9 CFR 114.18 - Reprocessing of biological products.

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§ 114.18 Reprocessing of biological products.

The Administrator may authorize a licensee to reprocess a serial of completed product subject to the conditions prescribed in this section.

(a) Reprocessing shall not include any method or procedure which would be deleterious to the product.

(b) All appropriate tests for purity, safety, potency, and efficacy for the product shall be conducted on the reprocessed product. A serial found unsatisfactory by a required test shall not be released.

(c) The reprocessed serial shall be identified by a new serial number and the records for the serial shall accurately reflect the action taken.

(d) Test samples of the reprocessed serial and test reports for all tests conducted shall be submitted to Animal and Plant Health Inspection Service. The licensee shall not release the serial until notified by Animal and Plant Health Inspection Service that the serial is eligible for release.

[ 50 FR 24904, June 15, 1985, as amended at 56 FR 66784, Dec. 26, 1991]

Title 9 published on 06-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR Part 114 after this date.

  • 2018-03-14; vol. 83 # 50 - Wednesday, March 14, 2018
    1. 83 FR 11139 - Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serial and Subserials and Determination of Expiration Date of Product
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Final rule.
      Effective April 13, 2018.
      9 CFR Parts 101 and 114
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