I 
116TH CONGRESS 
1ST SESSION H. R. 1478 
To amend the Federal Food, Drug, and Cosmetic Act to allow for the 
importation of affordable and safe insulin by wholesale distributors, phar-
macies, and individuals. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 28, 2019 
Mr. WELCH (for himself and Mr. ROONEY of Florida) 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 insulin 
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 Insulin Act 
of 2019’’. 
SEC. 2. IMPORTING AFFORDABLE AND SAFE INSULIN. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 804 
of such Act (21 U.S.C. 384) the following: 
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‘‘SEC. 804A. IMPORTATION OF SAFE AND AFFORDABLE IN-
SULIN BY WHOLESALE DISTRIBUTORS, PHAR-
MACIES, AND INDIVIDUALS. 
‘‘(a) IN GENERAL.— 
‘‘(1) REGULATION.—Not later than 180 days 
after the date of enactment of this section, the Sec-
retary shall promulgate regulations permitting the 
importation of qualifying insulin into the United 
States, in accordance with this section. 
‘‘(2) RELATION TO SECTION 804.—Nothing in 
section 804 shall be construed to supercede or limit 
the provisions of 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 insulin 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 in-
sulin to individuals in Canada, or, subject to 
subsection (e), the permitted country in which 
the pharmacy is located. 
‘‘(5) QUALIFYING INSULIN.—The term ‘quali-
fying insulin’ means insulin that— 
‘‘(A) is approved for use in patients, and 
marketed, in Canada, or subject to subsection 
(e), approved for use in patients, and marketed, 
in another permitted country; 
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