|What is USP 797?
USP 797 is an
important publication issued by the United States
Pharmacopeia. Widely agreed to improve the safety of the
compounding environment and the products produced in
that environment, USP 797 is mandated by some state
boards of pharmacy and recommended by others. Sterile
compounding environments designed, built, and operated
in compliance with USP 797 are considered by most
pharmaceutical professionals as state-of-the-art.
requirements also extend to architectural and
environmental areas. Consequently, hospital design,
construction and operations professionals should also
become familiar with it.
USP 797 is a
far-reaching regulation that governs a wide range of
pharmacy policies and procedures. It is designed both to
cut down on infections transmitted to patients through
pharmaceutical products and to better protect staff
working in pharmacies in the course of their exposure to
Issued by U.S. Pharmacopoeia
(USP), the regulation governs any pharmacy that prepares
"compounded sterile preparations" (CSPs). Many
pharmacies fit this description. Moreover, many large
hospitals have several pharmacies--a main one and
several satellite pharmacies--that will be affected.