Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Requirements applicable to all drugs.
Except for radiopharmaceuticals, all drugs dispensed to or
for a patient, other than an inpatient of a hospital must be labeled with the
following information:
A. name,
address, and telephone number of the pharmacy filling the prescription drug
order, except that central service pharmacies shall use the name, address, and
telephone number of the pharmacy dispensing the medication to the
patient;
B. patient's
name;
C. prescription
number;
D. name of prescribing
practitioner;
E. directions for
use;
F. name of manufacturer or
distributor of the finished dosage form of the drug;
G. auxiliary labels as needed;
H. date of original issue or
renewal;
I. generic or trade name
of drug and strength, except when specified by prescriber to the contrary. In
the case of combining premanufactured drug products, the names of the products,
or a category of use name shall suffice. In the case of compounding basic
pharmaceutical ingredients, the common pharmaceutical name, if such exists, the
names and strengths of the principal active ingredients or a category of use
name shall suffice;
J. prescription
drug orders filled as part of a central service operation must bear an
identifier that indicates the central service pharmacy at which they were
filled; and
K. after July 1, 2008,
any dispensed legend drug, or nonlegend drug not dispensed in the
manufacturer's original container, must be labeled with its physical
description, including any identification code that may appear on tablets and
capsules. This requirement does not apply to drugs dispensed as part of an
investigational drug study.
Subp.
2.
Small container labeling.
In cases where the physical characteristics of the immediate
container of the medication do not permit full labeling, a partial label
containing, at a minimum, the patient name and the prescription number may be
placed on the container and the complete labeling applied to an appropriate
outer container.
Subp. 3.
Customized patient medication packages.
In lieu of dispensing two or more prescribed drug products in
separate containers, a pharmacist may, with the consent of the patient, the
patient's caregiver, or the prescriber, provide a customized patient medication
package as defined in the United States Pharmacopeia (USP), chapter 661,
standards.
Subp. 4.
Veterinary prescription drug label.
The label for a filled veterinary prescription that is
dispensed by a licensed pharmacy must include:
A. in the case of non-food-producing animals,
the name of the client or animal. In the case of food-producing animals, the
name of the owner and the specific name and address of the facility at which
the filled prescription will be used;
B. identification of the species for which
the drug is prescribed or ordered;
C. the name, strength, and quantity of the
drug, except when specified by the prescriber to the contrary. In the case of
combining premanufactured drug products, the names of the products, or category
of use may suffice;
D. the name of
the manufacturer or distributor of the finished dosage form of the
drug;
E. the date of
issue;
F. directions for
use;
G. withdrawal time, excluding
non-food-producing animals;
H.
cautionary statements if appropriate for the drug;
I. the name, address, and telephone number of
the pharmacy, except that central service pharmacies must use the name,
address, and telephone number of the pharmacy dispensing the medication to the
client;
J. the name and address of
the prescribing veterinarian, except that the address of the prescribing
veterinarian is not required if the prescription is for a non-food-producing
animal; and
K. the prescription
number.
When the veterinary drug is in the manufacturer's original
package and the information that is required on the label includes the drug or
drugs, strength of the drug or drugs, directions for use, withdrawal time for
food-producing animals, and cautionary statements, a label will be required on
each individual bottle or package.
Subp. 5.
Radiopharmaceutical
labeling.
Radiopharmaceutical labeling shall comply with the
requirements in part
6800.8550.
Statutory Authority: MS s
151.06;
151.212;
152.02
