Nathan Beaver Discusses GLP-1 Compounding, FDA Deliberations

Foley & Lardner LLP partner Nathan Beaver discussed the ongoing deliberations at the U.S. Food and Drug Administration over a popular class of drugs in the PharmaVoice article, “GLP-1 compounding is still in limbo. Will the FDA leave it for the next administration?“

“Another wrinkle to the story is that recently there have been requests to add both semaglutide as well as tirzepatide to the [FDA’s] ‘Demonstrable Difficulties for Compounding List,’” Beaver said during a Foley webinar referenced in the article. That list, proposed by the FDA in March, “[does] not currently exist.”

“If FDA were to place these drugs on the DDC list,” Beaver explained, “the drugs would not qualify for certain statutory exemptions under the Federal Food, Drug, and Cosmetic Act, and more significantly, the drugs will not be allowed to be compounded by pharmacists, physicians, or outsourcing facilities under any circumstances,” even in a shortage.

Beaver added that in the interim period before the FDA’s next update, the agency “has indicated it does not intend to take enforcement action against the continued compounding of tirzepatide.”