White Paper: Understanding Testing Requirements for Compounded Drug Products
An Overview of Testing Standards for 503A and 503B Environments
Compounded medicines need the right testing to ensure they are safe, accurate and reliable for patient use. But understanding what testing is required, and when, can be challenging. Requirements differ depending on whether products are prepared in a traditional pharmacy (often called 503A) or in a larger sterile outsourcing facility (503B).
This white paper explains these differences in simple, practical terms, guiding you through the core testing needed to demonstrate product quality, sterility, stability and compliance. Whether you’re new to compounding or managing complex release programmes, this resource gives you clarity and confidence.
What This White Paper Covers:
This guide breaks down the essential testing expectations for compounded drug products, including:
- The key differences between pharmacy compounding (503A) and outsourcing facilities (503B)
- What testing is required to ensure product identity, strength, sterility and stability
- When method validation is necessary (and when verification is enough)
- How to justify beyond-use dates (BUD) with stability-indicating data
- What regulators look for during inspections
- Common testing gaps and how to avoid them
- How strong analytical and microbiological testing supports safe, compliant products
The content is based on real regulatory guidance and scientific best practices, including USP, FDA and CGMP requirements.
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Our laboratories in the UK, USA and EU provide GMP, GLP and ISO 17025 accredited testing, including:
Our teams combine scientific expertise with clear communication and reliable turnaround times to help you feel confident in every result.
Author:
Kishore Hotha, PhD, MBA
Kishore is General Manager of Cormica's TPM laboratories site. He is also a prolific author with over 100 publications, serves on editorial boards and frequently speaks at international conferences.
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