CFR section
21 CFR 606.121(i): 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(i) |
|---|---|
| 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, Drugs |
| Regulation text (excerpt) | (i) The following additional information must appear on the label for blood and blood components intended for autologous transfusion: (1) Information adequately identifying the patient, e.g., name, date of birth, hospital, and identification number. (2) Date of donation. (3) The statement: “AUTOLOGOUS DONOR.” (4) The ABO and Rh blood group and type, except as provided in paragraph (c)(9) of this section. (5) Each container of blood and blood component intended for autologous use and obtained… |
At a glance
- 1–9 Inspections citing this section
- None Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.