Updated December 8, 2022
Prescription Drug Importation
In the context of rising drug prices, the possibility of
into interstate commerce of a drug that is unapproved,
importing prescription drugs from other countries at lower
adulterated (e.g., held under insanitary conditions), or
prices is again being debated. Generally, the importation or
misbranded (e.g., the labeling does not include adequate
reimportation of a prescription drug that does not meet
directions for use) [FFDCA Sections 505(a), 301(a), (d)].
Food and Drug Administration (FDA) requirements is
Commercial Use. FFDCA Section 801(d)(1)(B) explicitly
prohibited. The policy debate has centered on creating a
prohibits the importation for commercial use of unapproved
new legal option for the import of lower-cost prescription
drugs manufactured outside of the United States, with two
drugs into the United States.
exceptions: (1) as authorized by the Secretary of Health and
Prescription Drug Regulation
Human Services (HHS) pursuant to a drug shortage, and (2)
pursuant to the authority at FFDCA Section 804, both of
FDA, under the Federal Food, Drug, and Cosmetic Act
which are discussed in the next section. This prohibition
(FFDCA), regulates prescription drugs. In order to market a
does not apply to drugs when, although manufactured
new drug in the United States, a manufacturer must obtain
outside of the United States, the manufacturer has
approval from FDA by submitting a new drug application
authorized them to be marketed in the United States and has
(NDA), or in the case of a generic drug, an abbreviated
labeled them according to relevant FFDCA requirements.
NDA (ANDA). To get approval, the manufacturer must (1)
demonstrate the drug’s safety and effectiveness according
Reimportation. Current law also prohibits the
to criteria specified in law and regulation, (2) ensure that its
reimportation—importing an exported U.S.-manufactured
manufacturing facility passes FDA inspection, and (3)
drug back into the United States—of a U.S.-manufactured
obtain approval for the drug’s labeling. Drugs made in
drug by anyone other than the manufacturer (FFDCA
foreign countries that are imported into the United States
Section 801(d)(1)(A)). Reimportation of a U.S.-
for commercial distribution must comply with the same
manufactured drug by anyone other than the original
FFDCA requirements as domestically manufactured drugs,
manufacturer is illegal even if it meets all of the
including registration and premarket approval. A drug
requirements for approval under the FFDCA because it
manufacturer may import drugs produced abroad that have
could have been mishandled or otherwise adulterated when
not yet received approval (e.g., drugs intended for further
it was outside of the reach of FDA. FFDCA Section
processing) by complying with FDA and U.S. Customs and
801(d)(2) allows for an exception to this prohibition,
Border Protection (CBP) requirements. See CRS Report
allowing for the HHS Secretary to authorize the
R41983, How FDA Approves Drugs and Regulates Their
reimportation of a U.S.-manufactured drug where required
Safety and Effectiveness, and CRS Report R46507, FDA’s
for emergency medical care, or under FFDCA Section 804,
Role in the Medical Product Supply Chain and
as described below.
Considerations During COVID-19.
The provision prohibiting the reimportation of U.S.-
Prescription Drug Importation
manufactured drugs was put in place in 1987 in an effort to
ensure a “closed system” for all prescriptio
Foreign-made versions of FDA-approved drugs that have
n drugs
not been evaluated through the FDA process are typically
marketed in the United States. Proponents of this
considered unapproved new drugs and are illegal. The
prohibition argued that it protected against the possibility of
FFDCA provides for the circumstances under which an
prescription drugs that were manufactured in the United
unapproved drug may be imported into the United States.
States and then exported from being brought onto the
This section discusses the circumstances under which
American market in possibly subpotent, mislabeled,
importation is prohibited, as well as the circumstances
adulterated, expired, or counterfeit form. Manufacturer
under which it is allowed.
reimportation was permitted to allow for standard inventory
control practices within the industry.
Importation That Is Prohibited Under Current Law Importation That Is Allowed Under Current Law
Under current law, the importation of unapproved new
drugs, including foreign-made versions of FDA-approved
FFDCA Section 804. Section 804 gives the HHS Secretary
drugs, is generally prohibited. This would entail bringing
authority to promulgate regulations to establish a drug
into the United States an unapproved drug manufactured
importation program under which pharmacists and
outside of the United States. Even in cases where the drug
wholesalers could import unapproved prescription drugs
is a foreign-made version of an FDA-approved drug (i.e.,
from Canada into the United States, with certain
the same active ingredient made by the same manufacturer),
qualifications. Specifically, the provision provides that the
FDA has stated that it is highly unlikely that the version for
program cannot become effective until the HHS Secretary
the foreign market would meet all of the requirements in the
certifies that the importation program would pose no
additional risk to the public’s health and safety
FFDCA for approval. Current law prohibits the introduction
and would
offer “significant reduction in the cost” to U.S. consumers.
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Prescription Drug Importation
Until recently, no Secretary had given such approval.
among others. Although then-Secretary Azar made a
However, on September 23, 2020, former HHS Secretary
certification, the final rule requires SIP sponsors to
Alex Azar made the requisite certification in a letter to
demonstrate that their program will adequately ensure the
Congress. HHS subsequently promulgated a final rule to
protection of public health and to explain how it will result
implement Section 804 (described further below).
in a significant reduction in the cost of covered products to
consumers. Proposals must specify the eligible drugs to be
Drug Shortages. Current law allows FDA to take various
included in the SIP, which would have to bear the required
actions when a drug is in shortage, including expediting
U.S. labeling and undergo testing for quality and
application review and facility inspection. One available
authenticity, in addition to meeting other supply chain
option (now under FFDCA Section 801(d)(1)(B)) is that the
requirements. SIP proposals also must identify the foreign
HHS Secretary may choose to exercise enforcement
seller in Canada that will purchase the eligible prescription
discretion and allow the temporary and tightly controlled
drug directly from its manufacturer, as well as the U.S.
importation and distribution of unapproved drugs to
importer that will purchase the drug directly from the
alleviate a drug shortage while domestic production gets
foreign seller. Both the foreign seller and importer are
back up to speed. This is generally done very rarely, only
subject to applicable U.S. registration, licensure and supply
after other options (e.g., diverting manufacturing to another
chain security requirements. FDA also issued final guidance
facility, working with a facility to address quality issues)
to implement the second pathway (under FFDCA Section
are considered. In response to Hurricane Maria, for
801(d)(1)(B)) to facilitate importation of foreign-made
example, FDA used “regulatory flexibility and discretion”
versions of FDA-approved drugs under their existing U.S.
to allow for the temporary importation of drugs not
approval. The guidance applies to drug manufacturers,
approved for use in the United States and manufactured in
offering them an option to import drugs that may provide
other countries (e.g., Ireland, Mexico, and Canada).
lower-cost alternatives to U.S. consumers. This is in
Personal Importation Policy (PIP). As outlined in FDA
contrast to the final rule, which creates a mechanism for
guidance, the agency allows some personal importation of
importation by entities other than the drug manufacturer
unapproved drugs on a case-by-case basis, but one of the
and does not require a manufacturer’s authorization. Also
criteria that FDA lists in allowing this personal importation
unlike the final rule, the guidance applies to small molecule
is that there can be no existing effective treatment available
drugs and biologics and is not limited to importation from
in the United States. Current law generally does not permit
Canada. In July 2021, Executive Order 14036 directed FDA
individuals to import or reimport prescription drugs for
to work with potential SIP sponsors; FDA has published
their own use; instead, it directs the Secretary to exercise
materials related to the final rule and the required cost
discretion to permit importation on a case-by-case basis by
analysis on its website.
an individual for drugs that are clearly for personal use, if
such use does not appear to present an unreasonable risk to
Drug Importation Policy
the individual. FFDCA Section 804(j) provides a statutory
Legislation to expand legal drug importation was
basis for the FDA waiver authority outlined in the PIP
introduced in the 117th Congress, and a provision
guidance, although the FDA issued the guidance prior to the
addressing both commercial and personal drug importation
establishment of Section 804. FDA has generally allowed
was included in the Senate user fee bill (S. 4348). Some
individuals to bring into the United States a 90-day supply
stakeholders express support for policies that would allow
of unapproved drugs for personal use where effective
commercial and personal importation of lower-cost drugs in
treatment is not available in the United States, it is for the
a way that ensures drug safety and integrity. On the other
treatment of a serious medical condition, and there is no
hand, proposals to expand drug importation have been
commercialization of the drug to U.S. residents. FDA’s PIP
opposed by several former FDA Commissioners and HHS
is not intended as a way for consumers to bring lower-
Secretaries, as well as by the pharmaceutical industry,
priced prescription drugs into the United States; rather,
citing safety concerns. Despite the promulgation of
FDA intended this enforcement discretion to allow
regulations implementing Section 804 and publication of
individuals to get treatments not otherwise available in the
final guidance as noted, it remains unclear to what extent or
United States.
if these policies will be successfully implemented; to date,
although a handful of states have submitted SIP proposals
Safe Importation Action Plan
to FDA (e.g., Florida, Colorado), FDA has not authorized
In July 2019, HHS and FDA announced the “Safe
any SIPs, and at least one lawsuit has been filed challenging
Importation Action Plan,” proposing two pathways to allow
the final rule. While the final guidance provides an option
or facilitate the importation of unapproved drugs. In
for drug manufacturers to import certain drugs, it is unclear
October 2020, HHS promulgated a final rule pursuant to
if manufacturers are interested in importing drugs intended
FFDCA Section 804 to implement the first pathway (21
for foreign markets. Further, other countries may be
C.F.R. Part 251). The rule allows states and tribes to submit
reluctant to support U.S. importation policies, as it may
to HHS for review proposals for, and FDA to authorize,
affect their domestic supply of drugs. In November 2020,
time-limited Section 804 Importation Programs (SIP) to
the Canadian government announced that certain drugs
permit the importation of certain prescription drugs from
intended for the Canadian market may not be sold outside
Canada, specifically Health Canada-approved versions of
of Canada if such sale would cause or worsen a drug
drugs marketed in the United States under an NDA or
shortage.
ANDA. Consistent with the statutory language of Section
804, certain drugs are ineligible for importation, including
Amanda K. Sarata, Specialist in Health Policy
biologics (e.g., insulin) and intravenously injected drugs,
IF11056
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Prescription Drug Importation


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https://crsreports.congress.gov | IF11056 · VERSION 6 · UPDATED

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