LABELING OF RADIOPHARMACEUTICALS

Subpart 1. Immediate container of bulk radiopharmaceutical product. Each compounded container must bear a label containing the following information: A. standard radiation symbol with words "Caution - Radioactive Material"; B. radiopharmaceutical name or its abbreviation; and C. radiopharmaceutical lot number. Subp. 2. Outer container of bulk radiopharmaceutical product. Each individual prepared dose must bear a label containing the following information: A. standard radiation symbol with words "Caution - Radioactive Material"; B. radiopharmaceutical name or its abbreviation; C. amount of radioactivity; D. calibration date and time; E. expiration date and time; F. volume - if liquid, weight - if solid, number of vials or ampoules - if gas, number of capsules - if capsules; G. added substances, such as stabilizers and preservatives; H. radiopharmaceutical lot number; I. name, address, and telephone number of nuclear pharmacy, if it is to be transferred for commercial distribution; and J. initials of preparing nuclear pharmacist, if it is to be transferred for commercial distribution. Subp. 3. Immediate container of each radiopharmaceutical dispensed. Each individual prepared dose must bear a label containing the: A. standard radiation symbol with words "Caution - Radioactive Material"; B. radiopharmaceutical name or its abbreviation; C. radiopharmaceutical prescription or lot number; and D. patient name. Subp. 4. Outer container of each radiopharmaceutical dispensed. Each individual prepared dose must bear a label containing the: A. standard radiation symbol with words "Caution - Radioactive Material"; B. radiopharmaceutical name or its abbreviation; C. amount of radioactivity; D. calibration date and time; E. expiration date and time; F. volume - if liquid, or weight - if solid, and number of vials or ampoules - if gas; G. added substances, such as stabilizers and preservatives; H. radiopharmaceutical prescription or lot number; I. name, address, and telephone number of nuclear pharmacy; J. patient name; and K. initials of dispensing nuclear pharmacist.