Compounding Pharmacy Accreditation: What It Means

Compounding pharmacy accreditation is voluntary — no pharmacy is required to be accredited. But accreditation signals a commitment to quality standards that go beyond the minimum regulatory requirements. For providers choosing a compounding partner, understanding these credentials helps evaluate quality claims.

PCAB Accreditation

The Pharmacy Compounding Accreditation Board (PCAB), administered by the Accreditation Commission for Health Care (ACHC), is the most recognized compounding pharmacy accreditation in the United States.

PCAB accreditation requires:

• Full compliance with USP 795 (non-sterile), 797 (sterile), and 800 (hazardous drug) standards
• On-site inspections by trained surveyors
• Policies and procedures documentation review
• Staff competency verification
• Environmental monitoring programs
• Quality assurance processes beyond minimum state requirements
• Annual renewal and periodic re-survey

USP Standards: The Quality Foundation

Whether or not a pharmacy is PCAB-accredited, USP standards are the baseline quality framework:

• USP 795: Non-sterile compounding standards — ingredients, equipment, processes, beyond-use dating
• USP 797: Sterile compounding standards — clean room requirements, garbing procedures, environmental monitoring, sterility testing
• USP 800: Hazardous drug handling — protecting staff and patients from exposure to hazardous compounds

Revised USP 795 and 797 standards took effect November 1, 2023, significantly tightening requirements for sterile compounding facilities.

Third-Party Testing vs. In-House Testing

One of the most important quality indicators — and one that accreditation alone doesn't guarantee — is whether a pharmacy uses third-party analytical testing:

• Third-party testing: Samples sent to an independent laboratory for potency, sterility, and endotoxin analysis. Results are unbiased.
• In-house testing only: Testing performed by the pharmacy's own staff. While valid, lacks the independence of external validation.

Promise Pharmacy uses third-party testing on every batch — not just spot checks — providing Certificates of Analysis to provider partners.

What to Ask Your Compounding Pharmacy

1. Are you PCAB-accredited? If not, what quality certifications do you hold?
2. Do you follow current USP 795, 797, and 800 standards?
3. Do you perform third-party testing? On every batch or periodic sampling?
4. Can you provide Certificates of Analysis for every compounded prescription?
5. When was your last state board inspection? Any findings?
6. What is your beyond-use dating methodology?