In 2012, contaminated injections made by a compounding pharmacy in Massachusetts sickened 751 people in 20 states and led to the death of 64. Since then, new laws and increased regulations have tightened oversight of compounding pharmacies to provide greater protection of patients and limit the possibility of another outbreak.
While most compounding pharmacies provide special versions of medications for in-house use or a small number of patients with very specific requirements, the pharmacy at the center of the 2012 outbreak prepared thousands of doses of preservative-free methylprednisolone acetate solution and shipped them nationwide. The Centers for Disease Control and Prevention identified the most common contaminants in these steroid injections as Exserohilum rostratum and Aspergillus. Initially, most patients presented with fungal meningitis. As the outbreak grew, localized spinal/paraspinal and peripheral joint infections accounted for the majority of infections.1
While the Food and Drug Administration (FDA) oversees commercial pharmaceutical manufacturing, states typically regulate pharmacies, including compounding pharmacies. To close the gap in oversight of compounding pharmacies that operate on a scale more akin to manufacturing, like the one involved in the 2012 outbreak, Congress passed the Drug Quality and Security Act (DQSA) of 2013.2 This law holds sterile drug compounders that operate as commercial suppliers to stricter quality standards. It also allowed compounding pharmacies to register at outsourcing facilities, subject to current good manufacturing practices and FDA inspections. Compounding pharmacies must also limit their interstate distribution to less than 30% of their total production. States continue to oversee traditional compounding pharmacies that compound customized preparations in response to specific prescriptions.
Many states also updated laws and regulations governing compounding pharmacies following the 2012 outbreak. Massachusetts responded with a new law in 2014 that tightened licensing, labeling, education and oversight requirements for compounding pharmacies.3 The law requires all in-state and out-of-state sterile and complex nonsterile compounding pharmacies to obtain a Massachusetts license. It authorizes state inspectors to make unannounced inspections and for the Board of Registration in Pharmacy to publish annual reports on its inspection and enforcement activities. It also calls for public reporting of adverse drug events by compounding pharmacies.
Like Massachusetts, other states now require licensing of in state and out-of-state compounding pharmacies that ship or distribute medications within state borders:
- Virginia requires a current inspection report for initial or renewal registrations of out-of-state pharmacies and, reflecting the concern that motivated the Drug Quality and Security Act, defined compounding of a large amount of a preparation that clearly exceeds historical levels of prescriptions to constitute manufacturing of drugs.
- California specifically enacted legislation that requires state licensing of pharmacies that compound, dispense or ship into the state any sterile drug products for injection, inhalation or ophthalmic administration. Pharmacies require a separate license for nonsterile compounding.4
- Other states, including Tennessee, Texas, and Florida require licensing and provide for inspections of compounding pharmacies both in state and out of state.
- Maryland required a sterile compounding facility to hold a sterile compounding permit.5
- Michigan requires compound pharmacies to have current accreditation through a national accrediting organization and to maintain a log of requests from and pharmaceuticals compounded for each prescriber, facility or agency and submit those records for inspection, if requested. Excess compounded pharmaceuticals may not be sold to other pharmacies.6
1. CDC. Multistate Outbreak of Fungal Meningitis and Other Infections. Healthcare-associated Infections (HAIs). October 23, 2013.
2. Compounding Quality Act. Title I of the Drug Quality and Security Act of 2013. U.S. Food and Drug Administration.
3. Commonwealth of Massachusetts. Acts 2014. An Act Relative to Pharmacy Practice in the Commonwealth.
4. Ross M. Compounders Face Firmer Oversight Following Deadly Meningitis Outbreak. Pharmacy Times. March 10, 2015.
5. State Regulation of Compounding Pharmacies. National Conference of State Legislatures. October 1, 2014.
6. Michigan Public Acts 279 and 280 of 2014. Compounding Pharmacy Regulation."