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.
[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.
[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. "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. "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. "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.
F. "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. "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 DRUGS, LABEL CONTENT:
A. All such drugs shall be labeled by the licensed retail
distributor as follows:
(1) name and address of the retail
distributor;
(2) consecutively numbered prescription or
order number;
(3) date of the prescription, or in the case
of a refill, the date of the refill of the original order or prescription;
(4) name and address of licensed veterinarian
prescriber;
(5) name of owner and/or consignee of the
animal or animals;
(6) directions for use and cautionary statements,
if any, contained in the order or prescription.
B. The attached label, where possible, will not obstruct the
manufacturer's label.
[03-07-80...08-27-90;
16.19.15.10 NMAC - Rn, 16 NMAC 19.15.10,
03-30-02]
16.19.15.11 PACKAGE INSERT: The package insert shall be left in the
dispensed container, unless the prescribing veterinarian indicates on the
prescription that it be removed by the dispenser.
[03-07-80...08-27-90;
16.19.15.11 NMAC - Rn, 16 NMAC 19.15.11,
03-30-02]
16.19.15.12 LABELS, CASE LOT DISTRIBUTION:
A. Labels as required in Section 10 of this Regulation shall
be placed on each drug container when quantity is in less than case lot
distribution.
B. If the prescriber orders in quantities of case lot or
carton, which is the same strength and dose units, the label shall be placed on
each case or carton.
[03-07-80...08-27-90;
16.19.15.12 NMAC - Rn, 16 NMAC 19.15.12,
03-30-02]
16.19.15.13 DANGEROUS VETERINARY USE DRUGS,
MISBRANDED: Dangerous veterinary use
drugs which are distributed at retail without the label required in Section 10
of this regulation shall be deemed to be misbranded under the provisions of the
New Mexico Drug and Cosmetic Act and the federal law.
[03-07-80...08-27-90;
16.19.15.13 NMAC - Rn, 16 NMAC 19.15.13,
03-30-02]
16.19.15.14 AUTHORIZATION:
A. A prescription or order of a licensed veterinarian shall
not be refilled without the authorization of the prescribing veterinarian. If
such authorization is other than written authorization, indicate the
information on the back of the original order or prescription with the date of
such authorization and the signature of the individual receiving such
authorization from the prescriber.
B. A prescription or order shall be valid for no more than
12 months from the date of issue.
[03-07-80...08-27-90;
16.19.15.14 NMAC - Rn, 16 NMAC 19.15.14,
03-30-02]
16.19.15.15 NUMBERED PRESCRIPTIONS: Prescriptions or orders must be consecutively
numbered and filed by the retail veterinary drug distributor. Such files shall
be kept for three years.
[03-07-80...08-27-90;
16.19.15.15 NMAC - Rn, 16 NMAC 19.15.15,
03-30-02]
16.19.15.16 INVOICES AND RECORDS FOR DANGEROUS
VETERINARY DRUGS: All procurement invoices and distribution
records for dangerous veterinary drugs shall be kept for three years and shall
be open to the inspection by an enforcement officer of the State.
[03-07-80...08-27-90;
16.19.15.16 NMAC - Rn, 16 NMAC 19.15.16,
03-30-02]
16.19.15.17 STOCK OR INVENTORY OF DANGEROUS
VETERINARY DRUGS:
A. All stock or inventory of dangerous veterinary drugs
shall be maintained in an area not accessible to the public. Such area shall
provide for the proper storage of drugs with adequate ventilation, lighting,
temperature controls and refrigeration as may be required.
B. Purchase, storage and control of dangerous drugs shall be
such as to prevent having outdated or deteriorated drugs in stock. Expiration
dated drugs shall be checked periodically for outdated products. Outdated
products shall be returned to the supplier or destroyed.
[03-07-80...08-27-90;
16.19.15.17 NMAC - Rn, 16 NMAC 19.15.17,
03-30-02]
16.19.15.18 DISPOSAL OF INVENTORY -- PERMISSION
REQUIRED: Written permission shall be obtained from
the Board before any disposal or sale, transfer, or other removal of a major
part or all the inventory, not in the ordinary course of business by a licensed
retailer of veterinary dangerous drugs.
[03-07-80...08-27-90;
16.19.15.18 NMAC - Rn, 16 NMAC 19.15.18,
03-30-02]
16.19.15.19 REPORT OF ROBBERY, FIRE AND FLOOD: When a retail veterinary drug distributor is
involved in a robbery, fire, flood or any unusual event in which dangerous
veterinary drugs might be missing or damaged, the owner shall immediately file
with the Board, a signed statement of the circumstances of such occurrence and
evidence that local authorities were notified, if applicable.
[03-07-80...08-27-90;
16.19.15.19 NMAC - Rn, 16 NMAC 19.15.19, 03-30-02]
16.19.15.20 CONSULTANT PHARMACIST: Any retail distributor licensed by the Board to
dispense veterinary prescription drugs is required to have a consultant
pharmacist.
A. Consultant pharmacists to retail distributors of
veterinary prescription products are required to visit the facility every other
month. Consultant pharmacists to retail
distributors of veterinary prescription products that do not dispense
controlled substances are required to visit the licensed facility quarterly.
B. The consultant pharmacist shall maintain a log or record
of all visits and activities at the retail distributor of veterinary prescription
products. That record shall document at
least the following:
(1) the date of the annual review of the
Policy and Procedure Manual required by 16.19.4.11 NMAC;
(2) prescriptions are in a consecutively numbered
file;
(3) all procurement, distribution by
precription wholesalers, and disposition records are maintained for at least 3
years;
(4) all inventory of dangerous drugs is
stored in an area not accessible to unauthorized persons;
(5) all dangerous drugs are stored according
to USP/NF requirements with adequate ventilation, lighting, temperature
controls and refrigeration;
(6) the facility is in compliance with all
State and Fedral laws and regulations for the procurement, storage and
dispensing of dangerous drugs; and
(7) orientation and training of all facility
employees, who have access to the dangerous drugs, to the legal requirements of
dangerous drugs and to the Policy and Procedure Manual of the facility.
[06-30-99;
16.19.15.20 NMAC - Rn, 16 NMAC 19.15.20, 03-30-02]
HISTORY
OF 16.19.15 NMAC:
Pre-NMAC
History: The material in this part was
derived from that previously filed with the State Records Center and Archives:
Regulation
No. 15, Dangerous Veterinary Drug Retail Distribution, 2-7-80.
Regulation
No. 15, Dangerous Veterinary Drugs - Retail Distribution, 10-24-85.
Regulation
No. 15, Dangerous Veterinary Drugs - Retail Distribution, 2-2-87.
Regulation
No. 15, Dangerous Veterinary Drugs - Retail Distribution, 7-27-90.
History
of Repealed Material: [RESERVED]
Other
History: 16 NMAC 19.15, Pharmacists -
Dangerous Veterinary Drugs - Retail Distribution, filed 02-02-96, reformatted
and renumbered to 16.19.15 NMAC, Dangerous Veterinary Drugs, effective
03-30-2002.