general chapter 797 a guide to sterile compounding for pharmacy personnel answers sorted by

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These tests often can be performed by the hospital laboratory, or they can be done by the certifier.

Note that if there is a discrepancy between the BUD limits and the stability time found in the package insert or other reference, the sterile compounding professional must use the shorter of the two for the BUD.

Personnel Training and Monitoring Training and monitoring of compounding personnel are critical components for safe and effective sterile compounding.

Water can splash or spread as droplets more than a meter from a sink.

USP provides minimum practice and quality standards for CSPs of drugs and nutrients, based on current scientific information and sterile compounding standards detailing requirements for compliance.

USP Chapter , Pharmaceutical Compounding: Sterile Preparations, became effective January 1, 2004• This is to prevent compromised sterility i.

Requirements and placement for Primary Engineering Controls PEC , i.

Facilities must be designed to minimize contamination of surfaces, to promote effective cleaning, to limit unnecessary personnel and materials traffic, and to include only furniture and equipment that is necessary for compounding.

The Expert Committee members review and incorporate comments as appropriate.

In addition to the USP and CMS requirements, most states have incorporated excerpts of or references to and texts in their pharmacy and health laws and regulations.

In other words, Pharmacies may be subject to inspection against USP Chapter standards• While not required by USP , it is considered best practice to use sterile wipes in the PEC• For best results, begin at the farthest corner of the room and mop backward toward the door.