Navigating the Direct Importation of Active Pharmaceutical Ingredients: Compliance Considerations for Compounding Pharmacies.

Abstract

The direct importation of Active Pharmaceutical Ingredients (APIs) presents significant opportunities for compounding pharmacies to optimize costs and expand their services. However, sourcing APIs from foreign manufacturers, particularly from countries like China, introduces complex regulatory challenges. This article examines the federal regulatory framework governing API importation, outlines due diligence measures that compounding pharmacies should undertake, and provides general guidance on state-level considerations. By adhering to these guidelines, compounding pharmacies can mitigate risks, better ensure compliance with applicable laws and regulations, and maintain the integrity of their compounding practices.