---
kind: "section"
citation: "9 C.F.R. § 114.12"
title: "9"
number: "114.12"
heading: "Expiration date required for a serial."
url: "https://uscodex.org/cfr/9/114.12"
---

# §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.


## Notes

### Amendments

[83 FR 11143, Mar. 14, 2018]

### Authority

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

### Source

Source: 39 FR 16869, May 10, 1974, unless otherwise noted.

### Amendments

[83 FR 11143, Mar. 14, 2018]