Ch 19 P 17 Dangerous drugs and dangerous drug research Flashcards
Board
The New Mexico board of pharmacy.
Dangerous Drug
As defined in the New Mexico Drug, Device and Cosmetic Act, Subsection F of Section 26-1-2 NMSA 1978.
(1) The following substance(s) has(have) been declared by the N.M. board of pharmacy as “Dangerous Drugs” in accordance with Section 26-1-18 NMSA 1978 of the Drug, Device and Cosmetic Act, Section 26-1-18 NMSA 1978 and the Uniform Licensing Act (Sections 61-1-1 to 61-1-31 NMSA 1978). The board of pharmacy shall by regulation declare a substance a “dangerous drug” when necessary and notification shall be sent to all registered pharmacies in the state within 60 days of the adoption of the regulation. Ephedrine, USP, as ephedrine hydrochloride or ephedrine sulfate or as any other salt form. Any compound, mixture, or preparation containing one-half percent or less of ephedrine or of any salt form of ephedrine is exempt from the above. These products are exempt because they are approved for sale over the counter (OTC) without a prescription under federal law, are labeled and marketed in a manner consistent with the pertinent OTC tentative final or final monograph, are manufactured and distributed for legitimate medical use in a manner that reduces or eliminates the likelihood for abuse, and are not marketed, advertised or labeled for an indication of stimulation, mental alertness, energy, weight loss, appetite control, or muscle enhancement. These approved OTC products shall be reported as required of a pseudoephedrine containing product as defined in Subsection B of 16.19.20.53 NMAC.
(2) A dangerous drug shall be dispensed only upon the prescription of a practitioner licensed by law to administer or prescribe such drug.
Drug storage area
The area restricted to the storage, dispensing and distribution of dangerous drugs.
Research protocol
The written documentation stating the objective, method, means of measurement, and utilization procedure of the dangerous drug.
