Agency Proposes to Exclude GLP-1 Therapies from 503B Bulks List; Comments due June 29
May 1, 2026 | |
Agency Proposes to Exclude GLP-1 Therapies from 503B Bulks List; Comments due June 29
The Food and Drug Administration (FDA) issued a notice proposing to exclude three widely used GLP-1 therapies – semaglutide, tirzepatide, and liraglutide – from the 503B Bulks List, determining that there is no clinical need for outsourcing facilities to compound these products from bulk drug substances (press release). The proposal reflects FDA’s continued emphasis that compounding from bulk ingredients is… (Colocho, May 1, 2026) #Chronic Diseases, #Food and Drug Administration, #Prescription Drugs