FDA Requests that Health Care Providers and Regulators Encourage Outsourcing Facility Registration

Food and Drug Administration (FDA) Commissioner Margaret Hamburg has encouraged entities that purchase compounded sterile drugs to meet the medical needs of patients that cannot be met by FDA-approved products to consider requiring their providers to register as outsourcing facilities with FDA. In addition to sending letters to these entities, Hamburg sent additional letters to state governors, state boards of pharmacy, and state boards of health, asking state regulators to consider strategies that might encourage non-resident compounding pharmacies that ship compounded sterile drugs into their states to register as outsourcing facilities.

Under Title I of the Drug Quality and Security Act (DQSA), known as the Compounding Quality Act, drugs produced by compounders that are not registered as outsourcing facilities must meet the conditions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) – which was amended by the new law – to qualify for certain exemptions to labeling and drug approval requirements.