USP Chapter 795 Nonsterile Compounding

Study Notes

Nonsterile Compounding Overview

Reconstituting antibiotics is classified as simple compounding, requiring no additional documentation if following manufacturer's directions.
Documented training is mandatory for all staff involved in compounding or supervising nonsterile compounding, even if they have prior experience.

Training Requirements

Training must cover familiarity with USP Chapter 795 and related compounding procedures.
Involves demonstration of procedures by the trainer and supervised practice by the trainee.
Completion of training must be documented and signed by the trainer.

Documentation of Training

Participants must sign logs affirming they have read USP Chapter 795 and relevant procedures.
Training includes observation and practical application of compounding techniques, documented on compound records.

Beyond Use Dates (BUD)

BUD is the date after which a compounded nonsterile preparation must not be used, determined upon compounding date.
Stability information from literature or tests influences the determination of BUD.

Maximum BUDs for Compounded Preparations

Nonaqueous formulations: BUD is 6 months or the earliest ingredient expiration date, maintained at controlled room temperature.
Water-containing oral formulations: BUD is 14 days or the earliest ingredient expiration date, stored under cold conditions.
Water-containing topical or dermal formulations: BUD is 30 days or the earliest ingredient expiration date, stored at room temperature.

Labeling Requirements

Prescriptions must accurately label each active ingredient and its quantity by weight or measure.
Commercial names like "Magic Mouthwash" cannot be used on labels without detailed ingredient listing.
Labeling must include the BUD and storage/handling instructions as per USP Chapter 795.

Ongoing Training and Evaluation

Training must occur before an individual composes or supervises compounding and should be ongoing for new preparations.
Regular evaluations of compounding personnel are recommended on an annual basis.

Expiration Dates and BUD

Expiration dates of commercially available products do not dictate the BUD due to manipulation during compounding.
When compounding, alternate BUDs apply if there is no supporting documentation:
- Oral aqueous preparations: 14 days when refrigerated.
- Topical, dermal, or mucosal aqueous preparations: 30 days at room temperature.
- Nonaqueous preparations: 6 months at room temperature.

Description

Test your knowledge of USP Chapter 795 on nonsterile compounding. This quiz covers important concepts related to the reconstitution of antibiotics and other simple compounding procedures. Perfect for pharmacy students or professionals seeking to refresh their understanding of nonsterile preparation techniques.