So much information, but so little space on a label. Even the well-designed ISBT 128 labels for cellular therapy products cannot possibly fit all of the information health care personnel need to know about a product. This is where circulars of information come in: these are extensions of container labels that include the use of the cellular therapy product, indications, contraindications, side effects and hazards, dosage, and administration recommendations.
FACT Standards require Clinical Programs to have a circular of information available to its staff. Other Standards also require the use of biohazard and warning labels as outlined in the interorganizational Circular of Information for the Use of Cellular Therapy Products. This specific circular of information is developed with the input of 13 international organizations (including FACT), the U.S. Food and Drug Administration (FDA), and the U.S. Health Resources Services Administration (HRSA) for nonlicensed, minimally manipulated cellular therapy products such as standard of care hematopoietic progenitor cell (HPC) products.
This circular was updated in June 2021, and the current version can be found on the Resources page of the FACT website. It includes the following topics:
- Cellular therapy product sources.
- Cellular therapy product descriptions.
- Instructions for storage and administration of cellular therapy products.
- Dosing and administration.
- Cellular therapy product labeling and supporting documents.
- Biohazard and warning labels.
- Side effects and hazards.
- Reporting of adverse reactions.
- Table 1A. US Minimal Requirements for Testing for Transmissible Agents in Cellular Therapy Products.
- Table 1B. EU Minimal Requirements for Testing for Transmissible Agents in Cellular Therapy Products.
- Table 2. Biohazard and Warning Labels on Cellular Therapy Products Collected, Processed, and/or Administered in the United States.
At the end of the circular, there is space to include additional information for specific cellular therapy products as needed by the program. Since a new version was released this year, it is a perfect time to re-read and re-train on the content within the circular!