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Frequently Asked Questions for Pharmacists on Compounding Risk Levels / Identifying and Notifying the NC Board of Pharmacy


Compounding Rule - 21 NCAC 46 .2800

Q: My pharmacy engages in compounding. How should this be reported to the Board and what information should be provided?

A: Pharmacies that hold a permit from the North Carolina Board of Pharmacy and that engage in any type of compounding are required to notify the Board.  Such pharmacies must report (both on an initial permit application and as part of each annual renewal):  (1) whether they compound; (2) a good-faith estimate of the percentage of the pharmacy’s dispensing that involves compounded products; (3) whether the pharmacy engages in non-sterile compounding; (4) whether the pharmacy engages in sterile compounding; and (5) what risk level of sterile compounding, as defined by USP <797>, the pharmacy performs.  Accurate reporting of this information is crucial for at least two reasons:  First, failure to provide accurate information in connection with seeking or renewing a permit is grounds to revoke or void a pharmacy permit.  N.C.G.S. § 90-85.38.  Second, the Board’s risk-based inspection intervals are driven by the scope and type of service provided at a pharmacy, particularly compounding services.

Board staff has developed a guidance document intended to reduce any confusion about this reporting requirement:


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