No official summary available for this bill.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6509 Introduced in House (IH)]
<DOC>
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''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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