federal_register: 2010-23186

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2010-23186 Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product Proposed Rule We are proposing to amend the Virus-Serum-Toxin Act regulations concerning expiration dating to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. We also propose to require the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay; require stability monitoring of products after licensing; and specify a single standard for determining the expiration date for veterinary biologics in place of the current standard that specifies different procedures for products contingent upon whether they consist of viable or nonviable organisms. These amendments would update and clarify the regulations concerning expiration dating and establish a single uniform standard for determining the stability of veterinary biological products. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document. 2010-09-17 2010 9 https://www.federalregister.gov/documents/2010/09/17/2010-23186/viruses-serums-toxins-and-analogous-products-expiration-date-required-for-serials-and-subserials-and https://www.govinfo.gov/content/pkg/FR-2010-09-17/pdf/2010-23186.pdf Agriculture Department; Animal and Plant Health Inspection Service 12,22 We are proposing to amend the Virus-Serum-Toxin Act regulations concerning expiration dating to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency...

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