9 CFR § 114.12 - Expiration date required for a serial.

---
identifier: "/us/cfr/t9/s114.12"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "9 CFR § 114.12 - Expiration date required for a serial."
title_number: 9
title_name: "Animals and Animal Products"
section_number: "114.12"
section_name: "Expiration date required for a serial."
chapter_name: "ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE"
subchapter_number: "E"
subchapter_name: "VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS"
part_number: "114"
part_name: "PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4."
regulatory_source: "39 FR 16869, May 10, 1974, unless otherwise noted."
cfr_part: "114"
---


# 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]