Semaglutides
Compounding

FDA deadline passes for 503A pharmacies to stop compounding semaglutide copies

The end of a federal grace period means compounded semaglutide copies from 503A pharmacies should stop, affecting patients who have been relying on them [1][4].

By the Semaglutides news desk·

The 60-day window the Food and Drug Administration gave state-licensed 503A compounding pharmacies to stop making compounded semaglutide injections that are essentially copies of Ozempic and Wegovy closed on April 22, 2025 [1][4]. The deadline followed the agency's February 21, 2025 determination that the semaglutide injection shortage is resolved [1][4].

FDA said the manufacturer's supply is currently meeting or exceeding demand for Ozempic and Wegovy and that reserves of finished and semi-finished product mean supply will meet projected demand [1]. Semaglutide injection products were first added to the shortage list in March 2022 for Wegovy and August 2022 for Ozempic [1]. While a drug is on that list, compounders may make copies of it because the approved product is not treated as commercially available [2][3].

FDA's order gave state-licensed pharmacists and physicians working under section 503A 60 calendar days, until April 22, 2025 [1][4]. Outsourcing facilities working under section 503B received 90 calendar days, until May 22, 2025 [1][4]. The two groups differ in scale: 503A pharmacies compound for an individual patient with a prescription, while 503B facilities generally compound larger amounts without a patient-specific prescription [2][3]. Compounded drugs have not gone through FDA premarket review for safety, effectiveness, or quality [2][3].

FDA said the deadlines cover products that are essentially copies of approved drugs. The order does not restrict compounders from making semaglutide injections that are not essentially a copy, to meet individual patient needs, such as a different dose or a change in inactive ingredients because of adverse effects like allergic reactions [1][2][3]. FDA guidance describes an essentially-copy product as one with the same active ingredient in the same, similar, or easily substitutable strength, given by the same route of administration, unless a prescriber documents a change that produces a significant difference for an identified patient [4]. FDA also said it does not intend to act against a compounder that fills four or fewer prescriptions of such a product in a calendar month [4].

FDA acknowledged that some patients and pharmacists have reported trouble getting the approved drugs filled, and that a substantial amount of semaglutide compounding has been occurring [1]. The agency said those reports are most likely explained by supply-chain dynamics between the manufacturer, wholesalers, distributors, and local pharmacies rather than a continuing national shortage, and that localized disruptions may still occur [1][4]. The order does not prevent FDA from acting on other violations, such as a product that may be substandard or unsafe [4].

Why it matters for patients

People who have been receiving compounded semaglutide injections from a 503A pharmacy may find that supply stops. FDA wrote that some patients now receiving compounded products can be expected to seek the approved products once compounding is curtailed, and that information from patients, providers, and compounders did not show Novo Nordisk would be unable to meet projected demand [1]. FDA-approved Ozempic and Wegovy are the only FDA-approved semaglutide injection products [1]. Rybelsus is an oral semaglutide product and was not in shortage [1]. Whether a given patient's insurance will cover a switch, and what a switch would cost, has not been reported. On February 19, 2025, attorneys general from 38 states and U.S. territories asked acting FDA commissioner Sara Brenner to stop what they called bad actors profiting from counterfeit incretin-based drugs entering the country [2].

What happens next

  • Outsourcing facilities under section 503B of the FD&C Act may keep compounding, distributing, or dispensing semaglutide injection products that are essentially copies of approved drugs until May 22, 2025 [1][4].
  • On April 24, 2025, a federal district court denied the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.), so the 503A enforcement discretion period has ended [4].
  • FDA said it will keep monitoring supply and demand and will consider whether any semaglutide injection product should go back on the shortage list [1].
  • Semaglutide and tirzepatide do not currently appear on the 503B bulks list or on FDA's drug shortage list [4].

Sources

  1. https://www.fda.gov/media/185526/download
  2. https://www.burr.com/newsroom/articles/the-fda-removes-semaglutide-from-the-drug-shortage-list
  3. https://www.alston.com/en/insights/publications/2025/03/fda-resolves-semaglutide-shortage
  4. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

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