Clarifying Labeling for Third-Party Manufacturer Products
Sarah Litel-Smith, Manager, FACT Accreditation Services
Phyllis I. Warkentin, MD, FASTCT, FACT Chief Medical Officer
The recently published FACT-JACIE Standards for Hematopoietic Cellular Therapy, Ninth Edition (version 9.1) and FACT-JACIE International Standards for Immune Effector Cells, Third Edition (version 3.1) both include Standard D7.4.10, which requires cellular therapy products from third-party manufacturers to have labels that meet FACT-JACIE requirements and Applicable Law. This article provides clarification on the explanation provided in the accompanying FACT-JACIE Accreditation Manuals.
For products manufactured under an FDA Biologics License Application (BLA) or used under an Investigational New Drug (IND) application, required label content is dictated by applicable regulations. Therefore, a product bearing an FDA-approved label as part of a BLA or IND is compliant with the Standards because it meets Applicable Law. FACT does not require relabeling of licensed (BLA) or regulatory-authorized (IND) products by the receiving facility.
Although some third-party manufactured products may not bear ISBT 128-compliant labels, these may be acceptable if they have regulatory approval and provide sufficient traceability and chain of identity. Relabeling such products may introduce risks of error, confusion, delay in administration of the therapy, or conflict with regulatory information.
FACT encourages the use of ISBT 128 coding and labeling to the extent possible to improve safety and traceability. Supplemental labels are permissible when the institutional practices would increase safety and traceability. In addition, accredited facilities should:
- Encourage in-house and third-party manufacturers to use ISBT 128 coding and labeling when feasible.
- Encourage alignment with labeling expectations in Appendix I of the Standards.
- Encourage use of enhanced features of ISBT 128 coding and labeling as defined by ICCBBA in its Standards for cell collections intended for further manufacturing, including:
- Use of the Hybrid Label (ICCBBA ST-018), that incorporates both ISBT 128 traceability elements and manufacturer-specific information.
- Use of the Chain of Identity Identifier (ICCBBA ST-028).
The ICCBBA Standards referenced above were developed by collaborating stakeholders representing cellular therapy programs, industry, professional societies, and accreditation organizations. These approaches support traceability and consistency without creating conflicts with regulatory labeling.
