TL;DR
USP 797 (Sterile Compounding): Standards for compounded sterile preparations: cleanroom requirements, garbing, beyond-use dating, environmental monitoring.
USP 797 (Sterile Compounding)
Definition
Standards for compounded sterile preparations: cleanroom requirements, garbing, beyond-use dating, environmental monitoring.
Assessment Techniques
Standards for compounded sterile preparations: cleanroom requirements, garbing, beyond-use dating, environmental monitoring. Beyond-use dating, ISO classifications, and garbing procedures tested on PTCB exam.
Related drug class: ACE inhibitors includes lisinopril, enalapril, ramipril. Mechanism: Block angiotensin-converting enzyme, decrease angiotensin II, cause vasodilation and decreased aldosterone.
Regulatory Context
Regulatory framework for usp 797 (sterile compounding) in pharmacy:
- Schedule I
- No accepted medical use, high abuse potential. Examples: heroin, LSD, peyote, ecstasy, marijuana (federal). Storage: Not dispensed in pharmacies
- Schedule IV
- Low abuse potential relative to III. Examples: benzodiazepines, zolpidem, tramadol. Storage: 5 refills in 6 months
- Schedule III
- Moderate abuse potential. Examples: testosterone, ketamine, Tylenol with codeine. Storage: 5 refills in 6 months, written/oral/electronic Rx
Overview
Standards for compounded sterile preparations: cleanroom requirements, garbing, beyond-use dating, environmental monitoring. Beyond-use dating, ISO classifications, and garbing procedures tested on PTCB exam.
Related drug class: Insulins includes lispro (rapid), regular (short), NPH (intermediate), glargine (long). Mechanism: Replaces endogenous insulin, facilitates glucose uptake into cells.
Safety Considerations
Safety standards for usp 797 (sterile compounding) in pharmacy practice are governed by FDCA: Federal Food Drug and Cosmetic Act: drug approval, labeling requirements, adulteration/misbranding, OTC monograph system
Enforcing agency: FDA. Compliance is mandatory and subject to inspection.
Professional Standards
Professional standards governing usp 797 (sterile compounding) in pharmacy:
Poison Prevention Packaging Act (CPSC): Child-resistant packaging required unless patient/prescriber requests non-CRC. Exceptions: sublingual NTG, oral contraceptives
USP 795 (USP): Non-sterile compounding: formulation records, BUD assignment, stability testing, equipment calibration
Why It Matters
Beyond-use dating, ISO classifications, and garbing procedures tested on PTCB exam.
Practice This Topic
Ready to practice for the PTCB?
Adaptive practice powered by Item Response Theory targets your weak areas. Start with 3 free sessions.
Start free practice →