GLP-1 Compounding Legal Status: What's Actually Legal Now

Current Status: December 2025

Timeline: How We Got Here

The Legal Framework: What's Still Permitted

Under Section 503A of the FD&C Act, compounding pharmacies cannot produce drugs that are "essentially copies" of commercially available drugs — unless specific exceptions apply.

The "Essentially a Copy" Definition

According to FDA guidance, a compounded product is "essentially a copy" if it has:

• The same active ingredient
• The same or similar route of administration
• The same or easily substitutable dosage strength
• The same or similar dosage form

The Clinical Difference Exception

Compounding is still permitted when a prescriber determines that a compounded product provides a "significant difference" (503A) or "clinical difference" (503B) for an individual patient.

Documentation Requirements

For the clinical difference exception to apply:

• The prescriber must document the specific clinical reason on the prescription
• If not initially documented, the pharmacist must contact the prescriber and note the rationale
• Documentation must be retained for 6 years (regardless of state requirements)
• Vague rationales like "medically necessary" or "hypersensitivity to commercial product" without specifics are not acceptable

What Changes Actually Create a "Clinical Difference"?

This is where it gets murky. Companies are taking various approaches to continue compounding:

The Court Battles

The Outsourcing Facilities Association (OFA) — a trade group representing 503B compounding facilities — sued the FDA over both shortage declarations. Both cases were heard in the U.S. District Court for the Northern District of Texas before Judge Mark Pittman.

Tirzepatide Case: OFA v. FDA (4:24-cv-00953)

Outcome: FDA prevailed. Judge Pittman denied OFA's preliminary injunction on March 5, 2025, and ruled in favor of the FDA on the merits on May 7, 2025.

The court found that:

• FDA acted within its statutory authority in determining shortage status
• The agency's discretion in managing the drug shortage list is broad
• Plaintiffs did not demonstrate sufficient harm to warrant judicial intervention

Semaglutide Case: OFA v. FDA (4:25-cv-00174)

Status: Preliminary injunction denied in April 2025. Final ruling pending as of December 2025.

OFA's argument:

Novo Nordisk's response:

Manufacturer Actions: Beyond FDA Enforcement

Eli Lilly and Novo Nordisk haven't relied solely on FDA enforcement:

Cease and Desist Letters

Both companies have been sending cease and desist letters to compounding pharmacies, telehealth companies, and clinics that continue to offer compounded GLP-1s.

Patent Infringement Litigation

Companies have initiated patent infringement lawsuits against compounders. Semaglutide and tirzepatide are protected by multiple patents that don't expire until the 2030s.

Demonstrably Difficult to Compound Petitions

Both manufacturers have submitted petitions to the FDA requesting that their active ingredients be added to the "Demonstrably Difficult to Compound" (DDC) list. If granted, this would permanently prohibit compounding of these drugs under any circumstances — even with a clinical difference justification.

State-Level Complications

Adding to the complexity, state Boards of Pharmacy and Boards of Nursing have issued their own guidance — which sometimes conflicts:

• Kentucky Board of Nursing: APRNs must only prescribe FDA-approved GLP-1s; compounded alternatives are not acceptable substitutes
• Kentucky Board of Pharmacy: Allows narrow exceptions for prescriber-documented clinical differences
• Ohio: Has pursued enforcement actions even when providers documented clinical differences

This creates a situation where federal law may permit compounding, but state boards may not — or vice versa.

What This Means for Patients

If You're Currently on Compounded GLP-1s

The compounding pharmacy filling your prescription is operating in a legally uncertain environment. Your options:

• Ask about their legal basis: Is your prescriber documenting a specific clinical difference? If so, what is it?
• Consider transitioning to FDA-approved versions: With shortages resolved, brand-name medications should be more accessible
• Evaluate cost assistance: Novo Nordisk and Eli Lilly both offer manufacturer savings programs

If You're Seeking New GLP-1 Treatment

FDA-approved medications (Wegovy, Ozempic, Mounjaro, Zepbound) are now the safest legal pathway. If cost is a barrier, explore:

• Manufacturer savings cards and patient assistance programs
• Insurance coverage (increasingly common for FDA-approved weight loss medications)
• Legitimate telehealth providers that work with brand-name medications