federal_register: 2018-05143
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2018-05143 | Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serial and Subserials and Determination of Expiration Date of Product | Rule | We are amending the regulations 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 are also requiring the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay, stability monitoring of products after licensing, and specifying a single standard for determining the expiration date for veterinary biologics | 2018-03-14 | 2018 | 3 | https://www.federalregister.gov/documents/2018/03/14/2018-05143/viruses-serums-toxins-and-analogous-products-expiration-date-required-for-serial-and-subserials-and | https://www.govinfo.gov/content/pkg/FR-2018-03-14/pdf/2018-05143.pdf | Agriculture Department; Animal and Plant Health Inspection Service | 12,22 | We are amending the regulations 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 are also requiring the expiration dating period... |