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Additional Regulatory Requirements

Reporting

Adverse reactions: Per 21 CFR 1271.350(a), the FDA requires the investigation of any adverse reaction involving a communicable disease related to an HCT/P made available for distribution. Within 15 calendar days of the initial receipt of information, an adverse reaction involving a communicable disease must be reported if it is fatal, life-threatening, results in permanent impairment of a body function or permanent damage to body structure, or necessitates medical or surgical intervention, including hospitalization. An HCT/P adverse reaction must be reported on a Form FDA 3500A; additional information for reporting HCT/P adverse reactions is available on FDA's MedWatch Web page. HCT/P adverse reaction reports may be submitted electronically, by paper or by telephone.

Deviations: As stated in 21 CFR 1271.350(b), all deviations related to a distributed HCT/P for which an establishment performed a manufacturing step must be investigated. Furthermore, deviations must be reported related to core CGTP requirements if the deviation occurred at the facility or in a contracted facility during manufacture. The deviation report should include a description of the HCT/P deviation, information relevant to the event and manufacture of the HCT/P, and information on all follow-up actions that have happened or will be taken. The FDA developed a standardized format — Form FDA 3486 — for reporting HCT/P deviations, which may be submitted electronically or in paper form. Read more about HCT/P deviations including submission instructions, guidance and rules, and a list of reporting codes.

Labeling

The HCT/P labeling requirements in 12 CFR 1271.370 state that each HCT/P made available for distribution must be labeled clearly and accurately. The FDA requires the following information to appear on the label of an HCT/P:

  • Distinct identification code (DIN)
  • Description
  • Expiration date, if any
  • Warnings, if applicable and physically possible.

If it is not physically possible to include the required warnings on the label, the warnings must accompany the HCT/P. The following information must appear either on the HCT/P label or accompany it:

  • Name and address of the establishment that determines that the HCT/P meets release criteria and makes the HCT/P available for distribution
  • Storage temperature
  • Other warnings, where appropriate
  • Instructions for use related to the prevention of the introduction, transmission or spread of communicable diseases.

The Circular of Information for the Use of Cellular Therapy Products was developed as an extension of the product label for minimally manipulated cellular products such as peripheral blood progenitor cells, bone marrow, cord blood, and leukocytes. It has been prepared and is endorsed by AABB and other cellular therapy organizations. The FDA and Health Resource and Services Administration provided liaisons to the group responsible for the development of the Circular. Each processing/issuing facility has the option to provide additional facility or product-specific information in the space provided in the Circular and is encouraged to do so.