The National Association of Boards of Pharmacy is developing a national adverse event reporting clearinghouse for compounded medications that will collect reports of patient harm and share them among state boards of pharmacy and the FDA.
The organization said the initiative is intended to address a gap in the federal adverse event reporting system because compounded medications dispensed by 503A pharmacies are not subject to the reporting requirements that apply to registered drug manufacturers and 503B outsourcing facilities, according to a July 29 news release. As a result, adverse events involving compounded medications may not be centrally recorded or shared with regulators.
NABP said it also plans to work with the FDA to expand real-time information sharing within existing legal authority, develop model standards for verifying bulk drug substances used in compounding and establish coordinated referral pathways among boards of pharmacy, state medical boards and state attorneys general for cases that cross jurisdictional lines.
In the coming months, the association said it will convene boards of pharmacy, the FDA and other industry stakeholders to determine the clearinghouse’s design, governance and integration with state and federal reporting programs.
