Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serial and Subserials and Determination of Expiration Date of Product
plant-animal-health · Animal and Plant Health Inspection Service · Rule · Published 2018-03-14 · Effective 2018-04-13 · 83 FR 11139
Document
Document number
2018-05143
Federal Register citation
83 FR 11139
CFR reference
9 CFR 101
Type
Rule
Action
Final rule.
Category
plant-animal-health
Sub-agency
Animal and Plant Health Inspection Service
Publication date
2018-03-14
Effective date
2018-04-13
USDA docket
Docket No. APHIS-2009-0028
Abstract
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