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# Keep GLP-1s Off Bulks List: FDA
- URL: https://www.fdaweb.com/keep-glp-1s-off-bulks-list-fda/
- Published: 2026-04-30T12:00:00.000Z
- Updated: 2026-09-14T13:38:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161070

FDA says it has determined that there is no clinical need for outsourcing facilities to use semaglutide, tirzepatide, and liraglutide (the active pharmaceutical ingredients in Novo Nordisk’s and Lilly’s GLP-1 diabetes and weight loss drugs) in compounding. A 5/1 *Federal Register* [notice](https://www.federalregister.gov/public-inspection/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-the-federal-food-drug-and?utm%5Fmedium=email&utm%5Fsource=govdelivery) invites public comment until 6/29 on the proposal not to include the drugs on the 503 Bulks List of drugs approved for compounding.

In an [announcement](https://content.govdelivery.com/accounts/USFDA/bulletins/41537f8?ref=fdaweb.com) of the proposal, FDA commissioner **Marty Makary** says that when FDA-approved drugs are available, outsourcing facilities cannot lawfully compound bulk drug substances unless there is a clear clinical need. “This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input,” he says.

The *Federal Register* notice says that in considering nominations for drug products to be included on the Bulks List, the agency answers two questions:

- whether there is a basis to conclude, for each FDA-approved product that includes the nominated bulk drug substance, that **(a)** an attribute of the FDA-approved drug product makes it medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation, and **(b)** the drug product proposed to be compounded is intended to address that attribute; and
- whether there is a basis to conclude that the drug product proposed to be compounded must be produced from a bulk drug substance rather than from an FDA-approved drug product.

If the answers to both questions are affirmative, FDA says, there may be a clinical need for compounding from bulk substances, and the agency evaluates the substance further, considering these factors:

- the physical and chemical characterization of the substance;
- any safety issues raised by using the substance in compounding;
- the available evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and
- current and historical use of the substance in compounded drug products, including information about the medical condition(s) that the substance has been used to treat and any references in peer-reviewed literature.

The notice says FDA did not answer in the affirmative to both of the initial screening questions and thus did not proceed to further evaluation.

FDA says it will consider submitted comments before making its final determination.