Ch. 55 - The Regulation of Animal Drugs

What is an adulterated drug?

An unrecognized drug (by the FDA) because it does not meet the standards set by the FDA

What is the FDA?

Food and Drug Administration

What is a contaminated drug?

A drug in which a foreign substance (or substances) are present

What is a misbranded drug?

When the contents of the drug itself is no longer accurately described by the label

What is the CVM?

Center for Veterinary Medicine

What is the FFDCA?

Federal Food Drug and Cosmetic Act

When was the FFDCA passed by congress?

1938

What is the exception to the fact that most drugs can be used up to 6 months past the expiry date in extreme cases?

Tetracyclines

What is the power of the FDA and CVM?

Regulation of the manufacturing and distribution of drugs, food additives, and medical devices used in veterinary species

Where does the legal justification for the FDA/CVM regulation come from?

FFDCA

What is a drug designated as when it is deemed unsafe within the meaning of the FFDCA?

Adulterated

What is a device?

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions

A device needs to be FDA approved.

True

What is the USDA?

US Department of Agriculture

What is the EPA?

Environmental Protection Agency

What is the governing body of animal drugs?

FDA

What is the governing body of pesticides?

EPA

What does ADME mean in terms of drugs?

Absorption, distribution, metabolism, or excretion

What is an animal drug?

A product intended for use in animals for the diagnosis, cure, mitigation, treatment, or prevention of disease, or a product other than food, intended to affect the structure or any function of the body of animals. Including any drug intended for use in animal feed but not including the animal feed.

What is mitigation?

Inability to prevent a disease but can lessen the effects of the disease

When was the Kefauver-Harris Drug Amendment (KHDA) passed?

1962

What is GADPTRA?

Generic Animal Drug and Patent Term Restoration Act

When was GADPTRA passed?

November 16th, 1988

What is a generic animal drug under GADPTRA?

A generic animal product may be approved by providing evidence that it has the same active ingredients, in the same concentration, as the approved animal drug product, and that it is bioequivalent to the approved animal drug product

How long is the market exclusivity under GADPTRA?

3 years

What is an ANADA?

Abbreviated New Animal Drug Application

What is the AMDUCA?

Animal Medicinal Drug Use Clarification Act

What levels does AMDUCA operate at?

Federal and State

When was AMDUCA passed?

1994

What did the passage of AMDUCA allow in veterinary medicine?

The use of drugs in an extra label manner

When was Title 21 of the CFR amended to add part 530 entitled Extra-label Drug Use in Animals enacted?

1996

What did Title 21 part 530 allow under AMDUCA?

Permit veterinarians to prescribe extralabel uses of certain approved animal and human drugs to treat animals under certain conditions

What is the pathway for extralabel use of drugs under AMDUCA?

1. Must be by or on the order of a veterinarian

2. Within the context of a veterinarian-client-patient relationship (VCPR)

3. Must not result in violative residues in food producing animals

4. Certain listed compounds are prohibited from extralabel uses in food-producing animals

What is the authority of the agency in regards to extralabel use?

Ability to establish safe and violative levels for residues for extralabel use and may require development of analytical methods for residue detection

What happens after affording an opportunity for public comment the FDA finds a risk to public health or no analytical method has been developed and submitted?

The agency may prohibit the extralabel use

According to the textbook time of writing, 14 prohibitions on using drugs in an extralabel have been enacted in food-producing animals.

True

What are the prohibitions of extralabel use in food-producing animals?

1. Chloramphenicol

2. Clenbuterol

3. Diethylstilbestrol (DES)

4. Dimetridazole

5. Ipronidazole

6. Other nitroimidazoles

7. Furazolidone

8. Nitrofurazone

9. Sulfonamides drugs in lactating dairy cattle (with exceptions)

10. Fluoroquinolones

11. Glycopeptides

12. Phenylbutazone

13. Cephalosporins

14. Adamantines and neuraminidase inhibitors

Why was chloramphenicol added to the prohibition list?

Can cause aplastic anemia

What type of drug is clenbuterol?

Repartitioning agent

What is diethylstilbestrol (DES)?

A known carcinogen

Which of the following can only be used per label?

Fluoroquinolones

What is a federal label?

Contains ALL information needed for federal use and distribution from the manufacturer (including packaging and package inserts)

What is a state label?

Anything you will be dispensing (patient name, owner name, veterinarian name, instructions for use, etc.)

How do you prevent covering any of the federal label with the state label?

Using flagging

What is the establishment of a tolerance?

The FDA maximum concentration of the marker residues within the target tissue or the European version of a tolerance (maximum residue limit MRL) is determined based on the marker residue

What is the target tissue for tolerance?

The edible tissue from which residues most slowly deplete

What is tolerance measured in?

PPM or PPB

What is withdrawal time?

The time between the last administered dose and when the drug residues drop below the safe concentration

Withdrawal times also apply even when you use the drug in an extra label manner or above the approved dosage.

False, all bets are off when you use them in an extra label manner or above the approved dosage

Withdrawal times also apply even when you use the drug in an extra label manner or above the approved dosage.

False, all bets are off when you use them in an extra label manner or above the approved dosage

What section of the FFDCA defines a “label”?

Section 201K

How does the FFDCA define label?

A display of written, printed, or graphic matter upon the immediate container of any article

What does a drugs label include?

All labels and other written, printed, or graphic matter, such as package inserts, on the drug, its containers or wrappers or accompanying the drug

How is labeling information derived?

Studies submitted by the pharmaceutical sponsor to the FDA to support new animal drug approval and is developed in collaboration between FDA and the drug sponsor

What are the heading that safety information can be provided under?

Contraindications, warnings, precautions, adverse reactions, and animal safety

Who is responsible for determining the marketing status of animal drug products?

FDA

How is it determined if a drug is going to be prescription vs. over the counter?

Whether or not it is possible to prepare “adequate directions for use” under which a laypersons can use the drug safely and effectively

What is the shorthand for prescription?

Rx

What is the shorthand for over the counter?

OTC

Prescription products can be dispensed only by or upon the lawful written order of a licensed veterinarian.

True

The same drug substances can be marketed in a number of different dosage forms, intended for use by different routes of administration, and in different species of animals.

True

What statement must veterinary prescription drugs bear within the legend?

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

What is a VFD?

Veterinary feed directive

Which of the following classes of drugs is regulated by state pharmacy bodies?

Rx

Extralabel use of a VFD is permitted.

False, never

What is the correct relationship between dosage and withdrawal time?

Control of dose = control of withdrawal time

When was the Minor Use and Minor Species Animal Health Act passed?

2004

What did the MUMS Act create?

Office of Minor Use and Minor Species Animal Drug Development (OMUMS)

What is OMUMS responsible for?

Overseeing the development and legal marketing of new animal drugs for minor use in major species and for minor species

What defines minor use?

Disease conditions that are rare in major species

What species fall under major species?

Cattle, swine, chickens, turkeys, dogs, cats, and horses

What are the key ways that MUMS legislation modified the provisions of the FFDCA?

Conditional approval, indexing, and designation

What is conditional approval?

Allows the sponsor to market the drug after proving the drug is safe and establishing a reasonable expectation of effectiveness, but before collecting all of the effectiveness data needed to support a full approval

What is indexing?

Allows the FDA to add a minor species drug to an index of unapproved new animal drugs that may be legally marketed when the potential market for the drug is too small to support the costs of the drug approval process, even under conditional approval

What is designation?

Provides incentives for approvals such as grants to support safety and effectiveness testing

What is the primary purpose for maintaining the FDA/CVM/ADE database?

Provide an early warning or signaling system for adverse effects not detected during premarket test of the FDA-approved animal drugs and for monitoring the performance of drugs not approved for use in animals

Veterinarians are the only people encouraged to report adverse experiences and product failures to the government agency that regulates the product.

False, animal owners are encouraged to report as well

How are veterinarians supposed to report adverse experiences?

By filling out the Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report

What is the PMO?

Pasteurized milk ordinance