21 CFR 640.17
§ 640.17 Modifications for specific products.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 640.17, § 640.17 Modifications for specific products, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88475
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Full text
Red Blood Cells Frozen: A cryophylactic substance may be added to the Red Blood Cells for extended manufacturers' storage at −65 °C or colder, provided the manufacturer submits data considered by the Director, Center for Biologics Evaluation and Research, as adequately demonstrating through in vivo cell survival and other appropriate tests that the addition of the substance, the materials used and the processing methods results in a final product that meets the required standards of safety, purity, and potency for Red Blood Cells, and that the frozen product will maintain those properties for the prescribed dating period. Section 640.11 (a) and (b) do not apply while a cryophylactic substance is present.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.