§640.93. General requirements.
21 C.F.R. § 640.93
Preservative. The final product shall not contain a preservative.
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.
Notes, amendments, and revision history
Source
Source: 42 FR 27583, May 31, 1977, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.
Source
Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.