CFR section
21 CFR 606.165(b): Distribution and receipt; procedures and records
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart I-Records and Reports
Key facts
| Citation | 21 CFR 606.165(b) |
|---|---|
| Section | Distribution and receipt; procedures and records |
| Part | PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
| Subpart | Subpart I-Records and Reports |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs |
| Regulation text (excerpt) | (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. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.