Minn. R. agency 164, ch. 6800, RADIOACTIVE DRUGS, pt. 6800.8550 - 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.

Notes

Minn. R. agency 164, ch. 6800, RADIOACTIVE DRUGS, pt. 6800.8550

36 SR 237

Statutory Authority: MS s 151.06