CFR section
21 CFR 606.121(c)(8): Container label
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart G-Additional Labeling Standards for Blood and Blood Components
Key facts
| Citation | 21 CFR 606.121(c)(8) |
|---|---|
| Section | Container label |
| Part | PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
| Subpart | Subpart G-Additional Labeling Standards for Blood and Blood Components |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (8) If the product is intended for transfusion, the statements: (i) “Rx only.” (ii) “See circular of information for indications, contraindications, cautions, and methods of infusion.” (iii) “Properly identify intended recipient.” (iv) “This product may transmit infectious agents.” (v) The appropriate donor classification statement, i.e., “paid donor” or “volunteer donor,” in no less prominence than the proper name of the product. (A) A paid donor is a person who receives monetary payment for a… |
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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.