Compounding pharmacy

Drug compounding outsourcing facilities operated under section 503B are required to register with the FDA and outsourcing facility must re-register and pay the annual establishment fee for each year that it wishes to remain registered as an outsourcing facility. The annual registration period is from October 1-December 31.

Registered outsourcing facilities must submit a drug product report upon initial registration under section 503B of the Federal Food, Drug, and Cosmetic Act and twice each year in June and December for drug products produced during the previous six-month period.

We can help you to comply registration and product reporting requirements, contact us for more information.