I 
116TH CONGRESS 
1ST SESSION 
H. R. 447 
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 
JANUARY 10, 2019 
Mr. CUMMINGS (for himself, Mr. DOGGETT, Mr. WELCH, Mr. COHEN, Mr. 
KHANNA, Ms. LEE of California, Ms. NORTON, Ms. PINGREE, Ms. 
DELAURO, Mr. SHERMAN, Mr. POCAN, Ms. JAYAPAL, Ms. OMAR, Mr. 
KRISHNAMOORTHI, Ms. GABBARD, Mr. LANGEVIN, Ms. JACKSON LEE, 
Mr. BLUMENAUER, Ms. SCHAKOWSKY, Mr. NEGUSE, Ms. OCASIO-COR-
TEZ, and Ms. TLAIB) introduced 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 this section, the Secretary shall 
promulgate regulations permitting the importation of 
qualifying prescription drugs into the United States, in ac-
cordance 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-
vider, or a repackager) engaged in wholesale dis-
tribution. 
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‘‘(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— 
‘‘(i) is approved for use in patients, 
and marketed, in Canada, or subject to 
subsection (e), approved for use in pa-
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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 
‘‘(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) a practitioner who has conducted at 
least 1 in-person medical evaluation of the pa-
tient; or 
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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); 
‘‘(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 
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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; 
‘‘(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, 
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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 
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 
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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 
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-
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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 
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 
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