Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter F - Biologics |
Part 606 - Current Good Manufacturing Practice for Blood and Blood Components |
Subpart I - Records and Reports |
§ 606.165 - Distribution and receipt; procedures and records.
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§ 606.165 Distribution and receipt; procedures and records.
(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.