General requirements.

21 C.F.R. § 640.83
in effectEffective: 2024-07-01
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(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.

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