USP General Chapter: Compounding Regulations and Personnel Training

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What is the purpose of the USP General Chapter regarding hazardous drugs?

To provide training on proper use of equipment
To introduce the concept of water activity
To establish quality standards for nonsterile products
To minimize the exposure to hazardous drugs within health care settings (correct)

What is a requirement for personnel involved in compounding nonsterile products?

Initial training and a documented refresher training every 12 months (correct)
Only a documented refresher training every 12 months is required
Initial training and a documented refresher training every 6 months
Only initial training is required

What is a core competency of training for personnel involved in compounding nonsterile products?

Proper use of equipment
Documentation and record-keeping
Measuring and mixing
All of the above (correct)

What is a significant change introduced in the updated USP General Chapter?

The concept of water activity (aw) (C) Signup and view all the answers

What is required for personal hygiene and garbing in nonsterile compounding?

Gloves and handwashing, and removing personal jewelry and watch (D) Signup and view all the answers

When did the revised USP General Chapter become official?

November 1, 2023 (C) Signup and view all the answers

What is the main regulatory body responsible for overseeing pharmacy compounding?

State Board of Pharmacy (A) Signup and view all the answers

What is the purpose of the Drug Quality and Security Act (DQSA)?

To give the FDA more authority to regulate and monitor compounding (C) Signup and view all the answers

What type of pharmacies are subject to stricter regulations and guidelines for compounding?

503A and 503B pharmacies (D) Signup and view all the answers

What organization issues national standards for compounding?

USP (C) Signup and view all the answers

What is the purpose of a hood in pharmacy compounding?

To prevent contamination and exposure to hazardous drugs (A) Signup and view all the answers

What is the primary concern when handling hazardous drugs in pharmacy compounding?

Protecting the compounder from exposure to hazardous drugs (D) Signup and view all the answers

What is the minimum duration for washing hands and forearms with soap and water?

30 seconds (C) Signup and view all the answers

What is the purpose of a Beyond Use Date (BUD)?

To indicate the date after which a compounded preparation must not be used (B) Signup and view all the answers

What is the primary purpose of garbing in non-sterile compounding?

To protect the compounded preparation from contamination (C) Signup and view all the answers

What is the difference between a Beyond Use Date (BUD) and an expiration date?

A BUD is determined by the pharmacist, while an expiration date is established by the manufacturer (A) Signup and view all the answers

What is the purpose of drying hands and forearms completely before donning gloves?

To reduce the risk of microbial contamination (B) Signup and view all the answers

What should be outlined in a Standard Operating Procedure (SOP) for non-sterile compounding?

The garbing requirements and frequency of changing for personnel (C) Signup and view all the answers