USP <797>

Question 1

United States Pharmacopeia

Answer 1

Volunteers with extensive expertise from clinical practice, academia, and industry

Standards for medications, healthcare technologies and related practices

Chapters > 1000 are informational; < 1000 are enforceable

USP has no role in enforcement

Question 2

Why do we need USP <797>

Answer 2

Deaths in the 1960s and 1970s due to contaminated injectables

Series of ASHP recommendations in the 80s and 90s did not impact practice

Injuries and deaths continued

Question 3

USP 797 intro and scope

Answer 3

microbial contamination

excessive bacterial endotoxins

variability from the intended strength or corrected ingredients

physical or chemical incompabailities

use of ingredients of inappropriate quality

Question 4

The following must be sterile

Answer 4

injections, including infusions

irrigation of internal body cavities

ophthalmic dosage forms

aqueous preparations for pulmonary inhalation

baths and soaks for live organs and tissues

implants

Question 5

Hazardous drugs

Answer 5

in addition must comply with USP <800> hazardous drugs

Question 6

Sterile radio pharmaceuticals

Answer 6

not required to comply with 797 however must comply with USP 829 radio pharmaceuticals