Commissioner Of FDA Urges Compounding Pharmacies To Register
Dr. Margaret Hamburg, commissioner of the FDA, recently sent a letter to state agencies requesting they encourage compounding pharmacies in their area to adhere to the H.R. 3204: Drug Quality and Security Act, which was signed into law in November 2013 after a devastating meningitis outbreak in 2012.
According to the letter, compounding pharmacies are being asked to register as producers of sterile drugs. This request stems back to 2012, when contaminated steroid pain injections, produced by New England Compounding Center located in Framingham, led to the deaths of 64 individuals and affected over 750 more.
The Drug Quality and Security Act allows compounding pharmacies, with a large amount of manufacturing activity, to register with the FDA and receive federal inspections as necessary. However, this is voluntary. Dr. Hamburg stated in the letter, “If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers that purchase compounded drugs necessary to meet the medical needs of their patients can provide their patients with drugs that were compounded in outsourcing facilities." The letter was sent to the offices of governors, state boards of pharmacy and health departments across the nation.
U.S. Senator Tom Harkin, head of the Senate Health, Education, Labor and Pensions Committee, stated, "The letter from the FDA helps ensure the safety of compounded drugs and is aimed at helping to prevent a future public health crisis." According to the senator, 14 outsourcing facilities have already responded by registering with the FDA. He went on to say, "I urge state leaders in Iowa and around the country to continue this progress by working with the FDA and other health officials to move forward with the smooth and timely implementation of the law so that patients will have access to safe, high-quality compounded drugs."
While the FDA regulates manufacturers of medicines, it is the state boards that regulate compounding pharmacies. The meningitis outbreak of 2012 is an example of how a compounding facility can elude the radar of both regulatory offices. The law helps define compounding pharmacies and allows the FDA to properly regulate their activities.
Source: http://www.digtriad.com/news/local/article/312387/57/FDA-Register-Drugstores-In-Wake-Of-Meningitis-Outbreak