AABB Accepting Feedback on Cell and Gene Therapy Standards for Pharmacy

AABB is accepting feedback on the proposed first edition of Cell and Gene Therapy Standards for Pharmacy through Dec.16. This is the first new standards activity from AABB in several years and represents an important advancement in ensuring the highest level of quality and safety for cell and gene therapy (CGT) products.   

As more and more CGTs gain approval, pharmacies are becoming key players in managing these complex, high-value therapies. A review of existing pharmacy quality programs and available certifications revealed a lack of standards for handling and managing CGTs within 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. 

The Cell and Gene Therapy Standards for Pharmacy Committee encourages all interested individuals to submit comments before the deadline. The draft first edition of standards will be finalized after the comment period has concluded. The committee will review all comments submitted and provide a summary document that describes the committee’s rationale for its final decisions.