Compounding has received a lot of negative press in the last few months - the latest being a segment on the CBS News show 60 Minutes concerning the circumstances surrounding the tragic meningitis outbreak, deaths, and sickness associated with the injection of contaminated products from New England Compounding Center (NECC) in Framingham, MA. As with many high-profile, national issues there has been some distortion of the facts, half-truths, and misinformation coming from the press, the FDA, and the Massachusetts Board of Pharmacy that make it difficult for an individual to understand the actual size and scope of the issues so an informed decision can be made on whether to use a compounded medication, or not. Hopefully what follows will help:
- NECC has been closed down by the Massachusetts Board of Pharmacy and its owners have declared bankruptcy. It is generally accepted that NECC acted illegally and outside of its license as a pharmacy.
- It is also clear that the state and federal inspection processes broke down. The Massachusetts Board of Pharmacy and the FDA were aware of irregularities at NECC since 2004 - but did not take action. Both possessed the authority to close NECC but did not.
- Historically the FDA has been charged with the oversight of pharmaceutical manufacturers which mass-produce pharmaceuticals for national and international distribution and use. State boards of pharmacy have been charged with the oversight of pharmacies, including pharmacies that also compound medication.
- The NECC tragedy has been a wakeup call for state boards of pharmacy to make sure their regulations are up-to-date and are being appropriately enforced.
- Voluntary national standards for both sterile and non-sterile compounding have been in existence for years, having been developed and continually updated by the United States Pharmacopeia (USP). The USP also sets standards for the manufacture of drugs.
- Not all states have adopted the USP standards and integreted them into their compounding regulations. But there seems to be a lot of momentum currently in that direction.
- USP Chapters <795> and <797> are the “Gold Standard” for compounding. If a compounding pharmacy can “demonstrate” that it meets these standards, an individual can be sure they are getting the best possible compounded product.
- If a pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB) you can be sure that they are meeting this “Gold Standard”.
- The US Congress will probably take some action that will affect compounding pharmacies’ and prescribers’ rights. The Senate is planning on draft legislation by the end of April.
- The FDA is pushing for a role in oversight of compounding pharmacies. This is a bad idea. By law, they have no roll in regulating compounding. Pharmacies which compound are regulated by state boards of pharmacy as per congressional legislation.
- Many national pharmacy organizations are actively working with state and federal policy makers to do what is necessary to assure that a NECC-type debacle does not happen again. Part of this is pushing to make USP <795> and <797> the minimum, uniform state standards for the nation.
- State boards of pharmacy are beginning to train inspectors specifically in compounding practice and are beefing-up their inspections.
- As with almost any profession a few bad apples reflect poorly on the many doing an excellent job within the law.
I hope this helps a little but stay tuned, the landscape is constantly changing!