Professional Documents
Culture Documents
• Introduce the Veterinary Feed Directive and its implications on veterinary practice
• Introduce the Controlled Substances Act and the Drug Enforcement Agency
• List various controlled substances used in veterinary medicine and which schedules
they fall under
Background
• Pharmacology:
• The branch of medicine concerned with the uses, effects, and modes of action of drugs in the
body
• Pharmacy laws and regulations are important to understand in order to prevent misuse
and illegal dispensing/handling of medications
Veterinarians are often “pharmacists”
• In many community practices, veterinarians dispense and sell
medications.
Agreement:
Examination: Follow-up:
Veterinarian accepts
Vet must have recently Vet agrees to be
responsibility for
examined the animal available for follow-up
treating the animal;
or documented a visit if a problem occurs
owner agrees to follow
to the farm with treatment
vet’s instructions
VCPR
• AVMA’s Principles of Veterinary Medical Ethics: Section III
• The veterinarian has assumed the responsibility for making medical judgments
regarding the health of the patient and the client has agreed to follow the
veterinarian's instructions.
• The veterinarian has sufficient knowledge of the patient to initiate at least a general
or preliminary diagnosis of the medical condition of the patient. This means that the
veterinarian is personally acquainted with the keeping and care of the patient by
virtue of:
• a timely examination of the patient by the veterinarian, or
• medically appropriate and timely visits by the veterinarian to the operation where the
patient is managed.
• The veterinarian is readily available for follow-up evaluation or has arranged for the
following:
• veterinary emergency coverage, and
• continuing care and treatment.
• The veterinarian provides oversight of treatment, compliance and outcome.
• Patient records are maintained.
VCPR
• IC 25-38.1-1-14.5"Veterinarian-client-patient relationship"
• Sec. 14.5. "Veterinarian-client-patient relationship" means a relationship between a
veterinarian and client that meets the following conditions:
• (1) The veterinarian has assumed the responsibility for making clinical judgments regarding
the health of the animal and the need for medical treatment, and the client has agreed to
follow the veterinarian's instructions.
• (2) The veterinarian has sufficient knowledge of the animal to initiate a diagnosis of the
medical condition of the animal. The veterinarian has recently seen and is personally
acquainted with the keeping and care of the animal by either of the following:
• (A) An examination of the animal.
• (B) By recently seeing and being personally acquainted with the keeping and care of representative
animals and associated husbandry practices by making medically appropriate and timely visits to
the premises where the animal is kept.
• (3) The veterinarian is readily available or has arranged for emergency coverage for follow-
up evaluation if there is an adverse reaction or failure of the treatment regimen.
• (4) When appropriate, the veterinarian has arranged for continuing care with another
licensed veterinarian who has access to the animal's medical record.
History of Important Laws
• Food and Drug Act of 1906 – prevention of mislabeling
• Products must contain what the label says it contains
• No safety testing required
• No efficacy testing required
• Note that some of these medications may not be marketed at this time
What does this mean?
• Veterinarian-Client-Patient Relationship (VCPR) required
• Written (nonverbal) statement from a licensed veterinarian
• Name of VFD drug
• Date of issuance, date of expiration (no more than 6 months from issuance)
• Veterinarian’s name, address, phone number, electronic or written signature
• Client’s name, address, phone number
• Location of animal/animals (i.e., a farm)
• Species and production class of animals to be fed
• Approximate number of animals to be fed
• Duration of use, Number of reorders authorized
• Indication
• WDT, special instructions and cautionary statements
• Statement: “ Use of feed containing this VFD drug in a manner other than as
directed on the labeling is not permitted”
Veterinary Feed Directive (VFD)
• Useful links:
• FDA’s Q&A on VFD Regulation:
• http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforce
ment/GuidanceforIndustry/UCM052660.pdf
• FDA’s Brochure on the VFD for veterinarians:
• https://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess
/UCM455480.pdf
Withdrawal Time (WDT)
• The WDT is the estimated time that tissues can be safely
consumed following the last dose of drugs in 99% of animals
treated.
• WDTs are expressed in days for meat and eggs, and hours for milk
• Meat: the animal cannot be slaughtered for food prior to that time
• Milk: the milk taken from the lactating cow must be discarded for that many
hours after the last dose of drug is given
• Drugs approved for use in food animals must contain WDT
information on their labeling
Food Animal Residue Avoidance
Database (FARAD)
• Supported by USDA
• A computer based decision support program to provide drug and pesticide WDTs for
producers, DVMs, and extension specialists
FARAD
• “The overarching goal of FARAD is to provide current and
accurate scientific information to veterinary practitioners and
thereby foster production of animal-derived human foods that
are devoid of unsafe chemical residues, including drugs,
pesticides, natural toxins and environmental contaminants.”
• http://www.farad.org/
Amendments to the Federal FDC Act
• MUMS = Minor Use/Minor Species Act of 2004
• Minor uses: disease affecting a small percentage of a species
• Minor Species: everything that’s not a major species
• Major Species:
• Cats
• Dogs
• Cattle
• Horses
• Pigs
• Chickens
• Turkeys
MUMS Approval Process
• CONDITIONAL APPROVAL: A sponsor can apply for “conditional approval,” which
allows the sponsor to make the drug available before collecting all necessary
effectiveness data, but after proving the drug is safe in accordance with the full FDA
approval standard and showing that there is a reasonable expectation of
effectiveness.
• DESIGNATION: Sponsors of “designated” new animal drugs are eligible to apply for
grants to support safety and effectiveness testing.
• INDEXING: In some cases, a minor species drug is intended for use in species that are
too rare or too varied to be the subject of adequate and well-controlled studies in
support of a drug approval. FDA may add the intended use to the Index of Legally
Marketed Unapproved New Animal Drugs for Minor Species (the Index). This provision
is limited to minor species that are not used as food for humans or other animals.
The Pathway to FDA Approval
•New Animal Drug Application (NADA)
• Full blown approval for pioneer drug