New
Mexico Register / Volume XXIII, Number 19 / October 15, 2012
This is an amendment to 16.19.15
NMAC, Sections 1, 3, 6, 7, and 9, effective 10-25-12.
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].
[02-15-96;
16.19.15.1 NMAC - Rn, 16 NMAC 19.15.1, 03-30-02; A, 10-25-12]
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; A,
10-25-12]
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; A, 10-25-12]
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.
[C.] 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".
[D.] 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.
[E.] 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.
[F.] 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.
[G.] 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.
[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]
16.19.15.9 DANGEROUS VETERINARY DRUGS AND
ANIMAL DRUG PRODUCT SELECTION: 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.
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.
[03-07-80...08-27-90;
16.19.15.9 NMAC - Rn, 16 NMAC 19.15.9, 03-30-02; A,
10-25-12]