21 C.F.R. § 640.83

Current through September 30, 2024
Section 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.

21 C.F.R. §640.83

42 FR 27582, May 31, 1977