Supporting state board of pharmacy efforts to enforce compounding regulations, the National Association of Boards of Pharmacy® (NABP®) is implementing a four-part action plan centered around inspection of nonresident compounding pharmacies and creating an information sharing network of regulatory details on such pharmacies. Focusing on inspections of nonresident compounding pharmacies and sharing this data among boards of pharmacy nationwide was determined by NABP and its member state boards of pharmacy to be key to preventing future tragedies like the current meningitis outbreak.
Development of the NABP action plan began at a November 2012 meeting of board of pharmacy executive directors and implementation quickly began. The 30 attendees of the meeting expressed a strong commitment to correcting system failures that allowed the meningitis outbreak to occur and agreed it was necessary to move quickly to implement the necessary solutions. Also discussed during the meeting was the Iowa Board of Pharmacy’s recent request for NABP to develop an inspection program for entities that are licensed by the state as nonresident pharmacies and dispensing compounded drugs in Iowa. The executive directors in attendance expressed their support of this inspection initiative, which became a cornerstone of the four-part action plan.
In the first part of its action plan, NABP shared the list of nonresident compounding pharmacies provided by the Iowa Board of Pharmacy with other NABP member boards of pharmacy and began coordinating the collection of information on these pharmacies. The boards’ collaboration on this data helped NABP identify the initial pharmacies to inspect. NABP believes that the list provided by Iowa represents a significant number of nonresident pharmacies dispensing compounded drugs across the country.
Implementing the inspection program is the second part of the action plan and initial results will reveal whether the selected pharmacies are compounding pursuant to a prescription in compliance with state regulations, or instead are engaging in manufacturing. Entities that refuse inspection may be subject to disciplinary action by the Iowa Board of Pharmacy and such actions will be shared with all of NABP’s member boards of pharmacy. Other boards have noted that they look forward to receiving the results from the Iowa program, and some have also expressed an interest in developing a similar inspection program with NABP. These inspections are currently underway and NABP is working with the Iowa Board of Pharmacy to share any resulting action from the inspections.
The third part of the action plan includes NABP collecting and maintaining data on the compounding pharmacies identified by the Iowa Board as well as those indicated by other boards of pharmacy. Initial data collected from the boards and the inspection reports will be stored in an NABP Pharmacy e-Profile, allowing the Association to disseminate pertinent public information among state boards. Ultimately, states will be able to submit inspection reports and other related information to NABP for inclusion in pharmacies’ e-Profiles.
“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,” states NABP President Michael A. Burleson, RPh. “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.”
As the final part of the action plan, NABP plans to schedule immediate and ongoing training of board of pharmacy inspectors and compliance officers via Webinar and field training opportunities. NABP will also continue cooperative efforts with Food and Drug Administration and legislators to address the regulatory quagmire that exists when traditional compounding is exceeded and manufacturing may be occurring.