Become AABB-Accredited: Cell and Gene Therapy Pharmacies

AABB Accredited

Why CGT Pharmacy Accreditation with AABB?

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:

  • Enhance patient safety
  • Safeguard product integrity
  • Strengthen documentation and traceability
  • Mitigate audit risk
  • Support outcomes-based agreements
  • Reinforce contingency planning
  • Address the full workflow, from pharmacy technician to pharmacist-in-charge

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

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.

Read Article

CGT Pharmacy Accreditation Toolkit

CGT Pharmacy Toolkit

The CGT Pharmacy Accreditation Toolkit is your go-to resource when beginning your journey towards achieving AABB CGT Pharmacy Accreditation. The toolkit includes:

  • On-boarding letter from AABB Biotherapies Leadership
  • Self-assessment and on-site assessment 'What to expect'
  • Meet the AABB accreditation team technical specialists
  • All the forms needed to submit your application
  • AABB CGT Pharmacy Accreditation process checklist

Please provide your email below to access the downloadable toolkit:

CGT Pharmacy Accreditation Process

Apply >Self-Assess > AABB Site Visit > Resolve > Accredited. AABB accreditation is fully tailored to your readiness, with ongoing support and a two-year renewal cycle.

Application

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.

Self-assessment

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.

On-site assessment

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.

Resolving non-conformances

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.

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.

Timeline

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.

CGT

Questions About Pursuing AABB CGT Pharmacy Accreditation?

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.