

Cell and gene therapies are living, personalized medicines that demand precise control and specialized handling. Traditional pharmacy accreditation and quality systems do not fully address the unique requirements necessary to safely manage these critical therapies.
AABB's Cell and Gene Therapy Standards for Pharmacy (CGT Standards) fill that gap - covering receipt, storage, handling, and dispensing of approved CGT products under pharmacy management. Developed by experts in specialty pharmacy, biotherapies, and regulatory practice the standards provide your team a clear operational framework.
AABB accreditation is more than a certificate, it serves as a guide to support operational readiness and advance optimal safety and quality. AABB's CGT for Pharmacy Accreditation program helps pharmacy and pharmaceutical distributors:
Prevent failure before it happens and signal 'We're ready' to your partners and manufacturers with AABB accreditation.
More resources highlighting the need for AABB's new CGT Pharmacy Accreditation program:
From innovation to implementation: Health-system pharmacy integration of cell and gene therapies
Cell and gene therapies (CGTs) represent a paradigm shift in modern medicine, offering targeted and potentially curative options for complex and rare diseases. Their integration into health-system pharmacy practice requires alignment with the medication-use process to ensure safety, efficacy, and compliance.

The CGT Pharmacy Accreditation Toolkit is your go-to resource when beginning your journey towards achieving AABB CGT Pharmacy Accreditation. The toolkit includes:
Please provide your email below to access the downloadable toolkit:
Getting started is straightforward.
Review AABB Institutional Membership and Accreditation Pricing, then submit an Institutional Membership Application indicating your interest in CGT Pharmacy Accreditation, along with basic information about your pharmacy's locations and current CGT activity. All the forms needed to submit your application are included in the CGT Pharmacy Accreditation Toolkit.
Email your completed forms to accreditation@aabb.org and our team will guide you through the next steps.
You'll complete a self-assessment against the CGT Standards using APEX, AABB's accreditation portal. APEX walks you through each requirement, tracks your progress and stores your documentation in one place. AABB staff are available throughout to answer questions and keep you on track.
Once your self-assessment is complete, you'll schedule an on-site visit with an AABB assessor.
The visit verifies that your policies, processes and procedures align with the standards-and that your team consistently follows them. Think of it as a collaborative review, not an audit.
If the assessor identifies non-conformances, you'll develop a Corrective Action Plan to address them and complete a Post-Assessment Questionnaire.
AABB may request additional documentation before finalizing your accreditation.
Once accredited, you can demonstrate your operational readiness to manufacturers, payers and clinical partners. You'll receive access to AABB's marketing toolkit - including logos, press release templates, digital banners and signage - to help you promote your achievement. Your facility will also be listed in AABB's Directory of Accredited Facilities.
How quickly you achieve accreditation depends on your facility's readiness when the process begins, your team's familiarity with quality systems, and the time and resources available to dedicate to the accreditation process. Most facilities complete the process within one to two years.

The AABB Accreditation Team looks forward to working with you on your journey toward accreditation, and are contactable by phone on +1.301.907.6977 or via email at accreditation@aabb.org.