Compounded GLP-1 products went from the fastest-growing category in compounding to the most scrutinized in under two years. The drug shortages that allowed pharmacies to compound semaglutide and tirzepatide broadly are over, the FDA has restated how it decides whether a compounded product is an unlawful copy, and its September 2026 warning letter to a large compounder put platforms and prescribers on notice alongside pharmacies. This guide lays out where things stand and how ordering works on ScriptLinkRx for clinics that still have patients with a documented need.
The post-shortage framework
- Tirzepatide was removed from the FDA drug shortage list in October 2024, a decision the agency reaffirmed on December 19, 2024. Enforcement discretion for 503A pharmacies ended February 18, 2025, and for 503B facilities March 19, 2025.
- Semaglutide was declared resolved on February 21, 2025. The grace periods ended April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B facilities.
- Since then, compounding either drug falls under the ordinary rules: a 503A pharmacy may not regularly, or in inordinate amounts, compound a drug that is essentially a copy of a commercially available approved product, and a 503B facility may not compound from a bulk substance that is not on the 503B bulks list or the shortage list.
"Essentially a copy" for 503A means the same active ingredient, the same, similar or easily substitutable strength, and the same route of administration as the approved product, unless the prescriber determines and documents a change that produces a significant difference for the identified patient.
What changed in 2026
April 1, 2026: the FDA's clarification. The agency reminded compounders that the exemptions in sections 503A and 503B only apply when their conditions are met. It used semaglutide combined with vitamin B12 as its example of a product it may treat as essentially a copy when the route matches and the semaglutide and B12 amounts are within 10% of the strengths of the commercially available products. It also restated that it does not generally intend to act against a 503A compounder filling four or fewer prescriptions of an essentially-copy product in a calendar month.
April 30, 2026: the 503B bulks list proposal. The FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk. The comment period has closed; no final decision had been published as of October 2026.
September 18, 2026: the Empower Pharmacy warning letter. Following a 2025 inspection, the FDA concluded that the pharmacy's tirzepatide/niacinamide and semaglutide/cyanocobalamin products remained essentially copies of the approved drugs despite the added ingredient. Three findings matter for clinics:
- Volume reads as pretext. The letter stated that the volume being produced suggested the differences from the approved products were pretextual.
- Templated justifications fail. The FDA flagged boilerplate significant-difference language and prescriptions with no determination at all.
- Platforms are in scope. The letter pointed to third-party platforms that offer prescribers pre-selected options as part of the problem.
A warning letter is a notice of alleged violations, not a final adjudication. But it is the clearest statement yet of how the FDA reads GLP-1 co-formulations and the systems around them.
What a compliant clinic workflow looks like
The rules put the determination on the prescriber. A workflow that holds up has these features:
- A patient first, then a prescription. The order starts from an identified patient and the prescriber's assessment, not from a product menu.
- A documented, specific difference. Where the prescriber concludes the patient needs a compounded product rather than the approved one, the reason is specific to that patient (a strength, formulation or ingredient the patient needs or cannot tolerate) and is recorded in the chart and on the prescription. Convenience, cost and "practice preference" are not significant differences.
- No templates. The same sentence on every prescription is exactly what the FDA criticized.
- The approved product where it fits. If the approved drug meets the patient's needs, prescribe it.
- Honest patient communication. Compounded GLP-1s are not FDA-approved, are not generic versions of the brand products, and should not be described as equivalent.
- Pharmacy selection by licensing, not price alone. The dispensing pharmacy must be licensed in the patient's state and is responsible for its own compliance with the copy restriction, including the volume question.
How ScriptLinkRx supports it
ScriptLinkRx is an ordering platform, not a pharmacy and not a prescriber. For GLP-1 orders that means:
- The prescriber selects the patient, writes the prescription with patient-specific directions and notes, and signs it through the platform's e-prescribing integration. The platform does not generate justification language or pre-select a formulation.
- Partner 503A compounding pharmacies list what they prepare and the states they are licensed in. The catalog shows a patient only what can lawfully ship to their state. Pharmacies may decline prescriptions that do not meet their own compliance review.
- No GLP-1 products are offered through the 503B office-use pathway, consistent with the bulks-list and shortage-list rules.
- Order, prescription and receipt records are retained per patient and per practice for board or FDA inquiries.
For product-level regulatory detail, see the provider guides on compounded semaglutide with B12, compounded tirzepatide with B6 and the regulatory status of retatrutide, which cannot be lawfully compounded at all.
Sources
- FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (April 1, 2026)
- FDA: FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (April 30, 2026)
- FDA: Warning Letters (search "Empower Clinic Services", September 18, 2026)
- Frier Levitt: FDA Warning Letter Targets Compounded GLP-1 Products
- FDA: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (guidance)