Product Code: 254027
ISBN: 978-1-56395-527-3
The 1st edition of Cell and Gene Therapy Standards for Pharmacy (CGT Standards) provides the latest standards of practice for cell and gene therapies in specialty pharmacy settings.
As cell and gene therapies have expanded, the role of specialty pharmacies in dispensing these biological products has become significant. AABB is the only organization setting standards for specialty pharmacies that handle cellular and gene therapy products. Although pharmacies adhere to general accreditation standards, existing quality standards and accreditations are not specifically tailored to address the new products. The specialized requirements for managing advanced therapies require unique storage and handling conditions, as well as trained personnel to maintain their integrity and effectiveness. AABB’s experience has enabled the organization to assemble a group of experts to provide both the standards and accompanying guidance.
This 1st edition becomes effective October 1, 2025 and will have a 2-year effective period.
Guidance for Cell and Gene Therapy Standards for Pharmacy includes verbatim requirements from the 1st edition of CGT Standards interspersed with guidance. Language from the CGT Standards that will maintain and enhance the quality and safety of services provided by pharmacies is presented; when there is appropriate guidance for that standard, the guidance language follows the standard with the heading "Guidance." This format allows the reader to see both the requirement and the associated guidance side by side.
Please note that there is no guidance for some standards. The Cell and Gene Therapy Services for Pharmacy Standards Committee has chosen to focus on those issues that may require additional context and/or examples to assist in attaining compliance with the CGT Standards.
BUNDLE: AABB, 2025, 91 pages, 978-1-56395-527-3 | AABB, 2025, 65 pages
Product Code: 254027
Member Price: $208
Nonmember Price: $252
View Table of Contents (pdf)
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View Table of Contents (pdf)
View Preface (pdf)
View Sample Pages (pdf)
