescription drug presents a risk to
conducted in an approved U.S.the public health. Requires the
laboratory. The importer is requiredSecretary to prevent the unauthorized
to provide any other information thatdisclosure of any trade secret,
the Secretary determines is necessaryconfidential, or privileged
to ensure the public health.information. The Secretarys
requirements do not apply to
personal-use imports.



CRS-28
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
804(d)(2). Maintenance by theImporters of drugs are to maintain
Secretary. Records regardingrecords for two years.
imported prescription drugscovered
products must be provided to the
Secretary, and then kept for such time
as the Secretary determines to be
appropriate.
anufacturerNo provision.804(g)(2)(B). Approval Status;804(g)(2)(C). Section 505; ApprovalNo provision.


irementsPetition by Manufacturer; GeneralStatus; Notice by Manufacturer;
Provisions. A drug manufacturer mayGeneral Provisions. A manufacturer
iki/CRS-RL32568file a petition with the Secretaryof any drug that may be imported
g/wrequesting that a drugs import cease.must submit to the Secretary a notice
s.orThe petition must claim that the drugis changed from the U.S. label drug inthat includes each difference in thedrug from a condition established in
leaka manner that, if made to the U.S.the approved application for the U.S.
://wikilabel drug in the United States, wouldneed a supplemental application. Thelabel drug beyond the variationsprovided for in the application; any
httppetition must also state whether,difference in labeling; the date on
under FDA regulations, the changewhich the drug with such difference
could be made pending anwas, or will be, introduced for
applications approval or whether, incommercial distribution in a permitted
consideration of a bioequivalencecountry; and such additional
matter, the changed drug could not beinformation as the Secretary may
sold before such an approval. Therequire; or states that there is no
manufacturer’s chief executivedifference in the drug from a
officer, chief legal counsel, and chiefcondition established in the approved
medical officer must each certify thatapplication for the U.S. label drug
the information in the petition isbeyond the variations provided for in
complete and true. Unless the petitionthe application and differences in
makes a nonequivalence claim, thelabeling.
petitioner pays a fee that is equivalent
to the PDUFA fee established for aThe manufacturer must notify the
human drug application for whichgovernment of the permitted country
clinical data on safety or effectivenessthat has approved (or has an
is required for approval. Subject toapplication pending) the drugs

CRS-29
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
appropriations acts, the collected feescommercial distribution that it is
are available to the Secretary to payfiling this notice. The notice must
for administering this section. Theinclude the material (with verified
Secretary must grant or deny aEnglish translation, if necessary) that
petition within 180 days of its filing.the manufacturer submitted to the
permitted country in seeking
marketing approval. The chief
executive officer and the chief
medical officer of the manufacturer
involved must each certify in the
notice that the information provided is
iki/CRS-RL32568complete and true; and provide a copy
g/wof the notice to the Federal Trade
s.orCommission and to the Assistant
leakAttorney General in charge of the
Antitrust Division of the Department
://wikiof Justice.
httpIf a notice submitted shows that the
difference would require the
submission of a supplemental
application if made as a change to the
U.S. label drug, the person that
submits the notice shall pay to the
Secretary a fee in the same amount as
would apply if the person were paying
a PDUFA fee for a supplemental
application. Subject to appropriations
Acts, fees collected by the Secretary
are available only to the Secretary and
are for the sole purpose of paying the
costs of reviewing notices.
Timing of notice submission to the
Secretary:



CRS-30
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
For a notice regarding drug
differences that would require
approval 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
country, unless the country requires
that earlier distribution, in which case
the notice must be submitted no later
than the day the drug is commercially
iki/CRS-RL32568introduced in that country, and
g/wannually thereafter. For a notice
s.orregarding drug differences that would
leakrequire a supplemental application but
not require pre-market approval or for
://wikia drug that would not require a
httpsupplemental application, the noticemust be submitted no later than the
day the drug is commercially
introduced in that country.
The Secretary shall treat these notices
as if they related to a manufacturing
change to the U.S. label drug under
Section 506A of the FFDCA; and
shall review and approve or
disapprove the notice within 120 days
of its submission. If the review would
require an inspection by the Secretary
of the manufacturing establishment,
such inspection shall be authorized.
Through the Internet website of the
Food and Drug Administration, the
Secretary shall readily make available



CRS-31
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
to the public a list of notices
submitted and the status of the
Secretarys review, including
determinations. The Secretary shall
promptly update the Internet website
with any changes to the list.
804(g)(2)(D). Approval Status;804(g)(2)(D). Notice; Drug
Petition; Drug Changes RequiringDifference Requiring Prior Approval.
Prior Approval. A petition raising aIf the notice regarding an imported
“bioequivalence consideration”drug shows that it requires the
iki/CRS-RL32568claims either a “possibleapproval of a supplemental
g/wnonequivalence claim or aapplication before the difference
s.or“nonequivalence claim.” If thepetition raises a possiblecould be make to the U.S. label drug,the Secretary must notify registered
leaknonequivalence claim, the petitioningexporters, registered importers, the
://wikimanufacturer must notify the foreigncountry that approved the drug forFederal Trade Commission, and theAssistant Attorney General that the
httpcommercial distribution in writingnotice has been submitted with
that there is a claim submitted to therespect to the drug involved. If the
Secretary and that the petition hasSecretary has not made a
with it the information submitted todetermination whether a supplemental
the foreign country to obtain anapplication regarding the U.S. label
approval there. The drug maydrug would be approved or
continue to be imported and receiversdisapproved by the date on which the
are notified that there is a possibledrug involved is to be introduced for
nonequivalence claim. If thecommercial distribution in a permitted
Secretary decides that the petitioncountry, the Secretary must order that
drug is not bioequivalent, then thethe importation of the drug involved
Secretary may grant the petition andfrom the permitted country cease
imports may cease.during the period in which the
Secretary completes review of the
If the petition makes anotice; and promptly notify registered
nonequivalence claim, the Secretaryexporters, registered importers, the
must order imports to cease during theFederal Trade Commission, and the
petition review, and if the finding isAttorney General of the order. If the



CRS-32
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
that the drug is not bioequivalent,Secretary decides that such a
then the order to cease importssupplemental application regarding
continues.the U.S. label drug would not be
approved, the Secretary shall stop all
If a petition makes a possible-importation of the drug involved from
nonequivalence claim or athe permitted country, and notify the
nonequivalence claim and if thepermitted country that approved the
petition drug was approved fordrug for commercial distribution of
commercial distribution by FDAthe determination; and promptly
and/or a foreign government on ornotify registered exporters, registered
after January 1, 2004, the Secretaryimporters, the Federal Trade
iki/CRS-RL32568may not accept the petition unless theCommission, and the Assistant
g/wpetitioner submits informationAttorney General of the
s.orshowing that: (1) the drugs differ duedetermination. If the Secretary
leakto a difference in the legal approvaldetermines that the supplemental
requirements between the U.S. andapplication regarding the U.S. label
://wikithe foreign country; or (2) thedrug would be approved, the
httppetitioner has submitted asupplemental application to theSecretary shall vacate the order tocease trade, if any, and permit
Secretary or to the foreignimportation of the drug and promptly
government to remove the differencenotify registered exporters, registered
between the petition drug and the U.S.importers, the Federal Trade
label drug. If the Secretary ceasedCommission, and the Assistant
imports of a drug, the Secretary shallAttorney General of the
rescind the order promptly after adetermination.
supplemental application is approved.
The Secretary must rescind any order
if false, fictitious, or fraudulent
statements in the petition influenced
the Secretarys decision.
804(g)(2)(C). Approval Status;804(g)(2)(E). Notice; Drug
Petition; Drug Changes NotDifference Not Requiring Prior
Requiring Prior Approval. For aApproval. If the imported drug does
petition drug which would have beennot require the approval of a
allowed to be sold pending thesupplemental application before the



CRS-33
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
supplemental application approval,difference could be made to the U.S.
the importation may continue whilelabel drug the following shall occur:
the Secretary considers theDuring the period in which the notice
manufacturer’s petition to ceaseis being reviewed by the Secretary,
importation. For importation tothe authority under this subsection to
continue, the importer must inform allimport the drug involved continues in
purchasers that the manufacturer iseffect. If the Secretary determines
making a claim that the drug isthat such a supplemental application
different than the U.S. label drug andregarding the U.S. label drug would
the registered exporter must notify allnot be approved, the Secretary shall
individuals importing the drug fromorder that the importation of the drug
iki/CRS-RL32568the exporter for individual personalinvolved from the permitted country
g/wuse that the manufacturer is makingcease, shall notify the permitted
s.orthe claim. If the Secretary decidescountry that approved the drug for
leakthat the supplemental applicationcommercial distribution of the
regarding the U.S. label drug woulddetermination, and shall promptly
://wikinot be approved, the Secretary shallnotify registered exporters, registered
httpgrant the petition and order thatimports of that drug cease.importers, the Federal TradeCommission, and the Assistant
Attorney General of the
d e ter minatio n.
804(g)(2)(F). Notice; Drug
Difference Not Requiring Approval;
No Difference. If the differences
between the U.S. label drug and the
drug to be commercially distributed in
a permitted country would not require
a supplemental application, the
Secretary may not stop the
importation and shall promptly notify
registered exporters and registered
imp o r ter s.



CRS-34
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
804(g)(2)(G). Differences in Active
Ingredients, Route of Administration,
Dosage Form, or Strength. A
manufacturer of a U.S. label drug
must submit an application under
Section 505(b) [new drug approval]
of the FFDCA for a drug that it
manufactures for distribution in a
permitted country when each active
ingredient of the drug is related to an
active ingredient of the U.S. label
iki/CRS-RL32568drug [for purposes of this application,
g/wactive ingredients are related if they
s.orarethe same; or different salts,
leakesters, or complexes of the same
moiety.”], and there is no drug for
://wikiexport from at least half of the
httppermitted countries with the sameactive ingredients, route of
administration, dosage form, and
strength as the U.S. label drug. The
application must request approval of
the drug for the indications 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 drugs
commercial distribution; include a
right of reference to the application
under Section 505(b) for the U.S.
label drug; and include such
additional information as the
Secretary may require. This



CRS-35
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
application shall be submitted to the
Secretary not later than the day on
which the previous information is
submitted to the government of the
permitted country. The Secretary
shall promptly notify registered
exporters, registered importers, the
Federal Trade Commission, and the
Assistant Attorney General of a
determination to approve or to
disapprove an application.
iki/CRS-RL32568
g/ws804(l)(1). Commencement ofNo provision.No provision.No provision.
s.ornsProgram. The drug import programcan begin only if the Secretary first
leakcertifies to Congress that its
://wikiimplementation would pose noadditional risk to public health and
httpsafety, and would result in a
significant reduction in the cost of
covered products to American
c o nsume r s.
804(l)(2). Termination of Program.No provision.No provision.No provision.


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

CRS-36
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
certification is 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
an increased risk to the public health;
identifies, in qualitative and
quantitative terms, the nature and
causes of the increased risk; considers
whether measures can be taken to
avoid, reduce, or mitigate the
iki/CRS-RL32568increased risk and, if those measures
g/wwould require additional statutory
s.orauthority, to report to Congress
leakdescribing needed legislation;
identifies, in qualitative and
://wikiquantitative terms, the benefits that
httpwould 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 detriment with
those benefits and determines the
benefits do not outweigh the
d e tr iment.
804(g). Suspension of Importations.804(b)(4). Suspension and804(b)(4). Suspension andSection 6. Adds new Section 817,
If the Secretary discovers a pattern ofTermination. The Secretary mayTermination. Same as S. 2307, exceptSuspension of Importation. Allows
counterfeit or violative products, thesuspend a registration if, after noticeit refers to the importer as well as thethe Secretary to immediately order the
agency must suspend importation ofand opportunity for a hearing, theexporter.suspension of the importation of a
that specific prescription drug or thatexporter fails to maintain substantialparticular prescription drug or a
specific importer. The suspensioncompliance with registrationparticular dosage form by a drug
must stay in effect until the Secretaryconditions. In addition, the Secretaryimportation facility, pharmacy,
investigates and determines whethershall suspend immediately, withoutInternet pharmacy, or wholesaler or a



CRS-37
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
the public is being adequatelyprior notice, the exporter’scountry (but not an individual
protected from counterfeit andregistration if the exporter hasimporting for personal use or an
violative drug products under existingexported a non-qualifying drug, notindividual engaged in an Internet
regulations.met the requirements relating to apharmacy transaction) if the Secretary
U.S. label drug, or exported a drug todetermines it presents a risk to the
an individual who did not meet thepublic health. Allows this action to
conditions under law. The Secretarybe appealed; requires that the
must give the exporter a hearingSecretary, after providing opportunity
within 10 days of the suspension. Iffor an informal hearing, confirm or
the Secretary determines that thereterminate the order within 30 days.
would be no further violations, theAn order under this section shall not
iki/CRS-RL32568Secretary may reinstate the suspendedbe subject to judicial review.
g/w r e gi st r a t i o n.
s.orIf the Secretary determines that a drug
leakAfter notice and the opportunity for aimportation facility, pharmacy,
hearing, the Secretary may terminateInternet pharmacy, or wholesaler, or a
://wikia registration if the exporter has acountry (but not an individual
httppattern or practice of violating one ormore registration condition. Theimporting for personal use or anindividual engaged in an Internet
Secretary may terminate a registrationpharmacy transaction) is engaged in a
permanently or for a fixed period ofpattern of importation that violates the
not less than one year. A registrationAct’s requirements, the Secretary may
will have no legal effect if, during theimmediately order suspension of
period in which a registration isimportation of prescription drugs
terminated, the exporter or a partnerfrom that person or country.
or principal officer of the enterprise
assisted in the preparation of theAllows that this action be appealed;
registration.and requires the Secretary, after
providing opportunity for an informal
hearing, to confirm or terminate the
order within 30 days. An order under
this section shall not be subject to
judicial review.



CRS-38
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
804(k). Construction. Nothing in this813(i). Effect of Section. Similar to
section limits the Secretarys authoritycurrent law. Nothing in this section
relating to the importation of[Pharmacy and Wholesaler
prescription drugs, other than withImportation of Prescription Drugs]
respect to Section 801(d)(1), whichlimits the authority of the Secretary
allows only the manufacturer torelating to the importation of
import a prescription drug.prescription drugs (including the
interdiction of prescription drugs that
are unapproved, adulterated, or
misbranded), other than with respect
to the banning of anyone other than
iki/CRS-RL32568the manufacturer from importing a
g/wprescription drug that had been
s.orsupplied as a charitable contribution.
leak804(b)(2). Approval or disapproval804(b)(2). Approval or disapproval814(b)(3). Requires the Secretary,
://wikiof registration. The Secretary mustapprove or disapprove a registrationof registration. Same as S. 2307.not later than 60 days after receipt ofa completed registration, to assign a
httpwithin 90-days of its submission. Ifregistration number to each registered
the registration is disapproved, thedrug importation facility, pharmacy,
Secretary must notify the exporter asInternet pharmacy, and wholesaler,
to why. After a registration has beenand notify the registrant of the receipt
denied, if and when the exporter is inof the registration.
compliance, the Secretary must notify
the exporter. Within 30 days of814(c). Requires that the Secretary
receiving an exporter’s complianceprovide for and require electronic
plan, described above, the Secretaryfiling of registrations, with adequate
must decide if the change affects theauthentication protocols to allow
exporter’s registration approval andidentification of the registrant and
inform the exporter.validation of the data.
804(b)(3). Publication of Contact804(b)(3). Publication of ContactRequires that the Secretary keep an
Information for Registered Exporters.Information for Registered Exporters.up-to-date list of registrants and make
The Secretary shall post publicly onSame as S. 2307 except it does notit available to the public on an
the FDA website a list of registeredrequire a requested link on the FDAInternet website and through a
exporters, including contactwebsite to the Internet site of thetoll-free telephone number.



CRS-39
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
information; update this information;exporter.
and provide, if requested by the
exporter, a link to the exporters
we b site.
ies andSection 1122. Study and Report on804(a)(4)(B)(ii). Report. Within 18No provision.811*(4)(B). Report. Requires that
sImportation of Drugs. The lawmonths after enactment, the Secretarythe Secretary, three years after
requires the Secretary, in consultationmust submit to Congress a report thatenactment, submit to the Senate
with appropriate governmentdescribes the impact of the new drugCommittee on Health, Education,
agencies, to conduct a study on theimport program on the safety andLabor, and Pensions and the House
importation of drugs in the Unitedintegrity of the U.S. prescription drugCommittee on Energy and Commerce
iki/CRS-RL32568States pursuant to Section 804 of thedistribution system, the prevalence ina report that includes a list of
g/wFederal Food, Drug, and Cosmeticthe United States of counterfeit,permitted countries and why the
s.orAct (as added by Section 1121 of P.L.108-173). The Secretary shall submitadulterated, or misbranded drugs, andpatient drug therapy; describes theSecretary determined that drugimports from such countries would
leakthe report to Congress not later thanpotential impact of permitting importsnot increase risk to the public health.
://wiki12 months after the enactment of thisAct.from additional countries; includesproposed legislation to improve theRequires the Secretary to list thosecountries from which prescription
httpsafety, efficiency, and efficacy of thedrug imports are not permitted and
Section 1123. Study and Report ondrug importation program. Requireswhy and what possible actions those
Trade in Pharmaceuticals. The lawthe Secretary also, in consultationcountries might take to avoid, reduce,
requires the President’s designees towith the Federal Trade Commission,or mitigate increased risk. Authorizes
conduct a study and report on issuesto evaluate the extent to which thethe Secretary to determine whether to
related to trade and pharmaceuticals.new import program achieves lowerdesignate as permitted other countries
[The conference report on H.R. 1,prices through competition in the U.S.at any time after submission of the
which became P.L. 108-173, providesprescription drug market, and toreport.
detail regarding the reports requiredidentify how the import program
by Sections 1122 and 1123.]could be improved to meet thatAdds [in Sec. 4 and Sec. 14] new
objective.FFDCA sections 511(f) and 740A to
require the Secretary to report to
Congress annually on the
implementation of the user fee
authority and the use of those fees.
forcementNo provision.Section 3(b). Prohibited Acts.Section 4(b). Prohibited Acts.Section 2(c). Prohibited Act.
Amends Section 301 of the FFDCA,Similar to S. 2307, but refers to saleAmends Section 301 of the FFDCA



CRS-40
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
as amended by Section 1121(b) ofby a pharmacist rather than anby prohibiting the dispensing or
P.L. 108-173, to prohibit the importerimporter.offering to dispense a prescription
of a qualifying drug, imported fordrug imported into the United States
commercial purposes, to sell that drugin violation of the requirements of the
unless the drug is sold at retail as it isnew Section 813 (relating to
dispensed to a customer of thepharmacy and wholesaler
importer, or is sold or traded to theimportation).
registered exporter from which the
importer imported the drug. It also
prohibits an individual who imports
the drug for personal use from selling
iki/CRS-RL32568or trading that drug. Prohibits making
g/wfalse, fictitious, or fraudulent
s.orstatements in filing a petition to stop a
leakdrugs importation; if made, requires
the maker to be imprisoned not more
://wikithan 10 years, fined, or both.
httpSection 3(c). Civil Penalty. Amends
Section 303 of the FFDCA to make
technical corrections to the numbering
of the provision. A person who
knowingly violates the revised Act by
providing false statements that were a
material factor in the Secretarys
decision to issue an order to cease
importation is liable for a civil penalty
not to exceed a reasonable estimate of
the gross revenue that would have
been collected from sales of
qualifying drugs by the registered
exporter during the period for which
the order was in effect.
Section 3(e). Amendment of Certain
Provision. The Secretary may not



CRS-41
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
send a warning notice to an individual
who is importing a qualifying drug for
personal use unless the importation is
not in accordance with Section 804.
Section 4(e)(1). Anticompetitive
Practices Relating to Importing and
Exporting Drugs to the United States.
Amends the Clayton Act (15 USC 12
et seq.) to add a new Section: Section
27. Restraint of Trade Regarding
iki/CRS-RL32568Prescription Drugs.
g/w
s.orSection 27(a) makes it “unlawful forany person engaged in commerce ...”
leakto charge a price to, deny or restrict
://wikisupplies to, or refuse to do businesswith a registered exporter, other
httpperson that exports prescription drugs
to the United States, a registered
importer, or other person that
distributes, sells, or uses prescription
drugs imported to the United States
under Section 804 of the FFDCA
more than to others who do not export
or import under Section 804. It is
also unlawful to fail to submit a
required manufacturer notice in the
required time or provide information
requested by the Secretary; to submit
a notice witha materially false,
fictitious, or fraudulent statement;”
fail to submit a timely application
regarding differences between the
drug that may be imported and
another drug; to fail to provide a copy



CRS-42
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
to the permitted country; to make
false statements; or to fail to timely
provide information requested by the
Secretary; to “cause there to be a
difference (including a difference in
active ingredient, route of
administration, dosage form, strength,
formulation, manufacturing
establishment, manufacturing process,
or person that manufactures the drug)
between a prescription drug for
iki/CRS-RL32568distribution in the United States and a
g/wprescription drug for distribution in
s.orAustralia, Canada, a member country
leakof the European Union as of January
1, 2003, Japan, New Zealand, or
://wikiSwitzerland for the purpose of
httprestricting importation of the drug tothe United States ...”; to refuse to
allow a required inspection or fail to
conform to good manufacturing
practice; or to “engage in any other
action that the Federal Trade
Commission determines to unfairly
restrict competition under Section 804
....”
Section 27(b). Presumption.A
difference (including a difference in
active ingredient, route of
administration, dosage form, strength,
formulation, manufacturing
establishment, manufacturing process,
or person that manufactures the drug)
between a prescription drug for
distribution in the United States and a



CRS-43
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
prescription drug for distribution in
a permitted country in Section 804 of
the FFDCAmade after January 1,
2004, shall be presumed to be for the
purpose of restricting importation of
the drug to the United States unless
(1) ... the difference was required by
the country in which the drug is
distributed; (2) the Secretary ...
determines that the difference was
necessary to improve the safety or
iki/CRS-RL32568efficacy of the drug; or (3) the person
g/wmanufacturing the drug for
s.ordistribution in the United States has
leakgiven notice to the Secretary ... that
the drug for distribution in the United
://wikiStates is not different from a drug for
httpdistribution in ...” at least half of thepermitted countries.
Section 27(c). Affirmative Defense.
“It shall be an affirmative defense to
a charge that a person has violated
paragraph (1), (2), (3), (4), or (5) of
subsection (a) that the higher prices
charged for prescription drugs sold to
a person, the denial of supplies of
prescription drugs to a person, the
refusal to do business with a person,
or the specific restriction or delay of
supplies to a person is not based, in
whole or in part, on (1) the person
exporting or importing prescription
drugs to the United States ...; or (2)
the person distributing, selling, or
using prescription drugs imported to
the United States....”



CRS-44
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
Section 27(d). Definitions. Applies
the definitions in Section 503(b)(1) of
the FFDCA for prescription drug, and
in new Section 804 for registered
importer and registered exporter.
Section 4(e)(2). Applicability of
Amendments to Importation Under
the Pharmaceutical Market Access
and Fair Trade Act of 2004. [sic; S.
2328 was renamed the
iki/CRS-RL32568Pharmaceutical Market Access and
g/wDrug Safety Act of 2004 before it was
s.orintroduced.] Section 27 of theClayton Act shall apply to personal-
leakuse importation from Canada. A
://wikinotice filed under paragraph 6 abovewill apply to notices required in new
httpSection 804(g)(2)(C)(i) that are not
submitted by the dates required under
(c)(1)(C,D).
Section 4(f). Exhaustion. Amends
Section 271 of Title 35 USC by
inserting a new subsection 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 in the United States
without regard to the U.S. patent.
Section 6. Civil Actions RegardingSection 7. Civil Actions RegardingSection 7. Debarment for Repeated
Property. Amends Section 303 of theProperty. Same as S. 2307.or Serious Drug Importation
FFDCA: Penalties by adding (g)(1) toViolations. Amends Section 306(b)



CRS-45
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
authorize the Attorney General toof the FFDCA to allow the Secretary
commence civil action in any federalto debar a person (other than an
court if a person is importing a drugindividual importing for personal use
that violates the Act. The court actionor an individual engaged in an
may enjoin the alienation orInternet pharmacy transaction) from
disposition of property or issue aimporting a prescription drug for up
restraining order to prohibit anyto five years if the personhas been
person from withdrawing,convicted of a felony for conduct
transferring, removing, dissipating, orrelating to the importation into the
disposing of such property or propertyUnited States of any prescription
of equivalent value; and to appoint adrug; or ... has engaged in a pattern of
iki/CRS-RL32568temporary receiver to administer theimporting or offering for import a
g/worder. Such proceedings must beprescription drug that presents a risk
s.orcarried out in the same manner asto the public health.” Allows the
leakapplies under Section 1345 of Title 18Secretary to withdraw the debarment
USC [regarding injunctions againstif the conviction on which it was
://wikimail fraud].based is reversed or if it “serves the
httpinterests of justice and adequatelyprotects the integrity of the ...
prescription drug importation
process.
Section 7(e). Amends Section 801 by
adding a subsection (s), Importation
of 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, and
not otherwise be transferred. While
the prescription drug is held under a
bond, it may not be delivered. While
the drug is being held, prohibits 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



CRS-46
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
person if that person shows, at their
own expense, that the drug complies
with FFDCA requirements.
Section 9. Enforcement Through
Denial of Deduction for Certain
Advertising Expenses. Amends the
Internal Revenue Code of 1986 by
adding a new section: Section 280L.
Advertising Expenditures of
Taxpayers Who Discriminate Against
iki/CRS-RL32568Foreign Sellers of Prescription Drugs
g/wto Domestic Consumers. In general,
s.orno tax deduction is allowed unless thetaxpayer certifies that it took no direct
leakor indirect action to prevent or place
://wikiconditions on the authorizedimportation of a qualifying drug into
httpthe United States from a registered
exporter to a pharmacy or an
individual. The Secretary will decide
how the certification must be made
and what fees to charge to cover the
cost of confirming the certification.
Advertising includes direct-to-
consumer advertising and any activity
designed to promote the use of the
drug directed to providers or others
who may make decisions about a
drugs use (other than the provision of
free samples). The amendment will
apply to taxable years beginning after
enactment of this Act.
Section 10. Compliance Through
Allowance of Research and
Development Tax Credit. Amends



CRS-47
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
Section 41 of the Internal Revenue
Code of 1986 to increase the amount
of credit by 20% if the taxpayer
certifies that it has taken no direct or
indirect action to prevent the
authorized importation of qualifying
drugs into the United States from a
registered exporter to a pharmacy or
individual, and has not set conditions
on import terms. The Secretary will
decide how the certification is made
iki/CRS-RL32568and what fees should be charged to
g/wcover the costs of confirming the
s.or cer tificatio n.
leak804(j). Standards for Refusing804(g)(4). Section 501; Standards forSection 11. Authority to Mark
://wikiAdmission. A qualifying drug from aregistered exporter may be refusedRefusing Admission. Similar to S.2307. Numbers (1) through (4) applyPrescription Drugs RefusedAdmission into the United States.
httpentry into the United States only if:if the import is from a registeredAmends Section 801 of the FFDCA
the shipping container does not bearexporter to an individual.(as amended by Section 10(a) of this
the required markings; the containerAct) to allow the Secretary to require
or markings appear to be counterfeit804(i)(2). Notice Regarding Drugthe owner or consignee of the drug to
or appear to have been tampered with;Refused Admission. If a registeredlabel any prescription drug refused
the container appears damaged in aexporter ships a drug to an individualadmission indicating that, with the
way that could affect the strength,and the drug is refused admission toowner or consignee responsible for all
quality, or purity of the drug; thethe United States, a written noticelabeling expenses, until the Secretary
Secretary becomes aware that theshall be sent to the individual and todetermines that the prescription drug
drug may be counterfeit, beenthe exporter that informs them of thehas been brought into compliance
prepared, packed, or held underrefusal and the reason for the refusal.with this Act. Amends Section 502 of
insanitary conditions, or if the drugthe FFDCA so that if the prescription
was not made or stored under gooddrug does not carry the label after the
manufacturing processes; theSecretary has informed the owner, it
Secretary has obtained an injunctionshall be considered misbranded. This
against the drug, prohibitingdoes not apply to a personal-use
distribution in commerce, or hasimport or a commercial transaction
withdrawn the approval of the drug;between an Internet pharmacy and an
orindividual. This section does not limit



CRS-48
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
the authority of the [HHS] Secretary
or the Secretary of the Treasury to
require the marking of prescription
drugs refused admission under any
other provision of law.
if the manufacturer has instituted a804(k). Drug Recalls. A813(f). Drug Recalls. Requires that
recall of the drug.manufacturer of a drug imported froma drug importation facility promptly
a permitted country shall promptlyprovide the Secretary and any person
inform the Secretary if the drug isto whom the prescription drug was
recalled or withdrawn from thedistributed a notice that the drug has
iki/CRS-RL32568market in a permitted country; howbeen recalled or withdrawn from the
g/wthe drug may be identified, includingmarket. Requires that the notification
s.orlot number; and the reason for therecall or withdrawal. The Secretaryinclude identifying information(including the lot number) and the
leakshall enter into an agreement with thereason for the recall or withdrawal.
://wikigovernment of each permitted countryto receive information about recalls
httpand withdrawals of prescription drugs
in the country; or monitor recalls and
withdrawals of prescription drugs in
the country using any information that
is available to the public. The
Secretary may notify registered
exporters, registered importers,
wholesalers, pharmacies, or the public
of a recall or withdrawal of a
prescription drug.
Section 5(a). Creates a new SectionSection 6. Creates in the FFDCA aSection 5(a). Creates in the FFDCA a
805 in the FFDCA, Disposition ofnew Section 805. Disposition ofnew Section 816, Administrative
Certain Drugs Denied Admission, toCertain Drugs Denied Admission.Detention. An officer or qualified
establish that any import shipment ofSimilar to S. 2307 except it (1) refersemployee of the FDA may order the
drugs valued at less than $10,000 into the Secretary of Homeland Securitydetention of any prescription drug that
violation of standards set in Sectionsas the refuser of admission; (2) doesit believes to present a risk to the
801(a) or 801(d)(1) shall be refusednot state that this section does notpublic health. If the Secretary
admission. These standards aretransfer to the Secretary responsibilityapproves, requires that the drug be



CRS-49
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
referred to in Section 804(j) and meanfor carrying out this section; anddetained for up to 30 days, labeled as
that the drugs are not sufficientlystates that procedures for carrying outdetained and in a secure facility.
marked.this section shall be established withinUntil the Secretary releases the drug
90, rather than 30, days of enactmentor the detention period expires,
Drugs refused admission must beof this Act.prohibits the transfer of the drug from
destroyed unless the U.S. Attorneydetention, including delivery pursuant
General determines they are needed asto the execution of a bond. Allows
evidence or potential evidence. Inthe claimant to appeal the detention
general, refused admission andand the Secretary must confirm within
destruction of drugs may be donefive days or the order will be
without notice to the importer, owner,terminated.
iki/CRS-RL32568or consignee of the drugs, with
g/wreceipts and record keeping done on aSection 5(b) amends Section 801 of
s.orsummary basis to efficiently utilizethe FFDCA by adding a paragraph (r),
leakfederal resources. This section has noTemporary Hold at Port of Entry.
effect on laws regarding shipments ofWith approval by the Secretary or a
://wikidrugs that are valued equal to ordesignated official (director of the
httpgreater than $10,000, nor does thissection transfer to the Secretarydistrict in which the drug is located,or a senior official of the director),
responsibility for carrying out thisdirects an FDA officer or qualified
section. Procedures to carry out thisemployee who believes there is a risk
section must be established within 30to public health and was unable to
days of enactment of this Act.inspect to request the Secretary of the
Treasury to detain the prescription
drug for 24 hours to allow inspection.
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 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 between an Internet
pharmacy and an individual.



CRS-50
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
rsonal use804(j). Waiver Authority for804(i)(1). Personal Use; Conditions804(i)(1). Individuals; Conditions for812. Personal Importation. Allows
Importation by Individuals.for Importation. Individuals canImportation From Canada. Similar toan individual to import a prescription
804(j)(1). Declaration. Congressimport up to a 90-day supply of aS. 2307 except it also allows thedrug from Canada or a permitted
declares that the Secretary should usequalifying drug if the drug isprescribing practitioner to be licensedcountry into the United States for
discretion when enforcing the currentaccompanied by: a copy of awhere the individual receives care;personal use (not for resale) if the
legal prohibition against personsprescription that is valid under federalrefers to Canada specifically, ratherprescription drug is purchased from a
importing drugs or devices. Theand state laws and was issued by athan “the exporting country; andlicensed pharmacy in Canada or a
Secretary should focus enforcementpractitioner who, under the state lawrequires that the Canadian document,permitted country and dispensed in
on cases where the importing mayof which the individual resides, isin addition to the U.S. prescription, becompliance with that countrys
pose a significant threat to publicauthorized to administer drugs; amarked as filled. The individual mustapplicable laws; it is imported for
health. When the importation isstatement that provides sufficienthave given the registered exporter apersonal use (not for resale) by the
iki/CRS-RL32568clearly for personal use and theinformation for the Secretary tocomplete list of all drugs used by theindividual; it is imported physically
g/wprescription drug or device does notdetermine whether the prescriptionindividual for review by those whoby the individual; it does not exceed a
s.orappear to present an unreasonable riskmeets those regulations, including thedispense the drug.90-day supply during any 90-day
leakto the individual, the Secretary shouldprescribers licensure; and theperiod; and the prescription drug is
exercise discretion to permit thedocumentation required by theSection 4(c)(3). Not less than 15 daysaccompanied by a copy of a
://wikiimportation by the individual.exporting country to dispense a drug.after the enactment of this Act andprescription valid in a state and
http804(j)(3). The Secretary is requiredAll prescriptions must be marked toindicate they have been filled tountil 60 days from promulgation ofthe interim rule, the Secretary shall,cosigned by a prescribing physician inCanada or the permitted country or, if
to grant waivers, by regulation, soprevent duplicative filling by anotherthrough the Internet website of thethe prescription drug is available in
persons can import for personal usepharmacist. The Secretary canFood and Drug Administration, makeCanada or the permitted country
up to a 90-day supply of an FDA-prohibit from import drugs that werereadily available to the public a list ofwithout a prescription, a copy of the
approved prescription drug from aapproved under acceleratedpersons licensed in Canada tovalid prescription signed by a
licensed pharmacy in Canada, so longprocedures for serious or life-dispense prescription drugs who arepharmacist licensed in that country.
as the drugs final dosage form wasthreatening illness.willing to export drugs to individuals
made in an FDA-registered facility,in the United States.Compassionate Use. Authorizes the
came from a registered Canadian804(i)(2). The exporter must notifySecretary to permit an individual to
seller, was accompanied by a validthe individual carrying a qualifyingSection 4(c)(4). The provisions onimport up to a 90-day supply of a
prescription, and was imported underdrug into the United States fordisposal of drugs denied admissiondrug that is not approved by the
conditions the Secretary determinespersonal use that the shippingand civil action regarding propertySecretary under FFDCA Section 505
were necessary to ensure publiccontainer must be intact and be(Sections 6 and 7 of this bill) do notif the importation is for continuation
safety.marked as in compliance withapply to personal-use imports byof personal use by the individual for
requirements that the drug isindividuals.treatment, begun in a foreign country,
approved for distribution in aof a serious medical condition.


permitted country and isSection 4(d). Amendment of Certain
manufactured in a facility that alsoProvision [Section 801]. If a drug is
manufactures it for U.S. distribution;imported by a person not in the

CRS-51
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
and the drug has the same ingredients,importation business or shipped by an
route of administration, dosage form,unregistered exporter and is refused
and strength as the U.S. label drug.admission, the Secretary shall notify
the individual of the refusal, that the
804(i)(3). There is a presumption thatimport is not subject to a waiver, and
the drug imported isan approvedthat the individual may legally import
drug under Section 505(b)(1) if thecertain prescription drugs from
criteria described in subsectionregistered Canadian exporters, a list
(g)(A)(i-ii) are met.” [sic; probablyof which is posted on the FDA
should be (g)(2)(A)(i-ii)]website.
iki/CRS-RL32568Section 4. Additional WaiversSection 5. Additional Waivers
g/wRegarding Personal Importation;Regarding Personal Importation;
s.orEnforcement Policies of Secretary.Enforcement Policies of Secretary.
leakAmends Section 801 by establishingSimilar to S. 2307, except that it
a new category of waivers forrequires that the Secretary establish
://wikiindividuals and allows the Secretaryby regulation a waiver of standards
httpto establish by regulation a waiver ofthe requirement that onlyfor personal use imports if the drugwas dispensed to the individual while
manufacturers import drugs if thethat person was in a foreign country
drug was dispensed in the Unitedand met that countrys laws and
States by a licensed pharmacist orregulations. In addition, the quantity
practitioner and the individualof the imported drug may not exceed
traveled from the United States witha 90-day supply if the drug is
the drug, and the individual returns todispensed in Australia, Canada, a
the United States with the drug. Themember country of the European
drug cannot appear adulterated, andUnion as of January 1, 2003, Japan,
not be more than a 30-day supply. ItNew Zealand, or Switzerland;
must be accompanied by a statementotherwise, the limit is a 14-day
that the individual seeks to import thesupply.


drug under a personal import waiver,
and complies with such additional
standards the Secretary decides are
needed to protect the public health.
The Secretary may, by regulation,
waive standards for personal use

CRS-52
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
imports if the drug was dispensed to
the individual while that person was
in a foreign country, met that
country’s laws and regulations, and
was approved for commercial
distribution in the foreign country in
which the drug was obtained. The
drug is entering with the individual
and does not appear adulterated, does
not exceed a 10-day supply, has a
statement from the individual seeking
iki/CRS-RL32568to import the drug under a personal
g/wwaiver, and complies with such
s.oradditional standards that the Secretary
leakdetermines to be appropriate to
protect the public health. The
://wikiSecretary may not administer any
httpenforcement policy that permitsimports of drugs in violation of this
act or Section 351 of the Public
Health Service Act. The Secretarys
authority to establish waivers of the
standards in Section 801(a) of the
FFDCA for personal use imports is
not limited by this Act; waivers must
not, however, be more permissive
than current FDA regulatory#
gui d a nc e .
deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:
) when the intended use is appropriately identified, such use is not for treatment of a serious condition, and the product is not known to represent a significant health risk; or (2)
en (a) the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;
) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; (c) the product is considered not
epresent an unreasonable risk; and (d) the individual seeking to import the product affirms in writing that it is for the patients own use (generally not more than three month
pply)and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the
ntinuation of a treatment begun in a foreign country. FDA Regulatory Procedures Manual at [http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html].



CRS-53
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
emakingNo provision.Section 3(d)(1). Implementation;Section 4(c)(1)(A)(i). Section 8(b). Requires that the
esRulemaking. The Secretary mustImplementation; Rulemaking;Secretary, not later than one year after
publish, within 90 days of enactmentPromulgation by Secretary. Same asenactment, promulgate regulations to
and without notice and comment, anS. 2307.carry out Section 814 [to register
interim final rule for implementingprescription drug importation
Section 804; and publish a final rulefacilities].
by one year after the interim rule.
fective datesNo provision.Section 3(d)(2). Implementation;Section 4(c)(1)(A)(ii). Effect ofSection 2(b)(1)(B). Directs that
Personal Importation from Canada.Rules. An individual may import apersonal-use importation be allowed
Until 45-days after the promulgationprescription drug for personal orfrom enactment of this Act, even if
iki/CRS-RL32568of the interim final rule, an individualfamily-member use from a registeredthe Secretary has not issued
g/wmay import up to a 90-day supply ofexporter beginning when the interimregulations.
s.ora qualifying drug from Canada, forpersonal or family-member use,rule is promulgated.
leakaccording to conditions in this act.
://wikiA registered importer may import aSection 2(b)(2)(B). Directs that
httpprescription drug from Canadapharmacy and wholesaler importation
beginning when the interim rule isbe allowed one year after enactment
promulgated.of this Act even if the Secretary has
not issued regulations.
A registered importer may import a
prescription drug from the otherSection 8(b). Directs that registration
permitted countries beginning oneof prescription drug importation
year after enactment.facilities requirements take effect on
the effective date of the final
Section 4(c)(1)(B). Registrationsregulations or, if the final regulations
submitted by entities in Canada thathave not been made effective, one
are significant exporters ofyear after enactment.


prescription drugs to individuals in
the United States as of the date of the
enactment of this Act will have
review priority during the period in
which the interim rule is in effect.
The Secretary must approve or
disapprove of the registration within

CRS-54
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
30 days, rather than the 90-day limit
that this bill sets for approval or
disapproval of registration in general.
Section 4(c)(1)(C). Regarding drugs
to be imported from Canada, (1) a
manufacturer’s notice that, because of
differences from the U.S. label drug,
requires prior approval from the
Secretary must be submitted to the
Secretary within 30 days of
iki/CRS-RL32568enactment; (2) a notice regarding a
g/wdrug that does not require prior
s.orapproval must be submitted to the
leakSecretary within 90 days of
enactme nt.
://wiki
httpSection 4(c)(1)(D). For drugs to beimported from Australia, a member
country of the European Union as of
January 1, 2003, Japan, New Zealand,
or Switzerland, (1) a manufacturer’s
notice that, because of differences
from the U.S. label drug, requires
prior approval from the Secretary,
must be submitted to the Secretary
within 180 days of enactment; (2) a
notice regarding a drug that does not
require prior approval must be
submitted to the Secretary within 270
days of enactment.
Section 4(c)(2). Implementation;
Personal Importation from Canada.
For the 60 days after the interim rule
is promulgated, an individual may
import a prescription drug from



CRS-55
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
Canada for personal or family-
member use (rather than for resale),
according to conditions in this act.
propriations804(m). Authorization ofNo provision.No provision.No provision.
Appropriations. Authorizes to be
appropriated such sums as are
necessary to carry out this section.
otectionNo provision.No provision.No provision.Section 3. Protection Against
ainstAdulterated Prescription Drugs.
iki/CRS-RL32568ulteratedescriptionAmends Section 801(h) of theFFDCA [as added by P.L. 107-188] to
g/wugsinclude prescription drugs along with
s.orfood, as follows. Directs the
leakSecretary to give high priority to
://wikiimproving FDA informationmanagement systems to allow the
httpSecretary to better allocate resources,
detect the intentional adulteration, and
facilitate the importation of
prescription drugs. Also requires the
Secretary to improve linkages with
other federal regulatory agencies,
states and Indian tribes to ensure the
safety of imported prescription drugs.
ternetNo provision.No provision.No provision.Section 4. Adds to the FFDCA a new
armaciesSection 511, Internet Pharmacies.
511(a). Definitions. Defines the
terms “advertising service provider,”
designated payment system,”
federal functional regulator,”
restricted transaction,” “unlawful
Internet pharmacy request,” “credit,”
creditor,” “credit card,” “electronic



CRS-56
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
fund transfer,” “financial institution,”
money transmitting business,” and
money transmitting service.”
Includes references to the
Communications Act of 1934 [47
USC 230(f)], the Gramm-Leach-
Bliley Act [15 USC 6809; note: the
bill also cites 21 USC 6805(a),
perhaps in error], the Truth in
Lending Act [15 USC 1602], the
Electronic Fund Transfer Act [15
iki/CRS-RL32568USC 1693a], and the Uniform
g/wCommercial Code [Article 4A].
s.or
leakIn particular, definesInternet
pharmacy” as a person that dispenses
://wikior offers to dispense a prescription
httpdrug through an Internet website ininterstate commerce in the United
States regardless of whether the
physical location of the principal
place of business of the Internet
pharmacy is in the United States or in
another country. Defines “unlawful
Internet pharmacy request” as “the
request, or transmittal of a request,
made to an unlicensed Internet
pharmacy for a prescription drug by
mail (including a private carrier),
facsimile, phone, or electronic mail,
or by a means that involves the use, in
whole or in part, of the Internet.”
511(b,c). Licensing of Internet
Pharmacies. To dispense a
prescription drug to a person in the
United States, requires that an Internet



CRS-57
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
pharmacy be licensed with the
Secretary and have its principal place
of business in the United States,
Canada, or a permitted country.
Requires that the license application
include verification of compliance, in
each state in which the Internet
pharmacies seeks to dispense
prescription drugs, with all federal
and state laws regarding the practice
iki/CRS-RL32568of pharmacy and the manufacturing
g/wand distribution of controlled
s.orsubstances and, for an Internet
leakpharmacy in Canada or a permitted
country, verification regarding
://wikicompliance with applicable laws of
httpthat country. Also requires theapplication to 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 agreement between the Internet
pharmacy and a patient releasing
liability for negligence is null and
vo i d .
Identification 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;
names of all states or countries where
the pharmacy and pharmacists are
licensed or otherwise authorized to



CRS-58
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
dispense prescription drugs; name,
address, telephone number, and state
of licensure of any health 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.
Professional Services Requirements.
Requires an Internet pharmacy to
iki/CRS-RL32568maintain patient medication profiles,
g/wconduct prospective drug use reviews,
s.orensure patient confidentiality in
leakaccordance with the Health Insurance
Portability and Accountability Act of
://wiki1996, offer “interactive and
httpmeaningful consultation by a licensedpharmacist,” establish a mechanism to
report errors and suspected adverse
reactions and to document responses,
develop system to inform about drug
recalls, educate about disposal of
medications, assure saleis in
accordance with a prescription from
the treating provider of the
individual,” and verify prescription
validity by mail or electronic mail
receipt from the treating provider. If
the prescription is for a controlled
substance, the Internet pharmacy must
confirm with the treating provider that
the prescription is accurate and must
provide the individuals name and
address, identity and quantity of the
drug, date prescription was presented
to the Internet pharmacy, date and



CRS-59
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
time of the verification request, and
the name, telephone, fax, and e-mail
contacts of the Internet pharmacy
contact person. If the treating
provider does not respond within 72
hours or informs the pharmacy that
prescription is inaccurate or expired,
the Internet pharmacy may not fill
prescription. The Internet pharmacy
must maintain records of direct
communications with treating
iki/CRS-RL32568 provid ers.
g/w
s.orLicensure Procedure. Requires that
leakthe Secretary assign an ID number
and notify applicant of license
://wikiapplication receipt and issue a license
httpwithin 60 days if pharmacy complieswith 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.
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 days before the
start of each fiscal year, and allow 30
days for comment, the licensing fee



CRS-60
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
based on anticipated costs of
enforcing requirements of this section
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.
iki/CRS-RL32568Requires the Secretary, in 2005 and
g/weach subsequent year, to submit a
s.orreport to Congress describing the
leakimplementation of the licensing fee
authority and the use of the fees
://wikicollected. Allows the Secretary to
httpterminate a license if the Internetpharmacy has a pattern of
noncompliance, made an untrue
statement in the license application, or
is in violation of an applicable federal
or state law. Requires that, before
renewing 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.
511(d). Providers of Interactive
Computer Services or Advertising
Services. Establishes that these
providers are liable if they accept



CRS-61
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
advertising for a prescription drug
from an unlicensed Internet pharmacy
or accept advertising stating a
physicians prescription is not needed
to obtain a prescription drug.
511(e). Policies and Procedures
Required To Prevent Payments for
Unlawful Internet Pharmacy
Requests. Requires regulations within
a year of enactment regarding design
iki/CRS-RL32568(using, for example, authorization
g/wcodes) of the payment system (with
s.orsystem participant participation, if
leakfeasible) to prevent or block restricted
transactions. Establishes that there be
://wikino liability for blocking or refusing to
httphonor a restricted transaction.Requires that the Federal Trade
Commission and other federal
functional regulators (as defined in
the Gramm-Leach-Bliley Act, 15
USC 6809) enforce this section taking
into consideration the persons history
and extent of compliance, the extent
to which the person knew the
transaction related to an unlawful
Internet pharmacy request, and the
feasibility of any specific remedy.
511(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



CRS-62
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
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
year to the Secretary.
Section 4(b). Prohibited Acts.
Amends FFDCA Section 301, adding
violations of Section 511 including
drug sale or Internet pharmacy
iki/CRS-RL32568ownership, representing that a
g/wprescription drug may be obtained
s.orwithout a prescription, or accepting
leakadvertising from an Internet pharmacy
without having a copy of the
://wikipharmacys license on file.
httpSection 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 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.
Section 4(d). Requires that the
Secretary, within one year of
enactment, promulgate interim final
regulations consistent with the



CRS-63
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
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
iki/CRS-RL32568prescription drug from an unlicensed
g/wInternet pharmacy be refused
s.oradmission and that the Secretary
leakreturn it to the pharmacy at the
pharmacys expense. Directs the
://wikiSecretary to return to the pharmacy at
httpthe pharmacys expense a refusedshipment from a licensed Internet
pharmacy and to notify the individual
and the Internet pharmacy along with
the reason. Prohibits the return of a
prescription drug that is required to be
destroyed.
ohibition ofNo provision.No provision.No provision.813(a)(2). Limitation to Certain
shoppingPorts. Allows the Secretary to limit
to a reasonable number the 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



CRS-64
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
available to the public on an Internet
we b site.
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 reoffering
the prescription drug affirmatively
establishes, at the expense of the
owner or consignee of the
iki/CRS-RL32568prescription drug, that the prescription
g/wdrug complies with the applicable
s.orrequirements of this Act, as
leakdetermined by the Secretary. This
section does not apply to a personal-
://wikiuse import or to a commercial
httptransaction between an Internetpharmacy and an individual.
ti-Section 15(d). Anticounterfeiting
unterfeitingPrograms. Requires the Secretary to
ramsestablish a “Counterfeit Alert
Network to notify health
professionals and the public of
counterfeit drugs; develop, publish,
and keep up-to-date (quarterly) an
Internet accessible reference
document to identify prescription
drugs marketed in the United States,
Canada, and other countries as the
Secretary permits. Directs the
Secretary to develop and publish a
range of materials, including those to
help the identification and reporting
of counterfeit drugs, practice
guidelines (in cooperation with drug



CRS-65
S. 2307 (Grassley 4/8/04)
Current law:Reliable Entry for Medicines at
Medicare Prescription Drug,Everyday Discounts throughS. 2493 (Gregg 6/2/04)
Improvement, and ModernizationImportation with EffectiveS. 2328 (Dorgan 4/21/04)Safe Importation of Medical
Act of 2003, enacted 12/8/2003 asSafeguards (REMEDIES) Act ofPharmaceutical Market AccessProducts and Other Rx Therapies
picP.L. 108-173 [117 Stat. 2464]2004and Drug Safety Act of 2004(IMPORT) Act of 2004
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.


iki/CRS-RL32568
g/w
s.or
leak
://wiki
http