What Is PCAB Accreditation and Why Does It Matter?

What PCAB Accreditation Is

PCAB (Pharmacy Compounding Accreditation Board) accreditation, now administered by the Accreditation Commission for Health Care, is a voluntary third-party review of how a compounding pharmacy operates. Out of approximately 3,000 compounding pharmacies in the United States, fewer than 200 — less than 1% — hold it.

What the Review Covers

An accredited pharmacy has been evaluated for:

• Quality management systems governing how preparations are made and documented
• Personnel qualifications — staff must demonstrate competency
• Facility and equipment standards measured against USP guidelines
• Standard operating procedures for each stage of compounding
• Third-party potency testing arrangements

ProCompounding's Quality Measures

• Periodic third-party potency testing, depending on the preparation
• Compliance with USP 795 (non-sterile) and USP 800 (hazardous drugs)
• Negative pressure environment for compounding hazardous medications
• Humidity and temperature-controlled environments
• Surface testing for contaminants
• Error prevention software
• Regular employee competency exams

Why It Matters to You

Accreditation tells you that an outside body has reviewed the pharmacy against a published set of standards, and that it is re-examined on a recurring basis rather than once. It covers how ingredients are sourced, how staff are trained, how procedures are documented, and how the facility is maintained.

You do not have to take our word for any of it. If you want to confirm a pharmacy's credentials yourself, our guide on how to verify a compounding pharmacy's license walks through checking a pharmacy with its state board of pharmacy.

For a deeper look at what the accreditation process audits and how to verify a pharmacy's status, read our full guide: PCAB-Accredited Compounding Pharmacy: What PCAB Means.

Learn More

Visit our Quality page to learn more about our accreditation and quality measures, or call us at 423-975-0597.