2026 Compliance Shift: What Clinic Owners Must Know About Peptides and GLP-Based Therapies

Regulation around peptides and GLP therapies is tightening—and fast. If your clinic offers these treatments, now is the time to understand what's changing, why it matters, and how to adapt your model before continued enforcement impacts your operations.

This isn't about shutting down access. It's about moving from fragmented protocols and gray-market products toward clinically structured, legally sound care.

Federal regulators are stepping up enforcement against the clinical use of substances labeled “research only” or “not for human use.” Simply labeling a product that way no longer shields it from oversight if real-world use suggests otherwise.

Translation: If your marketing, operations, or patient workflows indicate therapeutic use—regardless of the label—you are on regulatory radar.

These changes are part of a broader effort to increase patient safety and close loopholes in the sale and administration of unapproved or compounded medications.

The SAFE DRUGS Act of 2025 (H.R. 6509)

Introduced December 9, 2025, this bill targets unsafe mass compounding practices [1]. It codifies the definition of “essentially a copy” and expands FDA oversight by requiring reporting from pharmacies shipping more than 20 out-of-state prescriptions monthly [2].

The Drug Shortage Compounding Patient Access Act (H.R. 5316)

Introduced September 11, 2025, this bill strengthens patient access to essential medications during shortages by codifying FDA guidance that permits compounding during legitimate shortages [3][4].

Together, these bills reflect Congressional intent to balance patient access with prevention of inappropriate compounded substitutes for FDA-approved drugs.

• Peptides and GLPs must be delivered within structured clinical programs
• Licensed provider oversight is required
• Eligibility screening and standardized dosing are expected
• Ongoing monitoring, documentation, and informed consent are mandatory

Clinics relying on self-selection tools, supplement-style menus, or informal workflows are increasingly vulnerable to enforcement action.

GLP-1 therapies such as semaglutide and tirzepatide have drawn particular scrutiny due to widespread adoption in weight-management programs.

Current Enforcement Status

Tirzepatide

• Shortage resolved December 19, 2024 [5]
• 503A enforcement discretion ended February 18, 2025 [6]
• 503B enforcement discretion ended March 19, 2025 [6]

Semaglutide

• Shortage resolved February 21, 2025 [7]
• 503A enforcement discretion ended April 22, 2025 [8]
• 503B enforcement discretion ended May 22, 2025 [8]

As of January 2026, all enforcement discretion periods have ended. Compounding is now restricted to documented clinical differences under Section 503A [9].

In September 2025, the FDA issued more than 50 warning letters to entities compounding or marketing GLP-1 products [10].

Claims that compounded products are “generic,” “equivalent,” or contain the “same active ingredient” as branded GLP-1s were explicitly cited as false and misleading [11].

There is no single compliance deadline. Enforcement is already active and ongoing.

• Clinics selling unapproved peptides without provider oversight
• Compounders making unlawful equivalence claims
• Online portals offering therapy without clinical evaluation

Waiting to adapt increases risk.

1. Audit offerings for “research-only” or informal use
2. Review compliance framework and protocols
3. Ensure licensed provider oversight
4. Revise marketing language to remove equivalence claims
5. Monitor ongoing litigation and FDA guidance [12]

Peptide and GLP-based therapies are not being banned. They are being pulled into a more defensible, structured, and scalable medical model.

Clinics that adapt early will lead in trust, compliance, and long-term viability.

1. U.S. Congress. H.R.6509 – SAFE DRUGS Act of 2025.
2. Wilson Sonsini. FDA Sends Warning Letters to More Than 50 GLP-1 Compounders.
3. U.S. Congress. H.R.5316 – Drug Shortage Compounding Patient Access Act of 2025.
4. McDermott Will & Emery. Semaglutide Shortage Resolved.
5. FDA. GLP-1 Supply Stabilization Notice.
6. Harris Beach Murtha. GLP-1 Drugs Off Shortage List.
7. FDA. Declaratory Order: Semaglutide Shortage Resolution.
8. HCH Lawyers. FDA Update on GLP-1 Compounding.
9. Empower Pharmacy. End of GLP-1 Shortages.
10. STAT News. FDA Takes on GLP-1 Compounding Boom.
11. Wilson Sonsini. GLP-1 Warning Letters.
12. Foley & Lardner. FDA Removes Semaglutide from Shortage List.