USP Chapter 795 Nonsterile Compounding

Questions and Answers

Is reconstituting an antibiotic considered nonsterile compounding?

Yes (correct)

A pharmacist does not need documented training for nonsterile compounding.

False

What must training include for nonsterile compounding?

Training must include familiarity with USP Chapter 795, related procedures, demonstration and repetition of procedures, documentation of training, and the trainer's signature.

How is training documented in nonsterile compounding?

Training is documented with signed logs, observed training on compound records, and signatures of trainers. Signup and view all the answers

What is the Beyond Use Date (BUD) defined as in USP Chapter 795?

The date after which a compounded nonsterile preparation should not be used. Signup and view all the answers

What are the maximum BUDs for nonaqueous formulations?

No longer than 6 months or the earliest expiration date of any ingredient used. Signup and view all the answers

What are the BUDs for water-containing oral formulations?

No longer than 14 days or the earliest expiration date of any ingredient used, stored at controlled cold temperatures. Signup and view all the answers

What is the maximum BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations?

No longer than 30 days or the earliest expiration date of any ingredient used. Signup and view all the answers

What labeling is required for compounded prescriptions?

Prescriptions must include the common or usual name of each active ingredient and an accurate statement of the quantity. Signup and view all the answers

How frequently must training occur for compounding personnel?

Training is ongoing and must be completed before compounding, with documentation for new preparations and recommended annual evaluations. Signup and view all the answers

Why can't the expiration date of commercially available products be used for the Beyond Use Date (BUD)?

The commercially available products' expiration dates are specific to those products in their original containers and may not apply once manipulated. Signup and view all the answers

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.