Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Tuesday, September 18, 2012
Louisiana Board of Veterinary Medicine Rules and Regulations Relating to Prescriptions
of Veterinary Medical Ethics of the American Veterinary Medical Association
III. THE VETERINARIAN - CLIENT – PATIENT
veterinarian - client - patient relationship (VCPR) is the basis for
interaction among veterinarians, their clients, and their patients. A VCPR exists when all of the following
conditions have been met:
veterinarian has assumed responsibility for making clinical judgments regarding
the health of the animal(s) and the need for medical treatment, and the client
has agreed to follow the veterinarian’s instructions.
veterinarian has sufficient knowledge of the animal(s) to initiate at least a
general or preliminary diagnosis of the medical condition of the
animal(s). This means that the
veterinarian has recently seen and is personally acquainted with the keeping
and care of the animal(s) by virtue of an examination of the animal(s), or by
medically appropriate and timely visits to the premises where the animal(s) are
veterinarian is readily available, or has arranged for emergency coverage, for
follow-up evaluation in the event of adverse reactions or the failure of the
B.When a VCPR
exists, veterinarians must maintain medical records (See section VII).
prescribing a prescription product requires a VCPR.
should honor a client’s request for a prescription in lieu of dispensing.
valid VCPR, veterinarians’ merchandising or use of veterinary prescription
drugs or their extra-label use of any pharmaceutical is unethical and is
illegal under federal law.
veterinarians are responsible for choosing the treatment regimens for their
patients. It is the attending
veterinarian’s responsibility to inform the client of the expected results and
costs, and the related risks of each treatment regimen.
unethical for veterinarians to prescribe or dispense prescription products in
the absence of a VCPR.
unethical for veterinarians to promote, sell, prescribe, dispense, or use
secret remedies or any other product for which they do not know the ingredient
unethical for veterinarians to use or permit the use of their names,
signatures, or professional status in connection with the resale of ethical
products in a manner which violates those directions or conditions specified by
the manufacturer to ensure the safe and efficacious use of the product.
Several of the following terms are
used to describe veterinary pharmaceutical products. Some have legal status, others do not. Although not all of the terms are used in the
Principles, we have listed them here for clarification of meaning and to avoid
Product: A product for which the
manufacturer has voluntarily limited the sale to veterinarians as a marketing
decision. Such products are often given
a different product name and are packaged differently than products that are
sold directly to consumers. “Ethical products” are sold only to veterinarians
as a condition of sale that is specified in a sales agreement or on the product
Drug: A synonymous term for a veterinary
prescription drug. The name refers to
the statement (legend) that is required on the label (see veterinary
prescription drug below).
Counter (OTC) Drug: Any drug that can be
labeled with adequate direction to enable it to be used safely and properly by
a consumer who is not a medical professional.
Drug: A drug that cannot be labeled with
adequate direction to enable its safe and proper use by non-professionals.
Prescription Drug: A drug that is
restricted by federal law to use by or on the order of a licensed veterinarian,
according to section 503(f) of the federal Food, Drug, and Cosmetic Act. The law requires that such drugs be labeled
with the statement: “Caution, federal
law restricts this drug to use by or on the order of a licensed veterinarian.”
PRESCRIBING, MARKETING AND MERCHANDISING
(1)Dispensing is the direct distribution of products by
veterinarians to clients for use on their animals.
is the transmitting of an order authorizing a licensed pharmacist or equivalent
to prepare and dispense specified pharmaceuticals to be used in or on animals
in the dosage and in the manner directed by a veterinarian.
(3)Marketing is promoting and encouraging animal owners to
improve animal health and welfare by using veterinary care, services, and
is the buying and selling of products or services.
Prescribe, Prescribing or
Prescription—an order for any drug, medicine, chemical or controlled
substance provided by a veterinarian licensed by the board, stemming from the
veterinarian-client-patient relationship, that is patient specific, which is
1. dispensed or administered
by the prescribing veterinarian;
2. dispensed by a
veterinarian licensed by the board other than the prescribing veterinarian; or
3. written, electronically
communicated or given orally to a registered pharmacist to be filled,
compounded or dispensed by the pharmacist in a registered pharmacy.
G. Providing Prescriptions
1. A client is not obligated
to purchase a prescription medication from the prescribing veterinarian.
Therefore, when a veterinarian-client-patient relationship exists and a
veterinarian has determined that a prescription medication will be used in a
patient's treatment or preventive health plan, it shall be considered a
violation of the rules of professional conduct, within the meaning of R.S.
37:1526(14), for a veterinarian to refuse to provide a written prescription to
the client so long as the following conditions exist:
a. the veterinarian has
determined that the patient's life is not endangered without the immediate
administration of the prescription medication; and
b. in the veterinarian's
medical opinion, the prescribed substance is medically safe for in-home
administration by the client.
2. A veterinarian shall not
be required under §705 to write a prescription for controlled substances or a
prescription for any medication that, in the veterinarian's medical judgment,
is not appropriate for the patient's medical care.
3. A veterinarian may refuse
to write a prescription under §705 if it is not directly requested by a client
with whom a veterinarian-patient-client relationship exists.
4. A written prescription
can be construed to include any manner of authorization for filling a
prescription, including verbal or electronic communication.
H. It shall be a violation of
the rules of professional conduct under R.S. 37:1526(14) for a veterinarian in
the course of his veterinary practice to use or dispense any products,
including drugs, which are expired.
I. It shall be a violation
of the rules of professional conduct under R.S. 37:1526(14) for a veterinarian
to be in possession of drugs or other medical products which are over six
months past their expiration date unless the materials are obviously removed
from use and it can be documented that said drugs are in the process of being
returned or otherwise disposed of.
J. Only a veterinarian
licensed by the board may prescribe any drug, medicine, chemical or controlled
substance for a patient after the establishment of the
veterinarian/client/patient relationship, with the exception of the delegation
of such authority pursuant to Subsection M below.
K. The veterinarian is
responsible for and shall maintain accurate medical records when prescribing
any drug, medicine, chemical or controlled substance which includes the
1. client's name;
2. patient's name;
3. date of prescription;
4. name of drug;
5. usage dosage including
the route of administration;
6. quantity dispensed and
number of refills;
7. name of veterinarian
prescribing the drug, medicine, chemical or controlled substance;
8. telephone calls changing
the prescription or dosages must be recorded in the medical record of the
9. refill information must
be recorded on the prescription and in the medical record of the patient.
prescription of a legend drug shall be communicated personally or by telephone
to the pharmacy by the veterinarian. The initial prescription and any refills
of a controlled drug shall be communicated personally or by telephone to the
pharmacy by the veterinarian. A written prescription for a controlled drug
shall be personally prepared by the prescribing veterinarian. A written
prescription for a controlled drug shall be handwritten or typed, and shall
contain the specific client/patient’s names (or identifying information if
herd, etc.) and the drug(s) prescribed with usage directions, appropriate
government registration numbers, dated, and signed by the prescribing
veterinarian, affixed with his signature stamp, or electronic signature thereon
if transmitted electronically to a pharmacy. However, the use of a signature
stamp or electronic signature will have the presumption the prescribing
veterinarian knows of, and has personally provided, the prescription for the
use of the patient.
M. The veterinarian may
delegate to an office employee the authority to communicate a refill of a
legend drug to the pharmacy on behalf of the veterinarian pursuant to written
protocol established prior to the delegation of such authority.
N. The written protocol
required in Subsection M above shall be maintained on the premises as part of
the prescribing veterinarian's facility procedure and shall include, but not be
limited to, the following:
1. an authorization dated
and signed by the veterinarian delegating specific authority to the office
2. the authorization shall
be for a stated limited period;
3. the authorization shall
specify the exact nature and extent of the delegation of authority;
4. the medical record of the
patient shall be documented to show the exercise of the delegated authority at
the time the office employee communicates to the pharmacy the order to refill;
5. the office employee who
has the delegated authority and the veterinarian shall sign the written
6. the written protocol
shall be made available to the pharmacy at issue on request.
O. A veterinarian licensed by
the board may lawfully prescribe and/or dispense Rompun (legend drug), Telazol
(controlled substance), and/or Ketamine (controlled substance), or a mix of
these drugs, to a deer farmer licensed by, and in good standing with, the
Department of Agriculture and Forestry only under the following terms and
1. For the purpose of this
Section, deer, deer farmer, and deer farm operation shall
apply to cervids only which are further exclusively defined as imported
exotic deer and antelope, elk and farm raised white tail deer
as defined in R.S. 3:3101 et seq.
veterinary-client-patient relationship must first be established, and
thereafter maintained, as defined in §700 and §705.A.2.
3. The veterinarian shall be
familiar with the deer farm operation at issue and have general knowledge of
the species and numbers of animals on the premises.
4. The licensed deer farmer
shall personally maintain a perpetual written inventory of the drugs referenced
in this Section, including the following information:
a. name of drug and date
b. name and address of
veterinarian the drug was purchased from and a written receipt;
c. amount purchased;
d. date of each use;
e. amount used for each
f. reason for each
g. the identity of each
animal by electronic device, tattoo and/or tag upon capture; and
h. the date and amount of
drug wasted, spilled or lost.
5. The licensed deer farmer
shall comply with all state and federal laws regarding the storage of the
drugs, and the perpetual written inventory, in a double locked container when
not in use.
6. The licensed deer farmer
who obtains the drugs from the veterinarian shall be the only person allowed to
use or administer the drugs on his deer and for capture purposes only.
7. Prior to obtaining the
referenced drugs, the licensed deer farmer must successfully complete a board
approved chemical capture course. The veterinarian prescribing and/or
dispensing the drugs must initially obtain and maintain in his records a copy
of the deer farmer's current license issued by the Department of Agriculture
and Forestry and a copy of the licensed deer farmer's current certificate
verifying successful completion of the chemical capture course approved by the
board. The licensed deer farmer must successfully complete a board approved
chemical capture course every three consecutive calendar years.
8. The veterinarian may only
lawfully prescribe and/or dispense the drugs referenced herein in minimal
quantities based on the size of the herd at issue and the history of prior use,
if applicable, of the drug or drugs requested by the licensed deer farmer.
9. Upon requesting a refill
of, or an additional permissible amount of a drug, the licensed deer farmer
shall provide to the prescribing and/or dispensing veterinarian a copy of the
deer farmer's current license issued by the Department of Agriculture and
Forestry, a copy of the current certificate verifying successful completion
within the last three consecutive calendar years of the chemical capture course
approved by the board, and a copy of the perpetual written inventory, as well
as return all empty or sealed containers of the drugs in the case of a refill.
The copy of the deer farmer's current license, the copy of the current
certificate verifying successful completion within the last three consecutive
calendar years of the board approved chemical capture course, the copy of the
perpetual written inventory, and all empty or sealed containers shall be kept
by the veterinarian for his record keeping purposes as required in §701.
10. Any prescribing and/or
dispensing veterinarian who has reason to believe that a licensed deer farmer
is not in compliance with the items and conditions of this Section, or is
otherwise abusing the privileges established by this Section, shall notify, in
writing, the board and the Department of Agriculture and Forestry immediately.
11. The prescribing and/or
dispensing veterinarian shall comply with all state and federal laws and/or
regulations regarding the prescribing and/or dispensing of Rompun (legend
drug), Telazol (controlled substance), Ketamine (controlled substance), or a
mix of these drugs, to a deer farmer licensed by, and in good standing with,
the Department of Agriculture and Forestry.
12. Any prescribing and/or
dispensing veterinarian who violates, or otherwise fails to comply with this
Section, or any part thereof, including all state and federal laws and/or
regulations, shall be guilty of unprofessional conduct within the meaning of
AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1518.