Compliance alert: 503Bs and GLP-1 compounding

In recent days APC has received several emails and texts asking whether a 503B outsourcing facility may prepare compounded drugs using GLP-1 API now that FDA has resolved the shortage. 

Under Section 503B of the Food, Drug & Cosmetic Act, 503B outsourcing facilities may only prepare drugs that are listed as “currently in shortage” on FDA’s Drug Shortage List, or are listed on the 503B Bulks List maintained by FDA, or are covered under FDA’s interim guidance for 503Bs. Semaglutide and tirzepatide are no longer formally in shortage and are not among APIs included on any of those FDA lists.

Under the present circumstances — drugs no longer in shortage, API not on the appropriate lists — we know of no authority under which a 503B is allowed to prepare or distribute drugs containing semaglutide and tirzepatide.

If you are a 503A and are approached about acquiring GLP-1 drugs prepared by a 503B for dispensing to patients pursuant to a prescription — and are considering doing so — we urge you to consult your attorney for advice.