Regulations that affect the use

of drugs, biologics and pesticides

in Veterinary Medicine

Inder Sehgal DVM, Ph.D.

 Regulations that affect the
Practice of Veterinary Medicine
 Topics

Rights & Responsibilities of Practitioner

Agencies responsible for oversight

Laws which affect the Practitioner--ELDU

Rights of the Veterinarian
•A licensed veterinarian is entitled to
purchase, administer, dispense and
prescribe drugs, biological products,
and pesticides
•Veterinarians may not prescribe any
drugs for human use
•Veterinarians may prescribe human
label drugs for use in animals if in
compliance with AMDUCA (Animal
Medicinal Drug Use Clarification Act)
 Responsibilites
• Label drugs: read, understand, and
follow the entire label.
• Know when extralabel use is allowed
• Explain use, expected outcomes, and
risks to client
• Pesticides: most are over-the-counter
(OTC) products and should be used
according to directions
 Agencies involved in veterinary
pharmaceuticals
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• Drug Enforcement Administration (DEA)
• U.S. Dept. of Agriculture (USDA)
– Animal and Plant Health Inspection Service (APHIS)
– Center for Veterinary Biologics (CVB)
– Food Safety Inspection Service (FSIS)
 USDA
• Regulation of biologic products such as
vaccines, bacterins, antisera and
diagnostic kits.
• CVB licenses all biologics
• FSIS mission is to protect the U.S. supply
of foods of animal origin.
• FSIS oversight includes inspection of
meats & poultry for residue and
investigation of human illness from eating
animal food products
 USDA
APHIS
•Veterinary Accreditation: a voluntary
program certifying private veterinarians to
work cooperatively with Federal veterinarians
and State animal health officials.
Accredited Veterinarians help ensure that exported
animals will not introduce diseases into another State or
country.
•Issue health certificates, reports of
vaccination, inspection—applies to pets as
well as livestock.
 USDA
APHIS

•Enforces the Animal Welfare Act (AWA) to

provides for care and use of vertebrates in
research, testing, teaching, and exhibition.

•Determining standards of humane care and

treatment of horses in shows.
 FDA
• The Food and Drug Act of 1907 established
the first federal control over drugs (response to Upton
Sinclair’s The Jungle)

• The Food, Drug, and Cosmetic Act of 1937

established the FDA and required evidence of
safety for drugs as well as standards for foods
(response to 170 deaths by solvent used to mix a sulfanilimide).

• The Kefauver-Harris Amendment of 1962 set

stronger safety standards and required proof
of efficacy not just safety (followed the European thalidomide toxicities)
 FDA
• The FDA Center for Vetetrinary Medicine
was established in 1984
• The Generic Animal Drug and Patient
Restoration Act of 1988 set guidelines for
approval of generics
• Animal Medicinal Drug Use Clarification
Act of 1994 set off-label use guidelines
 FDA
• In summary, the FDA ensures the safety
of all foods except for meat, poultry and
some egg products.
• It regulates the safety of all drugs, human
biological products, medicinal devices
and animal drugs and feed.
 EPA
• The Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) of 1947 governs the
regulation of pesticides in the U.S.
• The EPA was established in 1970 to protect
water, land and air. The enforcement of
FIFRA was delegated to the EPA.
• EPA regulates most topical anti-parasitic
drugs because they are considered pesticides
 DEA
• The Controlled Substances Act (CSA) of 1970
regulated the manufacture and distribution of
narcotics, stimulants, depressants,
hallucinogens, anabolic steroids, and chemicals
used in the production of controlled substances.

• Controlled substances are categorized into 5

schedules based on medicinal value,
harmfulness and potential for abuse or addiction.
 DEA
• DEA Schedules place the most
dangerous substances (lysergic acid
diethylamide) in Schedule 1 and the least
offensive (codeine) in Schedule V
• Amendments to the CSA in 1984 added
authority to deny or revoke a practitioner
registration if it was deemed “contrary to
the public interest”.
• Veterinarians can administer these drugs
for anesthesia, pain and euthanasia.
 DEA Registration
• Can apply as Practitioner or Researcher
• Need:
– Social Security Number
– State Controlled Substance Registration
– State Medical License Information
– Information pertaining to controlled substances in
the applicant's background
• Get:
– DEA registration certificate, which indicates the
issue and expiration dates.
– DEA number (ex. AJ2233445)
 Selected roles of federal agencies
regarding Veterinary drug regulations
USDA FDA EPA DEA
drug residue non-meat food external pesticides schedule drugs
detection of meat safety
vaccines drugs anabolic steroids

antisera extra label drug use

drug prohibition list
compounding
 Extra-Label Drug Use
• Animal Medicinal Drug Use Clarification Act of
1994 (AMDUCA) defines extra-label drug use for
the veterinarian.
• Extra-label (or extralabel) use refers to the use of
an approved drug in a manner that is not in
accordance with the approved directions.
• Off-label use may be a change in dose, route of
administration or species.
• FDA’s primary concern is that off-label use does
not result in violative residues in food animals or
their products.
 Checklist to Apply to AMDUCA
• Licensed veterinarian only
• FDA approved animal or human drugs only
• Must have a valid Veterinary-Client-Patient-
relationship (VCPR).
• Therapeutic use only
• Can not result in violative food residue or
present risk to human health
• Cannot be a drug agent prohibited for extra-
label use in food animals (FDA.gov/cvm and avma.org)
 AMDUCA Prescription
label
• Name and Address of prescribing veterinarian
• Tradename of drug
• Cautionary statements
• Withdrawal time
• Specified directions for use:
– Species/class
– Animal identification
– Dosage, frequency of administration, route, and
duration
 AMDUCA Record Keeping
• Identify animal (individual or group)
• Species
• Number
• Diagnosis
• Trade and generic name
• Dosage and duration of therapy
• Withdrawal time or withholding time
• Keep record for 2 years.
 Veterinary Pharmacy
• Veterinarians write prescriptions and
veterinary feed directives (VFD)
• Prescriptions (Rx) may be written for
either veterinary or human drugs
• Advantages:
– May not need to handle Schedule II drugs
(fentanyl)
– May have a drug compounded by a pharmacy
– May want a small drug inventory
 Veterinarian as Prescriber
• Allopathic & osteopathic physicians,
veterinarians, dentists, and podiatrists
have full prescribing power. Optometrists
can prescribe medications to treat certain
eye diseases. Nurse practitioners and
physician assistants have some form of
prescriptive authority in all 50 states.
Registered pharmacists have some
prescriptive authority in 6 states.
 Veterinarian as Prescriber
• State Boards of Pharmacy regulate
pharmacies and prescription writing
• DEA Registration is required to write Rx for
controlled substances
• State Health Department registration is also
required.
• Prescriptions can only apply to FDA approved
legend drugs (“on the order of or by . . .)
 Prescription Components
• The Superscription
– Date
– Identity and address of client
– Identity of patient-breed and name or number(s)
• Rx (abbr. of Latin Recipe): The Inscription
– the drug
– historically contained the chief ingredient , an
"adjuvant" to cure quickly, a "corrective" to lessen
any undesirable effect (tuto) and an "excipient"
 Prescription Components

• The Subscription
– # to be dispensed
– dosage strength
• The Signa (signature)
– directions to patient for quantity of drug to be
taken, route, frequency and potential adverse
reactions.
– Veterinarian signature
• Refill line
Prescription blank example
 Some Abbreviations
• bid (bis in die) means "twice a day"
• gt (gutta) means "drop"
• od (oculus dexter) means "right eye"
• os (oculus sinister) means "left eye"
• po (per os) means "by mouth"
• pc (post cibum) means "after meals"
• prn (pro re nata) means "as needed"
• q 3 h (quaque 3 hora) means "every 3 hours"
• qd (quaque die) means "every day"
 Some Abbreviations
• qid (quater in die) means "4 times a day"
• sig (signa) means "write"
• tid (ter in die) means "3 times a day“
• cap means capsule
• tab means tablet
• h means hour
• sol means solution
• div means divide
 Compounding

• Compounding is any manipulation of an

existing FDA legend drug or the creation
of a formulation different from that using
the same FDA approved bulk drug
• Manipulation includes mixing, diluting,
concentrating, flavoring, or changing a
drug dosage form.
• Compounding should be done to support
the treatment of a specific patient
 Compounding Examples

• Mixing 2 drugs into a single dosage form

(i.e. a single syringe)
• Adding flavoring
• Changing the concentration
• Making a topical preparation from an oral
suspension
• Making a new drug using bulk drug and
different excipients
 Compounding Rules
• A valid VCPR must exist
• An animal(s) health must be threatened
• Must be no FDA approved product
available to treat
• Must be made from an available FDA
approved drug
• Must be compounded by a licensed vet or
pharmacist
 Compounding Rules
• The compounded drug must be safe.
• The compounded drug must be effective
• The amount of drug made must be
consistent with the need of the patient
• For food animals, a withdrawal time must
be established
• For food animals, the drug cannot be
listed as prohibited in food animals
 Compounding Rules
• Veterinarian must follow AMDUCA
labeling and record keeping rules
 Internet Pharmacies
• The Rx you give to a client may be filled
by an internet pharmacy
• Your client may go to an internet
pharmacy without bringing the patient to
you—if the pharmacy calls you for a
verbal Rx, you should do so only if you
have a valid VCPR.
• You should honor the patient’s right to an
Rx rather than the dispensed drug.
 Internet Pharmacies
• If a cleint is considering internet
pharmacies, then advise them to look for
NABP-VIPPS (verified internet pharmacy
practice site) at vipps@nabp.net
• Remember to advise on proper use and
risks when writing Rx
• Foreign internet pharmacies: drugs may
or may not be counterfeit
 Foreign Internet Pharmacies
• No guarantee of safety or effectiveness
• No guarantee of purity or true
concentration
• No guarantee of storage or shipping
conditions
• Little recourse in case of fraud
 Veterinary Feed Directives
• Allows producers to obtain medicated
feeds without going through pharmacist or
dealing with state pharmacy laws
• Requires Veterinary Patient-Client
Relationship
• For FDA VFD drugs only---not OTC drugs
• The drug manufacturer usually supplies
the VFD form
 Veterinary Feed Directives
• The veterinarian fills out the form and
gives it to the producer who then gives it
to the feed supplier
• VFD approved drugs are almost always
antimicrobials
VFD
form