Compounding Flashcards
Definitions and other notes
USP general chapter <795>
Provides standards, procedures, and definitions relating to nonsterile compounding of pharmaceutical products.
Compounding
process of combining two or more commercially available products into a single preparation that is not commercially available.
Nonsterile products include:
solutions, suspensions, ointments, lotions, creams, powders, suppositories, tablets, or capsules prepared for external or oral use.
Trituration
using a mortar and pestle to grind a solid drug to reduce particle size or mix two solids together.
Levigation
dispersing a drug solid into a small amount of mineral oil, glycerin, or other liquid before incorporating into a compounding base, like a cream.
Geometric dilution
method of mixing a small amount of potent drug into an equal amount of inactive/nonpotent compound until all compound is mixed with the drug.
Beyond Use Date (BUD)
assigned to all compounded preparations based on chemical and physical stability, compatibility, microbial growth, and other factors. Should not exceed the soonest expiration date of the ingredients. USP Chapter <795> provides guidelines for BUD assignment.
UPS general chapter <797>
provides standards, procedures, and definitions for sterile compounding.
What agencies develop guidelines and regulations related to sterile compounding, hazardous drug handling, and use of PPE to ensure workplace saftey?
OSHA and NIOSH