Overview of USP 797 – June 1, 2008 Update The purpose of U. Pharmacopeia (USP) 797 is to provide the practice standards to help ensure that compounded sterile preparations are of high quality, and is for the pre-administration phase of sterile preparations.
All hazardous drugs must be stored and prepared in a negative pressure ISO 7 with an ISO 7 ante area. Of course, waste disposal should be according to state and federal regulations.
The current language in the proposed chapter includes the word “shall,” meaning required, and “should,” meaning strongly recommended.
The chapter will be useful in addressing the following in relation to HDs: Hazardous drug definition and risks A HD is defined as any chemical that is a health hazard, including those considered to be carcinogens, teratogens, reproductive toxins, genotoxins, irritants, corrosives, sensitizers, and/or agents that produce target organ effects.2,3 While the proposed chapter does not contain a list of HDs, they refer to The National Institute for Occupational Safety and Health (NIOSH) list of HDs which is updated periodically.10 Drugs that are classified as chemotherapy, antivirals, hormones, and immunosuppressants are commonly considered hazardous.
Opened or needle-punctured single-dose containers must be used within one hour if opened in worse than ISO Class 5 air quality and remaining contents discarded.
Opened single-dose ampuls must be discarded and may not be stored for any time period.