AABB Releases First Edition of Cell and Gene Therapy Standards for Pharmacy

AABB is pleased to announce the release of the first edition of the Cell and Gene Therapy Standards for Pharmacy (CGT Standards), which establish quality systems for specialty pharmacies that dispense approved cell and gene therapy (CGT) products. The standards take effect Oct. 1 and will remain in effect for two years.

Developed by leading experts representing key biotherapies and pharmacy stakeholders, the CGT Standards are designed to optimize and advance quality and safety for the receipt, storing, handling and dispensing of approved CGT products under pharmacy management. The program intends to help pharmacy programs enhance patient safety, safeguard product integrity and support operational readiness as they enter this new space.

The first edition is now available in the AABB Store as a print edition, digital edition or print-digital bundle. AABB also offers a bundle that includes the print edition and the accompanying Guidance for Cell and Gene Therapy Standards for Pharmacy.

Organizations interested in adopting the Cell and Gene Therapy Standards for Pharmacy can participate in a complimentary two-week trial of the electronic version in the Standards Portal. Individuals with questions regarding the standards should contact standards@aabb.org.

Pharmacies involved in the receipt, storage and dispensing of approved cell and gene therapy products can now apply for AABB accreditation. Contact accreditation@aabb.org for additional information.