Semaglutides
Compounding

Deadline passes for 503B outsourcing facilities to stop compounding semaglutide copies

As of May 22, 2025, FDA's enforcement grace period for 503B outsourcing facilities making semaglutide copies ended, closing the legal path that supplied many compounded weight-loss shots.

By the Semaglutides news desk·

The last federal grace period for mass-compounded semaglutide expired on May 22, 2025. After that date, FDA outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act could no longer rely on the drug shortage list to justify compounding, distributing or dispensing semaglutide injection products that are essentially copies of Ozempic or Wegovy [1][4].

The deadline traces back to February 21, 2025, when FDA issued a declaratory order finding that the semaglutide injection shortage was resolved. The agency concluded that Novo Nordisk's supply was meeting or exceeding demand and that the company held finished-product reserves plus significant semi-finished inventory to cover projected demand [1]. Wegovy had been on the shortage list since March 31, 2022, and Ozempic since August 23, 2022 [1].

To avoid abrupt treatment gaps, FDA gave compounders staggered wind-down windows: 60 calendar days for state-licensed pharmacies and physicians compounding under section 503A, ending April 22, 2025, and 90 calendar days for 503B outsourcing facilities, ending May 22, 2025 [1][4]. Lawyers at Alston & Bird noted the 503B window was longer than the 60 days FDA guidance normally allows after a drug leaves the shortage list, and that it mirrored the schedule FDA used when it declared the tirzepatide shortage resolved [3].

Compounders went to court to stop the change. On April 24, 2025, a federal district court in the Northern District of Texas denied the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174, which left the May 22 date in place for 503B facilities [4]. FDA also said it can still act against compounded products for other reasons, such as substandard quality or safety problems [4].

Novo Nordisk used the same day to push patients toward its approved product, issuing a release titled "New Novo Nordisk initiatives support patient access to authentic, FDA-approved Wegovy as federal ban on mass compounding of 'semaglutide' takes effect" [2]. Dave Moore, the company's executive vice president of US operations, said at the time that "mass compounding of 'semaglutide' is illegal, dangerous, and must stop now, which is why we are doubling down on our commitment to accessibility, availability, and affordability of authentic, FDA-approved Wegovy" [2]. The specific pricing and program terms of those initiatives are not described in the sources available here.

Why it matters for patients

Many people had been getting semaglutide through telehealth companies and compounders at prices and in formats that differ from the branded pens. The legal basis for that supply on a large scale is gone: FDA has said semaglutide does not appear on the 503B bulks list or on the drug shortage list [4].

The rules are not a blanket ban on every compounded preparation. FDA's order does not restrict compounding of semaglutide products that are not essentially a copy of an approved drug and are made to meet an individual patient's needs, such as a different dose or different inactive ingredients [3]. FDA has since spelled out how it reads "essentially a copy," including that a mix of semaglutide and vitamin B12 can count as a copy when strengths are within 10% of the commercially available products, and that it does not intend to act when a compounder fills four or fewer prescriptions of such a product in a calendar month [4].

FDA also warned that even with the national shortage resolved, patients and prescribers may still see intermittent, localized supply disruptions as product moves from manufacturer to wholesalers to pharmacies [1][4]. The agency said it expected some patients on compounded products to seek the approved versions once compounding was curtailed [1]. Attorneys advised providers to plan for insurance hurdles such as prior authorizations during the switch [3].

What happens next

FDA said it will keep monitoring supply and demand and could return semaglutide injection products to the shortage list if conditions change [1]. On May 2, 2025, FDA accepted Novo Nordisk's filing for oral semaglutide 25 mg for obesity [2]. On June 23, 2025, Novo Nordisk terminated its Wegovy collaboration with Hims & Hers, citing what it called illegal mass compounding and deceptive marketing [2].

Sources

  1. https://www.fda.gov/media/185526/download
  2. https://www.pharmexec.com/view/novo-nordisk-ends-hims-hers-collaboration
  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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