Regulatory Essentials for Safe and Compliant Compounding

CEimpact Podcast

Compounded medications serve a critical role in meeting patient-specific needs, but compliance is essential to ensure safety and quality. This episode covers what pharmacists need to know about documentation, prescription validity, beyond-use dating, and common missteps that can put compliance at risk. Tune in to strengthen your compounding practices and stay aligned with current regulatory expectations.
HOST
Joshua Davis Kinsey, PharmD
VP, Education
CEimpact

Jessica Gustin, PharmD
CMO & PIC/COO
Gwinnett Drugs/SynerGrx

Joshua Davis Kinsey and Jessica Gustin have no relevant financial relationships to disclose.
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CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Identify key compliance requirements related to patient-specific prescriptions and compounded medication preparation.
2. Describe common compliance challenges in pharmacy compounding and strategies to avoid regulatory missteps.
0.05 CEU/0.5 Hr
UAN: 0107-0000-25-273-H07-P
Initial release date: August 18, 2025
Expiration date: August 18, 2026
Additional CPE details can be found here.

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Chapters

1. Introduction to Compounding Compliance (00:00:00)

2. Understanding 503A Compounding (00:02:46)

3. USP Standards and Requirements (00:05:20)

4. Patient-Specific Prescriptions and BUDs (00:07:36)

5. Workflow and Documentation Essentials (00:16:33)

6. Maintaining Compliance and Patient Safety (00:25:07)

7. Challenges and Staying Audit-Ready (00:30:54)

8. The Future of Compounding Pharmacy (00:35:44)