I 
116TH CONGRESS 
2D SESSION 
H. R. 6049 
To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced 
security for the medical supply chain. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 2, 2020 
Mr. GALLAGHER (for himself and Mr. POCAN) 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 
provide enhanced security for the medical supply chain. 
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 ‘‘Medical Supply Chain 
Security Act’’. 
SEC. 2. MEDICAL SUPPLY CHAIN SECURITY. 
(a) ADDITIONAL MANUFACTURER REPORTING FOR 
ESSENTIAL MEDICAL DEVICES.—Section 506C of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) 
is amended— 
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(1) in subsection (a)— 
(A) in the matter preceding paragraph (1), 
by inserting ‘‘or device’’ after ‘‘a drug’’; and 
(B) in the flush matter by inserting ‘‘or 
device’’ after ‘‘drug’’ each place such term ap-
pears; 
(2) in subsection (c), by inserting ‘‘and devices’’ 
after ‘‘drugs’’; 
(3) in subsection (g)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘drug shortage of a drug’’ and in-
serting ‘‘shortage of a drug or device’’; 
(B) in paragraph (1), by striking ‘‘; or’’ 
and inserting a semicolon; 
(C) by redesignating paragraph (2) as 
paragraph (3); 
(D) by inserting after paragraph (1) the 
following: 
‘‘(2) expedite the review of a device subject to 
premarket approval under section 515 that could 
help mitigate or prevent such shortage; or’’; and 
(E) in paragraph (3), as so redesignated, 
by striking ‘‘drug shortage’’ and inserting 
‘‘shortage’’; 
(4) in subsection (h)— 
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(A) by amending paragraph (2) to read as 
follows: 
‘‘(2) the term ‘shortage’, with respect to a drug 
or device, means a period of time when the demand 
or projected demand for the drug or device within 
the United States exceeds the supply of the drug or 
device; and’’; and 
(B) in paragraph (3)(A), by inserting ‘‘or 
device’’ after ‘‘drug’’; and 
(5) by adding at the end the following: 
‘‘(j) ADDITIONAL MANUFACTURER REPORTING FOR 
ESSENTIAL DRUGS AND DEVICES.—Each manufacturer 
of a drug or device described in subsection (a) shall pro-
vide to the Food and Drug Administration, on an annual 
basis, or more frequently at the request of the Secretary, 
information related to the manufacturing capacity of such 
drug or device. Such information shall include— 
‘‘(1) details about— 
‘‘(A) all locations of production; 
‘‘(B) the sourcing of all component parts; 
‘‘(C) the sourcing of any active pharma-
ceutical ingredients; and 
‘‘(D) the use of any scarce raw materials; 
and 
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‘‘(2) any other information determined by the 
Secretary to be relevant to the security of the supply 
chain of the drug or device.’’. 
(b) PROVISION OF ADDITIONAL INFORMATION.—Sec-
tion 506C–1 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356c–1) is amended— 
(1) in the heading, by striking ‘‘DRUG SHORT-
AGES’’ and inserting ‘‘DRUG OR DEVICE SHORT-
AGES’’; 
(2) by striking ‘‘drug shortages’’ each place it 
appears and inserting ‘‘drug or device shortages’’; 
(3) in subsection (a)— 
(A) in paragraph (3)(B)— 
(i) in clause (i), by striking ‘‘section 
506C(g)(1)’’ and inserting ‘‘paragraph (1) 
or (2) of section 506C(g)’’; and 
(ii) in clause (ii), by striking ‘‘section 
506C(g)(2)’’ 
and 
inserting 
‘‘section 
506C(g)(3)’’; and 
(B) in paragraph (5), by striking ‘‘drug 
shortage’’ and inserting ‘‘drug or device short-
age’’; and 
(4) in subsection (c), by striking ‘‘ ‘drug short-
age’ or’’. 
Æ 
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