119 S3794 RS: Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026 U.S. Senate 2026-07-27 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

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

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).

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.

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.

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.

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

Reporting requirement

(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.

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.

July 27, 2026

Reported with an amendment