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‘‘(5) EXISTING AUTHORITIES.—Nothing in this 
section restricts any authority vested in the Sec-
retary by any other provision of this Act or the Pub-
lic Health Service Act for establishing conditions of 
authorization for a product.’’; and 
(6) in subsection (g)— 
(A) in the heading, by striking ‘‘REVOCA-
TION OF AUTHORIZATION’’ and inserting ‘‘RE-
VIEW, MODIFICATION, AND REVOCATION
OF 
AUTHORIZATION’’; 
(B) in paragraph (1), by striking ‘‘periodi-
cally review’’ and inserting ‘‘review not less 
than every three years’’; and 
(C) by adding at the end the following: 
‘‘(3) MODIFICATION.—The Secretary may mod-
ify an authorization under this section or the condi-
tions of such an authorization, at any time, based on 
a review of the authorization or new information 
that is otherwise obtained, including information ob-
tained during an emergency.’’. 
SEC. 7. ADDITIONAL PROVISIONS RELATED TO MEDICAL 
PRODUCTS FOR EMERGENCY USE. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 564 
(21 U.S.C. 360bbb–3) the following: 
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‘‘SEC. 564A. ADDITIONAL PROVISIONS RELATED TO MED-
ICAL PRODUCTS FOR EMERGENCY USE. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘product’ means a drug, device, 
or biological product. 
‘‘(2) The term ‘eligible product’ means a prod-
uct that is— 
‘‘(A) approved or cleared under this chap-
ter or licensed under section 351 of the Public 
Health Service Act; and 
‘‘(B) intended to be used to diagnose, pre-
vent, or treat a disease or condition involving a 
biological, chemical, radiological, or nuclear 
agent or agents during— 
‘‘(i) a domestic emergency or military 
emergency involving heightened risk of at-
tack with such an agent or agents; or 
‘‘(ii) a public health emergency affect-
ing national security or the health and se-
curity of United States citizens abroad. 
‘‘(b) EXPIRATION DATING.— 
‘‘(1) IN GENERAL.—The Secretary may extend 
the expiration date and authorize the introduction or 
delivery for introduction into interstate commerce of 
an eligible product after the expiration date provided 
by the manufacturer if— 
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‘‘(A) the eligible product is intended to be 
held for use for a domestic, military, or public 
health 
emergency 
described 
in 
subsection 
(a)(2)(B); 
‘‘(B) the expiration date extension is in-
tended to support the United States’ ability to 
protect— 
‘‘(i) the public health; or 
‘‘(ii) military preparedness and effec-
tiveness; and 
‘‘(C) the expiration date extension is sup-
ported by an appropriate scientific evaluation 
that is conducted or accepted by the Secretary. 
‘‘(2) REQUIREMENTS
AND
CONDITIONS.—Any 
extension of an expiration date under paragraph (1) 
shall, as part of the extension, identify— 
‘‘(A) each specific lot, batch, or other unit 
of the product for which extended expiration is 
authorized; 
‘‘(B) the duration of the extension; and 
‘‘(C) any other requirements or conditions 
as the Secretary may deem appropriate for the 
protection of the public health, which may in-
clude requirements for, or conditions on, prod-
uct sampling, storage, packaging or repack-
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aging, transport, labeling, notice to product re-
cipients, recordkeeping, periodic testing or re-
testing, or product disposition. 
‘‘(3) EFFECT.—Notwithstanding any other pro-
vision of this Act or the Public Health Service Act, 
an eligible product shall not be considered an unap-
proved product (as defined in section 564(a)(2)(A)) 
and shall not be deemed adulterated or misbranded 
under this Act because, with respect to such prod-
uct, the Secretary has, under paragraph (1), ex-
tended the expiration date and authorized the intro-
duction or delivery for introduction into interstate 
commerce of such product after the expiration date 
provided by the manufacturer. 
‘‘(c) CURRENT
GOOD
MANUFACTURING
PRAC-
TICES.— 
‘‘(1) IN GENERAL.—The Secretary may, when 
the circumstances of a domestic, military, or public 
health emergency described in subsection (a)(2)(B) 
so warrant, authorize, with respect to an eligible 
product, deviations from current good manufac-
turing practice requirements otherwise applicable to 
the manufacture, processing, packing, or holding of 
products subject to regulation under this Act, in-
cluding requirements under section 501 or 520(f)(1) 
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or applicable conditions prescribed with respect to 
the eligible product by an order under section 
520(f)(2). 
‘‘(2) EFFECT.—Notwithstanding any other pro-
vision of this Act or the Public Health Service Act, 
an eligible product shall not be considered an unap-
proved product (as defined in section 564(a)(2)(A)) 
and shall not be deemed adulterated or misbranded 
under this Act because, with respect to such prod-
uct, the Secretary has authorized deviations from 
current good manufacturing practices under para-
graph (1). 
‘‘(d) MASS DISPENSING.—The requirements of sec-
tion 503(b) and 520(e) shall not apply to an eligible prod-
uct, and the product shall not be considered an unap-
proved product (as defined in section 564(a)(2)(A)) and 
shall not be deemed adulterated or misbranded under this 
Act because it is dispensed without an individual prescrip-
tion, if— 
‘‘(1) the product is dispensed during an actual 
emergency described in subsection (a)(2)(B); and 
‘‘(2) such dispensing without an individual pre-
scription occurs— 
‘‘(A) as permitted under the law of the 
State in which the product is dispensed; or 
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