New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
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.