Pharm: Professional organization and government agencies

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Questions and Answers

Regulation of animal drugs is administered by the ______

Food and Drug Administration aka FDA

What act gave the FDA authority of regulating animal drugs?

FFDCA aka Federal Food Drug Act and Cosmetic Act

Meat inspection and animal _____ products remained with the _

Meat inspection and animal biologic products remained with USDA

What does the FDA regulate?

Human and animal drugs, human vaccines and devices Signup and view all the answers

The FDA has the easiest approval standards

False (B) Signup and view all the answers

What does the USDA regulate?

It regulates vaccines, antitoxins, and diagnostics used to prevent, treat or diagnose animal diseases Signup and view all the answers

The USDA has easier approval standards compared to the FDA

True (A) Signup and view all the answers

What does EPA stand for?

Environmental protection agency Signup and view all the answers

What does the EPA regulate?

Pesticides (used on animals and inanimate objects) Signup and view all the answers

The EPA has even ___ approval standards

The EPA has even easier approval standards Signup and view all the answers

What does DEA stand for?

Drug enforcement agency Signup and view all the answers

What does the DEA regulate?

It regulates drugs with potential for human abuse Signup and view all the answers

What are the responsibilities of the Center of Veterinary Medicine (CVM)? More than one may apply

Ensure animal drugs are safe and effective (A), Animal drugs are properly made (B), Ensures the animal drug is labeled and packaged (D) Signup and view all the answers

What is NOT regulated by CVM?

The practice of veterinary medicine and doesn’t provide veterinary advice Signup and view all the answers

How does CVM handle post-market surveillance of animal drugs and devices?

It monitors side effects and product quality problems (B) Signup and view all the answers

Which of the following is part of CVM's international role?

Leading and managing CVM’s international activities (A) Signup and view all the answers

Who does CVM educate about regulations?

CVM educates pet owners, animal producers, veterinarians and the animal health industry. Signup and view all the answers

CVM works to make more animal drugs legally available for which of the following?

Minor species and minor uses in major species (A) Signup and view all the answers

Under which act is the EPA authorized to regulate certain animal products?

Federal Insecticide, Fungicide, and Rodenticide Act (C) Signup and view all the answers

How do the FDA and EPA determine whether a product is regulated as a drug or a pesticide?

They collaborate through an informal agreement (B) Signup and view all the answers

What type of identification number is given to products regulated by the EPA?

EPA registration number Signup and view all the answers

How many schedules are drugs divided into based on the potential for abuse?

5 Signup and view all the answers

DEA is not only regulated by federal law, but also state regulated.

True (A) Signup and view all the answers

Every veterinarian must be registered with the ____ if they order, dispense, prescribe or administer a controlled substance

DEA Signup and view all the answers

What determines whether a product is classified as a New Animal Drug (NAD)?

Its intended use (B) Signup and view all the answers

Which of the following is true regarding New Animal Drugs (NAD)?

They are intended to diagnose, cure, mitigate, treat, or prevent disease in animals (B) Signup and view all the answers

Which statement correctly describes the regulation of drugs in animal feed?

Drugs used in feed are considered New Animal Drugs, but the feed itself is not (B) Signup and view all the answers

When is a drug NOT considered a New Animal Drug?

When it is not generally recognized as safe and effective under labeled conditions (A) Signup and view all the answers

What is required for a New Animal Drug (NAD) to be legally sold?

It must be approved through a New Animal Drug Application (NADA) or an Abbreviated New Animal Drug Application (ANADA) (A) Signup and view all the answers

What is the key difference between a Conditionally Approved New Animal Drug (CNADA) and a fully approved New Animal Drug (NADA)?

CNADA requires “reasonable expectation of effectiveness” rather than “substantial evidence of effectiveness” (A) Signup and view all the answers

Conditional approval of an animal drug is available for:

Only minor species or major species under special circumstances (B) Signup and view all the answers

What is the main reason a drug may receive conditional approval instead of full approval?

It has not yet met the effectiveness standard for full approval (A) Signup and view all the answers

Under conditional approval, the drug must demonstrate which of the following?

A “reasonable expectation of effectiveness” and safety when used as labeled (D) Signup and view all the answers

How long is a conditional approval valid before requiring renewal?

One year (A) Signup and view all the answers

What is required for a drug to be approved? (Hint 4 requirements)

The drug must be safe for the animal, safe for the humans consuming food derived from treated animals , safer for the user or the person administering the drug and for the environment, must be effective for its intended uses, and must be properly labeled to inform the user of the product Signup and view all the answers

Which regulatory standard ensures that an approved drug is consistently produced with high quality?

Good Manufacturing Practice (GMP) regulations (A) Signup and view all the answers

What does drug labeling need to include?

How to use the product, safety considerations, withdrawal procedures and storage and handling instructions Signup and view all the answers

What is the public mission of the Center for Veterinary Medicine (CVM) regarding drug approval?

Ensuring that only safe, effective, quality-manufactured, and properly labeled products reach users (A) Signup and view all the answers

What is required in a NAD application? (Hint: THE CEAL)

Target animal safety, human food safety, effectiveness, chemistry, manufacturing and controls, environmental impact, all other information and labeling. Signup and view all the answers

What does "labeling" include for an animal drug?

All written, printed, or graphic matter, including package inserts and accompanying materials (B) Signup and view all the answers

Who collaborates to develop the labeling for a new animal drug?

Signup and view all the answers

The information on an animal drug label is derived from:

Studies submitted by the pharmaceutical sponsor to the FDA (A) Signup and view all the answers

Who determines the marketing status of an animal drug (Prescription vs. OTC vs. Feed Additive)?

The FDA (C) Signup and view all the answers

What factor determines whether an animal drug can be sold over-the-counter (OTC)?

Whether adequate directions for safe and effective use can be provided for a layperson (A) Signup and view all the answers

What is the purpose of the Generic Animal Drug and Patent Restoration Act (GADPTRA)?

To allow the approval of generic copies of previously approved animal drugs (A) Signup and view all the answers

Under GADPTRA, a generic animal drug must:

Be bioequivalent to the approved animal drug (B) Signup and view all the answers

What exclusivity protection does GADPTRA provide for the original drug manufacturer?

It provides market exclusivity for a number of years before a generic version can be approved (A) Signup and view all the answers

Flashcards

Who regulates animal drugs?

Administers regulation of animal drugs.

What act regulates animal drugs?

Gave the FDA authority to regulate animal drugs.