21 CFR 607.31
§ 607.31 Additional blood product listing information.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 607.31, § 607.31 Additional blood product listing information, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88399
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Full text
(a) In addition to the information routinely required by §§ 607.25 and 607.30, the Director of the Center for Biologics Evaluation and Research may require submission of the following information by letter or by Federal Register notice:
(1) For a particular blood product so listed, upon request made by the Director of the Center for Biologics Evaluation and Research for good cause, a copy of all advertisements.
(2) For a particular blood product so listed, upon a finding by the Director of the Center for Biologics Evaluation and Research that it is necessary to carry out the purposes of the act, a quantitative listing of all ingredients.
(3) For each registrant, upon a finding by the Director of the Center for Biologics Evaluation and Research that it is necessary to carry out the purposes of the act, a list of each listed blood product containing a particular ingredient.
(b) [Reserved]
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.