21 CFR 640.93 - General requirements.

Regulations last checked for updates: Dec 17, 2025

Title 21 - Food and Drugs last revised: Dec 11, 2025

View all text of Subpart I [§ 640.90 - § 640.94]

§ 640.93 - 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.

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 640.93