Novo Nordisk again asks FDA to bar compounding of semaglutide
A listing on the FDA's hard-to-compound register would close off pharmacy-made semaglutide even if the drug went into shortage again.
Novo Nordisk has asked the FDA again to place semaglutide on its Demonstrable Difficulties for Compounding lists — the register of drug products the agency considers too complex to compound safely — according to a running timeline of FDA peptide actions [1]. The nomination was first filed in October 2024 under docket FDA-2017-N-2562 and was posted on the agency's website that month [1][2].
The DDC lists identify drugs that are too complicated to produce and that could pose substantial safety risks to patients if made incorrectly. Compounders are not allowed to produce drugs on the list regardless of supply constraints [2].
Novo's filing argues that its semaglutide products, which the company makes using yeast systems and recombinant DNA technology, have "unique characteristics and properties that are challenging to reproduce using a synthetically produced peptide" [2]. The company said synthetic and compounded versions of the drug "have different impurity profiles and different physical and chemical stabilities" compared with the FDA-approved versions [2]. Novo also told the agency that compounded semaglutide lacks clinical testing, has been linked to calls to poison control centers, and shows what the company described as problematic immunogenicity profiles [2].
"We have not identified any actual or potential benefit that would outweigh the risks presented by compounded semaglutide products," Novo wrote in the filing [2]. Along with the DDC nomination, Novo asked the FDA to convene its Pharmacy Compounding Advisory Committee and its Drug Safety and Risk Management Advisory Committee to take up the matter [2].
Semaglutide is marketed as Ozempic for type 2 diabetes and as Wegovy for chronic weight management [2]. Novo struggled to keep supply in step with demand; in September 2024 it said shortages of lower doses of Ozempic could last into the fourth quarter of that year [2]. Since then, the FDA removed semaglutide and tirzepatide from its drug shortage list, and on Aug. 27, 2026, the Fifth Circuit upheld that removal [1]. Bulk compounding of semaglutide and tirzepatide for general use is no longer allowed, while patient-specific compounding for an individual with a documented medical need remains legal [1].
A separate proposal published April 30, 2026 would exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list. That proposal and the DDC nomination both remain pending [1]. Placement on the DDC list would bar compounding of semaglutide even if a future shortage were declared, making it a backstop to the 503B exclusion [1].
Why it matters for patients
For people who have been getting semaglutide from a compounding pharmacy, the effect of the nomination depends on which pathway their prescription came through. Bulk compounding for general use is already barred after the shortage-list removal the Fifth Circuit upheld in August [1]. Patient-specific compounding under section 503A for a patient with a documented medical need is still permitted [1]. If the FDA were to add semaglutide to the DDC lists, that route would close as well, including during any future shortage — the defining feature of the DDC framework is that supply constraints do not reopen compounding [2].
FDA enforcement on unapproved GLP-1 products is running on a separate track. On Aug. 24, 2026, the agency's Center for Drug Evaluation and Research issued warning letters to five online sellers — Peptide Partners LLC, Peak Performance Peptides, Royal Peptides LLC, NuScience Peptides LLC, and TXP Innovations LLC (Tex Peptides) — over injectable semaglutide, tirzepatide and other peptides sold under "research use only" labels, which the letters classify as unapproved new drugs [1]. Those letters were posted Sept. 1 and carry a 15-business-day response window, with possible escalation to seizure and injunction [1]. They are direct-to-consumer unapproved-drug cases, not compounding cases [1].
What happens next
The DDC nomination and the 503B bulks-list exclusion both remain undecided, and no decision date has been reported [1]. The Fifth Circuit ruling of Aug. 27, 2026 ended the last legal avenue for bulk compounding of these molecules for general use [1]. The FDA has not said when, or whether, it will act on Novo's requests [1].
Sources
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