FDA’s Human Drug Compounding Progress Report Jan 2017

Just over three years ago, on November 27, 2013, Congress amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by enacting the Drug Quality and Security Act (DQSA). The first title of the DQSA, known as the Compounding Quality Act, was passed in response to numerous serious adverse events, including deaths, linked to poor quality compounded drugs. In particular, in 2012, injectable drug products produced by a compounder and shipped across the country caused a fungal meningitis outbreak that resulted in more than 60 deaths and 750 cases of infection, affecting patients in 20 states.

Compounded drugs can serve an important medical need for patients. However, if a compounded drug does not meet appropriate quality standards (e.g., if an injectable drug is contaminated, or if a tablet contains too much active ingredient), it could cause serious injury or death. Therefore, in implementing and enforcing the compounding-related provisions of the FD&C Act, FDA seeks to strike a balance between preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them while protecting patients from the risks associated with compounded drugs that are not produced in accordance with the applicable requirements of federal law.

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