SAFE Drugs Act of 2026

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3794 Introduced in Senate (IS)]

<DOC>

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

_______________________________________________________________________

                                 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 2026'' or the ``SAFE Drugs Act
of 2026''.

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>