21 CFR 606.165 - Distribution and receipt; procedures and records.

§ 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.

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 606 after this date.

  • 2015-12-28; vol. 80 # 248 - Monday, December 28, 2015
    1. 80 FR 80650 - Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is December 28, 2015.
      21 CFR Parts 606 and 610