Compounded drugs are not FDA-approved. This means that FDA does not review these drugs to evaluate their safety, effectiveness, or quality before they reach patients. FDA has investigated many cases of serious patient injury linked to poor quality compounded drugs. In 2012, contaminated drugs compounded by a Massachusetts pharmacy led to more than 750 cases of infection and more than 60 deaths of patients in 20 states.
Congress passed the Drug Quality and Security Act (DQSA) in response to the 2012 fungal meningitis outbreak, as well as numerous other serious adverse events, including deaths, linked to poor quality compounded drugs. The DQSA, which was enacted on November 27, 2013, made important updates to the Federal Food, Drug and Cosmetic Act (FD&C Act) regarding human drug compounding. Since DQSA enactment, FDA has worked diligently to issue draft and final policy documents to implement the law.
The DQSA eliminated provisions concerning advertising of compounded drugs that had been found to be unconstitutional from existing law addressing compounding – section 503A of the FD&C Act. This removed uncertainty about the validity of section 503A, which Congress otherwise left intact.
Section 503A describes the conditions under which compounded human drug products are exempt from the FD&C Act sections on FDA approval prior to marketing, current good manufacturing practice (CGMP) requirements, and labeling with adequate directions for use. One of these conditions is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions.
The DQSA also added a new section 503B to the FD&C Act, which established a new, voluntary category of compounders known as outsourcing facilities. Unlike compounders operating under section 503A, outsourcing facilities are subject to CGMP requirements, and they may distribute compounded drugs either pursuant to a patient-specific prescription or in response to an order from a health care provider, such as a hospital, that is not for an identified individual patient (e.g., for office stock).
Outsourcing facilities are inspected by FDA according to a risk-based schedule, and must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
See provisions of federal law that apply to human drug compounding and FDA’s policies on other related activities for more information. See also information about the Pharmacy Compounding Advisory Committee, which provides FDA with advice as it implements certain provisions of sections 503A and 503B of the FD&C Act.
Additionally, find information on FDA’s work to develop the lists of bulk drug substances that can be used in compounding under sections 503A and 503B of the FD&C Act.