Deadline passes for large-scale compounding of semaglutide copies

The last federal grace period for compounding copies of semaglutide, the drug in Ozempic and Wegovy, ended on May 22, 2025, completing the FDA's wind-down of large-scale compounded versions of the medicine ^[1][4].

FDA determined on February 21, 2025 that the semaglutide injection shortage was resolved, saying Novo Nordisk's supply was meeting or exceeding demand and that the company held reserves of finished and semi-finished product ^[1]. The agency's order set two transition windows: state-licensed pharmacies and physicians compounding under section 503A had until April 22, 2025, and outsourcing facilities under section 503B had until May 22, 2025 — 60 and 90 calendar days from the order ^[1][3][4]. Semaglutide injections had been on FDA's shortage list since March 31, 2022 for Wegovy and August 23, 2022 for Ozempic ^[1].

The 503A window closed as scheduled ^[4]. A district court denied a preliminary injunction motion in Outsourcing Facilities Association v. FDA on April 24, 2025, so the 503B date was not extended ^[4].

The deadlines apply to compounded products that are "essentially a copy" of an FDA-approved drug — the same active ingredient in the same, similar or easily substitutable strength, given by the same route ^[4]. FDA has said its order does not stop compounders from making semaglutide products that are not essentially a copy, such as versions with a different dose or different inactive ingredients, compounded for an individual patient's needs ^[3].

FDA acknowledged in the order that some patients and pharmacists reported trouble filling prescriptions, and said those problems were more likely explained by how product moves from the manufacturer through wholesalers to local pharmacies than by a continuing national shortage ^[1]. The agency said patients and prescribers may still see intermittent, limited disruptions at the local level ^[1][4].

Novo Nordisk announced new programs on the same day aimed at supporting patient access to FDA-approved Wegovy as the federal restriction on mass compounding took effect, and said it would double down on the accessibility, availability and affordability of the brand product ^[2]. The company did not describe the specific terms of those programs, and details have not been reported ^[2]. Dave Moore, Novo Nordisk's executive vice president of US operations, said in a statement that "mass compounding of 'semaglutide' is illegal, dangerous, and must stop now" ^[2].

On June 23, 2025, Novo Nordisk ended a collaboration that had given Hims & Hers customers access to Wegovy, citing illegal mass compounding and deceptive marketing ^[2]. Novo said its investigation found that many compounded semaglutides sold by telehealth services were manufactured by suppliers in China at sites that FDA had not inspected or approved ^[2].

Why it matters for patients

People who were getting compounded semaglutide from a 503B outsourcing facility are the group most directly affected by the May 22 cutoff, because that supply is no longer covered by FDA's enforcement discretion ^[1][4]. The FDA-approved semaglutide injections are Ozempic and Wegovy; Rybelsus is the approved oral semaglutide tablet and was not in shortage ^[1].

Compounded drug products have not gone through FDA premarket review for safety, effectiveness or quality, according to a law firm advisory on the order ^[3]. At the same time, the advisory noted that FDA's order does not bar compounding of semaglutide products that are not essentially copies of approved drugs, which may matter to patients whose prescribers document a need for a different formulation ^[3].

The same advisory told providers to expect insurance obstacles such as prior authorizations during the transition and to inform patients about that likelihood ^[3]. FDA has said it will keep monitoring supply and can add semaglutide products back to the shortage list if appropriate ^[1].

What happens next

No further compounding grace period for semaglutide copies has been announced ^[4]. FDA has said it may still take action on other violations, such as findings that a product may be of substandard quality or otherwise unsafe ^[4]. Novo Nordisk has said it will work with telehealth companies that share its commitment to patient safety ^[2]. Separately, FDA accepted Novo Nordisk's filing for oral semaglutide 25 mg in May 2025; if approved, it would be the first oral GLP-1 treatment for obesity, and a decision date has not been disclosed ^[2].