Congress Introduces SAFE Drugs Act of 2025, Expanding FDA Oversight of Compounded GLP-1 Drugs and Telehealth Providers

 

Takeaways

• The bill would limit 503A pharmacies from compounding large volumes of drugs that are “essentially copies” of commercially available FDA-approved products.
• Interstate compounding pharmacies would face new annual FDA reporting obligations for compounded drugs shipped across state lines.
• Even before enactment, FDA and state attorneys general are already intensifying enforcement against misleading marketing and unsafe compounding practices.

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For those in the drug compounding space, especially GLP-1s, 2026 is shaping up to be a compliance inflection point. On December 9, 2025, the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025 (H.R. 6509) was introduced in Congress, aiming to tighten federal oversight of compounding and outsourcing facilities. Seeking to amend the federal Food, Drug, and Cosmetic Act (FDCA), the bill’s sponsors frame the proposed legislation as essential to protect patients from “untested, unapproved, and potentially dangerous mass compounded drugs.” The bill was immediately referred to the House Committee on Energy and Commerce.

If enacted, the SAFE Drugs Act would make several significant changes to how compounding pharmacies and outsourcing facilities operate under federal law.

503A Compounding Pharmacies

Limitations on Compounding “Copies” of Commercial Drugs

The SAFE Drugs Act proposes to amend Section 503A of the FDCA to (i) codify the definition of “essentially a copy of a commercially available drug product” and (ii) prevent compounding pharmacies from compounding more than 20 units per month of any drug that is “essentially a copy” of a commercially available product unless tailored to an individual patient. Although the FDA has issued industry guidance on 503A compounding, detailing what it perceives to be “essentially a copy,” this guidance falls short of establishing legally enforceable responsibilities for compounders. While the proposed legislation leaves room for the prescribing practitioner’s discretion, the Act itself moves to set more exacting boundaries for 503A compounders.

Reporting Requirements for Interstate Compounding

Further, the Act, if passed, would require compounding pharmacies, facilities, or physicians that ship more than 20 compounded prescriptions containing active ingredients found in commercially available drugs to patients residing outside the state to submit annual reports to the FDA detailing the products and quantities involved. This reporting obligation would flip the FDA’s oversight from a system based on complaints and inspections to one informed by a data-driven map of where large-scale compounding is actually occurring. Notably, the Act contains an exception to this reporting requirement for drug products compounded by a pharmacy located on the premises of the hospital for administration to the hospital’s own patients. The structure of the exception suggests that Congress’s compliance concerns are directed toward telehealth-associated and independent compounding models that function across state lines, as opposed to hospital-based compounding confined to a single institution.

503B Outsourcing Facilities

Enhanced Oversight of Large-Scale Outsourcing Facilities

With respect to 503B outsourcing facilities, the SAFE Drugs Act would require (i) a pre-compounding inspection of any outsourcing facility before it initiates work on a new drug and (ii) biennial re-inspections of facilities that compound more than 100 products in a calendar year. If passed, these requirements would shift cGMP compliance for 503B facilities operating at scale from an episodic enforcement matter into a gatekeeper for whether new drugs can be compounded at all.

Current FDA Enforcement in the Compounded Drug Space

The FDA does not approve compounded drugs for safety, effectiveness, or quality prior to their marketing. Compounded products are intended to serve patients with unique medical needs when FDA-approved alternatives are unavailable or unsuitable. Following the surge in demand for GLP-1s such as tirzepatide, semaglutide (and retatrutide anticipated in the near future) for diabetes and weight management, compounded versions of GLP-1s have proliferated online and through telehealth platforms. It is this rapid expansion—which has persisted even after GLP-1s were removed from the FDA drug shortage list—that prompted the introduction of the SAFE Drugs Act and has simultaneously driven heightened FDA oversight. The FDA has expressed several concerns that many of these compounded products:

• are marketed like FDA-approved drugs;
• are not subject to premarket review;
• have been linked to dosing errors and adverse events; and
• may use active pharmaceutical ingredients (APIs) from unregistered or foreign sources.

In September 2025, the FDA and the Department of Health and Human Services (HHS) launched an enforcement initiative targeting misleading advertising in the compounded drug space. This effort included issuing a wave of warning letters to telehealth providers and companies promoting compounded GLP-1 products. The agency flagged claims about “generic” or “clinically proven” versions of approved GLP-1 therapies as potentially misbranded advertising in violation of the FDCA.

In addition to this enhanced federal scrutiny, state attorneys general have signaled a willingness to engage in consumer protection enforcement relating to compounded drugs, particularly those marketed online. In recent coordinated actions, a coalition of 38 State AGs raised concerns regarding:

• products containing unknown contaminants or incorrect dosages;
• online sales of active GLP-1 ingredients labeled as “research use only” but marketed to consumers without prescriptions;
• public health risks from unsanitary compounding practices; and
• the need for the FDA to escalate investigations, inspections, and warning letters against non-compliant actors.

While the SAFE Drugs Act remains under legislative consideration, the FDA and state attorneys general appear to already be implementing more aggressive oversight measures until a more stringent oversight framework is in place. Compounding pharmacies, outsourcing facilities, and telehealth entities must remain vigilant to ensure they stay on top of an increasingly rigorous web of federal and state oversight.