SEC. 2. ENSURING THE AVAILABILITY OF CRITICAL MEDI-
CATIONS IN THE EVENT OF PUBLIC HEALTH 
EMERGENCIES. 
(a) IN GENERAL.—The Public Health Service Act is 
amended by inserting after section 319F–4 of such Act 
(42 U.S.C. 247d–6e) the following new section: 
‘‘SEC. 319F–5. ENSURING THE AVAILABILITY OF CRITICAL 
MEDICATIONS IN THE EVENT OF PUBLIC 
HEALTH EMERGENCIES. 
‘‘(a) LIST OF CRITICAL MEDICATIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall main-
tain a list of medications (in this section referred to 
as ‘critical medications’) with respect to which it is 
critical that the Federal Government ensure avail-
ability in the event of a public health emergency. 
‘‘(2) COLLABORATION.—The Secretary shall 
carry out this subsection and subsection (b) in col-
laboration with the Assistant Secretary for Pre-
paredness and Response, the Commissioner of Food 
and Drugs, the Director of the Centers for Disease 
Control and Prevention, and the Secretary of Home-
land Security. 
‘‘(3) TIMING OF LIST; REPORTING.—The Sec-
retary shall— 
‘‘(A) not later than 180 days after the date 
of the enactment of the this section— 
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‘‘(i) establish the initial list required 
by paragraph (1); 
‘‘(ii) submit a report, in a manner 
that does not compromise national secu-
rity, to the Committee on Appropriations 
and the Committee on Energy and Com-
merce of the House of Representatives and 
the Committee on Appropriations and the 
Committee on Health, Education, Labor, 
and Pensions of the Senate, setting 
forth— 
‘‘(I) the list in effect under para-
graph (1); 
‘‘(II) the reasons why each crit-
ical medication is included on the list; 
‘‘(III) the reasons why other 
medications described in paragraph 
(4) were not included; and 
‘‘(IV) which critical medications 
are designated critical medications 
under subsection (b) and the reasons 
for each such designation; and 
‘‘(iii) make publicly available the list 
in effect under paragraph (1) and the most 
recent report under clause (ii), subject to 
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any redactions or edits necessary to re-
move classified information or otherwise 
ensure that national security is not com-
promised; and 
‘‘(B) not later than March 15 of each year 
following the year in which the first list of crit-
ical medications is required by paragraph (1)— 
‘‘(i) update the list required by para-
graph (1); 
‘‘(ii) submit an updated report under 
subparagraph (A)(ii); and 
‘‘(iii) make publicly available such up-
dated list and report in accordance with 
subparagraph (A)(iii). 
‘‘(4) REQUIRED INCLUSION ON LIST.—Subject 
to paragraph (5), the Secretary shall include on the 
list under paragraph (1) the following medications: 
‘‘(A) Commonly-used medications likely to 
be needed in order to prevent, mitigate, or treat 
the adverse health effects which frequently re-
sult from a public health emergency, including 
medications routinely needed to effectively man-
age patients in hospital emergency rooms or in-
tensive care units, and medications needed dur-
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ing surgical procedures often required during a 
public health emergency. 
‘‘(B) Anti-infective medications, including 
antibiotic, antifungal, and antiviral medications, 
which are either commonly used to treat infec-
tious diseases or have a significant likelihood of 
being needed to treat an infectious disease that, 
if not so treated, may result in a public health 
emergency. 
‘‘(C) Commonly-used medications which 
are life-supporting, life-sustaining, or intended 
for the use in the prevention or treatment of a 
debilitating disease or condition, as such terms 
are defined in section 506C of the Federal 
Food, Drug, and Cosmetics Act and the regula-
tions thereunder. 
‘‘(5) LIMITATIONS ON INCLUSION ON LIST.— 
The Secretary— 
‘‘(A) shall not be required to include on 
the list under paragraph (1) every medication 
meeting the criteria described in paragraph (4); 
‘‘(B) shall prioritize the inclusion on the 
list under paragraph (1) of 300 to 400 medica-
tions meeting such criteria— 
‘‘(i) that are most commonly used; or 
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‘‘(ii) for which a shortage would be 
most likely to have the greatest potential 
adverse health consequences; 
‘‘(C) in applying subparagraph (B), shall 
count as a single medication— 
‘‘(i) all strengths, dosage forms, and 
package forms of a given medication; 
‘‘(ii) medications that are therapeuti-
cally equivalent (under the Food and Drug 
Administration’s most recent publication of 
‘Approved Drug Products with Therapeutic 
Equivalence Evaluations’); and 
‘‘(iii) a biological product licensed 
under section 351(a) and all biosimilar bio-
logical products that are licensed under 
section 351(k) using the biological product 
as the reference product; and 
‘‘(D) in applying subparagraph (B), shall 
not prioritize the inclusion of any medication 
that is a qualified countermeasure (as defined 
in section 319F–1(a)(2)), a security counter-
measure 
(as 
defined 
in 
section 
319F– 
2(c)(1)(B)), or a qualified pandemic and epi-
demic product (as defined in section 319F– 
3(i)). 
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‘‘(6) PUBLIC INPUT AND COMMENT.—In devel-
oping and updating the list under paragraph (1), the 
Secretary shall solicit public input, including by— 
‘‘(A) consulting (through public meetings 
or other forms of engagement) with relevant 
stakeholders, including health care providers, 
medical professional societies, public health ex-
perts, State and local public health depart-
ments, patient groups, and drug manufacturers 
and distributors; 
‘‘(B) publishing in the Federal Register, 
for public review and comment, the Secretary’s 
proposed list of critical medications, together 
with the Secretary’s reasons why each medica-
tion included on such proposed list was included 
and the reasons why other medications were not 
included; 
‘‘(C) accepting public comment on such 
proposed list and reasons for a period of not 
less than 60 days; 
‘‘(D) taking such comments into account 
in determining the final list under paragraph 
(1); and 
‘‘(E) addressing such comments in report-
ing under paragraph (3). 
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‘‘(7) ADDITIONAL CONSIDERATIONS.—In devel-
oping and updating the list under paragraph (1), the 
Secretary shall consider— 
‘‘(A) the most recent annual threat-based 
review conducted by the Secretary under section 
319F–2(a)(2), the most recent report of the 
Comptroller General of the United States under 
section 319F–2(a)(5), and the most recent rec-
ommendations of the Public Health Emergency 
Countermeasures Enterprise established under 
section 2811–1; 
‘‘(B) input from each member of the Pub-
lic Health Emergency Countermeasures Enter-
prise (or a designee thereof); and 
‘‘(C) if available, the report of the National 
Academies of Sciences, Engineering, and Medi-
cine prepared pursuant to section 3101 of the 
Coronavirus Aid, Relief, and Economic Stability 
Act (Public Law 116–136). 
‘‘(b) DESIGNATION OF CRITICAL MEDICATIONS FOR 
WHICH AVAILABILITY IS AT RISK IN THE EVENT OF A 
PUBLIC HEALTH EMERGENCY.— 
‘‘(1) IN GENERAL.—The Secretary shall— 
‘‘(A) evaluate each critical medication to 
determine whether there is adequate assurance 
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that it will be available in sufficient quantities 
in the event of a public health emergency, on a 
timely basis, within each portion of the United 
States where it is needed; and 
‘‘(B) designate each critical medication 
with respect to which the Secretary determines 
there is not such an adequate assurance. 
‘‘(2) FACTORS TO BE TAKEN INTO ACCOUNT.— 
In carrying out paragraph (1), the Secretary shall 
take into account factors including— 
‘‘(A) volume inventories of each critical 
medication that are normally available for use 
in the United States, in the public and private 
sector, in the absence of a public health emer-
gency; 
‘‘(B) current and expected production ca-
pacity, in the United States and in foreign 
countries, of each critical medication, including 
the domestic and foreign capacity to surge pro-
duction of each critical medication and the time 
required to do so, taking into account, among 
other things, current marketplace trends and 
factors and the economic viability of creating 
and maintaining such surge capacity in the ab-
sence of nonemergency commercial demand; 
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‘‘(C) the potential demand and historic de-
mand trends for each critical medication in the 
event of a public health emergency, including 
demand in the United States and in foreign 
countries; and 
‘‘(D) potential constraints on the timely 
manufacture and distribution of each critical 
medication in sufficient quantities for each por-
tion of the United States where it is needed in 
the event of public health emergency, including 
constraints due to the unavailability or limited 
availability of such critical medication or any 
key ingredients thereof (including active phar-
maceutical ingredients) from one or more for-
eign countries. 
‘‘(3) CONDUCT OF EVALUATION.—In carrying 
out paragraph (1), the Secretary may consider such 
other factors as the Secretary considers relevant to 
determining the supply chain vulnerability of each 
critical medication and each key ingredient thereof 
(including active pharmaceutical ingredients) in the 
event of a public health emergency, which may in-
clude— 
‘‘(A) whether and to what extent the exist-
ing sources of such supply for the United 
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States are domestic or foreign, the specific for-
eign countries from which any such foreign sup-
ply is obtained and in what quantities, and the 
extent of the risk of a disruption in supply from 
each such foreign country in the event of a pub-
lic health emergency; 
‘‘(B) the location of each domestic and for-
eign establishment registered under section 510 
of the Federal Food, Drug, and Cosmetic Act 
and identified in such registration as manufac-
turing, preparing, propagating, or compounding 
such critical medication or a key ingredient 
thereof, as well as, for each such establishment, 
the current and historical production thereof 
and the current production capacity thereof; 
‘‘(C) the likelihood of continued or in-
creased production from each domestic and for-
eign establishment referenced in subparagraph 
(B), and the timeframe necessary for any in-
crease in production, taking into account regu-
latory, logistical, economic, and other relevant 
factors; and 
‘‘(D) any economic, regulatory, or other 
impediments to domestic production thereof. 
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‘‘(4) TIMEFRAME FOR DESIGNATION AND RE-
EVALUATION.—The Secretary shall— 
‘‘(A) determine whether to designate a 
critical medication under paragraph (1) not 
later than 90 days after the earlier of— 
‘‘(i) the date that such medication was 
first proposed by the Secretary to be a 
critical medication through publication in 
the Federal Register in accordance with 
subsection (a)(4)(B); or 
‘‘(ii) the date that such medication be-
came a critical medication pursuant to the 
final determination of the Secretary in ac-
cordance with subsection (a)(1)(A); or 
‘‘(B) not later than March 15 each year, 
reevaluate in accordance with paragraph (1)(A) 
each designation in effect under paragraph 
(1)(B). 
‘‘(5) PUBLIC INPUT AND FACTORS TO BE CON-
SIDERED.—In carrying out paragraph (1), the Sec-
retary shall— 
‘‘(A) consult with relevant stakeholders, in-
cluding those described in subsection (a)(6)(A); 
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‘‘(B) consider the annual threat-based re-
view and reports referenced in and input re-
ceived under subsection (a)(7); and 
‘‘(C) consult with experts in medication 
production, distribution, and demand, including 
economists or other analysts with expertise in 
the economic factors affecting domestic and for-
eign production and distribution of critical 
medications. 
‘‘(6) INCORPORATION
OF
FINDINGS
AND
DE-
TERMINATIONS
IN
SUBMISSIONS
TO
CONGRESS.— 
With respect to each designated critical medication, 
the Assistant Secretary for Preparedness and Re-
sponse shall include in the annual coordinated 5-year 
budget plan required to be submitted under section 
2811(b)(7) such amounts as are determined to be 
necessary or appropriate to fund the procurement or 
contracting required under subsection (c) for such 
designated critical medications. 
‘‘(c) PROCUREMENT
OR CONTRACTING
FOR DES-
IGNATED CRITICAL MEDICATIONS TO ENSURE AVAIL-
ABILITY IN THE EVENT OF A PUBLIC HEALTH EMER-
GENCY.—Subject to the availability of appropriations, the 
Secretary shall procure for the Strategic National Stock-
pile pursuant to section 319F–2(a)(1)(A)(ii), or otherwise 
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enter into contracts under such section, as necessary to 
ensure the availability of each designated critical medica-
tion, in the quantities and at the times needed, in the 
event of a public health emergency. 
‘‘(d) EVALUATING IMPEDIMENTS TO DOMESTIC PRO-
DUCTION
OF CRITICAL MEDICATIONS, AND RELATED 
RECOMMENDATIONS.— 
‘‘(1) REPORT TO CONGRESS.—Not later than 
one year after the date of enactment of this section, 
the Secretary shall make available to the Committee 
on Appropriations and the Committee on Energy 
and Commerce of the House of Representatives and 
the Committee on Appropriations and the Com-
mittee on Health, Education, Labor, and Pensions 
of the Senate, a report containing— 
‘‘(A) findings on— 
‘‘(i) the domestic and foreign produc-
tion of critical medications and their key 
ingredients; and 
‘‘(ii) impediments to the domestic pro-
duction of critical medications and their 
key ingredients; and 
‘‘(B) 
recommendations 
for 
measures 
(which may include legislative, regulatory, or 
other policy changes) to remove such impedi-
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ments or otherwise promote such domestic pro-
duction (which may include measures to ensure 
the economic viability of such domestic produc-
tion or to address policies that competitively 
disadvantage such domestic production). 
‘‘(2) COORDINATION.—In preparing the report 
required by paragraph (1), the Secretary shall take 
into account any information provided to, and any 
findings and recommendations of, such Commission. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) The term ‘designated critical medication’ 
means a critical medication for which a designation 
is in effect under subsection (b). 
‘‘(2) The term ‘medication’ means a drug (as 
defined in section 201(g)(1) of the Federal Food, 
Drug, and Cosmetic Act), a biological product (as 
defined in section 351 of this Act), or a combination 
product (as described in section 503(g) of the Fed-
eral Food, Drug, and Cosmetic Act) that is ap-
proved, licensed, or cleared, as applicable, under 
chapter V of the Federal Food, Drug, and Cosmetic 
Act or section 351 of this Act. 
‘‘(3) The term ‘public health emergency’ means 
a disease or disorder, including pandemics and other 
significant outbreaks of infectious diseases, bioter-
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rorist attacks, the effects of chemical, biological, ra-
diological, or nuclear agents or toxins, or the effects 
of extreme weather, earthquakes, or other natural 
disasters, that the Secretary has declared or may de-
clare to be a public health emergency pursuant to 
section 319. 
‘‘(4) The term ‘United States’ include the terri-
tories of the United States.’’. 
(b) ENSURING THE AVAILABILITY OF DESIGNATED 
CRITICAL MEDICATIONS THROUGH THE STRATEGIC NA-
TIONAL
STOCKPILE.—Section 319F–2 of the Public 
Health Service Act (42 U.S.C. 247d–6b) is amended— 
(1) by amending subsection (a)(1) to read as 
follows: 
‘‘(1) IN GENERAL.— 
‘‘(A) MAINTAINING STOCKPILE OR STOCK-
PILES.—The Secretary, in collaboration with 
the Assistant Secretary for Preparedness and 
Response, the Commissioner of Food and 
Drugs, and the Director of the Centers for Dis-
ease Control and Prevention, and in coordina-
tion with the Secretary of Homeland Security 
(referred to in this section as the ‘Homeland 
Security Secretary’), shall— 
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‘‘(i) maintain a stockpile or stockpiles 
of drugs, vaccines, and other biological 
products, medical devices, and other sup-
plies (including personal protective equip-
ment, ancillary medical supplies, and other 
applicable supplies required for the admin-
istration of drugs, vaccines and other bio-
logical products, medical devices, and diag-
nostic tests in the stockpile) in such num-
bers, types, and amounts as are deter-
mined consistent with section 2811 by the 
Secretary to be appropriate and prac-
ticable, taking into account other available 
sources, to provide for and optimize the 
emergency health security of the United 
States, including the emergency health se-
curity of children and other vulnerable 
populations, in the event of a bioterrorist 
attack or other public health emergency 
and, as informed by existing recommenda-
tions of, or consultations with, the Public 
Health 
Emergency 
Medical 
Counter-
measure Enterprise established under sec-
tion 2811–1, make necessary additions or 
modifications to the contents of such stock-
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pile or stockpiles based on the review con-
ducted under paragraph (2); and 
‘‘(ii) enter into multiyear contracts 
(each of which shall have a term of no less 
than 5 years) with private entities to en-
sure the availability, in the event of a pub-
lic health emergency, of adequate domestic 
supplies of each designated critical medica-
tion, as determined by the Secretary under 
section 319F–5, in lieu of or as a supple-
ment to procuring and maintaining in such 
stockpile or stockpiles a physical accumula-
tion of such designated critical medica-
tions, through measures which may in-
clude— 
‘‘(I) one or more private entities’ 
agreement to maintain specified in-
ventory levels, in specified domestic lo-
cations, of one or more such des-
ignated critical medications, or of one 
or more key ingredients thereof (in-
cluding active pharmaceutical ingredi-
ents), under specified conditions (in-
cluding maintenance and inventory re-
placement prior to expiration), and to 
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