[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3794 Reported in Senate (RS)]
<DOC>
Calendar No. 524
119th CONGRESS
2d Session
S. 3794
To amend the Federal Food, Drug, and Cosmetic Act to further regulate
compounding pharmacies and outsourcing facilities, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 5, 2026
Mr. Banks (for himself and Mr. Heinrich) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
July 27, 2026
Reported by Mr. Cassidy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Safeguarding Americans from
Fraudulent and Experimental Drugs Act of 2026'' or the ``SAFE Drugs Act
of 2026''.</DELETED>
<DELETED>SEC. 2. DEFINITIONS RELATING TO COMPOUNDING OF DRUG
PRODUCTS.</DELETED>
<DELETED> Section 503A(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 353a(b)) is amended--</DELETED>
<DELETED> (1) by amending paragraph (1)(D) to read as
follows:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (2) by amending paragraph (2) to read as
follows:</DELETED>
<DELETED> ``(2) Definitions.--</DELETED>
<DELETED> ``(A) For purposes of paragraph (1)(D),
the term `essentially a copy of a commercially
available drug product' means any drug product--
</DELETED>
<DELETED> ``(i) that contains any active
ingredient found in a commercially available
drug product; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) For purposes of subparagraph (A),
the term `commercially available drug product' includes
any drug product that--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(ii) is not included in the
discontinued section of the list of products
described in section 505(j)(7)(A).''.</DELETED>
<DELETED>SEC. 3. REPORTING REQUIREMENT.</DELETED>
<DELETED> Section 503A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353a) is amended--</DELETED>
<DELETED> (1) by redesignating subsections (d) and (e) as
subsections (e) and (f), respectively; and</DELETED>
<DELETED> (2) by inserting after subsection (c) the
following:</DELETED>
<DELETED> ``(d) Reporting Requirement.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Contents.--Each report under paragraph (1)
shall identify--</DELETED>
<DELETED> ``(A) each type of drug product described
in paragraph (1) that is compounded for a patient
described in such paragraph; and</DELETED>
<DELETED> ``(B) for each month, the total number of
times each such type is so compounded.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 4. LARGE-SCALE OUTSOURCING FACILITIES.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(6) Inspections of large-scale outsourcing
facilities.--</DELETED>
<DELETED> ``(A) In general.--In the case of a large-
scale outsourcing facility, the risk-based inspections
under paragraph (4) shall include--</DELETED>
<DELETED> ``(i) an inspection prior to such
facility compounding any drug product for the
first time; and</DELETED>
<DELETED> ``(ii) the reinspection of such
facility not less than biennially.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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))''.</DELETED>
<DELETED> (c) Delayed Applicability.--The amendments made by
subsections (a) and (b) apply beginning 6 months after the date of
enactment of this Act.</DELETED>
<DELETED>SEC. 5. BASE ESTABLISHMENT FEE.</DELETED>
<DELETED> 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''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Safeguarding Americans from
Fraudulent and Experimental Drugs Act of 2026'' or the ``SAFE Drugs Act
of 2026''.
SEC. 2. 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.--
``(1) Serious adverse events.--Each licensed pharmacist or
licensed physician who compounds drug products under this
section and sends such drug products, or causes such drug
products to be sent, out of the State in which the compounding
occurs shall submit any report received by such licensed
pharmacist or licensed physician of a serious adverse event
associated with a compounded drug product, in accordance with
the content and format requirements established through
guidance or under section 310.305 of title 21, Code of Federal
Regulations (or any successor regulations), to--
``(A) the Secretary;
``(B) the State in which the compounding occurs;
and
``(C) each State to which such drugs are sent.
``(2) Interstate dispensing.--
``(A) In general.--Beginning with the first
calendar year that begins after the date of enactment
of the SAFE Drugs Act of 2026, not later than January
15 of each calendar year, each licensed pharmacist or
licensed physician who compounds drug products under
this section and sends, or causes to be sent, out of
the State in which the compounding occurs, more than 5
percent of the total annual amount of drug products
compounded by such licensed pharmacist or licensed
physician shall annually submit a report containing the
information described in subparagraph (B) to the
Secretary and the State to which such drug products are
sent.
``(B) Contents.--Each report under subparagraph (A)
shall identify--
``(i) the name, address, license number,
and State of license of the licensed pharmacist
or licensed physician who compounded the drug
product; and
``(ii) the total number of units of
compounded drug products, by type of product,
and by month, sent or caused to be sent to each
applicable State.
``(C) Form and manner.--A licensed pharmacist or
licensed physician shall submit each report under
subparagraph (A) in such form and manner as the
Secretary may prescribe.
``(D) Information sharing.--The Secretary shall use
an information sharing system for purposes of
facilitating the transmission of reports under
subparagraph (A) from a licensed pharmacist or licensed
physician to the Secretary and each applicable State in
a manner that reduces unnecessary administrative
burden.
``(E) Exclusion.--This subsection shall not apply
to the compounding of any drug products for hospital
patients by a pharmacy located on the premises of the
hospital.
``(3) Rule of construction.--Nothing in this section shall
be construed to preempt any requirement of a State or political
subdivision of a State that requires additional, more
stringent, or supplementary reporting with respect to a drug
product compounded under this section.''.
SEC. 3. LABELING.
Section 503A(b)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353a(b)(3)) is amended--
(1) in subparagraph (A), by striking ``; and'' and
inserting a semicolon;
(2) in subparagraph (B)(ii), by striking the period and
inserting ``; and''; and
(3) by inserting after subparagraph (B) the following:
``(C) the label of such drug product includes--
``(i) the statement: `This medication has
been compounded for dispensing to an individual
patients and has not been approved by the Food
and Drug Administration.';
``(ii) the following information to
facilitate adverse event reporting:
www.fda.gov/medwatch, and 1-800-FDA-1088 (or
any successor website or telephone number); and
``(iii) such other information as the
Secretary may prescribe by order, which may
include information to facilitate adverse event
reporting.''.
Calendar No. 524
119th CONGRESS
2d Session
S. 3794
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to further regulate
compounding pharmacies and outsourcing facilities, and for other
purposes.
_______________________________________________________________________
July 27, 2026
Reported with an amendment