19, as well as chemical, biological, radiological, 
and nuclear threats; and 
(B) of which sufficient and reliable, long- 
term domestic production of these products, 
mostly generic drugs, their active pharma-
ceutical ingredients, and key starting materials, 
is needed to minimize potential shortages by re-
ducing the Nation’s dependence on foreign 
manufacturers of these products. 
(3) 
The 
term 
‘‘medical 
countermeasure’’ 
means— 
(A) a qualified countermeasure (as defined 
in section 319F–1 of the Public Health Service 
Act (42 U.S.C. 247d–6a)); 
(B) a qualified pandemic or epidemic prod-
uct (as defined in section 319F–3 of such Act 
(42 U.S.C. 247d–6d)); 
(C) a security countermeasure (as defined 
in section 319F–2 of such Act (42 U.S.C. 
247d–6b)); or 
(D) personal protective equipment (such as 
gloves, respirators (face masks), and ventila-
tors). 
(4) The term ‘‘Public Health Industrial Base’’ 
means the facilities and associated workforces within 
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the United States, including research and develop-
ment facilities, that help produce essential medi-
cines, medical countermeasures, and critical inputs 
for the health care and public health sector. 
SEC. 4. REQUIRING BOXED WARNINGS ON POTENTIALLY 
CONTAMINATED DRUGS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall— 
(1) issue an order deeming a drug or active 
pharmaceutical ingredient (or a category thereof) to 
be misbranded within the meaning of section 502 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352) if such drug or active pharmaceutical 
ingredient (or category thereof)— 
(A) is manufactured in a country that the 
Secretary determines may be producing con-
taminated drugs or active pharmaceutical ingre-
dients because of systemic problems of super-
vision in the manufacture of drugs or active 
pharmaceutical ingredients; and 
(B) the labeling of such drug or active 
pharmaceutical ingredient (or category thereof) 
does not bear a boxed warning of the potential 
for contamination; 
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(2) make each such order effective for a period 
of not more than 180 days; and 
(3) renew each such order each time the pre-
ceding order ends and the criteria listed in para-
graph (1) continue to apply. 
(b) WAIVERS.—The Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs— 
(1) may waive the requirement to issue or 
renew an order under subsection (a) so long as the 
labeling of the drug or active pharmaceutical ingre-
dient (or category thereof) bears a boxed warning of 
the potential for contamination; 
(2) shall make any such waiver effective for a 
period not to exceed 180 days; and 
(3) may renew any such waiver one or more 
times. 
SEC. 5. LIMITATION ON WAIVER AUTHORITY UNDER THE 
TRADE AGREEMENTS ACT OF 1979. 
Section 301 of the Trade Agreements Act of 1979 
(19 U.S.C. 2511) is amended by adding at the end the 
following: 
‘‘(g) LIMITATION ON WAIVER AUTHORITY RELATING 
TO
ESSENTIAL
MEDICINES, 
MEDICAL
COUNTER-
MEASURES, AND CRITICAL INPUTS.— 
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‘‘(1) IN GENERAL.—The authority of the Presi-
dent under subsection (a) to waive the application of 
any law, regulation, procedure, or practice regarding 
Government procurement does not authorize the 
waiver of any preferences for goods that are essen-
tial medicines, medical countermeasures, or critical 
inputs. 
‘‘(2) DEFINITIONS.—In this subsection, the 
terms 
‘essential 
medicines’, 
‘medical 
counter-
measures’, and ‘critical inputs’— 
‘‘(A) have the meanings given such terms 
in section 3(c) of the Safe Medicine Act; and 
‘‘(B) include the 227 essential medicines, 
medical countermeasures, and critical inputs 
published on October 30, 2020, by the Food 
and Drug Administration in accordance with 
Executive Order 13944.’’. 
Æ 
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