In light of the horrific meningitis outbreak attributed to drugs compounded by Massachusetts’ New England Compounding Center (“NECC”) in 2012, state boards of pharmacy around the country are undertaking a comprehensive review of their regulations governing sterile compounding and the enforcement of existing and new regulations. Sterile compounding generally involves a pharmacy compounding drugs that enter the body by way of a syringe. These drugs are compounded under very controlled conditions. Most states that had or have pharmacy regulations governing sterile compounding base them on USP 797, a standard addressing sterile compounding which was set by the United States Pharmacopeia (“USP”) and which arguably is incorporated by reference in federal law as part of the National Formulary.
In order to get a better idea on the scope of sterile compounding in Florida, the Florida Board enacted an emergency rule (Rule 64B16ER12-1, FAC) on November 26, 2012 requiring all pharmacies in the state to complete a survey addressing the pharmacy’s compounding and sterile compounding activities. The Florida Department of Health and Florida Board of Pharmacy are using the results of the survey to prioritize pharmacy inspections in the following order: 1) pharmacies that perform sterile compounding; 2) pharmacies that perform sterile and non-sterile compounding; 3) pharmacies that only engage in non-sterile compounding; and pharmacies that do not engage in any compounding. The emergency rule also required non-resident pharmacies to provide the last two inspection reports from the pharmacy inspectors in their home state.
The Board has also appointed a committee of its members to study sterile compounding. Among the ideas coming out of this committee are:
- Review compounding pharmacy accreditation options
- Review existing regulations for any needed changes (primarily rules 64B16-27.797 and 64B16-28.820, FAC)
- Amend 465.017, FS to allow inspection of non-resident pharmacies (under current law inspectors can’t cross state lines) and obtain last two inspection reports
- Amend the Special Parenteral and Enteral Rule or have a separate special pharmacy permit to address different types of compounding pharmacy permits – rule workshops needed
- Train inspectors on the requirements for sterile compounding
- Hire additional pharmacist inspectors
- Consider a higher license fee for sterile compounding pharmacies
- Consider having different licensing (permit) categories and inspection frequency depending on the risk level of the sterile compounding
- Assess pharmacies’ policies and procedures to make sure that they are compliant with existing rules
- Retain an expert on sterile compounding to advise the Board on changes
Prior to the NECC tragedy, the Board had a proposed rule amendment under consideration to further restrict office use compounding. The Joint Administrative Procedures Committee (“JAPC”) used this rule filing as a vehicle to challenge the historical practice of office use compounding as drug distribution. Many in the audience at the February 6, 2013 meeting offered explanations and legal arguments as to why JAPC’s letter did not fully consider the pharmacy laws and how office use compounding can be distinguished from wholesale drug distribution. The Board directed its counsel to respond to the JAPC letter. This is a politically charged issue involving physicians’ need for office use drugs for their patients; the patient’s need for treatment; economic considerations of the drug manufacturers; the state’s desire to avoid another NECC type problem; and the pharmacist’s need to provide needed drugs for Florida’s citizens.
The Board will continue to weigh the need for regulations protecting patient safety while recognizing the need for patients to receive these lifesaving or, at a minimum, life improving drugs. The Board and the Compounding Committee appear well poised to strike the proper balance. Stay tuned.