Virginia Board of
Veterinary Medicine
Use of Compounded Drugs
in Veterinary Practice
Applicable Laws
§
54.1-3401. Definitions.
As used in this
chapter, unless the context requires a different meaning:
"Compounding"
means the combining of two or more ingredients to fabricate such ingredients
into a single preparation and includes the mixing, assembling, packaging, or
labeling of a drug or device (i) by a pharmacist, or within a permitted
pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic
purpose in the context of a bona fide practitioner-patient-pharmacist
relationship, or in expectation of receiving a valid prescription based on
observed prescribing patterns; (ii) by or for a practitioner of medicine,
osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his
administering or dispensing, if authorized to dispense, a controlled substance
in the course of his professional practice; or (iii) for the purpose of, or as
incident to, research, teaching, or chemical analysis and not for sale or for
dispensing. The mixing, diluting, or reconstituting of a manufacturer's product
drugs for the purpose of administration to a patient, when performed by a
practitioner of medicine or osteopathy licensed under Chapter 29 (§ 54.1-2900
et seq.), a person supervised by such practitioner pursuant to subdivision A 6
or A 19 of § 54.1-2901,
or a person supervised by such practitioner or a licensed nurse practitioner or
physician assistant pursuant to subdivision A 4 of § 54.1-2901
shall not be considered compounding.
§ 54.1-3410.2. Compounding; pharmacists' authority to compound under
certain conditions; labeling and record maintenance requirements.
A. A pharmacist
may engage in compounding of drug products when the dispensing of such
compounded products is (i) pursuant to valid prescriptions for specific
patients and (ii) consistent with the provisions of § 54.1-3303
relating to the issuance of prescriptions and the dispensing of drugs.
Pharmacists
shall label all compounded drug products that are dispensed pursuant to a
prescription in accordance with this chapter and the Board's [Pharmacy]
regulations, and shall include on the labeling an appropriate beyond-use date
as determined by the pharmacist in compliance with USP-NF standards for
pharmacy compounding.
B. A pharmacist
may also engage in compounding of drug products in anticipation of receipt of
prescriptions based on a routine, regularly observed prescribing pattern.
Pharmacists
shall label all products compounded prior to dispensing with (i) the name and
strength of the compounded medication or a list of the active ingredients and
strengths; (ii) the pharmacy's assigned control number that corresponds with
the compounding record; (iii) an appropriate beyond-use date as determined by
the pharmacist in compliance with USP-NF standards for pharmacy compounding;
and (iv) the quantity.
C. In accordance
with the conditions set forth in subsections A and B, pharmacists shall not distribute
compounded drug products for subsequent distribution or sale to other persons
or to commercial entities, including distribution to pharmacies or other
entities under common ownership or control with the facility in which such
compounding takes place.
A pharmacist
may, however, deliver compounded products dispensed pursuant to valid
prescriptions to alternate delivery locations pursuant to § 54.1-3420.2.
A pharmacist may
also provide compounded products to practitioners of medicine, osteopathy,
podiatry, dentistry, or veterinary medicine to administer to their patients in
the course of their professional practice, either personally or under their
direct and immediate supervision.
Pharmacists
shall label all compounded products distributed to practitioners for
administration to their patients with (i) the statement "For Administering
in Prescriber Practice Location Only"; (ii) the name and strength of the
compounded medication or list of the active ingredients and strengths; (iii)
the facility's control number; (iv) an appropriate beyond-use date as
determined by the pharmacist in compliance with USP-NF standards for pharmacy
compounding; and (v) quantity.
E. Pharmacists shall
ensure compliance with USP-NF standards for both sterile and non-sterile
compounding.
J. Practitioners
who may lawfully compound drugs for administering or dispensing to their own
patients pursuant to §§ 54.1-3301, 54.1-3304,
and 54.1-3304.1
shall comply with all provisions of this section and the relevant Board
regulations.
Guidance
Q: May a veterinarian prescribe a compounded drug product?
A: A Virginia licensed veterinarian may prescribe a compounded drug product by preparing a valid prescription pursuant to
federal and state laws and regulations for an individual patient with which
there exists a valid veterinarian-client-patient relationship. The client may obtain
the compounded drug product from a pharmacy of
their choice that is properly licensed by the Virginia Board of Pharmacy. The
payment arrangements for a prescribed compounded drug product are not under the
purview of the Board of Veterinary Medicine. However, a pharmacist must be
compliant with the Virginia Board of Pharmacy regulation, 18VAC110-20-390(A),
which states “A Pharmacist shall not solicit or foster prescription practice
with a prescriber of drugs or any other person providing for rebates,
‘kickbacks,’ fee-splitting, or special charges in exchange for prescription
orders unless fully disclosed in writing to the patient and any third party
payor.”
Q: May a veterinarian obtain compounded drug products from a
pharmacy for administration in their office?
A: Yes, a Virginia licensed veterinarian may obtain compounded drug products from a pharmacy that is properly licensed by
the Virginia Board of Pharmacy for administration
in the course of their professional practice. Pursuant to Virginia Code § 54.1-3410.2(C) the pharmacist is
required to label the compounded drug product with the statement “For Administering in Prescriber
Practice Location Only.”
Q: May a veterinarian dispense a compounded drug product?
A: A veterinarian may dispense a compounded drug product if
compounded by the veterinarian pursuant to Virginia Code § 54.1-3410.2(J).
Q: May a pharmacy provide compounded drug products to a veterinarian
for the veterinarian to dispense to his patients?
A: No, Virginia Code § 54.1-3410.2 prohibits pharmacists from distributing compounded drug products
for subsequent distribution or sale to other persons.
Q: What is the penalty for a licensee of the Virginia Board of
Veterinary Medicine who is found to be dispensing compounded drug product purchased from a pharmacy?
A: The licensee may be subject to disciplinary action.
source found here:
54.1-3410.2. Compounding; pharmacists' authority to compound ...
https://www.dhp.virginia.gov/vet/guidelines/150-5.docFile Format: Microsoft Word - Quick View
Feb 7, 2013 – Use of Compounded Drugs in Veterinary Practice ... as incident to, research, teaching, or chemical analysis and not for sale or for dispensing