CFR section
21 CFR 606.121(e)(5): 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(e)(5) |
|---|---|
| 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) | (5) Source Plasma labels must include the following information: (i) The cautionary statement, as specified in paragraph (c)(10) of this section, must follow the proper name with any appropriate modifiers and attributes and be of similar prominence as the proper name. (ii) The statement “Store at −20 °C or colder,” provided, that where plasma is intended for manufacturing into noninjectable products, this statement may be replaced by a statement of the temperature appropriate for manufacture of… |
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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.