Pharmacy Compounding Accreditation FAQ — PCAB, USP 795, 797 & 800
Last updated: October 2026
Answers to 15 questions on PCAB accreditation, USP compliance, 503A vs. 503B distinctions, state enforcement timelines, and inspection findings. For an overview of IHS's compounding pharmacy consulting services, see our PCAB Accreditation service page.
Frequently Asked Questions
What is PCAB accreditation and who needs it?
PCAB (Pharmacy Compounding Accreditation Board) is an accreditation for compounding pharmacies, administered through ACHC. PCAB accreditation is an independent third-party review of compliance with USP Chapters 795, 797, and 800. The Alliance for Pharmacy Compounding's snapshot of the profession, based in part on a fall 2023 survey of compounders, reports that 21% of pharmacies for which compounding is more than 20 percent of their business are PCAB accredited (APC snapshot, 2023 to 2024, page opened October 3, 2026). Organizations that may pursue it include: dedicated 503A compounding pharmacies; multi-state operations where PCAB is required for nonresident licensure (WA, OH); pharmacies approaching M&A transactions; and 503B outsourcing facilities.
What is the difference between USP 795, 797, and 800?
USP 795 governs non-sterile compounding — creams, capsules, oral liquids. The 2023 final version introduced a water activity metric and stricter BUD defaults. USP 797 governs sterile compounding. The 2023 version replaced the old risk-level framework with a Category 1/2/3 BUD continuum and added Designated Person designation, semi-annual gloved fingertip sampling, media fill testing, and category-specific environmental monitoring requirements. USP 800 governs hazardous drug handling for all NIOSH-listed drugs. USP lists December 1, 2019 as the official date of Chapter 800 and November 1, 2023 as the date it became compendially applicable (USP, General Chapter 800, Hazardous Drugs, page opened October 3, 2026).
What changed with the revised USP Chapter 797 effective November 2023?
Five major changes: (1) Risk-level framework (low/medium/high) replaced by Category 1/2/3 BUD continuum tied to environmental control level. (2) Formal Designated Person designation required. (3) Semi-annual gloved fingertip and thumb sampling mandated for all sterile compounding personnel. (4) Media fill testing documentation required before personnel may manipulate patient drugs. (5) Scientifically validated shipping system validation required for all products in transit.
What is the difference between a 503A and 503B compounding pharmacy?
The DQSA (November 2013) bifurcated compounding into two tracks. 503A pharmacies compound patient-specific prescriptions, regulated by state boards under USP standards. 503B outsourcing facilities register with FDA and may compound for office stock without patient-specific prescriptions, subject to cGMP requirements.
How much does PCAB accreditation cost?
ACHC does not publish a universal rate card. Request a current quote from ACHC. Ask ACHC whether any APC membership discount applies. No annual maintenance fees — costs consolidated into triennial survey. IHS consulting fees: engagement fees are customized based on your organization's complexity and timeline. Contact us for a tailored proposal. See our PCAB Cost Guide for full breakdown.
How long does the PCAB accreditation process take?
IHS plans for 7 to 8 months from engagement to accreditation when baseline state inspections are complete, and 12 to 18 months for a full build from a non-compliant state. Timeline: comprehensive gap assessment (weeks 1–2), SOP development (weeks 3–14), mock survey and remediation (weeks 15–18), application submission (week 19), on-site survey (months 5–8). PCAB runs on a 36-month cycle; renewal must begin at least 9 months before expiration.
Does PCAB accreditation satisfy state board of pharmacy USP compliance requirements?
PCAB is an independent review against USP 795, 797, and 800, standards that state boards of pharmacy may also enforce. But state requirements and PCAB are not legally identical. Washington and Ohio specifically require PCAB for nonresident licensure. Other states accept PCAB as evidence of compliance posture but may also conduct independent inspections. IHS can provide state-specific guidance in an engagement.
Which gaps can lead to PCAB inspection findings?
Gaps that can lead to findings include equipment calibration and maintenance, storage and labeling practices, shipping system validation, Designated Person designation, personnel training and competency, gloved fingertip and thumb sampling, and media fill testing documentation.
Is PCAB accreditation required or voluntary?
Mandatory in Washington and Ohio for nonresident licensure. Other states set their own rules.
What is the difference between PCAB and NABP VPP accreditation?
PCAB focuses specifically on compounding pharmacy quality through ACHC. NABP's Verified Pharmacy Program (VPP) is broader — covering dispensing operations, patient safety, and general pharmacy quality. Specialty pharmacies that both compound and dispense commercial drugs may pursue both credentials. See our PCAB vs. NABP VPP comparison.
What is a Designated Person and why is this role required under new USP standards?
The Designated Person (DP) is formally appointed to oversee the compounding quality program under new USP 795 and 797 frameworks. Responsibilities include quality oversight, deviation management, training program oversight, and regulatory compliance monitoring — documented in writing. An absent or inadequately documented DP designation can draw a PCAB citation.
What is media fill testing and what happens if it fails?
Media fill testing requires sterile compounding personnel to simulate the compounding process using microbiological growth media instead of active drug. It verifies that each compounder's aseptic technique does not introduce microbial contamination. Personnel must pass before they may manipulate actual patient drugs, and must pass ongoing periodic challenges. A failure means the compounder cannot perform sterile compounding until the failure is investigated, root cause identified, retraining completed, and a successful repeat test is documented. IHS can build media fill testing schedules, documentation protocols, and failure response procedures into a sterile compounding engagement.
Which states require PCAB accreditation for nonresident compounding pharmacy licensure?
Washington and Ohio currently require verifiable PCAB accreditation for nonresident licensure. State enforcement dates vary: Kentucky began enforcing revised USP chapters January 1, 2026; Ohio extended its grace period through February 28, 2027. IHS monitors state board developments and provides current state-specific guidance in an engagement.
What are the PCAB accreditation requirements for sterile compounding?
Under USP 797, PCAB assesses: Designated Person designation; initial and ongoing competency assessments; semi-annual gloved fingertip/thumb sampling; media fill testing documentation; cleanroom environmental monitoring at category-appropriate frequencies; temperature, humidity, and pressure differential documentation; Category 1/2/3 BUD assignment; shipping system validation; Master Formulation Records and Compounding Records; and deviation and CAPA documentation for all environmental excursions.
How do you maintain PCAB accreditation after earning it?
PCAB runs on a 36-month cycle with no annual fees. Ongoing requirements: continue all USP compliance activities (environmental monitoring, PT sampling, media fills, competency assessments); document all deviations and CAPAs; maintain equipment calibration logs; update SOPs when procedures change; monitor state board rule changes; initiate renewal at least 9 months before expiration. Significant operational changes — new Designated Person, modified compounding procedures, new test categories — may require ACHC notification and documentation updates. IHS offers post-accreditation compliance monitoring retainers.
Ready to Begin PCAB Preparation?
Schedule a gap assessment with Thomas G. Goddard, JD, PhD. IHS will assess your current USP 795/797/800 compliance posture and give you a clear roadmap to PCAB accreditation.