Minnesota Administrative Rules

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.

Statutory Authority:

MS s 151.06

History:

36 SR 237

Published Electronically:

September 21, 2011