health

April 30, 2026

FDA proposes excluding Novo, Lilly weight loss drugs from bulk compounding list in win for the companies

If that proposal is finalized, the exclusion would likely limit the mass compounding of those medicines unless they appear on the FDA's drug shortage list.

FDA proposes excluding Novo, Lilly weight loss drugs from bulk compounding list in win for the companies

TL;DR

  • The FDA proposed excluding semaglutide, tirzepatide, and liraglutide from bulk compounding by outsourcing facilities.
  • This exclusion would limit the mass compounding of cheaper alternatives to Novo Nordisk's Ozempic/Wegovy and Eli Lilly's Mounjaro/Zepbound.
  • The FDA stated there is no clinical need for outsourcing facilities to compound these drugs from bulk.
  • The proposal specifically targets 503B outsourcing facilities and does not affect 503A pharmacies compounding for individual prescriptions.
  • This proposal is seen as a win for Novo Nordisk and Eli Lilly, who have invested heavily in manufacturing capacity.

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