Deadline passes for 503A pharmacies to stop compounding semaglutide copies

The FDA's grace period for state-licensed 503A compounding pharmacies to stop making semaglutide injection products that are "essentially a copy" of Ozempic or Wegovy ran out on April 22, 2025 ^[1][4]. The date was set 60 calendar days after the agency issued a February 21, 2025 declaratory order finding that the national semaglutide injection shortage was resolved ^[1].

In that order, the FDA told Novo Nordisk it had concluded the company's supply "is currently meeting or exceeding demand" for Ozempic and Wegovy, and that reserves of finished and semi-finished product meant supply would also meet projected demand ^[1]. Semaglutide injection had been on the shortage list since March 31, 2022 for Wegovy and August 23, 2022 for Ozempic ^[1]. Rybelsus, the oral semaglutide tablet, was not in shortage ^[1].

The shortage listing mattered because being on the list was the legal exception that let compounders make near-copies of an approved drug ^[2][3]. Once the listing went away, the FDA said it would not take action against compounders for violations tied to the listing for a limited window: 60 days for 503A pharmacies and physicians, until April 22, 2025, and 90 days for 503B outsourcing facilities, until May 22, 2025 ^[1][4]. The agency said the staggered timeline was meant "to avoid unnecessary disruption to patient treatment" ^[2][4].

There was a litigation wrinkle. In a March 10, 2025 update, the FDA said the 503A window ran until April 22, 2025, or until the district court ruled on a forthcoming preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.), whichever was later ^[4]. The court denied that motion on April 24, 2025, and on April 28 the FDA confirmed that the 503A enforcement discretion period had ended and that the 503B period still ran to May 22, 2025 ^[4].

What is still allowed

The cutoff applies to products that are essentially copies of the approved drugs. The FDA's declaratory order does not bar 503A pharmacies or 503B facilities from compounding semaglutide injection products that are not essentially a copy and that are made to meet an individual patient's needs, such as a different dose or different inactive ingredients because of a reaction like an allergy ^[2][3]. FDA guidance describes a compounded product as essentially a copy when it has the same active ingredient as a commercially available drug in the same, similar or easily substitutable strength and can be given by the same route, unless a prescriber determines and documents a change that produces a significant difference for an identified individual patient ^[4].

Why it matters for patients

Many people started on compounded semaglutide during the shortage, often through telehealth platforms. Law firm analyses of the order warned that patients relying on those products could face gaps in treatment and that providers needed transition plans, including dealing with prior authorizations and other insurance barriers when switching to brand products ^[2][3].

The FDA itself acknowledged in the order that some patients and pharmacists have reported being unable to get the approved drugs, and that some people now on compounded versions "can be expected to seek Novo Nordisk's approved products when compounding is curtailed" ^[1]. The agency said intermittent local gaps are more likely explained by supply chain dynamics between the manufacturer, wholesalers and pharmacies than by a continuing national shortage ^[1].

Compounded drugs, unlike Ozempic and Wegovy, have not gone through FDA premarket review for safety, effectiveness or quality ^[2][3]. Separately, on February 19, 2025, attorneys general from 38 states and U.S. territories wrote to then-acting FDA commissioner Sara Brenner asking the agency to act against sellers of counterfeit incretin drugs entering the U.S. ^[2].

What happens next

May 22, 2025 is the end of the FDA's enforcement discretion window for 503B outsourcing facilities making semaglutide copies ^[1][4]. The FDA said it will keep monitoring supply and demand and could relist semaglutide injection products in the future if warranted ^[1]. It also noted it can still act on other violations, such as products found to be of substandard quality or otherwise unsafe ^[4]. How individual pharmacies and telehealth companies changed their offerings after the deadline is not detailed in these sources.