Thursday July 17, 2014
In November of 2013, President Obama signed into law the Drug Quality and Security Act (DQSA). This legislation gives the Food and Drug Administration (FDA) more authority to regulate and monitor compounding pharmacies in an effort to improve oversight and safety of their products. In response to the passage of the DQSA legislation, the FDA has published Title 1, the Compounding Quality Act to enumerate new policies to ensure production of safe, high quality products.
Fungal Meningitis Outbreak as the Impetus for the DQSA
Questions about the oversight of compounding pharmacies began to arise after an outbreak of fungal meningitis, a rare disease, occurred in 2012. As a result of the outbreak, 64 individuals died and 750 were infected in 20 states. The outbreak was quickly determined to be exposure to contaminated injectable steroidal painkillers that had been compounded in the New England Compound Pharmacy.
The outbreak was seen as evidence of insufficient regulation of compounding pharmacies, and U.S. Representative Fred Upton, a Republican from Michigan, introduced DQSA legislation in an attempt to improve the safety of products from compounding pharmacies. These are the objectives of the DQSA.
- Re-establish section 503 of the Food, Drug, and Cosmetic Act as the governing legislation over compounding pharmacies.
- Provide clarity regarding which entities are responsible for governing compounding pharmacies.
- Distinguish and define traditional compounding pharmacies from outsourcing facilities.
- Address the reality of the changing role of compounding pharmacies.
Changing Role of Compounding Pharmacies Addressed in the DQSA
Compounding pharmacies traditionally operated as part of an individualized model. They served patients as part of a three-way relationship between patients, physicians, and pharmacists; the role of compounding pharmacies was to provide custom-mixed prescription and non-prescription medications to patients.
Over the years, compounding pharmacies have shifted away from this traditional model. Although they still custom-mix medications, they often now also participate in large-scale compounding of sterile drugs.
Provisions Regarding Traditional Compounding Pharmacies and Outsourcing Facilities
The DQSA distinguishes outsourcing facilities from traditional compounding pharmacies in an effort to clearly explain rules for and oversight of each. Traditional compounding pharmacies remain under the jurisdiction of the states, although the DQSA include provisions to improve communication between states and the FDA. For example, states must report concerns or punitive actions as they occur.
Outsourcing facilities are pharmacies that compound sterile drugs in large batches that are not necessarily in direct response to a single patient's prescription. They are monitored and inspected by the FDA, and must pay an annual fee based on their total annual sales values. Twice per year, outsourcing facilities need to report which drugs they are compounding.
Inspections and Enforcement
The FDA is notoriously underfunded, and has insufficient resources to rigorously inspect all compounding pharmacies or even all outsourcing facilities. The FDA inspects outsourcing facilities using a risk-based schedule, in which the highest-risk facilities are more likely to be examined. Facilities found to be using unsafe practices or manufacturing impure mixtures are subject to fines, and they may also be charged re-inspection fees if they require a return visit from the FDA. Recalls of contaminated or otherwise unusable products can also help keep the public safe when using products from compounding pharmacies.