I 
119TH CONGRESS 
1ST SESSION H. R. 3162 
To amend the Federal Food, Drug, and Cosmetic Act to allow for the 
importation of affordable and safe drugs by wholesale distributors, phar-
macies, and individuals. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 1, 2025 
Ms. SCHAKOWSKY (for herself, Mr. COHEN, Mr. DOGGETT, Ms. OMAR, Ms. 
PINGREE, and Mr. POCAN) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
allow for the importation of affordable and safe drugs 
by wholesale distributors, pharmacies, and individuals. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Affordable and Safe 
Prescription Drug Importation Act of 2025’’. 
SEC. 2. FINDINGS; SENSE OF CONGRESS. 
(a) FINDINGS.—Congress finds the following: 
(1) Prescription drug prices are, on average, 
2.78 times more expensive in the United States com-
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pared to comparable countries in the Organisation 
for 
Economic 
Co-operation 
and 
Development 
(OECD). Drugs that are still under a patent are 
4.22 times more expensive in the United States than 
those in comparable nations in the OECD. 
(2) Multiple studies have demonstrated that 
tens of millions of Americans have opted to not fill 
a prescription due to the prohibitive cost of the pre-
scription. 
(3) The Food and Drug Administration has en-
tered into Mutual Recognition Agreements with the 
United Kingdom, the European Union, and Switzer-
land to recognize drug manufacturing inspections 
conducted by each entity as valid and equivalent to 
an inspection conducted by their own inspectors. 
(4) The Food and Drug Administration, in tes-
timony provided to Congress, acknowledged that 
fewer negative inspection outcomes were assessed to 
drug manufacturers in the European Union than in 
the United States, representing a drug manufac-
turing industry that is comparably safe and effective 
to that of the United States. 
(5) In 2022, the Food and Drug Administra-
tion found that 57 percent of all finished dosage 
form manufacturing sites for drugs categorized as 
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essential medicines were located in foreign nations 
and relied on importation to reach American pa-
tients. 
(6) Millions of Americans every year already 
benefit from safely importing their prescription 
drugs for personal use, which Federal law permits 
through enforcement discretion and waivers, but 
such importation remains technically illegal under 
most circumstances because many foreign drugs do 
not have the exact same formulations as the Food 
and Drug Administration-approved versions. Despite 
Federal law recognizing that ‘‘patients and their 
families sometimes have reason to import into the 
United States drugs that have been approved by the 
Food and Drug Administration’’ the existing restric-
tions mean Americans who are able to obtain relief 
from high prescription drug costs by importing pre-
scription drugs for personal use may occasionally 
lose access to these drugs as they are seized upon 
importation. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that— 
(1) the cost of prescription drugs in the United 
States represents a crisis that endangers the safety 
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of millions of Americans who must choose between 
their health and financial stability; 
(2) prohibitions on drug importation originally 
intended to protect American consumers have re-
sulted in artificially raised prices that harm the 
American people, even while the same drugs sell for 
significantly less in other countries; 
(3) since the initial prohibitions on drug impor-
tation were put in place, foreign nations, including 
Canada, the United Kingdom, Switzerland, and 
members of the European Union, have significantly 
advanced their ability to safely approve, manufac-
ture, and transport prescription drugs, including 
small molecules and biologics; 
(4) the American pharmaceutical supply chain 
already heavily relies on drugs that are manufac-
tured overseas and then imported to American pa-
tients, a process that has been done safely for dec-
ades and with exporting nations with which the 
Food and Drug Administration does not have a Mu-
tual Recognition Agreement; and 
(5) it is possible for the American people, with 
appropriate oversight from the Secretary of Health 
and Human Services and the Food and Drug Ad-
ministration, to safely engage in a global pharma-
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ceutical marketplace in order to obtain prescription 
drugs for fair prices. 
SEC. 3. IMPORTING AFFORDABLE AND SAFE DRUGS. 
(a) IN GENERAL.—Section 804 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384) is amended to 
read as follows: 
‘‘SEC. 804. IMPORTATION OF SAFE AND AFFORDABLE 
DRUGS 
BY 
WHOLESALE 
DISTRIBUTORS, 
PHARMACIES, AND INDIVIDUALS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of the Affordable and Safe Prescription 
Drug Importation Act of 2025, the Secretary shall pro-
mulgate regulations permitting the importation of quali-
fying prescription drugs into the United States, in accord-
ance with this section. 
‘‘(b) DEFINITIONS.—For purposes of this section: 
‘‘(1) CERTIFIED FOREIGN SELLER.—The term 
‘certified foreign seller’ means a licensed foreign 
pharmacy or foreign wholesale distributor that the 
Secretary certifies under subsection (d)(1)(B), that 
pays the fee required under subsection (d)(1)(C), 
and that is included on the list described in sub-
section (c). 
‘‘(2) FOREIGN
WHOLESALE
DISTRIBUTOR.— 
The term ‘foreign wholesale distributor’ means a 
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person (other than a manufacturer, a manufactur-
er’s co-licensed partner, a third-party logistics pro-
vider, or a repackager) engaged in wholesale dis-
tribution. 
‘‘(3) IMPORTER.—The term ‘importer’ means a 
dispenser (as defined in section 581(3)) or wholesale 
distributor registered under section 503(e) who im-
ports prescription drugs into the United States in 
accordance with this section. 
‘‘(4) LICENSED
FOREIGN
PHARMACY.—The 
term ‘licensed foreign pharmacy’ means a pharmacy 
located in Canada, the United Kingdom, a member 
state of the European Union, Switzerland, or subject 
to subsection (e), another applicable country, that— 
‘‘(A) operates in accordance with applica-
ble pharmacy standards set forth by the phar-
macy laws and regulations of the country in 
which the pharmacy is located; and 
‘‘(B) is licensed to operate and dispense 
prescription drugs to individuals in the country 
in which the pharmacy is located. 
‘‘(5) QUALIFYING
PRESCRIPTION
DRUG.—The 
term ‘qualifying prescription drug’— 
‘‘(A) means a prescription drug that— 
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‘‘(i) is approved for use in patients, 
and marketed, in Canada, the United 
Kingdom, a member state of the European 
Union, Switzerland, or subject to sub-
section (e), in another permitted country; 
‘‘(ii) has the same active ingredient or 
ingredients, route of administration, and 
strength as a prescription drug approved 
under chapter V, or, for purposes of sub-
paragraph (B)(iv), is biosimilar to an ap-
proved biological product and has the same 
route of administration and strength as the 
approved biological product; and 
‘‘(iii) is labeled in accordance with— 
‘‘(I) the laws of Canada, the 
United Kingdom, a member state of 
the European Union, Switzerland, or 
another country from which importa-
tion is permitted pursuant to sub-
section (e); and 
‘‘(II) the requirements promul-
gated by the Secretary, which shall in-
clude labeling in English; 
‘‘(B) with respect to importers only, in-
cludes— 
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‘‘(i) peritoneal dialysis solution; 
‘‘(ii) insulin; 
‘‘(iii) a drug for which a risk evalua-
tion and mitigation strategy is required 
under section 505–1; 
‘‘(iv) biological products, as defined in 
section 351 of the Public Health Service 
Act that are proteins (except any chemi-
cally synthesized polypeptides) or analo-
gous products; and 
‘‘(v) intravenously infused drugs; and 
‘‘(C) does not include— 
‘‘(i) a controlled substance (as defined 
in section 102 of the Controlled Sub-
stances Act); 
‘‘(ii) an anesthetic drug inhaled dur-
ing surgery; or 
‘‘(iii) a compounded drug. 
‘‘(6) VALID
PRESCRIPTION.—The term ‘valid 
prescription’ means a prescription that is issued for 
a legitimate medical purpose in the usual course of 
professional practice by a practitioner who has con-
ducted at least one in-person medical evaluation of 
the patient. 
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‘‘(c) PUBLICATION OF CERTIFIED FOREIGN SELL-
ERS.—The Secretary shall publish on a dedicated internet 
website a list of certified foreign sellers, including the 
internet website address, physical address, and telephone 
number of each such certified foreign seller. 
‘‘(d) ADDITIONAL CRITERIA.— 
‘‘(1) CERTIFIED FOREIGN SELLERS.— 
‘‘(A) IN GENERAL.—To be a certified for-
eign seller, such seller shall— 
‘‘(i) be certified by the Secretary in 
accordance with subparagraph (B); 
‘‘(ii) pay the registration fee estab-
lished under subparagraph (C); and 
‘‘(iii) sell only qualifying prescription 
drugs to importers or individuals who im-
port prescription drugs into the United 
States in accordance with this section. 
‘‘(B) CERTIFICATION.—To be a certified 
foreign seller, the Secretary shall certify that 
such seller— 
‘‘(i) is a foreign wholesale distributor 
or licensed foreign pharmacy operating an 
establishment, which may include an online 
foreign pharmacy, that is located in Can-
ada, the United Kingdom, a member state 
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of the European Union, Switzerland, or, 
subject to subsection (e), another per-
mitted country; 
‘‘(ii) is engaged in the distribution or 
dispensing of a prescription drug that is 
imported or offered for importation into 
the United States; 
‘‘(iii) in the case of a certified foreign 
seller that is a licensed foreign pharmacy, 
agrees to dispense a qualifying prescription 
drug to an individual in the United States 
only after receiving a valid prescription, as 
described in paragraph (2)(C); 
‘‘(iv) has processes established by the 
seller, or participates in another estab-
lished process, to certify that the physical 
premises and data reporting procedures 
and licenses are in compliance with all ap-
plicable laws and regulations of the coun-
try in which the seller is located and has 
implemented policies designed to monitor 
ongoing compliance with such laws and 
regulations; 
‘‘(v) conducts or commits to partici-
pate in ongoing and comprehensive quality 
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assurance programs and implements such 
quality 
assurance 
measures, 
including 
blind testing, to ensure the veracity and re-
liability of the findings of the quality as-
surance program; 
‘‘(vi) agrees that, pursuant to sub-
section (g), laboratories approved by the 
Secretary may be authorized to conduct 
product testing to determine the chemical 
authenticity 
of 
sample 
pharmaceutical 
products; 
‘‘(vii) agrees to notify the Secretary, 
importers, and individuals of product re-
calls in the country in which the seller is 
located, and agrees to cease, or refrain 
from, exporting such product; 
‘‘(viii) has established, or will estab-
lish or participate in, a process for resolv-
ing grievances, as defined by the Secretary, 
and will be held accountable for violations 
of established guidelines and rules; 
‘‘(ix) except as otherwise permitted 
under this section, does not sell products 
that the seller could not otherwise legally 
sell in the country in which the seller is lo-
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cated to customers in the United States; 
and 
‘‘(x) meets any other criteria estab-
lished by the Secretary. 
‘‘(C) CERTIFICATION FEE.—Not later than 
30 days before the start of each fiscal year, the 
Secretary shall establish a fee to be collected 
from foreign sellers for such fiscal year that are 
certified under subparagraph (B), in an amount 
that is sufficient, and not more than necessary, 
to pay the costs of administering the program 
under this section, and enforcing this section 
pursuant to section 303(h), for that fiscal year. 
‘‘(D) RECERTIFICATION.—A certification 
under subparagraph (B) shall be in effect for a 
period of 2 years, or until there is a material 
change in the circumstances under which the 
foreign seller meets the requirements under 
such subparagraph, whichever occurs earlier. A 
foreign seller may reapply for certification 
under such subparagraph (B), in accordance 
with a process established by the Secretary. 
‘‘(2) INDIVIDUALS.—An individual may import 
a qualifying prescription drug described in sub-
section (b) from Canada, the United Kingdom, a 
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member state of the European Union, Switzerland, 
or another country pursuant to subsection (e) if 
such drug— 
‘‘(A) is dispensed, including a drug ordered 
from an online pharmacy, by a certified foreign 
seller that is a licensed foreign pharmacy; 
‘‘(B) is purchased for personal use by the 
individual, not for resale, in quantities that do 
not exceed a 90-day supply; and 
‘‘(C) is filled only after providing to the li-
censed foreign pharmacy a valid prescription 
issued by a health care practitioner licensed to 
practice in a State in the United States. 
‘‘(e) IMPORTATION FROM OTHER COUNTRIES.—Be-
ginning on the date that is 1 year after the date on which 
final regulations are promulgated to carry out this section, 
if, based on a review of the evidence obtained after such 
effective date, including the reports submitted under sec-
tion 2(d) of the Affordable and Safe Prescription Drug 
Importation Act of 2025, that importation of qualifying 
prescription drugs from Canada, the United Kingdom, a 
member state of the European Union, and Switzerland 
under this section was conducted safely, the Secretary 
shall have the authority to permit importation of quali-
fying prescription drugs by importers and individuals 
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from, in addition to Canada, the United Kingdom, a mem-
ber state of the European Union, and Switzerland, any 
country that— 
‘‘(1) has statutory or regulatory standards for 
the approval and sale of prescription drugs that 
would enable safe importation of prescription drugs 
into the United States; 
‘‘(2) authorizes the approval of drugs only if a 
drug has been determined to be safe and effective by 
experts employed by or acting on behalf of a govern-
mental entity and qualified by scientific training and 
experience to evaluate the safety and effectiveness of 
drugs; 
‘‘(3) requires that any determination of safety 
and effectiveness described in paragraph (2) be 
made on the basis of adequate and well-controlled 
investigations, including clinical investigations, as 
appropriate, conducted by experts qualified by sci-
entific training and experience to evaluate the safety 
and effectiveness of drugs; 
‘‘(4) requires the methods used in, and the fa-
cilities and controls used for, the manufacture, proc-
essing, and packing of drugs in the country to be 
adequate to preserve the identity, quality, purity, 
and strength of the drugs; and 
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‘‘(5) requires the reporting of adverse reactions 
to drugs and establish procedures to recall, and 
withdraw approval of, drugs found not to be safe or 
effective. 
‘‘(f) LABELING.—Any qualifying prescription drug 
imported that meets the labeling requirements described 
in subsection (b)(5)(A)(iii) is deemed not misbranded for 
purposes of section 502. 
‘‘(g) DRUG
TESTING
LABORATORIES.—The Sec-
retary may approve one or more laboratories to conduct 
random testing of prescription drugs sold by certified for-
eign sellers to assess the chemical authenticity of such 
drugs. 
‘‘(h) UNFAIR AND DISCRIMINATORY ACTS AND PRAC-
TICES.—It is unlawful for a manufacturer, directly or indi-
rectly (including by being a party to a licensing agreement 
or other agreement)— 
‘‘(1) to discriminate by charging a higher price 
for a prescription drug sold to a certified foreign 
seller that sells such drug to an importer in accord-
ance with this section than the price that is charged, 
inclusive of rebates or other incentives to the coun-
try from which the drug is exported, to another per-
son that is in the same country and that does not 
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import such a drug into the United States in accord-
ance with this section; 
‘‘(2) except with respect to a prescription drug 
on the drug shortage list under section 506E, dis-
criminate by denying, restricting, or delaying sup-
plies of a prescription drug to a certified foreign sell-
er, on account of such seller’s status as a certified 
foreign seller, that sells such drug to an importer in 
accordance with this section, or by publicly, pri-
vately, or otherwise refusing to do business with 
such a certified foreign seller on account of such 
seller’s status as a certified foreign seller; 
‘‘(3) cause there to be a difference (including a 
difference in active ingredient, route of administra-
tion, bioequivalence, strength, formulation, manufac-
turing establishment, manufacturing process, or per-
son that manufactures the drug) between a prescrip-
tion drug for distribution in the United States and 
the drug for distribution in Canada, the United 
Kingdom, a member state of the European Union, 
Switzerland, or another permitted country, subject 
to subsection (e), for the purpose of avoiding sales 
by certified foreign sellers; or 
‘‘(4) except with respect to a prescription drug 
on the drug shortage list under section 506E, en-
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