Expect Grater Enforcement of USP 797 In Wake of NECC Compunding Tradgedy

Expect greater legislative enforcement of pharmacuitcal companies, specifically drug compounding centers, as the outbreak of contaminated drugs from The New England Compounding Center of Framingham, Mass expands nationally.


USP 797 refers to chapter 797 "Pharmaceutical Compounding – Sterile Preparations," in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

The standards in this chapter are intended to apply to all persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared (e.g., hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physicians' practice facilities, and other locations and facilities in which CSPs are prepared, stored, and transported). USP 797 requirements affect all disciplines involved in sterile compounding, including physicians, nurses, pharmacists, and pharmacy technicians.