Expiration date required for a serial.

1. Law
2. CFR 9
3. Animals and Animal Products
4. Animal and Plant Health Inspection Service, Department of Agriculture
5. Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors
6. Production Requirements for Biological Products
7. Expiration date required for a serial.

§ 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]

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