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

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

Order Code RL32568
CRS Report for Congress
Received through the CRS Web
Senate Prescription Drug Importation Legislation:
A Side-by-Side Comparison of Current Law,
S. 2307, S. 2328, and S. 2493
September 7, 2004
-name redacted- and -name redacted-
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
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 (name redacted) and (name redacted),
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 (name redacted) and
(name redacted). For an analysis of the issues involved in drug importation, see CRS Report
RL32511, Importing Prescription Drugs: Objectives, Options, and Outlook, by (name redacted)
and (name redacted).
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.

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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.

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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.

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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].

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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.

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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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
Legislation
Section 804 of the Federal Food,
Section 2. Repeals Section 804 of the
Section 3. Repeals Section 804 of the
Section 2. Adds a new Subchapter B
Drug, and Cosmetic Act —
Federal Food, Drug, and Cosmetic
Federal Food, Drug, and Cosmetic
— “Importation of Prescription
Importation of Covered Products —
Act (FFDCA) as amended by Section
Act (FFDCA) as amended by Section
Drugs” — to Chapter VIII of the
was first established under the
1121(a) of P.L. 108-173.
1121(a) of P.L. 108-173.
Federal Food, Drug, and Cosmetic
Medicine Equity and Drug Safety Act
Act (FFDCA), adding Sections 811-
of 2000 (P.L. 106-387). Section
Section 3. Inserts a new Section 804.
Section 4. Inserts a new Section 804.
817.
1121(a) of the Medicare Prescription
D r u g , I m p r o v e m e n t , a n d
Also amends, deletes, or adds
Also amends, deletes, or adds
Section 16. Repeals Section 804 of
Modernization Act of 2003 (P.L. 108-
provisions in other sections of the
provisions in other sections of the
the FFDCA.
173) replaced Section 804 entirely.
FFDCA; and the Internal Revenue
FFDCA; and the Clayton Antitrust
Code of 1986 [31 USC 26]; and the
Act [15 USC 12 et seq.]; the
Also amends, deletes, or adds
Controlled Substances Import and
Controlled Substances Import and
provisions in other sections of the
Export Act [21 USC 956].
Export Act [21 USC 956]; Section
FFDCA; and the Controlled
271 [Infringement of Patent] of Title
Substances Import and Export Act [21
35 [Patents]; and Section 351 of the
USC 956].
Public Health Service Act [42 USC
262].
Findings
No provision.
No provision.
Section 2. Findings. Includes
No 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.
Direction to
804(b). Regulations. Section 801 of
804(a). Waivers Regarding
804(a). Importation of Prescription
Sectio n 2(b). Regulations.
regulate
the FFDCA allows only a drug’s
C o m m e r c i a l a n d P e r s o n a l
Drugs. The HHS Secretary shall
Authorizes the HHS Secretary to
manufacturer to import that drug.
Importation of Prescription Drugs.
provide, in regulations for importing
promulgate regulations to carry out
Section 804(b) requires the Secretary
The HHS Secretary shall provide, in
qualifying drugs by registered
Section 812 [personal importation]
of Health and Human Services
regulations, a waiver of Section
importers or from registered
and directs the Secretary to

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S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
(HHS), after consultation with the
801(d)(1) as long as the drug
exporters, a waiver of Section
promulgate interim final regulations
United States Trade Representative
complies with the standards of
801(d)(1) as long as the drug
to carry out Section 813 [pharmacy
and the Commissioner of Customs, to
Section 801(a), which allows only
complies with the standards of
and wholesaler importation of
promulgate regulations permitting
certain drugs to be imported. A
Section 801(a), which allows only
prescription drugs] of the FFDCA (as
pharmacists and wholesalers to import
qualifying drug may not be imported
certain drugs to be imported. A
added by this section). Even if the
prescription drugs from Canada into
unless the drug meets certain
qualifying drug may not be imported
Secretary has not promulgated
the United States.
conditions [stated in 804(h)] or the
unless the drug is imported by a
regulations, Section 812 shall take
imported drug is for personal use or
pharmacy or a wholesaler who is a
effect on the date of enactment of this
804(j)(2). Waiver Authority. The
for use by a family member and not
registered importer, or a by an
Act and Section 813 shall take effect
Secretary is authorized to grant
for resale and meets the conditions in
individual for personal or family-
one year after enactment.
waivers, either through rule-making
Section 804(i), as below.
member use (and not for resale) from
or on a case-by-case basis, of the law
a registered exporter.
813. Pharmacy and Wholesaler
that allows only manufacturers to
Importation of Prescription Drugs. A
import FDA-approved drugs, to allow
drug importation facility, pharmacy,
i n d i v i d u a l s t o b r i n g i n
Internet pharmacy, or wholesaler may
pharmaceuticals under conditions the
import a prescription drug from
Secretary determines appropriate.
Canada or a permitted country into
The Secretary must publish guidance
the United States.
d e s c r i b i n g t h e c o n s i s t e n t
circumstances in which waivers
would be granted to individuals.
Permitted
Stipulates that the Secretary’s
804(a)(4)(B). A “permitted country”
804(a)(4)(D). [For commercial
811*(4)(A). [Note: Section 811 does
countries
regulations would include only
is Canada and, 180 days after the
importation,] A “permitted country”
not have a letter designating the
Canada for imports by pharmacists
publication of a report (see below),
means Australia, Canada, a member
beginning of this subsection, which an
and wholesalers; does not specify
Australia, 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, and
Zealand, and Switzerland.
the European Union as of December
New Zealand. The Secretary may
31, 2003,* that is designated by the
designate any additional country that
8 0 4 ( i ) ( 1 ) . F o r p e r s o n a l -u s e
Secretary based on a report due to the
h a s e q u i v a l e n t r e g u l a t o r y
importation, includes Canada only.
Senate HELP Committee and the
requirements to ensure the safety and
House 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
health.
*The European Union as of January 1, 2003 consisted of the following 15 member states: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg,
the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. On May 1, 2004, 10 countries joined the European Union: Cyprus, the Czech Republic, Estonia, Latvia,
Lithuania, Hungary, Malta, Poland, Slovenia, and the Slovak Republic.**The European Economic Area consists of the European Union plus Iceland, Liechtenstein, and Norway.
***The European Free Trade Association consists of Iceland, Liechtenstein, Norway, Switzerland, and the member states of the European Union.
Definitions
804(a). Definitions. Defines
804(a)(4). Definitions.
804(a)(4). Definitions.
811. Definitions.
“importer” to mean a pharmacist or a
Defines “importer,” “pharmacist,”
Defines “registered exporter,”
Defines “drug importation facility” as
wholesaler; “pharmacist” to mean a
and “wholesaler” the same as current
“ r e g i s t r a t i o n c o n d i t i o n , ”
a “person, other than an individual
person licensed by a state to practice
law.
“pharmacist,” and “wholesaler” the
importing a prescription drug under
pharmacy, including the dispensing
same as S. 2307.
Section 812, located outside the
and selling of prescription drugs; and
Defines “exporter” to mean a person
United States (other than a
“wholesaler” to mean a person
who is (or seeks to be) in the business
Defines “exporter” to mean a person
transporter) that engages in the
licensed as a wholesaler or distributor
of exporting a drug to the United
who is in the business of exporting a
distribution or dispensing of a
of prescription drugs in the United
States after submitting a registration;
drug from Canada to individuals in
prescription drug that is imported or
States, but does not include the
“registered exporter” to mean an
the United States or that seeks to be in
offered for importation into the
manufacturer of the drug being
exporter with an approved registration
such a business pursuant to submitting
United States.” Defines “Internet
imported.
in effect; and “registration condition”
a registration; “pharmacy” to mean a
pharmacy” as a person that offers to
to mean a condition that must exist for
person licensed by a state to engage in
dispense a prescription drug through
a registration to be approved.
the business of selling prescription
an Internet website in interstate
drugs at retail and employs 1 or more
commerce, regardless of whether its
pharmacists; “importer” to mean a
physical location is in the United
pharmacy, a group of pharmacies, or
States. Defines “pharmacy” as a
a wholesaler that is in drug importing
person licensed by a state to dispense
business or that seeks an approved
prescription drugs or to provide
registration to do so; and “registered
pharmaceutical care. Defines

CRS-9
S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
importer” to mean a pharmacy, a
“treating provider” as “a licensed
group of pharmacies, or a wholesaler
health care provider that (A) performs
with an approved and in effect
a 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
contemporaneous medical records
concerning the individual; or (B)
provides care to an individual as part
of an on-call or cross-coverage
arrangement with a health care
provider described in subparagraph
(A).” Defines “wholesaler” as a
person 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. Defines “transporter”

CRS-10
S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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 drug” as a drug
Defines “covered prescription drug”
Defines “prescription drug” as a drug
811*(5). Defines “prescription drug”
subject to Section 503(b) [a drug
as an approved drug under Section
described in FFDCA Section
similarly to current law [an FDA-
intended for use by man that is not
505(b)(1) [an FDA-approved drug]
503(b)(1). Has the same definition
approved drug], with additional
safe for use except under the
that is subject to Section 503(b)(1) [a
for “qualifying drug” as S. 2307.
exceptions: a drug manufactured
supervision of a licensed practitioner]
drug requiring a prescription].
through any biotechnology process,
other than a controlled substance, a
Defines “qualifying drug” as a
including a therapeutic DNA plasmid
biological product, an infused drug,
covered prescription drug other than a
product, a therapeutic synthetic
an intravenously injected drug, a drug
controlled substance, a biological
peptide product of not more than 40
that is inhaled during surgery, or a
product, an infused drug, an
amino acids, a monoclonal antibody
parenteral drug that the Secretary
intravenously injected drug, or a drug
product for in vivo use, and a
determines poses a threat to the public
that is inhaled during surgery.
therapeutic recombinant DNA-
health.
derived product; a drug requiring
804(g)(2)(A). A “U.S. label drug” is
refrigeration at any time; or a
a drug approved for commercial
photoreactive 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
petitions.]
“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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
Qualifying
804(c). Limitation. Regulations must
804(c). Sources of Exporting
804(c). Sources of Qualifying Drugs.
No explicitly comparable provision;
drugs
ensure that all imported prescription
Qualifying Drugs. An exporter must
Same as S. 2307 except that the
however, requires that an imported
drugs meet the same safety and
only export a drug that has a verified
manufacturing establishment must be
prescription drug must be FDA-
efficacy standards as drugs approved
chain of custody from the
either inspected by the Secretary or
approved.
in the United States and that the
manufacturer to the exporter. The
registered under Section 510. The
importer comply with all information,
exporter must comply with the
manufacturing establishment can be
reporting, and testing requirements.
following: the drug must have been
in the United States or any foreign
The Secretary is permitted to adopt
manufactured in an FDA-registered
country, as in S. 2307, but the
such rules as necessary to safeguard
establishment [registered under (h) or
establishment can manufacture the
public health or as a means to
(i) of Section 510], which is located in
drug either for distribution in the US
facilitate the importation of
the U.S. or any foreign country, and
or for distribution in a permitted
prescription drugs.
the establishment manufactured the
country. Canada is the only foreign
drug for distribution in the U.S. and
country from which the exporter can
for distribution in a permitted
export the drug; the importer can
country; the drug came directly from
import from a permitted country only.
the manufacturing establishment or
The exporter or importer must retain
from an entity that, by contract with
a sample of each lot of the drug
the exporter, provides the exporter a
sufficient for testing by the Secretary.
chain of custody statement from the
ma n ufacturing estab l i s h me n t ,
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
country.

CRS-12
S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
Relationship to
No explicitly comparable provision;
804(g)(1). Compliance with Section
804(g)(1). Compliance with Section
813(b). Requirements. Requires that
FDA approval
however, the law requires that all
801(a) [Imports and Exports]. For
801(a). Similar to S. 2307. Each
each imported prescription drug be
imported drugs be FDA-approved.
each exported qualifying drug, the
qualifying drug exported or imported
FDA-approved [Section 505] and
exporter must comply with Section
by the registered exporter or importer
comply with FDA requirements
801(a) FFDCA standards subject to
must be in compliance with Section
regarding adulteration [Section 501]
the import approval status, labeling,
801(a) standards regarding admission
and misbranding [Section 502].
and standards for refused admission
of the drug into the United States,
Requires that the container have a
criteria under this Act [Sections
subject 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
Importation. A drug may be imported
Approval Status. There is a general
statement that the drug was imported,
into the United States if (1) the
presumption that a drug proposed for
naming the country from which it
Secretary has verified the source of
export or import is an FDA-approved
came; and a unique identifier,
the exported drug, including that the
drug if it complies with 804(c) and if
indicating that the drug has been
drug is approved for commercial
it has the same active ingredient or
imported, based on the national drug
distribution in a specified foreign
ingredients, route of administration,
code of the prescription drug.
country and that the establishment
dosage form, and strength, according
Requires that the drug comply with
that manufactures the drug also
to the labeling information (referred
any other FFDCA requirements.
manufactures the drug for distribution
to in this subsection as a ‘U.S. label
in the United States (referred to as a
drug’) as an FDA-approved drug that
“U.S. label drug”); and (2) it has the
is manufactured by or for the person
same active ingredients, route of
that manufactures the drug proposed
administration, dosage form, and
for 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.]
Testing
804(e). Testing. The importer or the
No 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
confidential.
Monitoring and
No provision.
804(d)(1). Monitoring of Facilities.
804(d)(1). Inspection of Facilities.
Section 10. Advance Notice of
inspections
The exporter must agree to assist the
Similar to S. 2307 except it also
Imported Prescrip tion Drug
Secretary to determine exporter
allows the Secretary to have on-site,
Shipments. Amends FFDCA Section
compliance with all required
day-to-day access to samples of such
801 to allow the Secretary to inspect
conditions. The exporter must permit
drugs. Also, any employee assigned
drug imports at ports of entry. The
the Secretary to assign one or more
by the Secretary must carry out the
person importing or offering for
employees to conduct day-to-day on-
functions of the section not less than
importation the prescription drug
site continuous monitoring of
every three weeks and that such an
must 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 that
continuous basis.
notice of: the established name,
relate to qualifying drugs; to have
dosage form, and quantity of the
day-to-day access to records including
prescription drug; the name of the
financial records; to verify the chain
shipper; the name of the country from
of custody of each qualifying drug,
which the prescription drug
monitor markings, and sample the
originates; the country from which it
exported drugs to assure compliance;
is shipped; the name of the port of
and to carry out other functions that
entry; documentation of the original
the Secretary determines necessary
source of the prescription drug; the
regarding compliance. The Secretary
quantity of each lot of the prescription
may allow periodic, rather than day-
drug originally received by the
to-day, inspections of a business with
facility 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
meets all labeling requirements under
this Act. Failure to provide notice
results in holding of drug at the point
of entry.
Section 13. Authority to Commission
Other Federal and State Officials to
Conduct 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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.
Records of
No provision.
804(d)(3). Certain Duties. The
804(d)(3). Certain Duties Relating to
Section 15(a). Anticounterfeiting
chain of
Secretary shall verify the chain of
Exporters. Similar to S. 2307 except
Provisions; Required Records.
custody
custody of each qualifying drug from
that these duties involve verifying the
Amends Section 503(e) of the
the drug manufacturer to the exporter.
chain of custody of a statistically
FFDCA by requiring the wholesale
If the qualifying drug is exported to
significant sample of qualifying drugs
distributor of record, for each
individuals for personal use, the
f r o m t h e m a n u f a c t u r i n g
distribution, to provide to the
Secretary is directed to randomly
establishment, which may be
recipient the identity of the
select samples of the exports to
accomplished by the use of anti-
immediately previous distributor of
determine whether the conditions
counterfeiting or track-and-trace
record from which the prescription
required for individual imports are
technologies, if available. Record
drug was purchased; and, for each
being met. The sampling process
review is the same as S. 2307.
wholesale distribution of an imported
must allow a statistically significant
However, the employees shall inspect,
drug, to provide the purchaser with
determination of compliance. The
as the Secretary determines is
identifying information, such as dates
Secretary is directed to monitor the
necessary, the warehouses and other
and the names and addresses of all
required markings of exports.
facilities of other parties in the chain
parties to each transaction. Requires
of custody of qualifying drugs, and
the distributor to keep the records
determine whether the exporter is in
available for two years for Secretarial
compliance with all other registration
inspection, 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 for
804(d)(4). Certain Duties Relating to
Importation. An importer may import
Importers. The Secretary must
a drug if it receives the drug directly
inspect not less than every three
from the mail, a common carrier, or a
weeks 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
vehicle or aircraft owned by the
business that relate to the receipt and
importer or a business organization of
distribution of a qualifying drug,
which the importer is a part. The
including each warehouse or other
personnel of the transporting entities
facility owned or controlled by, or
must have had exclusive custody of
operated for, the importer at which
the drug without the involvement of
qualifying drugs are received or from
any other entity including a wholesale
which they are distributed to
distributor. Although the wholesale
p h a r macies . D u r i ng t h e s e
distributor, or any entity not the
inspections, the Secretary (1) shall
importer, cannot at any point have
verify the chain of custody of a
custody of the drug, the wholesaler
statistically significant sample of
could negotiate price and other
q u a l i fyi n g d r u g s f r o m t h e
processes for purchasing drugs from
establishment in which the drug was
exporters.
manufactured to the importer, which
may be accomplished by the use of
anticounterfeiting or track-and-trace
technologies; (2) may inspect, if
necessary, the warehouses and other
facilities 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 of
Section 8. Wholesale Distribution of
Drugs; Statements Regarding Prior
Drugs; Statements Regarding Prior
Sale, Purchase, or Trade. Section
Sale, Purchase, or Trade. Same as S.
503(e) of the FFDCA gives
2307. It also removes the reference to
requirements of wholesale distributors
manufacturer and authorized
(guidelines). This bill would change
distributor, but does not insert
the exclusion of the manufacturer and
registered 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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 establish “alternative
requirements” to identify the chain of
custody of the drug through the
wholesale distribution chain if the
alternatives provide greater certainty
and alternatives are economically and
technically feasible. If the Secretary
does promulgate final rules for
“alternative requirements” then other
conditions are amended. Each
manufacturer distributing FDA
approved drugs shall maintain records
of authorized distributors who are
distributors with an ongoing
relationship with them to distribute
the manufacturer’s products.
Charitable
804(i). Charitable Contributions.
804(k). Charitable Contributions.
No provision.
813(g). Charitable Contributions.
contributions
Section 801(d)(1) of the Act, which
Similar 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
Repeal of
No provision.
Section 8. Repeal of Importation
Section 9. Repeal of Importation
Section 16(a). Conforming
controlled
Exemption Under Controlled
Exemption Under Controlled
Amendments. Repeals Section 1006
substances
Substances Import and Export Act.
Substances Import and Export Act.
of the Controlled Substances Import
exemption
This section repeals the exemption
Same 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.
Registration of
804(f). Registration of Foreign
804(b)(1). Registration of Foreign
804(b)(1). Registration of Importers
Section 8. Registration of
importers and
Sellers. Requires any Canadian
Exporters. To register, an exporter
and Exporters. To register, the
Prescription Drug Importation
exporters
establishment engaged in the
must submit to the Secretary:
importer or the exporter (referred to
Facilities. Adds to the FFDCA a new
distribution of a prescription drug
as the registrant) must submit to the
Section 814, Registration of Certain
imported or offered for importation
the name and addresses of every place
Secretary:
Importers, to require a drug
into the United States to register its
of business of the exporter that relates
importation facility, pharmacy,
name and place of business with the
to qualifying drugs, including each
the name and addresses of every place
Internet pharmacy, or wholesaler
Secretary. Also requires that the
warehouse or other facility owned or
of business of the registrant including
engaged in the importation or offering
Canadian establishment register the
controlled by, or operated for, the
each warehouse or other facility
for importation of prescription drugs
name of its U.S. agent.
exporter; and
owned or controlled by, or operated
into the United States, or in the
for, the registrant; and
dispensing 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
information necessary to demonstrate
information necessary to demonstrate
compliance with the conditions
that the importer is in compliance
relating to the sources of exported
with registration conditions relating to
drug; the monitoring of foreign
the sources of exported drugs; the
facilities; the marking of compliant
inspection of facilities of the importer;
shipments; fee payment; being
the payment of fees; compliance with
licensed as a pharmacy; and
the standards referred to in Section
compliance with Section 801(a)
801(a); and maintenance of records
standards [federal government can
and samples; and information
sample and inspect to prevent the
necessary to demonstrate that the
i mp o r t a t i o n o f a d u l t e r a t e d ,
exporter is in compliance with
misbranded, or non-FDA-approved
registration conditions relating to the
drugs];
sources of exported drugs; the
inspection of facilities of the exporter
and the marking of compliant
shipments; the payment of fees;
compliance with Section 801(a)
standards; being licensed as a
pharmacist; conditions for individual
importation from Canada; and
maintenance of records and samples.
The exporter must agree to export
The importer or the exporter must
only qualified drugs;
agree to not import or export any
nonqualifying drug.
to export only to persons authorized
The 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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 and
of an agent for service of process in
address of its U.S. agent for service of
the United States.
process;
to monitor compliance with all
The registrant agrees to ensure and
registration conditions, and correct
monitor compliance with each
a n d p r o m p t l y r e p o r t a n y
registration condition, to promptly
noncompliance conditions to the
correct any noncompliance, and to
Secretary;
promptly report to the Secretary any
such noncompliance; and
to submit a compliance plan that
to submit a plan as to how the
shows how the exporter will correct
registrant will comply with this
any violation;
agreement.
to notify the Secretary of any changes
The exporter must agree to update any
[814(b)(2)] timely notification of any
in information provided in the
information provided in the
change in the information.
registration or in the compliance plan;
registration or in the compliance plan.
and
to comply with any other conditions
The Secretary may require other
for registration that the Secretary
conditions for registration that would
requires to protect the public health
protect 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
to enforce a contract under subsection
(c)(3)(B) (records of chain-of-custody
of a drug) against a party in the chain
of custody of a qualifying drug and
under the authority of the Secretary to
inspect such statements to determine
their accuracy and agree to
inspections.
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.”
8 14(d)(2). I mp o rta tio n b y
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
importation facility, pharmacy,
Internet pharmacy, or wholesaler is
registered. Requires that the drug be
held in a secure facility and not be
transferred.
Licensing as
No provision.
804(f). Licensing as a Pharmacy.
804(h). Licensing as Pharmacist. A
No provision.
pharmacies and
The Secretary must determine that the
condition of registration is that the
pharmacists
exporter intending to export a
exporter agrees that a qualifying drug
qualifying drug for personal use is (1)
will be exported to an individual only
authorized under foreign law to
if the Secretary has verified that the
dispense prescription drugs, and (2)
exporter is authorized under Canadian
that the foreign country’s programs to
law to dispense prescription drugs;
regulate pharmacists are comparable
and the exporter employs enough
to U.S. state programs; or, if the
persons licensed under Canadian law
exporter is not a licensed pharmacist,
to dispense prescription drugs to
that the exporter employs a sufficient
dispense safely the qualifying drugs
number of pharmacists licensed by
exported by the exporter to
one of the states and assigns to those
individuals, and the exporter assigns
pharmacists responsibility for
to those persons responsibility for
dispensing drugs that individuals will
dispensing such qualifying drugs to
import into the United States for
individuals.
personal use.

CRS-23
S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
Fees
No provision.
804(e). Fees. As a condition of
804(e). Importer Fees. An importer
Section 14. Adds to the FFDCA a
registration, an exporter must pay a
must pay the Secretary a $10,000 fee
new Section 740A, Fees Relating to
semi-annual fee with the first payment
alo ng with the registration
Prescription Drug Importation.
included with the registration. The
submission. In addition, the importer
Requires the Secretary to establish a
aggregate fee total for each fiscal year
must pay the Secretary a semiannual
user fee program under which a drug
must cover the costs of administering
fee.
importation facility, pharmacy,
this program. These costs are for
Internet pharmacy, or wholesaler
monitoring foreign facilities;
The Secretary shall ensure that the
registering with the Secretary under
developing, implementing, and
aggregate total of fees collected for a
Section 814 shall be required to pay
maintaining a system to mark
fiscal year from all importers is
the Secretary a fee beginning for
shipments to indicate registration
sufficient, and no more than
FY2005. Directs the Secretary to
comp liance; and c o nd ucting
necessary, to pay the costs of
determine the amount annually based
inspections within the United States to
administering this section with respect
on anticipated costs of enforcing this
determine compliance with required
to registered importers for a fiscal
Act, publish the fee 60 days in
conditions for importers and for
year. These are costs for inspecting
advance of each fiscal year, hold a
imports for personal use. The
the facilities of importers; reviewing
public meeting and provide time for
Secretary may use these fees only for
qualifying drugs offered for import to
public comment. Directs the
these costs. For the first year,
importers; and determining the
Secretary to use the collected fees,
however, the Secretary may collect a
compliance of importers with
without further appropriation, to
lesser aggregate total of fees taking
registration conditions. The aggregate
enforce the Act.
into account the lesser number of
total of fees collected shall not exceed
registered exporters and the capacity
1% of the total price of drugs
The fee shall be payable annually and
of that group to pay the administrative
imported annually to the United States
only once for each facility. From 30
costs. Authorizes the collection of a
by registered importers under this
days after the due date, a registered
semi-annual fee from each exporter
section.
facility may not import a prescription
set by the Secretary as a pro rata share
drug until all fees are paid.
of the aggregate costs, including the
The fee for an individual importer
number of employees that the
shall be a reasonable estimate by the
Requires the Secretary, 60 days after
Secretary has assigned to that
Secretary of the semiannual share of
the end of FY2005 and annually
exporter.
the importer of the volume of drugs
thereafter, to submit a report to the
imported by importers. The Secretary
Senate Committee on Health,
must annually adjust the fees to
Education, Labor, and Pensions and
accurately reflect the actual costs, and
the House Committee on Energy and
to not exceed, in the aggregate, 1% of
Commerce describing implementation
the total price of drugs imported
of 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
annually to the United States by
fiscal year and the use by the
registered importers under this
Secretary 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
requirements for importers, as above,
except that the aggregate exporter fees
must cover the cost of monitoring
foreign facilities; developing,
implementing, and sustaining a
system to mark shipments to indicate
compliance with all registration
c o n d i t i o n s ; a n d c o n d u c t i n g
inspections within the United States to
determine compliance with conditions
for licensing exporting pharmacists
and for importation from Canada.
Packaging
No explicitly comparable provision;
804(d)(2). Marking of Compliant
804(d)(2). Marking of Compliant
Section 15(b). Anticounterfeiting
however, the law requires that all
Shipments. The exporter must agree
Shipments. Same as S. 2307.
Provisions; Electronic Track and
imported drugs be FDA-approved and
to mark each shipping container of
Trace Technology. Directs the
carry the FDA-approved labeling.
drugs identifying that the shipment is
Secretary to require, no later than
in compliance with all registration
December 31, 2007, the adoption and
conditions. The markings may
use of electronic track and trace
include anti-counterfeiting or track-
technology for a prescription drug at
and-trace technologies and shall be
the case and pallet level that will
designed to prevent unauthorized
identify 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
and addresses of all parties to the
transaction).
804(h). Approved Labeling. Requires
804(g)(3)(A). Labeling; Importation
804(g)(3)(A). Section 502; Labeling;
813(c). Approved Labeling. Requires
a drug manufacturer to give the
by Importer. If a qualifying drug is
Importation by Registered Importer.
that a drug importation facility
importer written authorization to use,
offered to a pharmacist or wholesaler
If an importer imports a qualifying
demonstrate to the Secretary that the
at no cost, the approved labeling for
for import or is imported, it must bear
drug, the drug must bear the labeling
labeling of the prescription drug to be
the prescription drug.
a copy of the labeling approved by
approved for the drug by FDA,
imported into the United States
FDA, whether or not the copy bears
without regard to whether the copy
complies with the requirements of
the trademark involved. The
bears the trademark. The label must
Sections 502 [adulteration] and 503
Secretary shall provide a copy of the
include the name and location of the
[misbranding]. Requires that the
approved labeling to the registered
manufacturer, the lot number assigned
Secretary approve or deny the
exporters upon request.
by the manufacturer; and the name,
application within 60 days of receipt
location, and registration number of
and notify the applicant of the
the importer. The Secretary shall
decision and, if the application is
provide a copy to the registered
denied, provide the reason for the
importer involved, upon request of the
denial. Requires the Secretary to
importer.
maintain an up-to-date list of
application 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; Importation
804(g)(3)(B). Section 502; Labeling;
by Individual. If a drug is imported
Importation 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
by an individual, it must bear a label
is imported by a registered exporter to
providing the directions for use by the
an individual, the drug must bear a
consumer, and a copy of any special
label providing the directions for use
labeling that would be required by the
by the consumer, and bear a copy of
Secretary had the drug been dispensed
any special labeling that would be
by a pharmacist in the United States,
required by the Secretary had the drug
without regard to whether the special
been dispensed by a pharmacist in the
labeling bears the trademark involved.
United States, without regard to
The Secretary shall provide to the
whether the special labeling bears the
registered exporter involved a copy of
trademark involved. The Secretary
the special labeling, upon request of
shall provide to the registered
the exporter.
exporter involved a copy of the
special labeling, upon request of the
exporter.
Records
804(d)(1). Information and Records.
Section 804(c) requires, among other
804(j). Maintenance of Records and
Section 15(a). Anticounterfeiting
Drug importers must provide
criteria, the manufacturer to provide a
Samples. Both importers and
Provisions; Required Records.
information that includes: the name
chain-of-custody statement to the
exporters must maintain records
Requires the wholesale distributor to
and amount of the active ingredient of
exporter.
required under this section for not less
create and maintain for two years
the drug, the dosage form of the drug,
than two years; and maintain samples
available to the Secretary, for each
the date the drug is shipped, the
of each lot of a drug required under
wholesale distribution, records of the
quantity shipped, information about
this section for not less than two
i m m e d i a t e l y p r e v i o u s a n d
its origin and destination, the price
years.
immediately subsequent distributors
paid by the importer, the original
of record; and, for each imported
source of the drug, the amount of each
drug, records of each previous and
lot received from that source, the
each 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 imported
Inspection of Records for Prescription
directly from the first foreign
Drugs. Authorizes the Secretary to
recipient from the manufacturer, there
establish, by regulation, requirements
must be documentation indicating that
relating to the establishment and
the drug came directly from the
maintenance, for not longer than two
manufacturer and was subsequently
years, 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
shipped by that recipient to the
importation facility, pharmacy,
importer; that the amount being
Internet pharmacy, or wholesaler
imported is not greater than the
engaged in the importation of
quantity that was originally received;
prescription drugs into the United
and verification that each batch of the
States, or in the dispensing of such
drug has been statistically sampled
drugs; and any person that processes,
and tested for authenticity and
packages, distributes, receives, holds,
degradation prior to importation.
or transports a prescription drug
Samples of subsequent shipments of
imported under this subchapter.
these drugs must also be tested for
authenticity and degradation.
If the Secretary has reason to believe
that an imported prescription drug
For a prescription drug not imported
presents a risk to the public health,
directly from the first recipient in the
requires that the drug importation
foreign country, there must be
facility, pharmacy, Internet pharmacy,
documentation demonstrating that
or wholesaler that imports the
each batch in each shipment of the
prescription drug, and each person
drug has been statistically sampled
that processes, packages, distributes,
and tested for authenticity and
receives, holds, or transports the
degradation prior to importation.
prescription drug permit the
Secretary’s officer or employee, with
Also, the importer or manufacturer
appropriate credentials and a written
must certify that the drug is FDA-
notice, “at reasonable times, within
approved, properly labeled, not
reasonable limits and in a reasonable
adulterated, and not misbranded,
manner,” to have access to and copy
provide laboratory records of
all records, in any format, at any
authenticity testing, including data,
location, needed to determine whether
and evidence that testing was
the prescription drug presents a risk to
conducted in an approved U.S.
the public health. Requires the
laboratory. The importer is required
Secretary to prevent the unauthorized
to provide any other information that
disclosure of any trade secret,
the Secretary determines is necessary
c o n f i d e n t i a l , o r p r i v i l e g e d
to ensure the public health.
information. The Secretary’s
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
804(d)(2). Maintenance by the
Importers of drugs are to maintain
Secretary. Records regarding
records for two years.
imported prescription drugs “covered
products” must be provided to the
Secretary, and then kept for such time
as the Secretary determines to be
appropriate.
Manufacturer
No provision.
804(g)(2)(B). Approval Status;
804(g)(2)(C). Section 505; Approval
No provision.
requirements
Petition by Manufacturer; General
Status; Notice by Manufacturer;
Provisions. A drug manufacturer may
General Provisions. A manufacturer
file a petition with the Secretary
of any drug that may be imported
requesting that a drug’s import cease.
must submit to the Secretary a notice
The petition must claim that the drug
that includes each difference in the
is changed from the U.S. label drug in
drug from a condition established in
a manner that, if made to the U.S.
the approved application for the U.S.
label drug in the United States, would
label drug beyond the variations
need a supplemental application. The
provided for in the application; any
petition must also state whether,
difference in labeling; the date on
under FDA regulations, the change
which the drug with such difference
could be made pending an
was, or will be, introduced for
application’s approval or whether, in
commercial distribution in a permitted
consideration of a bioequivalence
country; and such additional
matter, the changed drug could not be
information as the Secretary may
sold before such an approval. The
require; or states that there is no
manufacturer’s chief executive
difference in the drug from a
officer, chief legal counsel, and chief
condition established in the approved
medical officer must each certify that
application for the U.S. label drug
the information in the petition is
beyond the variations provided for in
complete and true. Unless the petition
the application and differences in
makes a nonequivalence claim, the
labeling.
petitioner pays a fee that is equivalent
to the PDUFA fee established for a
The manufacturer must notify the
human drug application for which
government of the permitted country
clinical data on safety or effectiveness
that has approved (or has an
is required for approval. Subject to
application pending) the drug’s

CRS-29
S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
appropriations acts, the collected fees
commercial distribution that it is
are available to the Secretary to pay
filing this notice. The notice must
for administering this section. The
include the material (with verified
Secretary must grant or deny a
English 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
complete and true; and provide a copy
of the notice to the Federal Trade
Commission and to the Assistant
Attorney General in charge of the
Antitrust Division of the Department
of Justice.
If 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
introduced in that country, and
annually thereafter. For a notice
regarding drug differences that would
require a supplemental application but
not require pre-market approval or for
a drug that would not require a
supplemental application, the notice
must 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
to the public a list of notices
submitted and the status of the
Secretary’s 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 Requiring
Difference Requiring Prior Approval.
Prior Approval. A petition raising a
If the notice regarding an imported
“bioequivalence consideration”
drug shows that it requires the
c l a i m s e i t h e r a “ p o s s i b l e
approval of a supplemental
nonequivalence claim” or a
application before the difference
“nonequivalence claim.” If the
could be make to the U.S. label drug,
p e t i t i o n r a i s e s a p o s s i b l e
the Secretary must notify registered
nonequivalence claim, the petitioning
exporters, registered importers, the
manufacturer must notify the foreign
Federal Trade Commission, and the
country that approved the drug for
Assistant Attorney General that the
commercial distribution in writing
notice has been submitted with
that there is a claim submitted to the
respect to the drug involved. If the
Secretary and that the petition has
Secretary has no t made a
with it the information submitted to
determination whether a supplemental
the foreign country to obtain an
application regarding the U.S. label
approval there. The drug may
drug would be approved or
continue to be imported and receivers
disapproved by the date on which the
are notified that there is a possible
drug involved is to be introduced for
nonequivalence claim. If the
commercial distribution in a permitted
Secretary decides that the petition
country, the Secretary must order that
drug is not bioequivalent, then the
the importation of the drug involved
Secretary may grant the petition and
from the permitted country cease
imports may cease.
during the period in which the
Secretary completes review of the
I f t h e p e t i t i o n m a k e s a
notice; and promptly notify registered
nonequivalence claim, the Secretary
exporters, registered importers, the
must order imports to cease during the
Federal Trade Commission, and the
petition review, and if the finding is
Attorney 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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 imports
supplemental 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
no nequi va l e nc e claim or a
the permitted country, and notify the
nonequivalence claim and if the
permitted country that approved the
petition drug was approved for
drug for commercial distribution of
commercial distribution by FDA
the determination; and promptly
and/or a foreign government on or
notify registered exporters, registered
after January 1, 2004, the Secretary
importers, the Federal Trade
may not accept the petition unless the
Commission, and the Assistant
petitioner submits information
A t t o r n e y G e n e r a l o f t h e
showing that: (1) the drugs differ due
determination. If the Secretary
to a difference in the legal approval
determines that the supplemental
requirements between the U.S. and
application regarding the U.S. label
the foreign country; or (2) the
drug would be approved, the
p e t i t i o ner h a s s u b mi t t e d a
Secretary shall vacate the order to
supplemental application to the
cease trade, if any, and permit
Secretary or to the foreign
importation of the drug and promptly
government to remove the difference
notify registered exporters, registered
between the petition drug and the U.S.
importers, the Federal Trade
label drug. If the Secretary ceased
Commission, and the Assistant
imports of a drug, the Secretary shall
A t t o r n e y G e n e r a l o f t h e
rescind the order promptly after a
determination.
supplemental application is approved.
The Secretary must rescind any order
if false, fictitious, or fraudulent
statements in the petition influenced
the Secretary’s decision.
804(g)(2)(C). Approval Status;
804(g)(2)(E). Notice; Drug
Petition; Drug Changes Not
Difference Not Requiring Prior
Requiring Prior Approval. For a
Approval. If the imported drug does
petition drug which would have been
not require the approval of a
allowed to be sold pending the
supplemental application before the

CRS-33
S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
supplemental application approval,
difference could be made to the U.S.
the importation may continue while
label drug the following shall occur:
the Secretary considers the
During the period in which the notice
manufacturer’s petition to cease
is being reviewed by the Secretary,
importation. For importation to
the authority under this subsection to
continue, the importer must inform all
import the drug involved continues in
purchasers that the manufacturer is
effect. If the Secretary determines
making a claim that the drug is
that such a supplemental application
different than the U.S. label drug and
regarding the U.S. label drug would
the registered exporter must notify all
not be approved, the Secretary shall
individuals importing the drug from
order that the importation of the drug
the exporter for individual personal
involved from the permitted country
use that the manufacturer is making
cease, shall notify the permitted
the claim. If the Secretary decides
country that approved the drug for
that the supplemental application
commercial distribution of the
regarding the U.S. label drug would
determination, and shall promptly
not be approved, the Secretary shall
notify registered exporters, registered
grant the petition and order that
importers, the Federal Trade
imports of that drug cease.
Commission, and the Assistant
A t t o r n e y G e n e r a l o f t h e
determination.
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
importers.

CRS-34
S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
drug [for purposes of this application,
active ingredients are related if they
are “the same; or different salts,
esters, or complexes of the same
moiety.”], and there is no drug for
export from at least half of the
permitted countries with the same
active 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 drug’s
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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.
Secretary’s
804(l)(1). Commencement of
No provision.
No provision.
No provision.
actions
Program. The drug import program
can begin only if the Secretary first
certifies to Congress that its
implementation would pose no
additional risk to public health and
safety, and would result in a
significant reduction in the cost of
covered products to American
consumers.
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
increased risk and, if those measures
would require additional statutory
authority, to report to Congress
describing needed legislation;
identifies, in qualitative and
quantitative terms, the benefits that
would result from the program,
including reductions in the cost of
drugs to U.S. consumers, which
would allow them to obtain needed
medications without foregoing other
necessities of life; and, in specific
terms, compares the detriment with
those benefits and determines the
benefits do not outweigh the
detriment.
804(g). Suspension of Importations.
804(b)(4). Suspension and
804(b)(4). Suspension and
Section 6. Adds new Section 817,
If the Secretary discovers a pattern of
Termination. The Secretary may
Termination. Same as S. 2307, except
Suspension of Importation. Allows
counterfeit or violative products, the
suspend a registration if, after notice
it refers to the importer as well as the
the Secretary to immediately order the
agency must suspend importation of
and opportunity for a hearing, the
exporter.
suspension of the importation of a
that specific prescription drug or that
exporter fails to maintain substantial
particular prescription drug or a
specific importer. The suspension
compliance with registration
particular dosage form by a drug
must stay in effect until the Secretary
conditions. In addition, the Secretary
importation facility, pharmacy,
investigates and determines whether
shall suspend immediately, without
Internet 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
the public is being adequately
prior notice, the exporter’s
country (but not an individual
protected from counterfeit and
registration if the exporter has
importing for personal use or an
violative drug products under existing
exported a non-qualifying drug, not
individual engaged in an Internet
regulations.
met the requirements relating to a
pharmacy transaction) if the Secretary
U.S. label drug, or exported a drug to
determines it presents a risk to the
an individual who did not meet the
public health. Allows this action to
conditions under law. The Secretary
be appealed; requires that the
must give the exporter a hearing
Secretary, after providing opportunity
within 10 days of the suspension. If
for an informal hearing, confirm or
the Secretary determines that there
terminate the order within 30 days.
would be no further violations, the
An order under this section shall not
Secretary may reinstate the suspended
be subject to judicial review.
registration.
If the Secretary determines that a drug
After notice and the opportunity for a
importation facility, pharmacy,
hearing, the Secretary may terminate
Internet pharmacy, or wholesaler, or a
a registration if the exporter has a
country (but not an individual
pattern or practice of violating one or
importing for personal use or an
more registration condition. The
individual engaged in an Internet
Secretary may terminate a registration
pharmacy transaction) is engaged in a
permanently or for a fixed period of
pattern of importation that violates the
not less than one year. A registration
Act’s requirements, the Secretary may
will have no legal effect if, during the
immediately order suspension of
period in which a registration is
importation of prescription drugs
terminated, the exporter or a partner
from that person or country.
or principal officer of the enterprise
assisted in the preparation of the
Allows 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
804(k). Construction. Nothing in this
813(i). Effect of Section. Similar to
section limits the Secretary’s authority
current law. Nothing in this section
relating to the importation of
[ P h a r m a c y a n d Wh o l e s a l e r
prescription drugs, other than with
Importation of Prescription Drugs]
respect to Section 801(d)(1), which
limits the authority of the Secretary
allows only the manufacturer to
relating 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
the manufacturer from importing a
prescription drug that had been
supplied as a charitable contribution.
804(b)(2). Approval or disapproval
804(b)(2). Approval or disapproval
814(b)(3). Requires the Secretary,
of registration. The Secretary must
of registration. Same as S. 2307.
not later than 60 days after receipt of
approve or disapprove a registration
a completed registration, to assign a
within 90-days of its submission. If
registration number to each registered
the registration is disapproved, the
drug importation facility, pharmacy,
Secretary must notify the exporter as
Internet pharmacy, and wholesaler,
to why. After a registration has been
and notify the registrant of the receipt
denied, if and when the exporter is in
of the registration.
compliance, the Secretary must notify
the exporter. Within 30 days of
814(c). Requires that the Secretary
receiving an exporter’s compliance
provide for and require electronic
plan, described above, the Secretary
filing of registrations, with adequate
must decide if the change affects the
authentication protocols to allow
exporter’s registration approval and
identification of the registrant and
inform the exporter.
validation of the data.
804(b)(3). Publication of Contact
804(b)(3). Publication of Contact
Requires 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 on
Same as S. 2307 except it does not
it available to the public on an
the FDA website a list of registered
require a requested link on the FDA
Internet website and through a
exporters, includ ing contact
website to the Internet site of the
toll-free telephone number.

CRS-39
S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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 exporter’s
website.
Studies and
Section 1122. Study and Report on
804(a)(4)(B)(ii). Report. Within 18
No provision.
811*(4)(B). Report. Requires that
reports
Importation of Drugs. The law
months after enactment, the Secretary
the Secretary, three years after
requires the Secretary, in consultation
must submit to Congress a report that
enactment, submit to the Senate
with appropriate government
describes the impact of the new drug
Committee on Health, Education,
agencies, to conduct a study on the
import program on the safety and
Labor, and Pensions and the House
importation of drugs in the United
integrity of the U.S. prescription drug
Committee on Energy and Commerce
States pursuant to Section 804 of the
distribution system, the prevalence in
a report that includes a list of
Federal Food, Drug, and Cosmetic
the United States of counterfeit,
permitted countries and why the
Act (as added by Section 1121 of P.L.
adulterated, or misbranded drugs, and
Secretary determined that drug
108-173). The Secretary shall submit
patient drug therapy; describes the
imports from such countries would
the report to Congress not later than
potential impact of permitting imports
not increase risk to the public health.
12 months after the enactment of this
from additional countries; includes
Requires the Secretary to list those
Act.
proposed legislation to improve the
countries from which prescription
safety, efficiency, and efficacy of the
drug imports are not permitted and
Section 1123. Study and Report on
drug importation program. Requires
why and what possible actions those
Trade in Pharmaceuticals. The law
the Secretary also, in consultation
countries might take to avoid, reduce,
requires the President’s designees to
with the Federal Trade Commission,
or mitigate increased risk. Authorizes
conduct a study and report on issues
to evaluate the extent to which the
the Secretary to determine whether to
related to trade and pharmaceuticals.
new import program achieves lower
designate 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, provides
prescription drug market, and to
report.
detail regarding the reports required
identify how the import program
by Sections 1122 and 1123.]
could be improved to meet that
Adds [in Sec. 4 and Sec. 14] new
objective.
FFDCA sections 511(f) and 740A to
require the Secretary to report to
C o n g r e s s a n n u a l l y o n t h e
implementation of the user fee
authority and the use of those fees.
Enforcement
No
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 sale
Amends 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
as amended by Section 1121(b) of
by a pharmacist rather than an
by prohibiting the dispensing or
P.L. 108-173, to prohibit the importer
importer.
offering to dispense a prescription
of a qualifying drug, imported for
drug imported into the United States
commercial purposes, to sell that drug
in violation of the requirements of the
unless the drug is sold at retail as it is
new Section 813 (relating to
dispensed to a customer of the
p h a r m a c y a n d w h o l e s a l e r
importer, or is sold or traded to the
importation).
registered exporter from which the
importer imported the drug. It also
prohibits an individual who imports
the drug for personal use from selling
or trading that drug. Prohibits making
false, fictitious, or fraudulent
statements in filing a petition to stop a
drug’s importation; if made, requires
the maker to be imprisoned not more
than 10 years, fined, or both.
Section 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 Secretary’s
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
Prescription Drugs.
Section 27(a) makes it “unlawful for
any person engaged in commerce ...”
to charge a price to, deny or restrict
supplies to, or refuse to do business
with a registered exporter, other
person 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 with “a 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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 ingredie nt , r o ut e o f
administration, dosage form, strength,
f o r m u l a t i o n , m a n u f a c t u r i n g
establishment, manufacturing process,
or person that manufactures the drug)
between a prescription drug for
distribution in the United States and a
prescription drug for distribution in
Australia, Canada, a member country
of the European Union as of January
1, 2003, Japan, New Zealand, or
Switzerland for the purpose of
restricting importation of the drug to
the 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
a c t i v e i ngr edient, route of
administration, dosage form, strength,
f o r m u l a t i o n , m a n u f a c t u r i n g
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
prescription drug for distribution in”
a permitted country in Section 804 of
the FFDCA “made 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
efficacy of the drug; or (3) the person
manufacturing the drug fo r
distribution in the United States has
given notice to the Secretary ... that
the drug for distribution in the United
States is not different from a drug for
distribution in ...” at least half of the
permitted 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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.
2 3 2 8 w a s r e n a m e d t h e
Pharmaceutical Market Access and
Drug Safety Act of 2004 before it was
introduced.] Section 27 of the
Clayton Act shall apply to personal-
use importation from Canada. A
notice filed under paragraph 6 above
will apply to notices required in new
Section 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 Regarding
Section 7. Civil Actions Regarding
Section 7. Debarment for Repeated
Property. Amends Section 303 of the
Property. Same as S. 2307.
or Serious Drug Importation
FFDCA: Penalties by adding (g)(1) to
Violations. Amends Section 306(b)

CRS-45
S. 2307 (Grassley 4/8/04)
Current law:
Reliable Entry for Medicines at
Medicare Prescription Drug,
Everyday Discounts through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
authorize the Attorney General to
of the FFDCA to allow the Secretary
commence civil action in any federal
to debar a person (other than an
court if a person is importing a drug
individual importing for personal use
that violates the Act. The court action
or an individual engaged in an
may enjoin the alienation or
Internet pharmacy transaction) from
disposition of property or issue a
importing a prescription drug for up
restraining order to prohibit any
to five years if the person “has been
p e r s o n f r o m w i t h d r a w i n g ,
convicted of a felony for conduct
transferring, removing, dissipating, or
relating to the importation into the
disposing of such property or property
United States of any prescription
of equivalent value; and to appoint a
drug; or ... has engaged in a pattern of
temporary receiver to administer the
importing or offering for import a
order. Such proceedings must be
prescription drug that presents a risk
carried out in the same manner as
to the public health.” Allows the
applies under Section 1345 of Title 18
Secretary to withdraw the debarment
USC [regarding injunctions against
if the conviction on which it was
mail fraud].
based is reversed or if it “serves the
interests of justice and adequately
protects 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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.
Ad vertisin g Exp en d itu res o f
Taxpayers Who Discriminate Against
Foreign Sellers of Prescription Drugs
to Domestic Consumers. In general,
no tax deduction is allowed unless the
taxpayer certifies that it took no direct
or indirect action to prevent or place
conditions on the authorized
importation of a qualifying drug into
the 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
drug’s 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
and what fees should be charged to
cover the costs of confirming the
certification.
804(j). Standards for Refusing
804(g)(4). Section 501; Standards for
Section 11. Authority to Mark
Admission. A qualifying drug from a
Refusing Admission. Similar to S.
Prescrip t i o n D r u g s Refu sed
registered exporter may be refused
2307. Numbers (1) through (4) apply
Admission into the United States.
entry into the United States only if:
if the import is from a registered
Amends Section 801 of the FFDCA
the shipping container does not bear
exporter to an individual.
(as amended by Section 10(a) of this
the required markings; the container
Act) to allow the Secretary to require
or markings appear to be counterfeit
804(i)(2). Notice Regarding Drug
the owner or consignee of the drug to
or appear to have been tampered with;
Refused Admission. If a registered
label any prescription drug refused
the container appears damaged in a
exporter ships a drug to an individual
admission indicating that, with the
way that could affect the strength,
and the drug is refused admission to
owner or consignee responsible for all
quality, or purity of the drug; the
the United States, a written notice
labeling expenses, until the Secretary
Secretary becomes aware that the
shall be sent to the individual and to
determines that the prescription drug
drug may be counterfeit, been
the exporter that informs them of the
has been brought into compliance
prepared, packed, or held under
refusal and the reason for the refusal.
with this Act. Amends Section 502 of
insanitary conditions, or if the drug
the FFDCA so that if the prescription
was not made or stored under good
drug does not carry the label after the
manufacturing processes; the
Secretary has informed the owner, it
Secretary has obtained an injunction
shall be considered misbranded. This
against the drug, prohibiting
does not apply to a personal-use
distribution in commerce, or has
import or a commercial transaction
withdrawn the approval of the drug;
between an Internet pharmacy and an
or
individual. 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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 a
804(k). Drug Recalls. A
813(f). Drug Recalls. Requires that
recall of the drug.
manufacturer of a drug imported from
a drug importation facility promptly
a permitted country shall promptly
provide the Secretary and any person
inform the Secretary if the drug is
to whom the prescription drug was
recalled or withdrawn from the
distributed a notice that the drug has
market in a permitted country; how
been recalled or withdrawn from the
the drug may be identified, including
market. Requires that the notification
lot number; and the reason for the
include identifying information
recall or withdrawal. The Secretary
(including the lot number) and the
shall enter into an agreement with the
reason for the recall or withdrawal.
government of each permitted country
to receive information about recalls
and 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 Section
Section 6. Creates in the FFDCA a
Section 5(a). Creates in the FFDCA a
805 in the FFDCA, Disposition of
new Section 805. Disposition of
new Section 816, Administrative
Certain Drugs Denied Admission, to
Certain Drugs Denied Admission.
Detention. An officer or qualified
establish that any import shipment of
Similar to S. 2307 except it (1) refers
employee of the FDA may order the
drugs valued at less than $10,000 in
to the Secretary of Homeland Security
detention of any prescription drug that
violation of standards set in Sections
as the refuser of admission; (2) does
it believes to present a risk to the
801(a) or 801(d)(1) shall be refused
not state that this section does not
public health. If the Secretary
admission. These standards are
transfer to the Secretary responsibility
approves, 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
referred to in Section 804(j) and mean
for carrying out this section; and
detained for up to 30 days, labeled as
that the drugs are not sufficiently
states that procedures for carrying out
detained and in a secure facility.
marked.
this section shall be established within
Until the Secretary releases the drug
90, rather than 30, days of enactment
or the detention period expires,
Drugs refused admission must be
of this Act.
prohibits the transfer of the drug from
destroyed unless the U.S. Attorney
detention, including delivery pursuant
General determines they are needed as
to the execution of a bond. Allows
evidence or potential evidence. In
the claimant to appeal the detention
general, refused admission and
and the Secretary must confirm within
destruction of drugs may be done
five days or the order will be
without notice to the importer, owner,
terminated.
or consignee of the drugs, with
receipts and record keeping done on a
Section 5(b) amends Section 801 of
summary basis to efficiently utilize
the FFDCA by adding a paragraph (r),
federal resources. This section has no
Temporary Hold at Port of Entry.
effect on laws regarding shipments of
With approval by the Secretary or a
drugs that are valued equal to or
designated official (director of the
greater than $10,000, nor does this
district in which the drug is located,
section transfer to the Secretary
or a senior official of the director),
responsibility for carrying out this
directs an FDA officer or qualified
section. Procedures to carry out this
employee who believes there is a risk
section must be established within 30
to 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
Personal use
804(j). Waiver Authority
for
804(i)(1). Personal Use; Conditions
804(i)(1). Individuals; Conditions for
812. Personal Importation. Allows
Importation by Individuals.
for Importation. Individuals can
Importation From Canada. Similar to
an individual to import a prescription
804(j)(1). Declaration. Congress
import up to a 90-day supply of a
S. 2307 except it also allows the
drug from Canada or a permitted
declares that the Secretary should use
qualifying drug if the drug is
prescribing practitioner to be licensed
country into the United States for
discretion when enforcing the current
accompanied by: a copy of a
where the individual receives care;
personal use (not for resale) if the
legal prohibition against persons
prescription that is valid under federal
refers to Canada specifically, rather
prescription drug is purchased from a
importing drugs or devices. The
and state laws and was issued by a
than “the exporting country;” and
licensed pharmacy in Canada or a
Secretary should focus enforcement
practitioner who, under the state law
requires that the Canadian document,
permitted country and dispensed in
on cases where the importing may
of which the individual resides, is
in addition to the U.S. prescription, be
compliance with that country’s
pose a significant threat to public
authorized to administer drugs; a
marked as filled. The individual must
applicable laws; it is imported for
health. When the importation is
statement that provides sufficient
have given the registered exporter a
personal use (not for resale) by the
clearly for personal use and the
information for the Secretary to
complete list of all drugs used by the
individual; it is imported physically
prescription drug or device does not
determine whether the prescription
individual for review by those who
by the individual; it does not exceed a
appear to present an unreasonable risk
meets those regulations, including the
dispense the drug.
90-day supply during any 90-day
to the individual, the Secretary should
prescriber’s licensure; and the
period; and the prescription drug is
exercise discretion to permit the
documentation required by the
Section 4(c)(3). Not less than 15 days
accompanied by a copy of a
importation by the individual.
exporting country to dispense a drug.
after the enactment of this Act and
prescription valid in a state and
All prescriptions must be marked to
until 60 days from promulgation of
cosigned by a prescribing physician in
804(j)(3). The Secretary is required
indicate they have been filled to
the interim rule, the Secretary shall,
Canada or the permitted country or, if
to grant waivers, by regulation, so
prevent duplicative filling by another
through the Internet website of the
the prescription drug is available in
persons can import for personal use
pharmacist. The Secretary can
Food and Drug Administration, make
Canada or the permitted country
up to a 90-day supply of an FDA-
prohibit from import drugs that were
readily available to the public a list of
without a prescription, a copy of the
approved prescription drug from a
a p p r o v e d u n d er a c c e l e r a t e d
persons licensed in Canada to
valid prescription signed by a
licensed pharmacy in Canada, so long
procedures for serious or life-
dispense prescription drugs who are
pharmacist licensed in that country.
as the drug’s final dosage form was
threatening 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 Canadian
804(i)(2). The exporter must notify
Secretary to permit an individual to
seller, was accompanied by a valid
the individual carrying a qualifying
Section 4(c)(4). The provisions on
import up to a 90-day supply of a
prescription, and was imported under
drug into the United States for
disposal of drugs denied admission
drug that is not approved by the
conditions the Secretary determines
personal use that the shipping
and civil action regarding property
Secretary under FFDCA Section 505
were necessary to ensure public
container must be intact and be
(Sections 6 and 7 of this bill) do not
if the importation is for continuation
safety.
marked as in compliance with
apply to personal-use imports by
of personal use by the individual for
requirements that the drug is
individuals.
treatment, begun in a foreign country,
approved for distribution in a
of a serious medical condition.
p e r m i t t e d c o u n t r y a n d i s
Section 4(d). Amendment of Certain
manufactured in a facility that also
Provision [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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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 that
import is not subject to a waiver, and
the drug imported is “an approved
that the individual may legally import
drug under Section 505(b)(1) if the
certain prescription drugs from
criteria described in subsection
registered Canadian exporters, a list
(g)(A)(i-ii) are met.” [sic; probably
of which is posted on the FDA
should be (g)(2)(A)(i-ii)]
website.
Section 4. Additional Waivers
Section 5. Additional Waivers
Regarding Personal Importation;
Regarding Personal Importation;
Enforcement Policies of Secretary.
Enforcement Policies of Secretary.
Amends Section 801 by establishing
Similar to S. 2307, except that it
a new category of waivers for
requires that the Secretary establish
individuals and allows the Secretary
by regulation a waiver of standards
to establish by regulation a waiver of
for personal use imports if the drug
t h e r e q u i r e me n t t h a t o n l y
was dispensed to the individual while
manufacturers import drugs if the
that person was in a foreign country
drug was dispensed in the United
and met that country’s laws and
States by a licensed pharmacist or
regulations. In addition, the quantity
practitioner and the individual
of the imported drug may not exceed
traveled from the United States with
a 90-day supply if the drug is
the drug, and the individual returns to
dispensed in Australia, Canada, a
the United States with the drug. The
member country of the European
drug cannot appear adulterated, and
Union as of January 1, 2003, Japan,
not be more than a 30-day supply. It
New Zealand, or Switzerland;
must be accompanied by a statement
otherwise, the limit is a 14-day
that the individual seeks to import the
supply.
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
to import the drug under a personal
waiver, and complies with such
additional standards that the Secretary
determines to be appropriate to
protect the public health. The
Secretary may not administer any
enforcement policy that permits
imports of drugs in violation of this
act or Section 351 of the Public
Health Service Act. The Secretary’s
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
guidance.#
#”In 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:
(1) 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)
when (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;
(b) 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
to represent an unreasonable risk; and (d) the individual seeking to import the product affirms in writing that it is for the patient’s own use (generally not more than three month
supply)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
continuation 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
Rulemaking
No
provision.
Section 3(d)(1).
Implementation;
S e c t i o n 4 ( c ) ( 1 ) ( A ) ( i ) .
Section 8(b). Requires that the
deadlines
Rulemaking. The Secretary must
Implementation; Rulemaking;
Secretary, not later than one year after
publish, within 90 days of enactment
Promulgation by Secretary. Same as
enactment, promulgate regulations to
and without notice and comment, an
S. 2307.
carry out Section 814 [to register
interim final rule for implementing
prescription drug importation
Section 804; and publish a final rule
facilities].
by one year after the interim rule.
Effective dates
No provision.
Section 3(d)(2). Implementation;
Section 4(c)(1)(A)(ii). Effect of
Section 2(b)(1)(B). Directs that
Personal Importation from Canada.
Rules. An individual may import a
personal-use importation be allowed
Until 45-days after the promulgation
prescription drug for personal or
from enactment of this Act, even if
of the interim final rule, an individual
family-member use from a registered
the Secretary has not issued
may import up to a 90-day supply of
exporter beginning when the interim
regulations.
a qualifying drug from Canada, for
rule is promulgated.
personal or family-member use,
according to conditions in this act.
A registered importer may import a
Section 2(b)(2)(B). Directs that
prescription drug from Canada
pharmacy and wholesaler importation
beginning when the interim rule is
be 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 other
Section 8(b). Directs that registration
permitted countries beginning one
of prescription drug importation
year after enactment.
facilities requirements take effect on
the effective date of the final
Section 4(c)(1)(B). Registrations
regulations or, if the final regulations
submitted by entities in Canada that
have not been made effective, one
are significant exporters of
year 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
enactment; (2) a notice regarding a
drug that does not require prior
approval must be submitted to the
Secretary within 90 days of
enactment.
Section 4(c)(1)(D). For drugs to be
imported 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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.
Appropriations
8 0 4 ( m) . A u t h o r i z a t i o n o f
No provision.
No provision.
No provision.
Appropriations. Authorizes to be
appropriated such sums as are
necessary to carry out this section.
Protection
No provision.
No provision.
No provision.
Section 3. Pro tection Against
against
Adulterated Prescription Drugs.
adulterated
Amends Section 801(h) of the
prescription
FFDCA [as added by P.L. 107-188] to
drugs
include prescription drugs along with
food, as follows. Directs the
Secretary to give high priority to
i mp ro ving FDA info rma t i o n
management systems to allow the
Secretary 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.
Internet
No provision.
No provision.
No provision.
Section 4. Adds to the FFDCA a new
pharmacies
Section 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
fund transfer,” “financial institution,”
“money transmitting business,” and
“money transmitting service.”
I n c l u d e s r e fe r e n c e s t o t h e
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
USC 1693a], and the Uniform
Commercial Code [Article 4A].
In particular, defines “Internet
pharmacy” as “a person that dispenses
or offers to dispense a prescription
drug through an Internet website in
interstate 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
of pharmacy and the manufacturing
and distribution of controlled
substances and, for an Internet
pharmacy in Canada or a permitted
country, verification regarding
compliance with applicable laws of
that country. Also requires the
application 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
void.
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
maintain patient medication profiles,
conduct prospective drug use reviews,
ensure patient confidentiality in
accordance with the Health Insurance
Portability and Accountability Act of
1996, offer “interactive and
meaningful consultation by a licensed
pharmacist,” 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 sale “is 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 individual’s 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
providers.
Licensure Procedure. Requires that
the Secretary assign an ID number
and notify applicant of license
application receipt and issue a license
within 60 days if pharmacy complies
with all required conditions. Directs
the Secretary to require electronic
submission of application and to
ensure adequate authentication
protocols.
Requires that the Secretary keep an
up-to-date list of licensees and make
the list available to the public by an
Internet website and a toll-free
telephone number.
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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.
Requires the Secretary, in 2005 and
each subsequent year, to submit a
report to Congress describing the
implementation of the licensing fee
authority and the use of the fees
collected. Allows the Secretary to
terminate a license if the Internet
pharmacy 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
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.
511(e). Policies and Procedures
Required To Prevent Payments for
Unlawful Internet Pharma cy
Requests. Requires regulations within
a year of enactment regarding design
(using, for example, authorization
codes) of the payment system (with
system participant participation, if
feasible) to prevent or block restricted
transactions. Establishes that there be
no liability for blocking or refusing to
honor 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 person’s 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
ownership, representing that a
prescription drug may be obtained
without a prescription, or accepting
advertising from an Internet pharmacy
without having a copy of the
pharmacy’s license on file.
Section 4(c). Links to Illegal Internet
Pharmacies. Amends FFDCA
Section 302, stating that U.S. district
courts and courts of the territories
shall have jurisdiction to order an
interactive computer service to
remove or disable access to a website
that violates this section. States that
relief shall be available after notice
and 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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
prescription drug from an unlicensed
Internet pharmacy be refused
admission and that the Secretary
return it to the pharmacy at the
pharmacy’s expense. Directs the
Secretary to return to the pharmacy at
the pharmacy’s expense a refused
shipment 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.
Prohibition of
No provision.
No provision.
No provision.
813(a)(2). Limitation to Certain
port shopping
Ports. 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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and Drug Safety Act of 2004
(IMPORT) Act of 2004
available to the public on an Internet
website.
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
prescription drug, that the prescription
drug complies with the applicable
requirements of this Act, as
determined by the Secretary. This
section does not apply to a personal-
use import or to a commercial
transaction between an Internet
pharmacy and an individual.
Anti-
Section 15(d). Anticounterfeiting
counterfeiting
Programs. Requires the Secretary to
programs
establish a “Counterfeit Alert
N e t wo r k ” t o n o t i fy h e a l t h
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 through
S. 2493 (Gregg 6/2/04)
Improvement, and Modernization
Importation with Effective
S. 2328 (Dorgan 4/21/04)
Safe Importation of Medical
Act of 2003, enacted 12/8/2003 as
Safeguards (REMEDIES) Act of
Pharmaceutical Market Access
Products and Other Rx Therapies
Topic
P.L. 108-173 [117 Stat. 2464]
2004
and 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.

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