Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards are Now Available #

The eighth Edition FACT-JACIE International Standards for Hematopoeitic Cellular Therapy Product Collection, Processing, and Administration and its accompanying eighth edition Hematopoietic Cellular Therapy Accreditation Manual have been officially published.

The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.

The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.

The eighth edition Standards become effective on August 16, 2021. All organizations accredited under these Standards are expected to be in compliance with the requirements by that date. Although there may be a few inspections remaining to be completed under the previous edition due to COVID 19-related delays, all other inspections scheduled after this date will be under the eighth edition.

Review the Summary of Changes for the eighth edition FACT-JACIE Standards
Download the eighth edition FACT-JACIE Standards for free
Download the eighth edition Hematopoietic Cellular Therapy Accreditation Manual for free
Purchase printed copies of the eighth edition FACT-JACIE Standards
Purchase printed copies of the eighth edition Hematopoietic Cellular Therapy Accreditation Manual
Download additional supporting documents

NEWS RELEASE: FACT Pursues Independent Operational Status #

NEWS RELEASE Issued: April 5, 2021 Contact: Linda Miller

OMAHA, Neb. — The Foundation for the Accreditation of Cellular Therapy (FACT) is pursuing an opportunity to establish independent operational functions by the end of 2021 thus ending the 25-year collaborative relationship with the University of Nebraska. Read full release

ICCBBA Releases Registration License Fee Flyer for ISBT 128 #

To assist entities with determining ISBT 128 registration fees, ICCBBA created a registration license fee flyer. View the flyer.

FACT Announces Accreditations in October and November 2020 #

In October and November 2020, 11 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

FACT Announces Accreditations in September 2020 #

In September 2020, five entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

FACT Announces Accreditations in August 2020 #

In August 2020, five entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

FACT Announces Accreditations in July 2020 #

In July 2020, three entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.