CFR section

21 CFR 226.110: Distribution records

PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES · Subpart E-Records and Reports

Key facts

Citation 21 CFR 226.110
Section Distribution records
Part PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
Subpart Subpart E-Records and Reports
Subchapter 21 CFR C Drugs General
Product types cited Drugs
Regulation text (excerpt) Complete records shall be maintained for each shipment of Type A medicated article(s) in a manner that will facilitate the recall, diversion, or destruction of the Type A medicated article(s), if necessary. Such records shall be retained for at least 2 years after the date of the shipment by the manufacturer and shall include the name and address of the consignee, the date and quantity shipped, and the manufacturing dates, control numbers, or marks identifying the Type A medicated article(s)…

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