I 
119TH CONGRESS 
1ST SESSION H. R. 6509 
To amend the Federal Food, Drug, and Cosmetic Act to further regulate 
compounding pharmacies and outsourcing facilities, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 9, 2025 
Mr. YAKYM (for himself and Mr. CARSON) 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 
further regulate compounding pharmacies and outsourc-
ing facilities, and for other purposes. 
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 ‘‘Safeguarding Ameri-
cans from Fraudulent and Experimental Drugs Act of 
2025’’ or the ‘‘SAFE Drugs Act of 2025’’. 
SEC. 2. DEFINITIONS RELATING TO COMPOUNDING OF 
DRUG PRODUCTS. 
Section 503A(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353a(b)) is amended— 
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(1) by amending paragraph (1)(D) to read as 
follows: 
‘‘(D) does not, more than 20 times in a 
single month, compound any drug product that 
is essentially a copy of a commercially available 
drug product.’’; and 
(2) by amending paragraph (2) to read as fol-
lows: 
‘‘(2) DEFINITIONS.— 
‘‘(A) For purposes of paragraph (1)(D), 
the term ‘essentially a copy of a commercially 
available drug product’ means any drug prod-
uct— 
‘‘(i) that contains any active ingre-
dient found in a commercially available 
drug product; and 
‘‘(ii) in which there is no change, 
made for an identified individual patient, 
which produces for that patient a signifi-
cant difference, as determined by the pre-
scribing practitioner, between the com-
pounded drug product and the comparable 
commercially available drug product. 
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‘‘(B) For purposes of subparagraph (A), 
the term ‘commercially available drug product’ 
includes any drug product that— 
‘‘(i) is sold in the commercial market-
place in the United States and manufac-
tured in one or more facilities required to 
comply with section 501(a)(2)(B); and 
‘‘(ii) is not included in the discon-
tinued section of the list of products de-
scribed in section 505(j)(7)(A).’’. 
SEC. 3. REPORTING REQUIREMENT. 
Section 503A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353a) is amended— 
(1) by redesignating subsections (d) and (e) as 
subsections (e) and (f), respectively; and 
(2) by inserting after subsection (c) the fol-
lowing: 
‘‘(d) REPORTING REQUIREMENT.— 
‘‘(1) IN
GENERAL.—For calendar year 2025 
and each calendar year thereafter, if a pharmacy, fa-
cility, or physician compounds, more than 20 times 
in a single month for patients who reside outside the 
State in which the compounding occurs, any drug 
product that contains any active ingredient found in 
a commercially available drug product (as defined in 
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subsection (b)(2)(B)), such pharmacy, facility, or 
physician shall submit a report to the Secretary. 
‘‘(2) CONTENTS.—Each report under para-
graph (1) shall identify— 
‘‘(A) each type of drug product described 
in paragraph (1) that is compounded for a pa-
tient described in such paragraph; and 
‘‘(B) for each month, the total number of 
times each such type is so compounded. 
‘‘(3) TIMING.—For any calendar year for which 
paragraph (1) applies, the pharmacy, facility, or 
physician shall submit the report under such para-
graph not later than the end of such calendar year. 
‘‘(4) FORM AND MANNER.—A pharmacy, facil-
ity, or physician shall submit each report under 
paragraph (1) in such form and manner as the Sec-
retary may prescribe. 
‘‘(5) HOSPITAL PHARMACY EXCLUSION.—This 
subsection does not apply to the compounding of any 
drug products for hospital patients by a pharmacy 
located on the premises of the hospital.’’. 
SEC. 4. LARGE-SCALE OUTSOURCING FACILITIES. 
(a) INSPECTIONS.—Section 503B(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353b(b)) is 
amended by adding at the end the following: 
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‘‘(6) INSPECTIONS OF LARGE-SCALE OUTSOURC-
ING FACILITIES.— 
‘‘(A) IN GENERAL.—In the case of a large- 
scale outsourcing facility, the risk-based inspec-
tions under paragraph (4) shall include— 
‘‘(i) an inspection prior to such facil-
ity compounding any drug product for the 
first time; and 
‘‘(ii) the reinspection of such facility 
not less than biennially. 
‘‘(B) LARGE-SCALE OUTSOURCING FACIL-
ITY DEFINED.—For purposes of this paragraph, 
the term ‘large-scale outsourcing facility’ means 
any outsourcing facility that compounds, more 
than 100 times in a single calendar year, any 
drug product.’’. 
(b) REGISTRATION
AND
REPORTING
REQUIRE-
MENT.—Section 510(g)(1) of such Act (21 U.S.C. 
360(g)(1)) is amended by inserting before the semicolon 
at the end the following: ‘‘, except that the exemption in 
this paragraph shall not apply to any outsourcing facility 
(as defined in section 503B(d)(4))’’. 
(c) DELAYED
APPLICABILITY.—The amendments 
made by subsections (a) and (b) apply beginning 6 months 
after the date of enactment of this Act. 
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SEC. 5. BASE ESTABLISHMENT FEE. 
Section 744K(c)(1)(A)(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–62(c)(1)(A)(i)) is 
amended by striking ‘‘$15,000’’ and inserting ‘‘a base 
amount deemed appropriate by the Secretary to fund ac-
tivities to ensure the safety of compounded drug prod-
ucts’’. 
Æ 
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