Bethesda, MD - The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to announce the release of the first edition of Cell and Gene Therapy Standards for Pharmacy, which take effect Oct. 1, 2025, and are now available for purchase on the AABB Store. These new Standards represent a critical advancement in strengthening quality and safety for cell and gene therapy (CGT) products managed by pharmacies.
As more CGTs gain approval, pharmacies are playing an essential role in handling these complex, high-value therapies. A review of existing quality programs and available certifications revealed a significant gap in standards addressing the unique requirements for CGTs within pharmacy settings.
Developed by an expert committee of academic, hospital, and industry stakeholders, and drawing on AABB’s longstanding expertise in quality systems, the Cell and Gene Therapy Standards for Pharmacy are designed to provide guidance for pharmacies in the receipt, storage, handling and dispensing of CGT products. The standards are designed to advance patient safety, safeguard product integrity and support pharmacies in building operational readiness.
Print and digital portal formats of the Standards, as well as a companion guidance are available for purchase on the AABB Store. Pharmacies may also apply for AABB Accreditation under this program. For more information, please contact accreditation@aabb.org.
About AABB Standards
AABB is the leader in setting standards that optimize and advance quality and safety for the blood and biotherapies field. Since 1957, AABB Standards have been the backbone of AABB’s mission. AABB Standards are currently applied to AABB-accredited facilities in more than 50 countries and other facilities to advance their quality and safety measures.
AABB Standards combine internationally accepted quality management system requirements with relevant technical requirements for each discipline. AABB Standards are based on AABB’s quality systems essentials, which leads the field in quality standards worldwide. AABB Standards incorporate both technical and quality systems standards to ensure that all facets are reviewed - from specification of equipment, materials management and organizational structure to documents, resource management and program assessment. Each edition of AABB's Standards is developed by a team of experts who volunteer their time as a member of a Standards Committee. Each edition of AABB's Standards is based on best medical practice, scientific data, and quality assurance, and applicable regulations. Each revision cycle includes a public comment period that seeks input from active professionals throughout the world. For more information and a list of current AABB Standards visit www.aabb.org/standards-accreditation/standards.
About AABB
AABB is an international, not-for-profit organization representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. The Association works collaboratively to advance the field by developing and delivering standards, accreditation, and education programs. AABB is dedicated to its mission of improving lives by making transfusion medicine and biotherapies safe, available, and effective worldwide. For more information, visit www.aabb.org.
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