North Carolina Pharmacy Law Update: Properly Identifying the Compounding Risk Levels and Notifying the Board

by admin on November 7th, 2016 at 8:20 am

Pharmacies that hold a permit in North Carolina and engage in any type of compounding are required to notify the North Carolina Board of Pharmacy (Board).

Pharmacies must report (both on their initial permit application and as part of each annual renewal) the following:

  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 any 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.
Per the Board, reporting accurate information is crucial. First, the failure to provide accurate information in connection with seeking or renewing a permit is grounds to revoke or void a pharmacy permit. Second, the Board’s risk based inspection intervals are driven by the scope and type of service provided at a pharmacy, particularly compounding services.  

The Board published a guidance document to reduce any confusion about this reporting requirement.