FDA Guidance Further Defines ‘Facility’ for Drug Compounding Purposes

The Food and Drug Administration Friday issued final guidance clarifying that an organization may operate both a compounding pharmacy and outsourcing facility at the same address or general location if they are completely segregated by clearly identified boundaries, for example permanent physical barriers such as walls or doors that are locked. If the pharmacy is not completely segregated from the outsourcing facility, FDA would generally consider the pharmacy part of the outsourcing facility and subject to Section 503B of the Federal Food, Drug and Cosmetic Act and current good manufacturing practice, the agency said. Both compounders also should clearly label their drug products as compounded at a pharmacy or outpatient facility, FDA said. The Drug Quality and Security Act of 2013 created the outsourcing facility category.