I 
116TH CONGRESS 
2D SESSION 
H. R. 6660 
To amend the Federal Food, Drug, and Cosmetic Act to require the holders 
of approved applications for drugs to conduct a risk assessment to 
identify and evaluate risks to their supply chain and develop, maintain, 
and implement risk mitigation plans to address such risks, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 1, 2020 
Ms. BLUNT ROCHESTER (for herself and Mr. CARTER of Georgia) 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 
require the holders of approved applications for drugs 
to conduct a risk assessment to identify and evaluate 
risks to their supply chain and develop, maintain, and 
implement risk mitigation plans to address such risks, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Limit Ongoing Short-
ages and Stabilize Supply Act of 2020’’ or the ‘‘LOSS 
Act of 2020’’. 
SEC. 2. RISK ASSESSMENTS AND RISK MITIGATION PLANS 
FOR DRUGS. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 506C– 
1 of such Act (21 U.S.C. 356c–1) the following new sec-
tion: 
‘‘SEC. 506C–2. RISK ASSESSMENTS AND RISK MITIGATION 
PLANS FOR DRUGS. 
‘‘(a) COVERED DRUG DEFINED.—In this section, the 
term ‘covered drug’— 
‘‘(1) means a drug that— 
‘‘(A) is described in section 506C(a); or 
‘‘(B) is included, or was included at any 
point during the preceding 5 years, in the drug 
shortage list in effect under section 506E; and 
‘‘(2) includes any such drug that is not required 
to be approved pursuant to an application under 
subsection (b) or (j) of section 505 of this Act or 
subsection (a) or (k) of section 351 of the Public 
Health Service Act to be lawfully marketed. 
‘‘(b) REQUIREMENT.—The manufacturer of a covered 
drug shall— 
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‘‘(1) conduct a risk assessment that identifies 
and evaluates risks to the supply of the drug, includ-
ing vulnerabilities that would likely lead to a mean-
ingful disruption in the supply of the drug in the 
United States; 
‘‘(2) develop and maintain a risk mitigation 
plan to ensure the supply of the drug during such 
a shortage; and 
‘‘(3) implement such plan during such a short-
age. 
‘‘(c) CONFIDENTIALITY.—The Secretary shall— 
‘‘(1) maintain the confidentiality of any risk as-
sessment, and any risk mitigation plan, under this 
section; and 
‘‘(2) limit the use by the Secretary of informa-
tion in such an assessment or plan to preventing, 
mitigating, or responding to a drug shortage. 
‘‘(d) GUIDANCE.—The Secretary shall publish guid-
ance on— 
‘‘(1) how manufacturers should work with their 
supply chain partners in developing the required risk 
assessments and risk mitigation plans; 
‘‘(2) the elements of a risk mitigation plan 
under this section; and 
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‘‘(3) the form and manner of developing and 
maintaining such plan. 
‘‘(e) INSPECTION.—A risk mitigation plan under this 
section shall be subject to inspection and copying by the 
Secretary under section 704. 
‘‘(f) EXPEDITED INSPECTIONS AND REVIEWS.—The 
Secretary may conduct an expedited inspection or review 
as described in section 506C(g) for the purpose of facili-
tating the implementation of a risk management plan de-
veloped pursuant to this section.’’. 
(b) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(fff) The failure to conduct a risk assessment, or 
to develop, maintain, and implement a risk mitigation 
plan, in accordance with section 506C–2.’’. 
(c) APPLICABILITY.—The amendments made by this 
section apply beginning on the date that is 24 months 
after the date of enactment of this Act, except that the 
Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall have discre-
tion to allow persons subject to such amendments addi-
tional time to comply with such amendments as the Sec-
retary determines necessary. 
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SEC. 3. DISCONTINUANCE OR INTERRUPTION IN PRODUC-
TION. 
(a) ACTIVE PHARMACEUTICAL INGREDIENTS.— 
(1) ACTIVE PHARMACEUTICAL INGREDIENTS.— 
Section 506C of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356c) is amended by adding 
at the end the following: 
‘‘(j) APPLICABILITY WITH RESPECT
TO ACTIVE 
PHARMACEUTICAL
INGREDIENTS.—This section shall 
apply with respect to an active pharmaceutical ingredient 
in a drug described in subsection (a) in the same manner 
and to the same extent as this section applies with respect 
to a drug described in subsection (a), except that sub-
section (i) shall not apply with respect to active pharma-
ceutical ingredients.’’. 
(2) GUIDANCE.— 
(A) ISSUANCE.—Not later than 24 months 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, 
shall issue final guidance on implementing the 
amendment made by paragraph (1). 
(B) CONTENTS.—The guidance required 
by subparagraph (A) shall specify— 
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(i) the form and manner of the disclo-
sures required by the amendment made by 
paragraph (1); and 
(ii) the details that need to be in-
cluded in such disclosures. 
(b) PROHIBITED ACTS WITH RESPECT TO DRUGS 
AND ACTIVE PHARMACEUTICAL INGREDIENTS.—Section 
301 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331), as amended by section 2(b), is further 
amended by adding at the end the following: 
‘‘(ggg) The failure of a manufacturer of a drug de-
scribed in section 506C(a) or an active pharmaceutical in-
gredient of such a drug, without a reasonable basis as de-
termined by the Secretary, to notify the Secretary of a 
permanent discontinuance or an interruption, and the rea-
sons for such discontinuance or interruption, as required 
by section 506C.’’. 
(c) APPLICABILITY.—The amendments made by sub-
sections (a) and (b) apply beginning on the date that is 
180 days after the date of enactment of this Act. 
Æ 
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