21 CFR 606.165
§ 606.165 Distribution and receipt; procedures and records.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 606.165, § 606.165 Distribution and receipt; procedures and records, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88384
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Full text
(a) Distribution and receipt procedures shall include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall, if necessary.
(b) Distribution records shall contain information to readily facilitate the identification of the name and address of the consignee, the date and quantity delivered, the lot number of the unit(s), the date of expiration or the date of collection, whichever is applicable, or for crossmatched blood and blood components, the name of the recipient.
(c) Receipt records shall contain the name and address of the collecting facility, date received, donor or lot number assigned by the collecting facility and the date of expiration or the date of collection, whichever is applicable.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.