CFR section
21 CFR 610.60(a): Container label
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart G-Labeling Standards
Key facts
| Citation | 21 CFR 610.60(a) |
|---|---|
| Section | Container label |
| Part | PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS |
| Subpart | Subpart G-Labeling Standards |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (a) Full label. The following items shall appear on the label affixed to each container of a product capable of bearing a full label: (1) The proper name of the product; (2) The name, address, and license number of manufacturer; (3) The lot number or other lot identification; (4) The expiration date; (5) The recommended individual dose, for multiple dose containers. (6) The statement: “ ‘Rx only’ ” for prescription biologicals. (7) If a Medication Guide is required under part 208 of this… |
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