APC: MEMBER ALERT: Compounding “essentially a copy” of an FDA-approved drug

May 5, 2023

MEMBER ALERT: Compounding “essentially a copy” of an FDA-approved drug

As Chairman Grzib wrote in last week’s Compounding Connections, three state boards of pharmacy recently issued licensee communications that contained incorrect information about FDA guidance on shortage drug compounding by 503A pharmacies.

FDA guidance states that if a drug is listed as “currently in shortage”—that’s the exact language—it may be compounded. While the FDA website is confusing in that it does speak of availability of certain drugs, availability is not mentioned in the FDA guidance. “Currently in shortage” is the determinative language, and as of this writing, semaglutide remains in that category. (To assure compliance, we advise that licensees compounding semaglutide should refer to the FDA drug shortage list daily; a substance’s status on the list can change without notice.)

In this matter, APC’s concern is not so much about semaglutide compounding in particular. Rather our concern is that states may misread FDA guidance and apply that misreading to the compounding of other FDA-approved drugs in shortage in the future.

Last Thursday, at APC’s urging, FDA sent a letter to NABP, to be shared with state boards of pharmacy, clarifying the issue described above. The FDA letter also included a statement on compounding of semaglutide sodium.