PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Version 00 · Introduced in House · Dec 9, 2025
Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 or the SAFE Drugs Act of 2025
This bill provides for increased oversight of drug compounding and imposes statutory limits on compounded drugs that are essentially copies of commercially available drugs.
Currently, subject to certain requirements, compounded drugs (i.e., drugs that are mixed or altered to meet patient needs) do not require Food and Drug Administration (FDA) approval. Additional limits apply to the compounding of drugs that are essentially copies of commercially available drug products.
Showing the opening paragraphs of the official summary.
Under the bill, a compounded drug is essentially a copy of a commercially available drug product if (1) the compounded drug contains any active ingredient found in a commercially available drug product, and (2) there is no change made for an individual patient that results in a significant difference between the compounded drug and the commercially available drug. (The FDA’s current definition of the term also addresses dosage strength and route of administration.)
The bill increases the frequency at which a licensed pharmacist or physician may compound a drug that is essentially a copy of a commercially available drug to 20 times per month. Current FDA policy allows four such prescriptions per month.
The bill also imposes annual reporting requirements on physicians, facilities, and pharmacies (except hospital-based pharmacies) that compound certain drug products for out-of-state patients more than 20 times per month. Further, the bill subjects certain large-scale outsourcing facilities (i.e., FDA-registered facilities that compound in bulk) to regular inspection and reporting requirements.
People & committees
Rep. Yakym, Rudy [R-IN-2] · R–IN
Legislative record
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Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
Source last updated: Sep 19, 2026. Consult Congress.gov for the current record.
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PlainBill explanation
Based on the full Introduced in House · 2025-12-09 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
This proposal would tighten rules for pharmacies, physicians and facilities that prepare compounded medicines. It would limit repeated preparation of certain copies of marketed drugs, require reports for some work serving out-of-state patients, and add inspections for large-scale facilities. It would also remove a registration/reporting exemption for outsourcing facilities and replace a specified base fee with an amount set by the Secretary.
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.
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.
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) 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)).
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.
The bill would use the short title SAFE Drugs Act of 2025.
This Act may be cited as the Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 or the SAFE Drugs Act of 2025.
Section 2 would replace a condition in section 503A with a limit of 20 times in a single month for compounding a drug product that is essentially a copy of a commercially available product. The surrounding statutory conditions are not supplied, so this is not established here as a universal ban on all compounding above that threshold.
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.
For that limit, a drug would count as essentially a copy if it shares any active ingredient with a commercially available drug and lacks a change for an identified patient that the prescribing practitioner determines makes a significant difference for that patient. A qualifying patient-specific change would therefore fall outside this definition.
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.
The definition of commercially available drugs would include products sold in the United States, manufactured in facilities required to comply with section 501(a)(2)(B), and absent from the discontinued section of the statutory product list. The referenced manufacturing requirements and product list are not reproduced.
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).
For calendar year 2025 and every year afterward, a pharmacy, facility or physician would have to report to the Secretary if it compounds a drug sharing any active ingredient with a commercially available drug more than 20 times in one month for out-of-state patients. This reporting trigger does not include the patient-specific significant-difference exception used in the copy definition.
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.
Each required report would identify the covered drug types compounded for out-of-state patients and give the number of times each type was compounded for those patients in each month.
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.
Reports would be due by the end of the calendar year they cover. The Secretary could prescribe how they must be submitted.
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.
A pharmacy, facility, or physician shall submit each report under paragraph (1) in such form and manner as the Secretary may prescribe.
The reporting requirement would exclude drugs compounded for hospital patients by a pharmacy located on that hospital's premises.
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.
For the new inspection rules, a large-scale outsourcing facility would mean an outsourcing facility that compounds any drug product more than 100 times in a calendar year.
the term large-scale outsourcing facility means any outsourcing facility that compounds, more than 100 times in a single calendar year, any drug product.
Large-scale outsourcing facilities would have to be inspected before first compounding any drug product and reinspected at least once every two years. These inspections would be included in the existing risk-based inspection framework.
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.
Section 4 would remove the section 510(g)(1) registration/reporting exemption for every outsourcing facility covered by the referenced statutory definition, not just those meeting the new large-scale threshold. The underlying exemption and outsourcing-facility definition are not reproduced.
(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)).
The inspection changes and removal of the registration/reporting exemption would begin six months after enactment, if the bill becomes law.
The amendments made by subsections (a) and (b) apply beginning 6 months after the date of enactment of this Act.
Section 5 would replace the $15,000 base establishment fee amount in the referenced statute with an amount the Secretary considers appropriate to fund activities ensuring compounded-drug safety. It does not specify the replacement amount.
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.
The supplied action snapshot, updated September 19, 2026, records introduction in the House and referral to the House Committee on Energy and Commerce on December 9, 2025. It supplies no later legislative action and does not establish whether the proposal subsequently advanced or became law.
Source snapshot updated 2026-09-19T23:34:01Z. 2025-12-09: Referred to the House Committee on Energy and Commerce. 2025-12-09: Introduced in House
A closer look
Reviewed version: Introduced in House · 2025-12-09. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy change attached to appropriations was identified in the complete supplied introduced text. This conclusion does not establish the absence of riders in other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish formal earmark status in accompanying materials.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
Findings to examine
The supplied introduced text contains a narrow exemption from the proposed reporting requirement. This classification describes preferential regulatory treatment, not its justification or merits.
Hospital pharmacies located on hospital premises would be exempt from the new reporting requirement when compounding drugs for that hospital's patients. This gives that defined setting relief from reporting that could otherwise apply to pharmacies, facilities and physicians serving out-of-state patients.
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.
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.
Full text preserved for this analysis. Legislative record snapshot: Sep 19, 2026. How PlainBill uses AI