Compound pharmacies are facilities operated by licensed pharmacists or physicians that combine, mix, or alter ingredients of drugs to create medications designed to meet the needs of particular patients.
Compound pharmacies are regulated by a complex set of federal and state laws and operate in a rapidly evolving regulatory environment. For the past several years, the laws, regulations and policies governing the operation of compound pharmacies have changed dramatically. Not only have state pharmacy boards taken an increasingly aggressive role in regulating compound pharmacies, but the federal Food, Drug and Cosmetic Act (FDCA) has changed drastically too. For starters, federal law now recognizes two types of compound pharmacies, the trade compound pharmacies and the “outsourcing facility.” Both types of compounding pharmacies are regulated by FDA, as well as state agencies, and must be cognizant of the specific requirements and regulations that are applicable to them. For instance, compounders operating as outsourcing facilities may qualify for certain exemptions from the FDCA but also must comply with registration and good manufacturing practices requirements.
Fuerst Ittleman David and Joseph’s FDA attorneys have years of experience representing compound pharmacies of all varieties in a wide array of contexts, including regulatory compliance, state and federal enforcement actions, civil and criminal litigation and commercial transactions.