For many years, the art of pharmaceutical compounding in the United States has been largely an overlooked and under regulated industry providing millions of patients each year with customized medications. Only after piecemeal enforcement resulted in hundreds of injuries and deaths in an event known as the New England Compounding Center Tragedy, did legislators and regulatory agencies refocus attention on current regulations in pharmaceutical compounding. Congress passed the Drug Quality and Security Act providing clarification for state and federal agencies as to their specific regulatory authority and responsibility to ensure patient safety in pharmaceutical compounding. However, the Drug Quality and Security Act instead created an ineffective and inefficient voluntary registration system, missed opportunities to ensure safer compounded pharmaceutical products, and did not provide other mechanisms or additional resources to aid state agencies in regulation and to increase patient-safety of compounded medications. This comment hopes to elaborate and identify several of the problems legislators at the state and federal level have seemingly overlooked and to suggest regulatory actions that may be taken to improve overall safety of all compounded preparations and the patients that receive them.
A False Sense of Safety: How the Drug Quality and Security Act Fails to Protect Patients from Harm,
St. Louis U. J. Health L. & Pol'y
Available at: https://scholarship.law.slu.edu/jhlp/vol9/iss2/9