Professional Documents
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THERAPEUTICS IN PRACTICE V
At referral centers, over 50% erinarians to prescribe (under establish the conditions for
of the prescriptions may be extra- the guidance of the FDA) human the use or intended use of
Barbara S. Simpson, PhD, DVM label.1 Until recently, veterin- and animal drugs in an extrala- the drug in animals.
The Veterinary Behavior Clinic arians made extralabel drug bel manner for their patients.
Southern Pines, North Carolina prescriptions under two FDA Thus, responsible extralabel At present, the details of these
Compliance Policy Guides 2 drug use, which was previously regulations are under advise-
Victoria L. Voith, DVM, PhD administered by the FDA’s Cen- regulated by Policy Guides, is ment by the FDA’s Center for
Pet Behavior ter for Veterinary Medicine.1 now regulated by law.3,4 Veterinary Medicine.
Dayton, Ohio The Policy Guides exercised
regulatory discretion over the
Food, Drug and Cosmetic Act. ■ The Animal Medicinal Drug Use Clarification
D
rugs that have been Compliance Policy Guide #7125.06 Act (AMDUCA) has now taken effect.
approved by the U.S. regulated extralabel use of vet- ■ The prescribing veterinarian is still responsible
KEY POINTS
Food and Drug Ad- erinary drugs in animals. Com- for the safe use of the drug, including adverse
ministration (FDA) for the treat- pliance Policy Guide #7125.35 drug effects, and for determining that the effica-
ment of human psychiatric dis- regulated the distribution and cy of a drug exceeds its risk.
orders are increasingly being veterinary use of drugs ap- ■ The establishment of a good veterinarian–
used by veterinarians for the proved for use in human client–patient relationship is crucial for protect-
treatment of animal behavior medicine. The latter guide stat- ing the veterinarian against legal liability in vet-
problems. Such use, however, ed that veterinary practitioners erinary behavior cases.
is extralabel. Extralabel drug may normally consider the use
use is the “actual or intended of human-labeled drug prod-
use of a new animal drug in a ucts in non–food-producing an- AMDUCA permits extralabel This permission to use FDA-
manner that is not in accor- imal practice without the threat use of FDA-approved human approved human drugs does
dance with the drug labeling.”1 of FDA enforcement actions. In drugs under the following con- not mean that the veterinarian
Using a veterinary drug la- rare circumstances (e.g., when ditions3,5: can prescribe human psychi-
beled for treatment of one vet- the health of the treated animal atric drugs with impunity. The
erinary medical condition to is harmed), the FDA might con- ■ The drug is used by or on prescribing veterinarian is still
treat a different veterinary con- sider regulatory action or (more the lawful written or oral responsible for the safe use of
dition (e.g., a behavior prob- likely) refer the matter to the order of a licensed veteri- the drug, including adverse
lem) is one type of extralabel state veterinary licensing au- narian. drug effects, and for determin-
use. Using a drug labeled for thority for investigation.2 ing that the efficacy of a drug
The regulations with regard ■ The drug is used within the
treatment of a human condi- exceeds its risk.4,6
to extralabel drug use changed context of a veterinarian–
tion, such as depression, to
according to the Animal Medic- client–patient relationship. Safety and Efficacy Data
treat an animal problem, such
as aggression, is another type inal Drug Use Clarification Act ■ The use is in compliance Obtaining scientific evidence
of extralabel use. of 1994 (AMDUCA, Public Law with regulations promulgat- that a drug will be safe and ef-
103-396). The new act, which ed by the Secretary of Health fective is a particular problem
Regulatory Guidelines has been in effect since late and Human Services and for veterinary behaviorists. Few
Extralabel use of drugs is 1996, supersedes the previous adopted by the FDA Center of the human psychotropic
common in veterinary medicine. Policy Guides and permits vet- for Veterinary Medicine that drugs have been well studied
Small Animal The Compendium March 1997