FDA issues new draft documents related to compounding of human drugs

The US Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products.

Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.