AABB Cell and Gene Therapy Pharmacy accreditation is AABB's program for U.S. hospital and retail specialty pharmacies that receive, store, handle and dispense FDA-approved cell and gene therapy (CGT) products, assessed against the AABB Cell and Gene Therapy Standards for Pharmacy, 1st edition. This service is for pharmacy quality leaders adding CGT handling or preparing for AABB's assessment. Integral Healthcare Solutions (IHS) builds the quality-system documents and evidence plan for the accreditation; your pharmacists approve handling.
Last reviewed: October 2026. AABB's standards, accreditation process, CGT pharmacy, activities and fee pages checked on October 2, 2026.
What is AABB Cell and Gene Therapy Pharmacy accreditation?
The governing text is the AABB Cell and Gene Therapy Standards for Pharmacy. AABB lists the "Current edition : 1st edition Effective date : October 1, 2025 Revision cycle : 24 months" (AABB CGT Standards for Pharmacy).
AABB states the purpose: the standards "will optimize and advance quality and safety for the receipt, storing, handling and dispensing of approved cell and gene therapy (CGT) products and biotherapies under pharmacy management." It also states the scope limit: "These standards do not cover activities such as starting material collection, product manufacturing or clinical administration" (AABB CGT Standards for Pharmacy).
AABB's accreditation activities list (Version 3, effective 4/2/2026) defines the activity: "Cell and Gene Therapy Activity for Pharmacy - A facility involved in any of the following: receipt, handling, storage, and dispensation of FDA licensed cell and gene therapy products through a pharmacy" (AABB Accreditation Activities).
The process runs in two phases. AABB's general process page says: "There are two phases involved with achieving AABB accreditation for the first time or adding a new activity: the self-assessment phase, followed by the on-site assessment phase" (AABB Accreditation Process). On the CGT pharmacy page, AABB says "You'll complete a self-assessment against the CGT Standards using APEX, AABB's accreditation portal," and the on-site visit "verifies that your policies, processes and procedures align with the standards-and that your team consistently follows them" (AABB CGT pharmacy accreditation). If the assessor finds non-conformances, "you'll develop a Corrective Action Plan to address them and complete a Post-Assessment Questionnaire" (AABB).
Who needs it and what triggers it
- U.S. pharmacies dispensing licensed CGT products. AABB says the program "is designed for U.S.-based hospital and retail specialty pharmacies that dispense FDA-approved CGT products" (AABB Biotherapies).
- Pharmacies whose current quality system was built for conventional dispensing. AABB's position is that "Traditional pharmacy accreditation and quality systems do not fully address the unique requirements necessary to safely manage these critical therapies" (AABB). That is AABB's claim about its own program.
- Pharmacies that have run CGT dispensing long enough to qualify. AABB's general process page says "a facility must be in operation for a minimum of 6 months (in the desired accreditation activity) before the initial accreditation process can begin" (AABB Accreditation Process).
- Accredited pharmacies approaching reassessment. AABB says its process "includes on-site assessments every two years" (AABB Biotherapies).
How IHS helps
IHS works from your pharmacy's purchased copy of the AABB Cell and Gene Therapy Standards for Pharmacy. The process:
- Gap assessment. A quality-system crosswalk that compares your current pharmacy procedures with each standard.
- Responsibility map. Who does what for receipt, storage, handling, dispensing and the hand-off to the administering clinical team, since administration sits outside the standards.
- Document and evidence mapping. Each standard tied to the policy, process, procedure or record that shows it is met, set up as the evidence plan for the APEX self-assessment.
- Drafting. IHS drafts controlled documents, deviation records and handling procedures for your CGT pharmacists to review and approve.
- Mock review. A review against the standards before AABB's on-site visit, listing what is missing.
- Readiness support. If the assessment produces non-conformances, IHS drafts the corrective action plan for your pharmacy to review and submit.
IHS draws on its URAC specialty pharmacy accreditation process for the pharmacy operations side. See the wider accreditation consulting practice for related programs.
What you supply: the standards, current pharmacy procedures, the manufacturers' handling instructions, and CGT pharmacists who approve all handling and validation content. Your pharmacy submits the application and completes the self-assessment in APEX.
The limit: product handling validation is technical work that stays with your pharmacists. IHS works from the published standards and AABB's public process pages; the accreditation decision is AABB's.
What to have ready
- A purchased copy of the AABB Cell and Gene Therapy Standards for Pharmacy, 1st edition, effective October 1, 2025 (AABB; prices on AABB Purchase Standards).
- A list of every CGT product you receive, store, handle or dispense, matched to the activity definition: "receipt, handling, storage, and dispensation of FDA licensed cell and gene therapy products through a pharmacy" (Accreditation Activities, Version 3).
- Written policies, processes and procedures for each of those steps. AABB's expectation is "that all standards are addressed in policies, processes and procedures (PPPs), and that PPPs are followed as written" (AABB Accreditation Process).
- Records showing staff follow those procedures, since the on-site visit checks that "your team consistently follows them" (AABB).
- A written boundary between pharmacy handling and clinical administration, since the standards "do not cover activities such as starting material collection, product manufacturing or clinical administration" (AABB).
- Evidence of at least 6 months of operation in the activity before you start (AABB Accreditation Process).
- Basic information about "your pharmacy's locations and current CGT activity" for the Institutional Membership Application (AABB).
- A named owner for the APEX self-assessment (AABB).
- A process for a Corrective Action Plan and Post-Assessment Questionnaire if non-conformances are found (AABB).
- A plan for public statements: "advertising any relationship to AABB is not permitted until the facility/new activity becomes accredited and receives their AABB certificate" (AABB Accreditation Process).
To go through the list with IHS, book the introductory call below.
How it compares
The table sets out the options the sources describe. Which one fits depends on your pharmacy's activities and its obligations.
| Option | What the sources say |
|---|---|
| AABB CGT Pharmacy accreditation | Standards for "receipt, storing, handling and dispensing" of approved CGT products under pharmacy management (AABB). |
| URAC or ACHC specialty pharmacy accreditation | General specialty pharmacy programs. This page does not summarize their requirements. AABB's own position is that traditional pharmacy accreditation does "not fully address" CGT requirements (AABB). |
| FACT accreditation | FACT says it "supports cellular therapy programs worldwide" (FACT). The sources reviewed do not say whether FACT accredits pharmacies dispensing licensed CGT products. |
| AABB Standards for Cellular Therapy Services | For facilities that "procure, process, store and/or distribute cellular therapy products" (AABB Biotherapies). For pharmacies, AABB's path is the CGT Pharmacy standards. |
| No accreditation | The sources reviewed do not say whether any manufacturer or payer requires AABB CGT accreditation. |
What it costs
AABB publishes its 2026 institutional dues and fees (2026 AABB Institutional Dues Fees, read October 2, 2026). The amounts that apply to CGT pharmacy accreditation:
| Item | AABB's published amount |
|---|---|
| Basic Membership, Accredited Institutions | $1,714 |
| Application Fee (new members only) | $1,740 |
| Annual Volume Fee, Cell and Gene Therapy, 1-20,000 | $750 |
| Cell and Gene Therapy activity fee | $2,717 |
| Accreditation fee for activities requiring lead assessor services | $3,694 |
| CGT Standards for Pharmacy, 1st ed, print | List $158.00; member $130.00 (AABB Purchase Standards) |
| CGT Standards, print and portal bundle | List $252.00; member $208.00 (AABB Purchase Standards) |
AABB notes that "Additional fees may apply if activities are performed at multiple sites." These are AABB's published dues and fees, not a total cost. The same AABB fee document lists a travel fee of $1,568 per year for non-U.S. locations (excluding Canada), notes that additional fees may apply for multi-site activities, and does not itemize other assessor charges. Verify current fees with AABB. IHS scopes each engagement after a free introductory call.
What this is not
- IHS is not AABB and does not grant, predict or influence an accreditation decision.
- IHS does not submit to or speak for your pharmacy to AABB. IHS drafts; your pharmacy submits through APEX.
- IHS does not validate product handling or make pharmacy practice decisions, and this page is not legal advice.
Frequently asked questions
What is AABB Cell and Gene Therapy Pharmacy accreditation?
It is AABB accreditation for pharmacies that receive, handle, store and dispense FDA-licensed cell and gene therapy products. The pharmacy is assessed against the AABB Cell and Gene Therapy Standards for Pharmacy, 1st edition, effective October 1, 2025.
Which pharmacies are eligible: hospital, health-system or retail specialty pharmacies?
AABB says the program is designed for U.S.-based hospital and retail specialty pharmacies that dispense FDA-approved CGT products. AABB's general process page also requires at least 6 months of operation in the activity before the initial accreditation process can begin.
What do the AABB Cell and Gene Therapy Standards for Pharmacy cover, and what do they leave out?
They cover the receipt, storing, handling and dispensing of approved CGT products and biotherapies under pharmacy management. AABB states they do not cover starting material collection, product manufacturing or clinical administration.
How long does AABB CGT pharmacy accreditation take?
AABB says most facilities complete the process within one to two years. After accreditation, AABB conducts on-site assessments every two years.
How much does AABB CGT pharmacy accreditation cost, including membership and assessment fees?
AABB's 2026 fee schedule lists basic membership at $1,714, a $1,740 application fee for new members, a $750 annual volume fee for 1-20,000, a $2,717 Cell and Gene Therapy activity fee and a $3,694 accreditation fee for lead-assessor activities. Additional fees may apply for multiple sites. Verify current fees with AABB.
What happens during the APEX self-assessment and the on-site assessment?
Your pharmacy completes a self-assessment against the CGT Standards in APEX, AABB's accreditation portal, and proceeds to on-site assessment after AABB reviews and approves it. The on-site visit verifies that your policies, processes and procedures align with the standards and that your team follows them. Non-conformances lead to a Corrective Action Plan and a Post-Assessment Questionnaire.
Do manufacturers require AABB CGT accreditation before a pharmacy can dispense their product?
The AABB pages reviewed for this page do not say, and no manufacturer or payer source was reviewed. Check each manufacturer's own site requirements.
How does AABB CGT pharmacy accreditation differ from URAC or ACHC specialty pharmacy accreditation?
The AABB program is built on standards written for CGT receipt, storage, handling and dispensing. AABB's position is that traditional pharmacy accreditation and quality systems do not fully address CGT requirements. This page does not summarize URAC or ACHC requirements.