Regulatory Affairs Certification (RAC) Practice Exam

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What regulatory compliance must a company developing an autologous cellular therapy adhere to?

  1. Only Subpart C of 21 CFR 1271

  2. All Subparts of 21 CFR 1271

  3. Subparts A and B of 21 CFR 1271

  4. Only Subpart A of 21 CFR 1271

The correct answer is: All Subparts of 21 CFR 1271

A company developing an autologous cellular therapy must adhere to all Subparts of 21 CFR 1271 because this regulation encompasses the requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Specifically, Subpart A provides general provisions and definitions, Subpart B contains the requirements for the establishment registration and listing, and Subpart C details the current good tissue practices necessary for the handling and distribution of human cells and tissues. Autologous cellular therapies involve using a patient’s own cells, requiring compliance with the entire range of regulations to ensure safety, quality, and efficacy. This compliance is crucial due to the potential risks associated with the manipulation and application of these biological materials. Therefore, being compliant with all subparts ensures thorough oversight and adherence to necessary provisions for these types of therapies.

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