21 CFR 640.83
§ 640.83 General requirements.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 640.83, § 640.83 General requirements, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88515
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.