§ 114.12 - Expiration date required for a serial.

§ 114.12 Expiration date required .

Cross Reference

Link to an amendment published at 83 FR 11143, Mar. 14, 2018.

Each

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 determined in accordance with the requirements provided in § 114.13 or § 114.14. 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 subsequent to after the expiration date appearing on the label.

[41 83 FR 4468711143, OctMar. 1214, 19762018]