An outbreak of fungal meningitis, traced to contamination in compounded injectable steroids, jump-started the movement to increase federal authority over compounding operations. Now, federal oversight is about to increase, with the President expected to sign into law the new Drug Quality and Security Act (DQSA). This bill is intended to prevent injury and death caused by compounded drugs that were not prepared properly. When enacted, DQSA will amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to make it easier to trace drugs throughout the U.S. supply chain, and to provide FDA with more authority to regulate compounding pharmacies. The bill creates new inspection, registration, labeling, and reporting requirements – such as adverse events reporting – for compounding pharmacies.
Title I- “Drug Compounding” preserves and protects the practice of traditional pharmacy compounding occurring in community pharmacies. It eliminates the unconstitutional provisions of Section 503A of the FFDCA that created uncertainty regarding the laws governing compounding, and requires FDA to engage in two-way communication with state regulators – a major deficiency in FDA’s response to the meningitis outbreak. “This new law will create a dramatic change in FDA’s jurisdiction over compounding pharmacies, and is intended to drastically increase FDA’s ability to ensure the safety of compounded drugs. It also creates “outsourcing facilities,” a new FDA-regulated entity which will be subject to FDA oversight, including registration and the submission of an annual report to FDA. This bill retains and clarifies section 503(a) of the FFDCA, which governs pharmacy compounding.
Title II- “Drug Supply Chain Security” will create a uniform national standard for drug supply chain security, to protect Americans against counterfeit drugs while eliminating needless government regulations, and will help prevent increases in drug prices. It will create a new framework for securing our prescription drug supply chain, and also establish a 10-year transition to a unit-level tracking system for enhanced security. It will also eliminate the patchwork of red tape, like California’s pedigree law, on drug industry members. These changes will help alleviate drug shortages and reduce government-imposed costs on prescription drugs. It also creates floor and ceiling licensure standards for wholesale distributors and third-party logistics providers, while preserving state authority for licensure issuance and fee collection.
