114.13—Expiration date determination.
Unless otherwise provided for in a Standard Requirement of filed Outline of Production, the expiration date for each product shall be computed from the date of the initiation of the potency test. Prior to licensure, stability of each fraction shall be determined by methods acceptable to Animal and Plant Health Inspection Service. Expiration dates based on this stability data shall be confirmed as follows:
(a) Products consisting of viable organisms.
Each serial shall be tested for potency at release and at the approximate expiration date until a statistically valid stability record has been established.
(b) Nonviable biological products.
Each serial presented in support of licensure shall be tested for potency at release and at or after the dating requested.
(c)
Subsequent changes in the dating period for a product may be granted, based on statistically valid data submitted to support a revision of the Outline of Production.