Lecture 2: Regulatory Considerations I

What do all FDA-approved animal drugs have?

a new animal drug application (NADA) number, or for generic animal drugs, an abbreviated new animal drug application (ANADA) number

What act set up for the modern FDA, requiring truthful labelling standards and purity and product strength standards?

1906 pure food and drugs act

What were the shortcomings of pure food and drugs act?

• 1. No authority over cosmetics (Some medical issues such as obesity were considered appearance at the time)

• 2. Very high standard (Had to prove intent to deceive instead of purely unsafe)

• Revisions were needed

What did the federal food, drug, and cosmetic act do?

• FDA had authority to regulate medical devices and cosmetics

• FDA could set standards for foods

• Drugs and devices were further regulated:

  • Provide adequate directions for use

  • Misbranding was illegal

  • Misbranding did not require intent to defraud

  • Drugs and devices that endangered health were illegal

  • New drugs had to be proven safe

• Essentially made it illegal to put something harmful into the food/medicine/cosmetic supply

• Differentiated between drug (FDA) and pesticide (EPA) - Cannot use pesticides in an ELDU manner

What did the delaney cause forbid?

forbids the addition to food of any additives shown to be dangerous in any species of animal or in humans

What is not covered by the federal food, drug, and cosmetic act?

nutritional supplements

What did AMDUCA (animal medicinal drug use clarification act of 1994) do?

• Permits veterinarians to prescribe extralabel drugs under certain conditions

• Extralabel usage: The use of an approved drug in a manner that is not in accordance with the approved label directions

Extralabel drug usage has to be under a valid _______?

VCPR

What is a VCPR?

• The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the patient and the client has agreed to follow the veterinarians' instructions

• The veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition of the patient

• The veterinarian is readily available for follow-up evaluation or has arranged for the following: veterinary emergency coverage, and continuing care and treatment

• The veterinarian provides oversight of treatment, compliance, and outcome

• Patient records are maintained

What are the limitations to extralabel use provisions of AMDUCA?

Not permissible if:

1. Extralabel use in an animal of an approved new animal drug or human drug by a lay person (except when under the supervision of a licensed veterinarian);

2. Extralabel use of an approved new animal drug or human drug in or on an animal feed;

3. Extralabel use resulting in any residue which may present a risk to the public health

4. Extralabel use resulting in any residue above an established safe level, safe concentration, or tolerance

What are the food animal considerations in AMDUCA?

• No approved food animal drug

• Diagnosis and evaluation of the condition

• Establish an extended withdraw period

• Institute procedures to assure the animal’s identity is maintained

• Take appropriate measures to assure that assigned withdraw times are met and no illegal residues occur

What labelling for extralabelly used drugs is required by AMDUCA?

1. The name and address of the prescribing veterinarian

2. The established name of the drug: Active ingredient(s)

3. Any directions for use specified by the veterinarian

4. Any cautionary statements

5. The veterinarian's specified withdrawal, withholding, or discard time(s): for meat, milk, eggs, or any food which might be derived from the treated animal(s)

What are the general prohibitions of AMDUCA?

• FDA may prohibit the extralabel use of an approved animal drug or approved human drug or class of drugs in food-producing animals if FDA determines that:

  • An acceptable analytical method needs to be established and such method has not been established or cannot be established; or

  • The extralabel use of the drug or class of drugs presents a risk to the public health

• Compounding: The extralabel drug use regulation does not permit animal drug compounding from active pharmaceutical ingredients (bulk drugs)

What are the food animal prohibitions of AMDUCA?

AMDUCA and the FDA have 3 groups of limitations/restrictions for food animals:

1. Drugs with No Allowable Extra-Label Uses in Any Food-Producing Animal Species

2. Drugs with Restricted Extra-Label Uses in Food-Producing Animal Species

3. Drugs with Special Restrictions for Grade "A" Dairy Operations

• There is no distinction between “pet/companion” food animals, and food animals intended for slaughter (Food animal designation is based on species, not role)

What can happen when impermissible ELDU occurs?

• civil penalties

• criminal penalties

• action against your license

How do you select ELDU?

1. Have a VCPR

2. Be in compliance with AMDUCA

3. Have a reason (paper, study, experience, documented treatment failure) for selecting a drug over an approved product for the species - Cost, convenience are not part of the algorithm, Client safety?

• If a food animal, be able to provide a withdraw time