Pharmacist Compounding Written 1 credit hour

The USP Quality Standards for Compounding establish critical expectations for quality, safety, documentation, and the handling of hazardous drugs across pharmacy practice settings. This course reviews key compliance expectations and commonly cited deficiencies associated with USP <795>, <797>, and <800>, including designated-person responsibilities, beyond-use dating, documentation practices, risk assessments, medical surveillance, and environmental monitoring. You will gain practical strategies to strengthen inspection readiness, support compliant compounding operations, and reinforce safe handling practices within your organization.

Learning Objectives

Upon successful completion of this application-based CPE course, pharmacists should be able to:
1. Describe key compliance considerations related to nonsterile compounding requirements under USP <795>.
2. Identify the responsibilities of the designated person related to compounding oversight, personnel competency, and quality assurance activities.
3. Describe documentation, personnel training, and environmental control expectations associated with USP <797> sterile compounding standards.
4. Describe risk assessment, medical surveillance, and environmental monitoring requirements associated with hazardous drug handling under USP <800>.
5. Evaluate compounding practices for potential compliance deficiencies and inspection readiness concerns.

Faculty

Kara Weatherman, PharmD, BCNP, FAPhA

Disclosures:

Kara Weatherman has no relevant financial relationships with ineligible companies to disclose.

Course Details