Compounding Pharmacies Face Added Scrutiny in Wake of Meningitis Outbreak
A nationwide outbreak of fungal meningitis, traced to medications from a Massachusetts compounding pharmacy, has prompted lawmakers and others to propose strengthening oversight and regulation of compounding pharmacies around the country. These pharmacies currently have no consistent system of federal oversight, although state governments have a wide range of regulations intended to promote drug quality and patient safety. Indiana’s Board of Pharmacy responded to the meningitis outbreak with reassurances about its oversight.
Two bills introduced towards the end of the last session of the 112th Congress sought to give the U.S. Food and Drug Administration (FDA) additional regulatory authority over certain compounding pharmacies, but neither bill made it out of committee. H.R. 6584, The Verifying Authority and Legality In Drug (VALID) Compounding Act, would have subjected compounding pharmacies that act as drug manufacturers to the same FDA regulations as drug manufacturing companies. It also would have required pharmacies to label compounded drugs to indicate that the FDA had neither inspected nor approved the drug, required reporting of adverse reactions to compounded drugs, and created a public “Do Not Compound” list.
H.R. 6638, the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act, would have mandated FDA registration for all compounding pharmacies, labeling of all compounded drugs, and FDA production standards and training programs for state health officials. It also would have required disclosure to patients that they are receiving a compounded drug, and improvements to communication between federal and state health regulators. Both bills were referred to the House Subcommittee on Health, where they died at the end of the 112th Congress.
While legislators were considering laws to promote pharmacy safety, the National Association of Pharmacy Boards (NASB) was supporting state investigative and enforcement efforts. The NASB reported in early 2013 that it sent investigators to six compounding pharmacies in four states the previous month. This was part of a collaboration with the Iowa State Board of Pharmacy, which is trying to improve its oversight of Iowa-licensed pharmacies located outside of the state. The NABP’s goal is reportedly to preserve state-level control over pharmacy regulation by assisting state pharmacy boards in investigating violations across state lines. Unless federal legislation passes, this does not conflict with the FDA’s role.
In an October 11, 2012 letter, the Indiana Board of Pharmacy described the regulations that governing compounding pharmacies in the state, seeking to assure the public about the safety of Indiana pharmacies. The Board’s regulations regarding compounding pharmacies, which it refers to as “sterile compounding,” are located in the Indiana Administrative Code at Title 856, Rule 1-30. Compounding pharmacies must be licensed by the state and must maintain certain types of equipment. Staff that engage in compounding must have specialized training. Compounded drugs must be labeled with specific information including the name and concentration of each drug contained in the preparation, the identity of the pharmacist and other personnel responsible for the preparation, and the date of preparation.
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