MOUNT PROSPECT, Ill. — A national group representing state boards of pharmacy has announced its support for efforts to strengthen regulations on compounding pharmacies.
The National Association of Boards of Pharmacy said Wednesday that it would implement a four-part action plan centered around inspection of compounding pharmacies and sharing data from the inspections among boards of pharmacies around the country.
The announcement comes in the wake of a nationwide meningitis outbreak linked to contaminated injectable steroid drugs prepared at the New England Compounding Center, in Framingham, Mass., which had sickened 590 and led to 37 deaths in 19 states as of Monday, according to the Centers for Disease Control and Prevention. The outbreak has led to calls by legislators and the Food and Drug Administration for stronger regulations of pharmacy compounding, particularly after an FDA inspection of the NECC found widespread contamination and unsanitary conditions.
The NABP's four-part plan consists of sharing a list of compounding pharmacies provided by the Iowa Board of Pharmacy with other NABP member boards and coordinating the collection of information on them; the second part involves implementing the inspection program to ensure they are doing business according to regulations and taking action against pharmacies that refuse inspection; the third part includes collection and maintaining of data on the pharmacies and storing it in an electronic profile; the fourth part involves training board of pharmacy inspectors and compliance officers, as well as cooperation with the FDA and legislators.
"Creating an information sharing network of verifiable data on compounding pharmacies, including information on the scope of operations, results of the Iowa inspection program and any disciplinary actions will provide a vital resource to support the boards' regulatory efforts in this area," NABP president Michael Burleson said. "The network will be made available at no cost to boards for use in making licensure and registration determinations for pharmacies and may also help to identify pharmacies whose operations are more akin to manufacturing than compounding."