NCPA and APC ask FDA for 60-day allowance to compound copies of tirzepatide injection

NCPA October 10, 2024

NCPA and APC sent a letter to the Food and Drug Administration requesting an emergency amendment to guidance allowing 503A compounding pharmacies to have at least a 60-day transition period for dispensing compounded copies of tirzepatide injection. This is in response to FDA’s recent statement that the shortage of tirzepatide injection is now “resolved.” Federal law permits the compounding of copies of FDA-approved drugs when a drug is in shortage.

During this transition period that NCPA and APC requested, prescriptions could be authorized for the FDA-approved products. Coverage determinations could be made by insurance companies. And, the FDA-approved products could be obtained by pharmacies to fill the prescriptions, all while preserving patients’ access to their medications. Additionally, the letter asked FDA for clarification on 503B outsourcing facilities’ distribution to 503A compounding pharmacies.

NCPA