New Mexico Board of Pharmacy Regular Board Meeting Agenda for the August 27-28, 2012 meeting to be held at Ruidoso Convention Center, 111 Sierra Blanca Dr. Ruidoso, New Mexico from 9:00 am to 5:00 pm indicates that new regulations dealing with the retail distribution of Dangerous Veterinary Drugs is to be discussed. That agenda can be viewed
here. The rule to be discussed is as follows:
TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 15 DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION
16.19.15.1 ISSUING AGENCY: Regulation and Licensing Department, Board of Pharmacy, 1650
University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505) 841-9102.
[02-15-1889...02-15-96; 16.19.15.1 NMAC - Rn, 16 NMAC 19.15.1, 03-30-02]
16.19.15.2 SCOPE: All retail veterinary drug distributors.
[02-15-96; 16.19.15.2 NMAC - Rn, 16 NMAC 19.15.2, 03-30-02]
16.19.15.3 STATUTORY AUTHORITY: Section 61-11-14.B. (13) NMSA 1978 authorizes the Board of Pharmacy to issue drug permits for wholesalers, retailers and distributors of dangerous drugs limited to veterinary use. Section 26-3-3(A) NMSA 1978 (the Drug Product Selection Act or “DPSA”) authorizes pharmacists to dispense lower cost versions of multiple-source drugs that meet a final determination of the federal government that is published in the federal register. Section 26-3-2 of the DPSA states that the purpose of the DPSA is to assure that all New Mexico citizens continue to receive high quality drugs at a reasonable cost.
[02-15-96; A, 04-30-98; 16.19.15.3 NMAC - Rn, 16 NMAC 19.15.3, 03-30-02]
16.19.15.4 DURATION: Permanent.
[02-15-96; 16.19.15.4 NMAC - Rn, 16 NMAC 19.15.4, 03-30-02]
16.19.15.5 EFFECTIVE DATE: February 15, 1996, unless a different date is cited at the end of a Section or Paragraph. This Part reformatted for inclusion into the New Mexico Administrative Code (NMAC) effective 2-15-96.
[02-15-96; A, 04-30-98; 16.19.15.5 NMAC - Rn, 16 NMAC 19.15.5, 03-30-02]
16.19.15.6 OBJECTIVE: The objective of Part 15 of Chapter 19 is to establish standards to be followed by retailers and distributors for the safe and competent delivery, distribution, and disposal of dangerous drugs limited to veterinary use. and to carry out the purpose of the Drug Product Selection Act by providing a uniform standard for drug product selection of animal drugs. Section 26-3-3(A) NMSA 1978 permits a pharmacist to select a lower cost multiple source drug that meets a final determination in the federal register when a more costly version of the drug is
prescribed. Animal drugs approved by FDA are subject to final determinations in the federal register and therefore qualify for drug product selection as described in this regulation.
[02-15-96; 16.19.15.6 NMAC - Rn, 16 NMAC 19.15.6, 03-30-02]
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.
CE. "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".
DF. "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. EG. "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.
FI. "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.
GJ. "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.
[03-07-80...08-27-90, 04-30-98; 16.19.15.7 NMAC - Rn, 16 NMAC 19.15.7, 03-30-02]
16.19.15.8 MANUFACTURER'S LABEL: Retail distribution of veterinary drugs which by federal law require the manufacturer to label the following legend: "CAUTION: Federal law restricted this drug to use or on the order of a licensed veterinarian" shall be as follows:
A. shall be sold at retail by the licensee or an employee or employees designated by the licensee only on the written order or prescription of a veterinarian licensed in this state; or
B. if the order or prescription is other than a written order, the designated individual receiving the
oral order or prescription shall immediately reduce such order to writing and the person receiving the order shall indicate the following information on the written record.
(1) name and address of the licensed veterinarian;
(2) name and strength of drug prescribed;
(3) quantity of drug ordered by the veterinarian;
(4) directions for use and cautionary statements, if given, by the veterinarian prescriber;
(5) date of order;
(6) name of owner and/or consignee of animal or animals;
(7) name of individual taking order from veterinarian prescriber.
[03-07-80...08-27-90; 16.19.15.8 NMAC - Rn, 16 NMAC 19.15.8, 03-30-02]
16.19.15.9 DANGEROUS VETERINARY DRUGS: All dangerous drugs distributed at retail on the order of a licensed veterinarian by the limited retail veterinary drug distributor shall be sold in the original, unbroken manufacturer's containers.
[03-07-80...08-27-90; 16.19.15.9 NMAC - Rn, 16 NMAC 19.15.9, 03-30-02]
16.19.15.10 ANIMAL DRUG PRODUCT SELECTION
A. Upon receipt of a prescription for an animal drug, a pharmacist may dispense any lower cost
animal drug that is:
(1) therapeutically equivalent to the prescribed animal drug;
(2) bioequivalent to the prescribed animal drug; and
(3) listed in FDA’s list of approved animal drug products (the “Green Book”).
B. When performing animal drug product selection pursuant to this regulation, a pharmacist may rely on the bioequivalence information found in the FDA FOIA Summaries published on the FDA internet website.
C. A licensed practitioner may prohibit animal drug product selection by writing with his hand the
words "no substitution" or the diminution "no sub" on the face of a prescription.D. If animal drug product selection occurs as permitted in this regulation, the pharmacist shall indicate on the label of the dispensed container the brand of drug prescribed and the name of the drug dispensed.
E. A pharmacist may not select a therapeutically equivalent animal drug unless he passes on to the
purchaser all savings between the net cost of the product prescribed and the product dispensed.