I 
117TH CONGRESS 
1ST SESSION H. R. 2181 
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 
MARCH 23, 2021 
Mr. WELCH (for himself, Ms. BUSH, Mr. DOGGETT, Ms. NORTON, Mr. POCAN, 
Mr. KHANNA, Mr. NEGUSE, Ms. OMAR, and Ms. SCHAKOWSKY) intro-
duced the following bill; which was referred 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’’. 
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SEC. 2. 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 180 days after 
the date of enactment of the Affordable and Safe Prescrip-
tion Drug Importation Act, the Secretary shall promulgate 
regulations permitting the importation of qualifying pre-
scription drugs into the United States, in accordance 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 
person (other than a manufacturer, a manufactur-
er’s co-licensed partner, a third-party logistics pro-
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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, or subject to subsection (e), an-
other applicable country, that— 
‘‘(A) operates in accordance with applica-
ble pharmacy standards set forth by the provin-
cial pharmacy rules and regulations enacted in 
Canada, or, subject to subsection (e), such ap-
plicable rules and regulations of the permitted 
country in which such seller is located; and 
‘‘(B) is licensed to operate and dispense 
prescription drugs to individuals in Canada, or, 
subject to subsection (e), the permitted 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, or subject to 
subsection (e), approved for use in pa-
tients, and marketed, in another permitted 
country; 
‘‘(ii) is manufactured in a facility reg-
istered under subsection (b)(1) or (i) of 
section 510 that is in compliance with good 
manufacturing practices regulations of the 
Food and Drug Administration; 
‘‘(iii) 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 
‘‘(iv) is labeled in accordance with— 
‘‘(I) the laws of Canada, or an-
other country from which importation 
is permitted pursuant to subsection 
(e); and 
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‘‘(II) the requirements promul-
gated by the Secretary, which shall in-
clude labeling in English; 
‘‘(B) with respect to importers only, in-
cludes— 
‘‘(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 
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a legitimate medical purpose in the usual course of 
professional practice by— 
‘‘(A) a practitioner who has conducted at 
least one in-person medical evaluation of the 
patient; or 
‘‘(B) a covering practitioner. 
‘‘(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. 
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‘‘(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, or, subject to subsection (e), another 
permitted 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) has been in existence for a pe-
riod of at least 5 years preceding the date 
of such certification and has a purpose 
other than to participate in the program 
established under this section; 
‘‘(iv) 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); 
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‘‘(v) 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 Canada, 
or, subject to subsection (e), the permitted 
country in which the seller is located, and 
has implemented policies designed to mon-
itor ongoing compliance with such laws 
and regulations; 
‘‘(vi) conducts or commits to partici-
pate in ongoing and comprehensive quality 
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; 
‘‘(vii) 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; 
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‘‘(viii) agrees to notify the Secretary, 
importers, and individuals of product re-
calls in Canada, or pursuant to subsection 
(e), the permitted country in which the 
seller is located, and agrees to cease, or re-
frain from, exporting such product; 
‘‘(ix) has established, or will establish 
or participate in, a process for resolving 
grievances, as defined by the Secretary, 
and will be held accountable for violations 
of established guidelines and rules; 
‘‘(x) except as otherwise permitted 
under this section, does not sell products 
that the seller could not otherwise legally 
sell in Canada, or, subject to subsection 
(e), the permitted country in which such 
seller is located to customers in the United 
States; and 
‘‘(xi) 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 
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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 or another country pursu-
ant to subsection (e) if such drug— 
‘‘(A) is dispensed, including through 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 
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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 2 years 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, that importation of qualifying prescrip-
tion drugs from Canada under this section resulted in cost 
savings for consumers in the United States and increased 
access to safe medication, the Secretary shall have the au-
thority to permit importation of qualifying prescription 
drugs by importers and individuals from, in addition to 
Canada, any country that— 
‘‘(1) is a member of the Organisation for Eco-
nomic Co-operation and Development; and 
‘‘(2) has statutory or regulatory standards for 
the approval and sale of prescription drugs that are 
comparable to the standards in the United States 
and that— 
‘‘(A) 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 governmental entity and qualified by 
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scientific training and experience to evaluate 
the safety and effectiveness of drugs; 
‘‘(B) requires that any determination of 
safety and effectiveness described in subpara-
graph (A) be made on the basis of adequate 
and well-controlled investigations, including 
clinical investigations, as appropriate, con-
ducted by experts qualified by scientific training 
and experience to evaluate the safety and effec-
tiveness of drugs; 
‘‘(C) requires the methods used in, and the 
facilities and controls used for, the manufac-
ture, processing, and packing of drugs in the 
country to be adequate to preserve the identity, 
quality, purity, and strength of the drugs; and 
‘‘(D) requires the reporting of adverse re-
actions to drugs and establish procedures to re-
call, 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)(iv) is deemed not misbranded for 
purposes of section 502. 
‘‘(g) DRUG
TESTING
LABORATORIES.—The Sec-
retary may approve one or more laboratories to conduct 
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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 
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 
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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 or another per-
mitted 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-
gage in any other action to restrict, prohibit, or 
delay the importation of a prescription drug under 
this section. 
‘‘(i) INFORMATION AND RECORDS.— 
‘‘(1) BIANNUAL REPORTS.—Each importer shall 
submit biannual reports to the Secretary which shall 
contain, for each qualifying prescription drug im-
ported into the United States— 
‘‘(A) the unique facility identifier of the 
manufacturer of the drug, described in section 
510; 
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‘‘(B) the transaction information described 
in section 581(26) (other than the information 
described in subparagraph (C)); and 
‘‘(C) the price paid by the importer for the 
drug. 
‘‘(2) MAINTENANCE
OF
RECORDS
BY
SEC-
RETARY.—The Secretary shall maintain information 
and documentation submitted under paragraph (1) 
for such period of time as the Secretary determines 
to be appropriate. 
‘‘(j) SUSPENSION OF IMPORTATION.— 
‘‘(1) PATTERNS
OF
NONCOMPLIANCE.—The 
Secretary shall require that importation of a specific 
qualifying prescription drug or importation by a spe-
cific certified foreign seller or importer pursuant to 
this section be immediately suspended if the Sec-
retary determines that there is a pattern of importa-
tion of such specific drug or by such specific seller 
or importer that involves counterfeit drugs, drugs 
that have been recalled or withdrawn, or drugs in 
violation of any requirement of this section, until an 
investigation is completed and the Secretary deter-
mines that importation of such drug or by such sell-
er or importer does not endanger the public health. 
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