21 CFR § 640.83
General requirements
June 25, 2020
(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]
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