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USP General Chapter: Compounding Regulations and Personnel Training

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18 Questions

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

To minimize the exposure to hazardous drugs within health care settings

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

Initial training and a documented refresher training every 12 months

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

All of the above

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

The concept of water activity (aw)

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

Gloves and handwashing, and removing personal jewelry and watch

When did the revised USP General Chapter become official?

November 1, 2023

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

State Board of Pharmacy

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

To give the FDA more authority to regulate and monitor compounding

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

503A and 503B pharmacies

What organization issues national standards for compounding?

USP

What is the purpose of a hood in pharmacy compounding?

To prevent contamination and exposure to hazardous drugs

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

Protecting the compounder from exposure to hazardous drugs

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

30 seconds

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

To indicate the date after which a compounded preparation must not be used

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

To protect the compounded preparation from contamination

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

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

To reduce the risk of microbial contamination

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

The garbing requirements and frequency of changing for personnel

Test your knowledge of USP General Chapter regulations, including updates to personnel training and hazardous drug handling in healthcare settings. Questions based on The Art, Science, and Technology of Pharmaceutical Compounding, 6th Edition.

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