What is 797 pharmacy?

USP 797 is the standard in place governing the sterile preparation of compounded pharmaceuticals. USP 797 covers the compounding of both hazardous and nonhazardous drugs with a focus on the protection of sterile compounds and environments from contamination.

What are the USP 797 room air requirements for a sterile pharmacy?

To achieve USP 797 compliance, pharmacies must perform sterile drug compounding within an ISO 5 (Class 100) hood environment, enclosed within a larger compounding “Buffer Zone” of ISO 7 (Class 10,000) positive pressure controlled-air environment (Cleanroom).

Why is USP 797 important to the pharmacy industry?

USP develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing.

Is USP 797 required?

To achieve the safety goals of USP <797>, it is necessary for hospitals and other facilities to perform a gap analysis by reviewing the procurement, storage, handling, compounding, and administration of drugs, as well as the design of the cleanroom where compounding takes place, the equipment used, operational …

What does USP 797 stand for?

Pharmaceutical Compounding – Sterile Preparations
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).

Why was USP 797 created?

The provisions and requirements of USP 797 are designed to achieve compounding accuracy and sterility to ensure the safety of patients. Through a series of written guidelines, USP 797 regulates the personnel conducting the compounding process and the process itself.

What is USP in pharmacy?

The U.S. Pharmacopeia is a reference of uniform preparations for the most commonly used drugs—with tests to ensure their quality, potency and purity. As the practice of pharmacy grew, medicines were increasingly made not only by pharmacists but by commercial providers.