Regulations last checked for updates: Nov 22, 2024

Title 9 - Animals and Animal Products last revised: Nov 05, 2024
§ 114.12 - Expiration date required for a serial.

Unless otherwise provided for in a Standard Requirement or filed Outline of Production, each serial or subserial of a biological product prepared in a licensed establishment shall be given an expiration date according to the dating period of the product when computed from a date no later than the date of the initiation of the first potency test of the serial or subserial. A licensed biological product shall be considered worthless under the Virus-Serum-Toxin Act after the expiration date appearing on the label.

[83 FR 11143, Mar. 14, 2018]
authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4
source: 39 FR 16869, May 10, 1974, unless otherwise noted.
cite as: 9 CFR 114.12