Current news about sterile compounding is important for pharmacists, compounding personnel and the public who receive specialty medications. With media attention focused on the safety of sterile compounded medications, coverage has focused on the implementation of minimum practice and quality standards, like USP Chapter 797, that have been implemented in many facilities involved in preparing, storing, handling and transporting compounded sterile preparations (CSPs).
Clarifying compounding versus manufacturing
One of the most prominent recent stories concerning CSP compliance failures was published in October 2014 in the national edition of USA TODAY.1 The article, entitled "Safety, Sanitary Problems Prompt Scores of Drug Recalls," detailed problems with several compounding pharmacies, and most particularly the New England Compounding Center (NECC), located in the Commonwealth of Massachusetts. As a result of poor compounding practices and facilities, 64 patients tragically died, and more than 750 fell ill due to NECC bulk compounded injections that caused fungal meningitis. This incident has had reverberations across the country.
Exhaustive investigation by the FDA and state inspectors found gaps in the oversight of compounding pharmacies. One very important finding was a need to have a clearer delineation between a "compounding" and a "manufacturing" entity. NECC's bulk compounding activities fell into a murky non-regulated area, and according to regulators, NECC was really a drug manufacturer masquerading as a pharmacy.
The Commonwealth of Massachusetts signed legislation in July 2014 that now requires all in-state and out-of-state sterile and complex nonsterile compounding pharmacies to obtain Massachusetts licenses. State inspectors will be trained in both USP 795 (nonsterile compounding) and USP 797 sterile compounding standards and will begin making unannounced inspections. The law clarifies the definition of a compounder versus a manufacturer.
New rules for Florida licensed non-resident pharmacies
Effective October 1, 2014, the state of Florida now requires all non-resident pharmacies to obtain a Nonresident Sterile Compounding Permit in order to ship, mail, deliver, or dispense, in any manner, a compounded sterile product into the state of Florida. Nonresident pharmacies must now obtain this new permit, in addition to the currently required Florida Nonresident Pharmacy Permit. Those pharmacies applying for the new Nonresident Sterile Compounding Permit are required to demonstrate full compliance with USP Chapter 797.2
USP 797's influence on proposed USP 800
The USP recently posted its proposed new chapter 800: Hazardous Drugs: Handling in the Healthcare Settings. USP 800 is intended to guide the proper handling of hazardous drugs in the healthcare setting. It delineates the requirements for receipt, storage, mixing, preparing, compounding, dispensing, and administration of hazardous drugs to protect the patient, healthcare personnel and environment. The genesis of USP Chapter 800 can be traced to the success of USP Chapter 797, concludes an article in the October 2014 Pharmacy Times.3 The authors maintain that USP 797 showed the important role that USP can play in protecting patients and improving pharmacy practices. USP hopes that Chapter 800 will serve the same purpose.
What sterile compounding developments will most impact your pharmacy practice?
1. Eisler, Peter, Schnaars, Christopher. Safety, sanitary problems prompt many drug recalls. USA TODAY October 6, 2014.
2. Florida Board of Pharmacy. Notice to Florida Licensed Non-Resident Pharmacies. Posted in latest news September 24, 2014. http://floridaspharmacy.gov/latest-news/notice-to-florida-licensed-non-resident-pharmacies/
3. Eckel, Fred M, RPh, MS, ScD. Handling Hazardous Drugs: USP in Pharmacy Practice. Pharmacy Times, October 1, 2014.