Large Animal Medicine Exam 1 with 312 actual answers.

Large Animal Medicine Exam 1 with 312
actual answers.
Large Animal Medicine Exam 1 with 312
actual answers.
Animal Drugs:

• "Under the Act, the term "drug" means articles recognized in the official United States Pharmacopoeia,
official Homeopathic Pharmacopoeia of the United States, or official National Formulary; articles
intended for use in the __________________, __________, mitigation, treatment, or
_____________________ of disease in man or other animals; and articles other than food intended to
affect the structure or any _________________ of the body of man or other animals." - ANSWER
diagnosis, cure;

prevention;

function



Animal Drugs:

• Over‐the‐Counter (OTC)

• ______________________ (Rx)

• Veterinary __________ __________________ (VFD)

- drugs delivered through the feed

• ____________ ____________ Drug Use (ELDU)

- Involves both OTC and Rx Drugs

• As the herd veterinarian you should be involved in how ALL drugs are used on your clients operations -
ANSWER Prescription;

Feed Directive;

Extra Label



Classifying RX, VFD and OTC Animal Drugs

• ________ is responsible for determining the marketing status (prescription, over‐the-counter, or VFD)
of animal drug products based on whether or not it is possible to prepare "adequate
___________________ for use" under which a layperson can use the drugs safely and effectively. -
ANSWER FDA;

,Large Animal Medicine Exam 1 with 312
actual answers.
directions



Classifying RX, VFD and OTC Animal Drugs "safely and effectively"

• Safe use includes safety to the ______________, safety of __________ ___________________ derived
from the animal, safety to the persons associated with the animal, and safety in terms of the drug's
impact on the _______________________.

• Effective use of a drug product assumes that an accurate ____________________ can be made with a
reasonable degree of certainty, that the drug can be properly _________________________, and that
the course of the disease can be __________________ so that the success or lack of success of the
product can be observed. - ANSWER animal;

food products;

environment;

diagnosis;

administered;

followed



Classifying RX, VFD and OTC Animal Drugs

• Prescription (Rx) products can be dispensed only by or upon the lawful written order of a
____________________ ________________________.

• Rx products must bear the legend:

- "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

• Veterinary Feed Directive (VFD) drugs, combination VFD drugs, and feeds containing VFD drugs or
combination VFD drugs must prominently and conspicuously display the following cautionary statement:

- ''Caution: Federal law restricts ____________________ __________ containing this VFD drug to use by
or on the order of a licensed veterinarian.'' - ANSWER licensed veterinarian;

medicated feed



What is AMDUCA?

• Animal ___________________ __________ ________ _______________________ Act of 1994

• The regulations that enforce this law took effect December 9, 1996

,Large Animal Medicine Exam 1 with 312
actual answers.
• Published at 21 CFR Part 530

• Established conditions for legal ___________ ___________ use of drugs in animals - ANSWER
Medicinal Drug Use Clarification;

extra‐label



What is AMDUCA?

• Extra Label Drug Uses of new animal drugs was considered illegal and permitted only as a matter of
enforcement discretion until the passing of AMDUCA.

• AMDUCA amended the Federal Food, Drug, and Cosmetic Act (the Act), legalizing extra‐label drug use
by and under the order of a licensed veterinarian within the context of a valid
______________________-_____________-________________ relationship, and became effective in
1996 when implementing regulations (21 CFR Part 530) were published.

• AMDUCA allows veterinarians to prescribe extra‐label uses of certain approved animal drugs and
approved ____________ drugs for animals under specified conditions. - ANSWER veterinarian‐client‐
patient;

human



AMDUCA Defines

• Requirements for Extra‐Label Drug Use

- Veterinary Client Patient Relationship

• ___________ requirements

• _______________ requirements

• Limitations

• Prohibitions - ANSWER Label;

Records



"Extra‐label use" is defined as:

• "Actual use or intended use of a drug in an animal in a manner that is not in accordance with the
approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for
indications (disease and other conditions) not listed in the labeling, use at ______________ levels,

, Large Animal Medicine Exam 1 with 312
actual answers.
frequencies, or ____________ of administration other than those stated in the labeling, and deviation
from labeled _____________________ time based on these different uses." - ANSWER dosage;

routes;

withdrawal



Definitions Under AMDUCA

• Under the provisions of the Animal Medicinal Drug Use Clarification Act of 1994, the FDA recognizes
the professional judgment of veterinarians, and allows the extra‐label use of drugs by veterinarians
under certain conditions.

• Any drug used in an extra‐label manner is by definition a _____________________ drug since the
involvement of a veterinarian is required.

- In the absence of a valid veterinarian‐client‐patient relationship, if an approved new animal drug (or
human drug) is used for a use for which it is not labeled, such use has caused the drug to be deemed
unsafe and therefore ________________________ under the Act - ANSWER prescription;

adulterated



THE AABP (American Association of Bovine Practitioners) IDENTIFIES THE FOLLOWING AREAS THAT ARE
CRITICAL COMPONENTS FOR ESTABLISHING AND MAINTAINING A VCPR (veterinarian-client-patient
relationship):

• _____________ Agreement

- Maintain written agreements for working relationships

• Veterinary Oversight

- Have a Veterinarian of Record

• Relationship with consultants and other veterinarians

- Clarify any and all relationships with consultants and other veterinarians

• ____________________ Protocols

- Provide written protocols

• Written/Electronic Treatment Records

- Ensure written or electronic treatment records are maintained

• Prescription Drugs