The Cell and Gene Therapy Standards for Pharmacy 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.
These standards do not cover activities such as starting material collection, product manufacturing or clinical administration.
Current edition: proposed first edition available for public comment
Effective date: to be confirmed
Revision cycle: 24 months
The print and portal versions of the first edition of Cell and Gene Therapy Standards for Pharmacy will be available for purchase in 2025.
The Association for the Advancement of Blood & Biotherapies (AABB) is launching new Cell and Gene Therapy Standards for Pharmacy to establish quality systems for pharmacies who dispense approved cell and gene therapy (CGT) products. With increasing approvals, pharmacies are becoming key players in managing these transformative, high-value therapies.
A review of existing pharmacy quality programs and available certifications revealed a lack of standards for handling and managing CGTs within the field of pharmacy.
Developed through a committee of diverse academic and industry stakeholders and drawing on AABB's expertise and history in quality system creation, AABB's Cell and Gene Therapy Standards for Pharmacy will guide pharmacies in the receipt, storage, handling and dispensing of these therapies. The program intends to assist pharmacy programs in enhancing patient safety by filling a critical gap in accreditation while addressing business risks by ensuring product integrity while in possession of a pharmacy.
AABB formed the Cell and Gene Therapy Pharmacy Committee to pair a team of experts and representatives from critical pharmacy stakeholders with AABB's extensive knowledge of quality systems and standards-setting in the biotherapies field. The committee including representatives from:
AABB has been a leader in setting standards that optimize and advance quality and safety for the biotherapies field. For more than 25 years AABB's Standards for Cellular Therapy Services, have been used for AABB accreditation of cellular therapy programs, including cord blood services, hematopoietic progenitor cell (HPC) and somatic cell services, and CT clinical services. As such, AABB is uniquely positioned to extend our knowledge of quality systems for living therapies into the pharmacy setting.
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