GLP-1 Compounding

As you likely know, the Food & Drug Administration (“FDA”) has recently determined the shortage of semaglutide injection products has resolved. The drug manufacturers have advised the FDA that their product availability and manufacturing capacity can meet the present and projected national demand. Pursuant to this determination, the FDA has announced that state-licensed pharmacies compounding under section 503A must cease compounding, distributing, and/or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product by April 22, 2025.

Similarly, the FDA has also determined the shortage of tirzepatide injection products has also resolved and tirzepatide has been removed from the FDA’s shortage list. Pursuant to this determination, the FDA has announced that state-licensed pharmacies compounding under section 503A must cease compounding, distributing, and/or dispensing tirzepatide injection products that are essentially a copy of an FDA-approved product by February 18, 2025.

Pharmacists Mutual wishes to advise you that failure to comply with the FDA’s orders could result in exposure for your company, including but not limited to an enforcement action against you by the FDA and/or a civil lawsuit(s) against you by the manufacturers of these patent-protected products. Failure to comply with the FDA’s orders could also potentially impact the coverage available to you under your Pharmacists Mutual insurance policy.

If you have any questions regarding this letter, please reach out to your Business Development Executive or Member Services. Thank you for being a valued Pharmacists Mutual insured.

Sincerely,

Kristen Jones, PharmD

AVP, Professional Liability Strategic Operations

Pharmacists Mutual Insurance Group