Veterinary Pharmacy and Pharmacy Law

Question 1

Fairness to Pet Owners Act

Answer 1

Act that wants to mandate prescription for all medications, including those filled in practice (not passed yet)

Question 2

Veterinarian-Client-Patient Relationship (VCPR)

Answer 2

Veterinarians must have a valid VCPR prior to prescribing prescription drugs for animal patients (including: agreement, examination, and follow-up)

Question 3

Food and Drug Act of 1906

Answer 3

Prevention of mislabeling:

• Products must contain what the label says it contains
• No safety testing required
• No efficacy testing required
• Forbade fraudulent curative claims where it could be proved the promoter intended to deceive the purchaser

Question 4

Food, Drug, and Cosmetic Act of 1938

Answer 4

Requirements for safety testing:

• Sulfanilamide disaster in 1937 (>100 people died of renal failure)
• Many amendments apply directly to animal drugs

Question 5

Animal Medicinal Drug Use Clarification of 1994 (AMDUCA)

Answer 5

Made extra-label drug use an FDA regulated veterinary medical activity, allowing veterinarians to prescribe extra-label uses of approved animal and human drugs when the health of an animal is threatened, or when suffering or death may result from failure to treat animals (extra-label has been illegal prior to this)

Question 6

Four reasons for AMDUCA

Answer 6

1. Make a careful diagnosis and evaluate the conditions for which the drug is to be used
2. Make sure there is not an approved medication that is labeled for such use in that species, or that contains the same active ingredient in the required dosage form and concentration (exception is if drug is clinically ineffective for its intended use for that patient)
3. Establish a substantially extended withdrawal period supported by appropriate scientific information prior to marketing milk, meat, eggs, or other edible products from the treated animals
4. In non-food producing animals, a drug labeled for use in humans can be administered even if an animal-label drug for that species and medical condition exists

Question 7

Extra-Label Drug Use (ELDU)

Answer 7

Describes the use of approved drug in a manner that is not in accordance with the approved labeling

• FDA approved if:
• -There is no approved animal drug that is labeled for such use, or that contains the same active ingredient in the required dosage form and concentration
• -An approved animal drug for that species and condition exists, but a veterinarian finds that the drug is clinically ineffective for its labeled use
• FDA can prohibit use if:
• -An acceptable method for residue detection needs to be or cannot be established
• -The extra label use of the drug/class of drugs presents a risk to public health

Question 8

Approved Labeling

Answer 8

• Information that comes with a medication
• The physical label on the bottle is an abbreviated form of the more extensive package insert included with every medication
• A label is a legal document that defines: indications, species, doses, routes, frequencies, etc.

Question 9

Animal Drug Availability Act of 1996 (ADAA)

Answer 9

Made it easier for drug sponsors to get animal drugs approved

• Allowed more animal drugs on the market
• New category of drugs (Veterinary Feed Directive Drugs)

Question 10

Veterinary Feed Directive (VFD)

Answer 10

• Avoid inappropriate or unnecessary use of medically important antimicrobials
• Limit to use in food-producing animals only when necessary for animal health
• Limit to use under veterinary oversight or consultation (“directive”)
• Reduce antimicrobial resistance through collaboration with the public, animal health, public health, and animal agriculture communities

Question 11

Withdrawal Time (WDT)

Answer 11

Estimated time that tissues can be safely consumed following the last dose of drugs in 99% of animals treated

• Expressed in days for meat and eggs, and hours for milk
• Drugs approved for use in food animals must contain WDT information on their labeling

Question 12

Food Animal Residue Avoidance Database (FARAD)

Answer 12

A computer based decision support program to provide drug and pesticide WDTs for producers, DVMs, and extension specialists
-Supported by the USDA

Question 13

Minor Use/Minor Species Act of 2004 (MUMS)

Answer 13

• Minor uses: disease affecting a small percentage of a species
• Minor species: everything that is not a major species (not cats, dogs, cattle, horses, pigs, chickens, or turkeys)

Question 14

MUMS conditional approval

Answer 14

Allows the sponsor to make the drug available before collecting all necessary effectiveness data, but after proving the drug is safe in accordance with the full FDA approval standard and showing that there is a reasonable expectation of effectiveness

Question 15

MUMS designation

Answer 15

Sponsors are eligible to apply for grants to support safety and effectiveness testing

Question 16

MUMS indexing

Answer 16

A minor species drug is intended for use in species that are too rare or too varied to be the subject of adequate and well-controlled studies in support of a drug approval. FDA may add the intended use to the index. This provision is limited to minor species that are not used as food for humans or other animals.

Question 17

New Animal Drug Application (NADA)

Answer 17

Full blown approval for pioneer drug

Question 18

Abbreviated New Animal Drug Application (ANADA)

Answer 18

Approval for generic of a pioneer approved drug

Question 19

Congress

Answer 19

Passes the laws that govern drug use

Question 20

Food and Drug Administration (FDA)

Answer 20

Regulations enforce congressional laws

• Responsible for protecting the public by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices
• Ensure the safety of the nations food supply and cosmetics

Question 21

Center for Veterinary Medicine (CVM)

Answer 21

Subsection of the FDA that overseas veterinary medical drugs

Question 22

Drug Enforcement Administration (DEA)

Answer 22

Enforces use of controlled substances

• Implements the Controlled Substances Act and may prosecute violators of these laws at both the domestic and international level
• Any individual that orders, handles, stores, and/or distributes controlled substances must be registered/licensed with the DEA
• Performs inspections

Question 23

Environmental Protection Agency (EPA)

Answer 23

Enforces use of topically applied anti-parasitic, sprays, and insecticides

Question 24

U.S. Department of Agriculture (USDA)

Answer 24

Regulates veterinary biologics (vaccines)

Question 25

Virus-Serum-Toxin Act of 1913

Answer 25

Federal legislation granting this regulatory authority to the USDA

Question 26

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Answer 26

Covers topical flea and tick products, as well as other environmental and topical pesticides, fungicides, and rodenticides
-If any substance is administered orally or parenterally, they are then under FDA jurisdiction

Question 27

Controlled Substances Act of 1970 (CSA)

Answer 27

Granted the Attorney General the power to classify substances based on their potential for addiction and abuse
-The addition, deletion, or change of schedule of a medication or substance may be requested by the DEA, Department of Health and Human Services, the FDA, or from any other party via petition to the DEA

Question 28

CSA Schedules

Answer 28

Five schedules of medications that are used to classify drugs - these are based on the abuse potential, medical applications, and safety

Question 29

Schedule I

Answer 29

High abuse potential, no accepted medical use

Question 30

Schedule II

Answer 30

High abuse potential, accepted medical use; use may lead to psychological/physical dependence

• Ex: hydromorphone, fentanyl, codeine, methadone
• No refills, must have new Rx every time

Question 31

Schedule III

Answer 31

Lower abuse potential, accepted medical use; may lead to moderate or low physical dependence or high psychological dependence
-Ex: ketamine, buprenorphine, pentobarbital

Question 32

Schedule IV

Answer 32

Low abuse potential, accepted medical use; may lead to limited physical dependence or psychological dependence
-Ex: tramadol, phenobarbital, butorphanol, benzodiazepines (alprazolam, diazepam, etc.)

Question 33

Schedule V

Answer 33

Low abuse potential, accepted medical use; may lead to limited physical dependence or psychological dependence relative to the drugs in schedule IV
-Ex: diphenoxylate + atropine (Lomotil)

Question 34

Drug diversion

Answer 34

• Use of a substance for a use other than what it was prescribed for
• Use of a substance by a person other than who it was prescribed for

Question 35

Veterinary Medicine Motility Act of 2014

Answer 35

Allows traveling veterinarians to transport/dispense controlled substances across state lines without needing a new CSR number for each state
-You must still be licensed and have CSR/DEA numbers in your original state of business

Question 36

Inventory

Answer 36

Must have initial inventory and at least biennially (every 2 years)

Question 37

Expired controlled substances

Answer 37

Must go to a reverse distributor (handles unwanted, unusable, outdated controlled substances)