The FDA determined the semaglutide shortage was resolved on February 21, 2025, closing the compounding exemption that 503A pharmacies and 503B outsourcing facilities had relied on for nearly three years. For a compounding pharmacist dispensing semaglutide, a GLP-1 medication, the question is no longer whether a shortage exists but whether each preparation is more than a lower-cost copy of an FDA-approved drug. The exposure: an FDA warning letter, a state board of pharmacy investigation, or a PBM audit referral tied to a preparation that no longer qualifies for the exemption.
FDA's Position After the Shortage Delisting
On February 21, 2025, FDA determined that the shortage of semaglutide injection products was resolved, confirming the manufacturer's supply could meet national demand. FDA built in a transition window: 60 days for state-licensed pharmacies compounding under Section 503A, and 90 days for outsourcing facilities compounding under Section 503B.
Litigation pushed the 503A deadline slightly. A federal court denied a preliminary injunction sought by the Outsourcing Facilities Association on April 24, 2025, and FDA confirmed the Section 503A discretion period had ended, consistent with the April 22, 2025 date already set. The Section 503B window ran through May 22, 2025. After those dates, no shortage-based enforcement discretion applies to routine semaglutide compounding.
503A and 503B Compounding After the Shortage Ends
The shortage delisting returned compounded semaglutide to the ordinary restrictions of Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic Act. A 503A pharmacy may still compound semaglutide for an individual patient under a prescription, but not as essentially a copy of the commercially available drug unless a prescriber documents a clinically significant difference for that patient. FDA will not pursue a compounder over that restriction if the pharmacy fills four or fewer prescriptions of the formulation in a calendar month, a threshold reaffirmed as recently as April 2026.
Outsourcing facilities under Section 503B may compound with a bulk drug substance only if it appears on the 503B bulks list or the drug is on FDA's shortage list at the time of compounding. Semaglutide satisfies neither condition, so bulk compounding of semaglutide by a 503B facility currently falls outside that exemption. Compounding pharmacy defense counsel tests each preparation against this standard before an inspection does. For the mechanics of the two frameworks, see 503A vs 503B: Which Framework Governs Your Compounding.
Once the shortage listing ends, the burden shifts to the pharmacy: prove, prescription by prescription, that the compounded product differs from the FDA-approved drug for a specific patient.
The Narrowing Limits of Enforcement Discretion
FDA has signaled the shortage-list fallback for 503B compounding may close permanently. On April 30, 2026, the agency proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for bulk compounding of any of them. The comment period closed June 29, 2026, with no final determination issued as of this writing.
If FDA finalizes the exclusion, outsourcing facilities lose both routes to lawful bulk compounding of semaglutide: the bulks list and the shortage list. The remaining path for a 503B facility would be compounding from an FDA-approved, already-marketed semaglutide product under the narrower conditions for compounding from an approved drug rather than a bulk substance. Pharmacists relying on the shortage-list contingency should treat the proposal as the likely long-term rule.
State Board Responses
State boards of pharmacy retain independent authority over compounding standards regardless of FDA's shortage determinations. California's Board of Pharmacy adopted new essentially a copy regulations effective June 17, 2025, codified at 16 CCR sections 1735.1, 1736.1, 1735.8, and 1736.8, requiring a pharmacist to document a clinically significant, patient-specific difference in a retrievable format before compounding a drug that would otherwise copy a commercially available product. A general statement that a patient prefers a different dosage form fails that standard.
The California approach is instructive nationwide. A pharmacy that satisfies FDA's essentially a copy exemption can still face a state board finding that falls short of a stricter state standard, since state pharmacy boards act independently of FDA's shortage timeline.
Why Early Legal Counsel Is Critical
It is critical that compounding pharmacies promptly retain experienced healthcare defense counsel upon receiving an FDA warning letter, audit notice, investigative request, or other government inquiry. Early legal intervention can protect the pharmacy's rights, ensure appropriate responses to government requests, avoid inadvertent admissions, preserve relevant defenses, and allow counsel to communicate with investigators on the pharmacy's behalf. Delaying legal representation can significantly affect the outcome of a matter and expose the pharmacy to unnecessary risk.
How Health Law Alliance Can Help
Health Law Alliance defends compounding pharmacies and prescribers through FDA warning letter responses and state board of pharmacy investigations tied to semaglutide compounding. If your pharmacy has received an inquiry on this issue, contact us today for a free consultation.
