CFR section
21 CFR 211.130(b): Packaging and labeling operations
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart G-Packaging and Labeling Control
Key facts
| Citation | 21 CFR 211.130(b) |
|---|---|
| Section | Packaging and labeling operations |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart G-Packaging and Labeling Control |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Devices, Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (b) Identification and handling of filled drug product containers that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots. Identification need not be applied to each individual container but shall be sufficient to determine name, strength, quantity of contents, and lot or control number of each container. |
At a glance
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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.