21 CFR 640.83 - General requirements.

Regulations last checked for updates: Jun 01, 2024

Title 21 - Food and Drugs last revised: May 30, 2024

View all text of Subpart H [§ 640.80 - § 640.84]

§ 640.83 - General requirements.

(a) Preservative. The final product shall not contain a preservative.

(b) Storage of bulk solution. After all processing steps have been completed, the sterile bulk solution shall be stored in a manner that will ensure the continued sterility of the product, and at a temperature that shall not exceed the recommended storage temperature of the final product prescribed in § 610.53 of this chapter.

[42 FR 27582, May 31, 1977]

authority: 21 U.S.C. 321,351,352,353,355,360,371; 42 U.S.C. 216,262,263,263a,264

source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

cite as: 21 CFR 640.83