N.M. Admin. Code § 16.19.15.7

Current through Register Vol. 35, No. 21, November 5, 2024

Section 16.19.15.7 - DEFINITIONS

A. "Limited licensure for retailers of veterinary drugs" means a license issued in accordance with the Pharmacy Act 61-11-14.B (13), which authorizes licensees to retail dangerous drugs limited to veterinary use, in accordance with the labeling provisions of the Drug and Cosmetic Act.

B. "Dangerous drug" means a drug...because of any potentiality for harmful effect or the method of its' use, or the collateral measures necessary to its' use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such drug, and hence for which adequate directions for use cannot be prepared.

C. "Animal drug" means a dangerous (prescription) drug that is the subject of an approved new animal drug application or an approved abbreviated new animal drug application under the Federal Food, Drug, and Cosmetic Act.

D. "FDA" means the United States food and drug administration.

E. "Adequate directions for use" means directions under which the layman can use a drug safely and for the purpose for which it is intended. A dangerous drug shall be sold at retail only on the order or prescription of a practitioner licensed by law to administer or prescribe such drug, if it bears the legend: "CAUTION -- federal law restricts this drug to use by or on the owner of a licensed veterinarian".

F. "Licensed practitioner" means a person engaged in a profession licensed by the state, who within the limits of his license, may lawfully prescribe, dispense or administer drugs for the treatment of a patient's condition, and includes doctors of medicine, osteopathy, dentistry, podiatry and veterinary medicine.

G. "Prescription" means an order given individually for the person for whom prescribed, either directly from the prescriber or indirectly by means of a written order, signed by the prescriber and shall bear the name and address of the prescriber, his license classification, the name and address of the patient, the name and quantity of the drug prescribed, directions for use and the date of issue. No person other than a licensed practitioner shall prescribe or write a prescription.

H. "Therapeutically equivalent" means animal drug products which have the same amount of the active drug in the same dosage form which when administered can be expected to provide the same therapeutic effect.

I. "Expiration date" means those drugs and particularly those that are biologic in origin, on which the label is required to bear an expiration date limiting the period during which the drug may be expected to have the labeled potency if it is stored as directed.

J. "Proper storage temperature" means the temperature at which the label on the drug indicates the product must be kept.

(1) Cold; any temperature not exceeding 46 degrees F.

(2) Cool; any temperature between 46 and 50 degrees F.

(3) Room temperature; the temperature prevailing in a working area.

(4) Controlled room temperature; temperature maintained thermostatically between 59 and 86 degrees F.

(5) Excessive heat; any temperature above 104 degrees F.

(6) Protection from freezing; where, in addition to the risk of breakage of the original container, freezing subjects a product to a loss of strength or potency, or to destructive alteration of the dosage form. The container label bears the appropriate notice to protect from freezing.

N.M. Admin. Code § 16.19.15.7

03-07-80...08-27-90, 04-30-98; 16.19.15.7 NMAC - Rn, 16 NMAC 19.15.7, 03-30-02; A, 10-25-12