The U.S. Pharmacopeial (USP) is a scientific nonprofit organization that sets standards for quality of products, such as medicines and food ingredients, that are manufactured, distributed, and consumed worldwide. The USP sets the standards the FDA enforces here in the U.S. as well as those used in over 140 other countries. On July 1, 2018, the code change from <797> to <800> will go into effect, meaning new standards for any laboratory or healthcare facility being built.
The main changes from code <797> to <800> are as follows:
- The code applies to both sterile and non-sterile compounding
- No low volume of compounding exemption
- Mandates the use of a closed system dug transfer device (CSTD)