The International Academy of Compounding Pharmacists (IACP) has submitted comments and Active Pharmaceutical Ingredient (API) lists to the Food & Drug Administration (FDA) for both 503A and 503B.
As covered in IACP’s submission letter, the Academy is extremely concerned that the FDA is intentionally setting an “impossible to meet” standard by requiring descriptions and justification for the use of APIs in lieu of commercially available products. That is especially troubling given that the agency has yet to vet and begin the appointment process for the Pharmacy Compounding Advisory Committee (PCAC).
Please click here to view IACP’s letter to FDA re: Nominations on Bulk Ingredients 503A Non-USP, Non-FDA Approved
Please click here to view IACP’s letter to FDA re: Nominations on Bulk Ingredients 503B Non-USP, Non-FDA Approved
Please click here to view IACP’s Bulk Drug Submission List for 503A Traditional Compounders (Please note this API list also was submitted for 503B.)
Please email IACP with questions. email@example.com