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Veterinary Pharmacology > Regulation of Animal Drugs > Flashcards

Regulation of Animal Drugs Flashcards

1
Q

What 4 federal agencies govern how drugs are used in veterinary medicine?

A
  1. Food and Drug Administration (FDA) - US Dept. of Health and Human Sevices
  2. Center for Veterinary Medicine (CVM) - subdivision of FDA responsible for regulating drugs, medical devices, and food additives administered to animals
  3. Drug Enforcement Agency (DEA) - division of the US Dept. of Justice responsible for enforcing the Controlled Substance Act
  4. United States Department of Agriculture (USDA)
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2
Q

What 2 state agencies govern how drugs are used in veterinary medicine?

A
  1. Board of Veterinary Medicine (BVM) - protects the health and safety of the public and animals through the regulation of veterinary practice as expressed in the state’s acts
  2. Board of Pharmacy (BOP) - regulates wholesale and pharmacy distribution of pharmaceutical products
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3
Q

What federal agency authorizes FDA governing in veterinary medicine? What ruling does it rely on?

A

US Congress

1938 Federal Foods, Drugs, and Cosmetics Act

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4
Q

What is the Freedom of Information Act?

A

provides the public the right to request access to records from any federal agency

  • keeps citizens in the know about their government
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5
Q

What are the New Animal Drug and Abbreviated New Animal Drug Applications?

A

NADA = seeks approval for new drug development

ANADA = seeks approval for the use of generic new animal drugs that are copies of an already approved drug for which patents are near expiration

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6
Q

What is assumed about a new animal drug that is not yet approved by the New Animal Drug Application?

A

considered unsafe

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7
Q

What federal agencies control veterinary biologics?

A
  • USDA APHIS
  • Veterinary Services
  • Veterinary Biologics

(vaccines, antitoxins, and diagnostics used to prevent, treat, or diagnose animal disease)

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8
Q

What act controls the development and use of medical devices?

A

1938 Federal Foods, Drugs, and Cosmetics Act

  • instruments, apparatuses, implements, machines, implants, in vitro reagents, or other related machinery intended for use in the diagnosis, mitigation, treatment, or prevention of disease
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9
Q

What federal agency controls pesticides? What 3 types of pesticides are included?

A

Environmental Protection Agency (EPA) under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (+FDA)

  1. preparations for use on inanimate objects (disinfectants)
  2. rodenticides
  3. insecticides
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10
Q

How long have veterinarians been a part of the FDA? When did regulation of veterinary pharmaceuticals begin?

A

since it was formed in 1927

1950s

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11
Q

What is the Generic Animal Drug and Patent Term Restoration Act of 1988?

A

provides a period of 3 years of marketing exclusively for a new use of an animal drug or 5 years for an animal drug not previously approved in any new animal drug application

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12
Q

What is the Green Book?

A

publication of a list of animal drug products eligible to be copied as generics arranged by the Center for Veterinary Medicine

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13
Q

What is the Animal Medicinal Drug Use Clarification Act of 1994? How were veterinarians required to act before this?

A

enabled veterinaries for the first time to use human or animals drugs in an extralabel manner for animals under certain conditions

prohibited from prescribing new animal drugs for any indications other than the specific conditions of use on the approved labeling or even using human drugs

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14
Q
  • Is extralabel drug use (ELDU) only for food-producing animals?
  • Is off-label use the same as ELDU?
  • Do you need to list a withdrawal time if the ELDU is for non-food-producing animals?
  • Are pesticides subject to ELDU?
A
  • NO
  • YES
  • NO
  • NO
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15
Q
  • Can you treat a patient with a drug labeled for another animal species?
  • Can clients decide to administer drugs in an extralabel function to their animals?
  • Are vaccines subject to ELDU?
  • Can you treat a patient with a drug labeled for use in people?
A
  • YES
  • NO
  • YES (canine rabies vax for zoo animals)
  • YES
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16
Q

When is ELDU permitted?

A

only for FDA-approved drugs for therapeutic uses (NOT PRODUCTION) under the supervision of a veterinarian

17
Q

In what 2 situations if ELDU prohibited?

A
  1. use in feed (rules apply for doses and drugs administered in water)
  2. if usage results in a violative food residue that can present a risk to public health (requires analytical methods for residue detection)
18
Q

What 12 drugs are prohibited for extralabel use in food-producing animals?

A
  1. Chloramphenicol
  2. Clenbuterol
  3. Diethylstilbestrol (DES)
  4. Dimetridazole
  5. Ipronidazole
  6. Other Nitroimidazoles
  7. Furazolidone (topical approved)
  8. Nitrofurazone (topical approved)
  9. Sulfonamide drugs in lactating dairy cows (sulfadimethoxine, sulfabromomethazine, and sulfaehoxypyridazine approved)
  10. Fluoroquinolones
  11. Glycopeptides (Vancomycin)
  12. Phenylbutazone for female dairy cattle
19
Q

In what 3 situations are Cephalosporins not approved for use in cattle, swine, and chickens? What is an exception?

A
  1. disease prevention
  2. at unapproved doses, frequencies, durations, or routes of administration
  3. if the drug is not approved for that species and production class

Cephapirin

20
Q

What 2 classes of drugs are not approved for treating or preventing influenza A infection in chickens, turkeys, and ducks?

A
  1. Adamantanes
  2. Neuraminidase inhibitors
21
Q

What 10 additional provisions of the Animal Medicinal Drug Use Clarification Act of 1994 were made for proper dispensing and labeling of prescribed drugs for animals?

A
  1. identify the animals
  2. animal species treated
  3. number of animals treated
  4. condition being treaed
  5. established name of the drug and active ingredient
  6. dosage prescribed or used
  7. duration of treatment
  8. specified withdrawal, withholding, or discard times for meat, eggs, or animal-derived food
  9. records must be kept for 2 years
  10. FDA may have access to these records to estimate public health risk
22
Q

What are the 5 label requirements for drugs prescribed to animals?

A
  1. name and address of the prescribing veterinarian
  2. established name of the drug
  3. any specified directions for use including class/species or identification of the animal or herd/flock/pen/lot, dosage frequency, route of administration, and duration of therapy
  4. cautionary statements
  5. specified withdrawal, withholding, or discard times for meat, milk, eggs, or food
23
Q

What is the purpose of the Animal Drug Availability Act of 1996?

A

increase the number of animal drugs on the market to reduce regulatory burdens on the animal health industry without undermining the safety of anmal drug products

24
Q

What 4 things were developed with this Animal Drug Availability Act of 1996?

A
  1. amendment to the definition of substantial evidence of a drug’s effectiveness to allow greater flexibility regarding number and types of adequate studies
  2. greater interaction between sponsors and FDA to reach a common understanding regarding what data will be needed to establish safety and effectiveness
  3. FDA broadens the approval process to increase the ability to market animal drugs with a range of doses (rather than an optimal one) = more drugs available for minor species
  4. created Veterinary Feed Directive Drugs to allow the approval and use of new drugs in or on animal feed (NOT prescription, under the supervision of veterinarians)
25
Q

True of false: Owners can decide to administer drugs in an extralabel fashion to their animals.

A

FALSE

26
Q

Which of the following extralabel drug use is considered legal under AMDUCA?

a. Use of clenbuterol in food-producing animal
b. Only use of certain approved human drugs
c. The administration of drugs in feed
d. The use of cephalexin (non animal-labeled product) in a dog with a skin infection

A

D

27
Q

True or false: If the extralabel use of a drug presents a risk to public health, this drug is restricted from ELDU.

A

TRUE

28
Q

All the following statements regarding CVM are correct except:

a. It is part of the FDA
b. Ensures that Animal drugs are safe
c. Established in 1984
d. Regulates pesticides

A

D - EPA

Veterinary Pharmacology (35 decks)

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