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NABP action plan zeroes in on compounding
December 12th, 2012
MOUNT PROSPECT, Ill. – The National Association of Boards of Pharmacy is enacting a four-part plan to foster inspection of nonresident compounding pharmacies and create an information sharing network of regulatory details on those pharmacies.
NABP said Wednesday that the initiative is intended to support state board of pharmacy efforts to enforce compounding regulation. The association and its member state boards of pharmacy determined that inspecting nonresident compounding pharmacies and exchanging that data with boards of pharmacy nationwide are key to preventing future calamities like the current meningitis outbreak.
Development of the action plan began at a November meeting of board of pharmacy executive directors, according to NABP. The 30 attendees showed a commitment to correcting system failures that allowed the meningitis outbreak to occur and agreed it was necessary to move rapidly to implement solutions, the association said.
Also discussed was a request by the Iowa Board of Pharmacy for NABP to develop an inspection program for entities licensed by the state as nonresident pharmacies and dispensing compounded drugs in Iowa. The executive directors at the meeting expressed support for the Iowa inspection initiative, which became a linchpin of the four-part action plan, NABP said.
In the first part of the action plan, NABP shared a list of nonresident compounding pharmacies provided by the Iowa pharmacy board with other NABP member boards and started coordinating the collection of data on those pharmacies. The boards' collaboration on that information data helped NABP identify the initial pharmacies to inspect.
NABP said it believes that the list provided by Iowa represents a significant number of nonresident pharmacies dispensing compounded drugs nationwide.
Implementing the inspection program is the second part of the plan, and NABP said initial results will show if the selected pharmacies are compounding according to a prescription in compliance with state regulations or are engaging in manufacturing. A key issue in the case of the New England Compounding Center in Massachusetts, identified as responsible for the meningitis outbreak, was whether the facility was indeed a compounding pharmacy or was actually a drug manufacturer
Entities that refuse inspection may be subject to disciplinary action by the Iowa Board of Pharmacy, and such actions will be shared with all member boards of pharmacy, NABP said.
The third part of the action plan includes NABP gathering and maintaining data on the compounding pharmacies identified by the Iowa board as well as those cited 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 relevant public information among state boards.
Ultimately, states will be able to submit inspection reports and other related data to NABP for inclusion in pharmacies' e-Profiles, according to NABP.
"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 in a statement. "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."
For the final part of the plan, NABP plans to schedule immediate and ongoing training of board of pharmacy inspectors and compliance officers via webinars and field training. The association said it 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.