H.R. 6509

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6509 Introduced in House (IH)]

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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 outsourcing facilities, and for other 
purposes.

Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Safeguarding Americans 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 Cosmetic Act (21 
U.S.C. 353a(b)) is amended--
(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 follows:
``(2) Definitions.--
``(A) For purposes of paragraph (1)(D), the term 
`essentially a copy of a commercially available drug 
product' means any drug product--
``(i) that contains any active ingredient 
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 significant 
difference, as determined by the prescribing 
practitioner, between the compounded drug 
product and the comparable commercially 
available drug product.
``(B) For purposes of subparagraph (A), the term 
`commercially available drug product' includes any drug 
product that--
``(i) is sold in the commercial marketplace 
in the United States and manufactured in one or 
more facilities required to comply with section 
501(a)(2)(B); and
``(ii) is not included in the discontinued 
section of the list of products described in 
section 505(j)(7)(A).''.

SEC. 3. REPORTING REQUIREMENT.

Section 503A of the Federal Food, Drug, and Cosmetic 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 following:
``(d) Reporting Requirement.--
``(1) In general.--For calendar year 2025 and each calendar 
year thereafter, if a pharmacy, facility, 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 subsection 
(b)(2)(B)), such pharmacy, facility, or physician shall submit 
a report to the Secretary.
``(2) Contents.--Each report under paragraph (1) shall 
identify--
``(A) each type of drug product described in 
paragraph (1) that is compounded for a patient 
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 paragraph not later than the end of such 
calendar year.
``(4) Form and manner.--A pharmacy, facility, or physician 
shall submit each report under paragraph (1) in such form and 
manner as the Secretary 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:
``(6) Inspections of large-scale outsourcing facilities.--
``(A) In general.--In the case of a large-scale 
outsourcing facility, the risk-based inspections under 
paragraph (4) shall include--
``(i) an inspection prior to such facility 
compounding any drug product for the first 
time; and
``(ii) the reinspection of such facility 
not less than biennially.
``(B) Large-scale outsourcing facility 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 Requirement.--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.

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 activities to ensure the safety of compounded drug products''.
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