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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2018]
[CITE: 21CFR1271.47]
See Related Information on What procedures must I establish and maintain? in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION

PART 1271 -- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS

Subpart C--Donor Eligibility

Sec. 1271.47 What procedures must I establish and maintain?

(a) General. You must establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of this subpart. Establish and maintain means define, document (in writing or electronically), and implement; then follow, review, and as needed, revise on an ongoing basis. You must design these procedures to ensure compliance with the requirements of this subpart.

(b) Review and approval. Before implementation, a responsible person must review and approve all procedures.

(c) Availability. Procedures must be readily available to the personnel in the area where the operations to which they relate are performed, or in a nearby area if such availability is impractical.

(d) Departures from procedures. You must record and justify any departure from a procedure relevant to preventing risks of communicable disease transmission at the time of its occurrence. You must not make available for distribution any HCT/P from a donor whose eligibility is determined under such a departure unless a responsible person has determined that the departure does not increase the risks of communicable disease transmission through the use of the HCT/P.

(e) Standard procedures. You may adopt current standard procedures, such as those in a technical manual prepared by another organization, provided that you have verified that the procedures are consistent with and at least as stringent as the requirements of this part and appropriate for your operations.

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