Tag Archives: USP 797
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:
- Whether they compound;
- A good-faith estimate of the percentage of the pharmacy’s dispensing that involves compounded products;
- Whether the pharmacy engages in any non-sterile compounding;
- Whether the pharmacy engages in sterile compounding; and
- What risk level of sterile compounding, as defined by USP <797>, the pharmacy performs.
The Board published a guidance document to reduce any confusion about this reporting requirement.