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# FDA Clarifies Compounding Policy for GLP-1 Products
- URL: https://www.fdaweb.com/fda-clarifies-compounding-policy-for-glp-1-products/
- Published: 2025-03-10T12:00:00.000Z
- Updated: 2026-09-14T14:54:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158793

FDA is [clarifying](https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize?ref=fdaweb.com) its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Texas that denied a preliminary injunction sought by the Outsourcing Facilities Association to allow continued compounding of the products.

Regarding tirzepatide (Lilly’s Zepbound and Mounjaro), the agency says that consistent with the recent ruling, enforcement discretion has ended for state-licensed pharmacy or physician compounding under Section 503A of the FD&C Act. For outsourcing facilities under section 503B, FDA does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on tirzepatide injection products’ inclusion on FDA’s drug shortage list until 3/19.

Regarding semaglutide (Novo Nordisk’s Wegovy and Ozempic), FDA says state-licensed pharmacy or physician compounding can continue until 4/22 or until the date of a pending court decision involving a similar preliminary injunction motion sought by the Outsourcing Facilities Association, whichever is later. For outsourcing facilities under Section 503B of the FD&C Act, they have until 5/22 or until the date of the court’s decision, whichever is later.