2A Clinical Pharmacology: Regulatory Considerations I

New Animal Drug Application (NADA) number

All FDA approved animals drugs have WHAT

Pure food and drug act

The problem with this act initially was that there was no authority over cosmetics and had very high standards meaning one had to prove intent to deceive the public AND unsafety for it to be removed from supply

Federal Food, Drug, and Cosmetic Act

This act meant the FDA had authority to regulate medical devices and cosmetics and they could set standards for foods = illegal to put harmful things into food/medicine/cosmetic supply. This also differentiated between DRUGS and PESTICIDES, meaning no pesticides were to be used in ELDU manners

EPA

Which body regulates pesticides?

Nutritional supplements

What is NOT covered by the Federal Food, Drug and Cosmetic Act and Delaney Clause?

Delaney Clause

This clause forbids the addition of any additives to food that are shown to be dangerous in any species of animals or humans

Animal Medicinal Drug Use Clarification Act of 1994

This permits veterinarians to prescribe extralabel drugs under certain conditions

Extralabel usage

This is the use of an approved drug in a manner that is not in accordance with the approved label directions such as different dose, route, indication, and species

Pure Food and Drug Acts

This act allowed lead toys inside candy, radioactive water, and banbar for diabetes treatment because these were advertised correctly to the public so they could not be discontinued

Under valid VCPR and in compliance with AMDUCA

What is the only way you can have extralabel drug use?

Extralabel drug use under valid VCPR

In order for this process to be carried out:

1. vet assumes responsibility for making clinical judgement and client has agreed

2. vet has sufficient knowledge

3. vet is readily available for followup

4. vet provides oversight of treatment, compliance, and outcome

5. vet maintains patient records

a. a lay person declares extralabel use

b. residue presents a risk to public health

d. there is an animal or human drug used in/on animal feed

Select when extralabel drug use is NOT permitted under AMDUCA:

a. a lay person declares extralabel use

b. residue presents a risk to public health

c. the vet assumes responsibility for making clinical judgement

d. there is an animal or human drug used in/on animal feed

e. vet maintains patient records

You need to establish an extended withdrawal period and be able to prove which animals you gave drugs to so they don't go into the supply chain

What kinds of considerations do you have to remember for food animal AMDUCA

1. name and address of prescribing vet

2. established name of drug

3. any directions for use specified by vet

4. cautionary statements

5. specified withdrawal period

Name the things that go on a label for AMDUCA extralabel use:

1. if an acceptable analytical method needs to be established

2. it presents a risk to public health

Why might the FDA prohibit the extralabel use of an approved animal drug or approved human drug?

True

TRUE OR FALSE: the extralabel drug use regulation does NOT permit animal drug compounding from active pharmaceutic ingredients

3

How many groups are there for AMDUCA and FDA limitations for food animals?

Group 1

Which group of AMDUCA food animal prohibition includes drugs with NO allowable extra-label uses in any food producing animal species?

Group 2

Which group of AMDUCA food animal prohibition includes drugs with restricted extra label uses in food producing animal species (so drugs that are not allowed under specific circumstances like growth promotion)

Group 3

Which group of AMDUCA food animal prohibition includes drugs with special restrictions for grade A dairy operations

FALSE

TRUE OR FALSE: there is a distinction between "pet/companion" food animals and food animals intended for slaughter according to AMDUCA extralabel drug use

1

Which class of AMDUCA prohibited drug is Chloramphenicol because it causes aplasia anemia in humans?

1

Which class of AMDUCA prohibited drug is Clenbuterol because it is tocolytic (stops uterine contraction in pregnancy) in humans?

1

Which class of AMDUCA prohibited drug is Diesthysilbestrol because it affects human reproductive health?

1

Which class of AMDUCA prohibited drug is Fluoroquinollones because it poses problems for human antimicrobial resistance?

1

Which class of AMDUCA prohibited drug is glycopeptides like vancomycin because it poses problems for human antimicrobial resistance?

1

Which class of AMDUCA prohibited drug is nitroimidazole and nitrofurans because they cause cancer?

2

Which class of AMDUCA prohibited drug is 3rd generation cephalosporins like Naxcel and Excede due to antimicrobial stewardship?

2

Which class of AMDUCA prohibited drug is gentian violet in all food animal feed due to cancer causing agents

2

Which class of AMDUCA prohibited drug is Indexed drugs in all food animals because they arent fully approved?

2

Which class of AMDUCA prohibited drug is sulfonamide antibiotics in lactating dairy cattle due to milk residue?

3

Which class of AMDUCA prohibited drug is in accordance with the Grade A pastuerized milk ordinance?

3

Which class of AMDUCA prohibited drug is non-medical grade DMSO, dipyrone, and colloidal silver?

FALSE. ex. horses using dog firocoxib

TRUE OR FALSE: extralabel drug use only applies to food animals

FARAD = food animal residue avoidance databank

Which resource advises for guidance based on residues in food animals on INDIVIDUAL cases

Compounding

This is any manipulation of a drug beyond that stipulated on the drug label, including mixing, combining, diluting, concentration, or flavoring drugs

Based on veterinarian's prescription to meet the medical needs of a specific patient

When is the only time you compound drugs?

1. from FDA approved animal or human drug under AMDUCA

2. from bulk drug substances = unapproved new animal drug and violates Federal Food, Drug, and Cosmetic act

What 2 sources are available for drug based compounding?

Compounding from from bulk drug substances = unapproved new animal drug and violates Federal Food, Drug, and Cosmetic act

When an approved drug is not commercially available, the needed compound cannot be made from the approved drug, and there is no product from which to compound the needed preparation, what kind of compounding can be used?

1. poison antidote

2. compounds for euthanasia/depopulation

3. sedation and anesthesia

For food animals SPECIFICALLY, under what circumstances can you compound from bulk drug substances?

a. chloramphenicol

b. fluoroquinolones

e. nitroimidazole

f. diesthylsilbestrol

Select Group 1 AMDUCA food animal prohibited drugs:

a. chloramphenicol

b. fluoroquinolones

c. 3rd generation cephalosporin

d. colloidal silver

e. nitroimidazole

f. diesthylsilbestrol

b. Gentian Violet

c. 3rd generation cephalosporin

f. Sulfonamide Antibiotics

Select Group 2 AMDUCA food animal prohibited drugs:

a. chloramphenicol

b. Gentian Violet

c. 3rd generation cephalosporin

d. colloidal silver

e. nitroimidazole

f. Sulfonamide Antibiotics

d. colloidal silver

e. dipryone

Select Group 3 AMDUCA food animal prohibited drugs:

a. chloramphenicol

b. Gentian Violet

c. 3rd generation cephalosporin

d. colloidal silver

e. dipryone

f. Sulfonamide Antibiotics