The Regulation of Animal Drugs

Question 1

“It is important for the practitioner to be aware of the ______, _________, and ________ that impact how they dispense, prescribe, or administered medications.”

Answer 1

“It is important for the practitioner to be aware of the rules, regulations, and standards that impact how they dispense, prescribe, or administered medications.”

Question 2

There are both ______ and ______ agencies which govern how drugs are used in veterinary medicine
–> Federal agencies:
* ____: an agency of the US Department of Health and Human Services
* Center for Veterinary Medicine (CVM): a subdivision of the _______ which is responsible for the regulating the _____, medical ______, and food _________ administered to animals
* Drug Enforcement Agency (DEA): a division of the US Department of ______ which is
responsible for the enforcement of the _____ of 1970

Answer 2

There are both state and federal agencies which govern how drugs are used in veterinary medicine
–> Federal agencies
* US Food and Drug Administration (FDA): an agency of the US Department of Health and Human Services
* Center for Veterinary Medicine (CVM): a subdivision of the FDA which is responsible
for the regulating the drugs, medical devices, and food additives administered to animals
* Drug Enforcement Agency (DEA): a division of the US Department of Justice which is
responsible for the enforcement of the Controlled Substance Act (CSA) of 1970

Question 3

State agencies
* Board of Veterinary Medicine (BVM): it protects the ______ and ______ of the _______
and ________ through the regulation of the practice of veterinary medicine as expressed
in the state’s veterinary practice act.
* Board of Pharmacy (BOP): It regulates the _________ and the pharmacy ________ of
pharmaceutical products (including veterinary drugs).

Answer 3

State agencies
* Board of Veterinary Medicine (BVM): it protects the health and safety of the public
and animals through the regulation of the practice of veterinary medicine as expressed
in the state’s veterinary practice act.
* Board of Pharmacy (BOP): It regulates the wholesale and the pharmacy distribution of
pharmaceutical products (including veterinary drugs).

Question 4

FDA is authorized by the US _________ to implement certain laws. For example, the predominant statutory authority for FDA to regulate animal drugs is the 1938 _____ Act

Answer 4

FDA is authorized by the US Congress to implement certain laws. For example, the predominant statutory authority for FDA to regulate animal drugs is the 1938 Federal Foods, Drugs and Cosmetics Act (FFDCA)

Question 5

In 1984, the Bureau of Veterinary Medicine became the current ?

Answer 5

In 1984, the Bureau of Veterinary Medicine became the current Center for Veterinary Medicine (CVM)

Question 6

The FDA/Center for Veterinary Medicine website is a good reference source to bookmark for keeping abreast of regulatory policies and issues pertaining to the regulation of animal ______ and _____

Answer 6

The FDA/Center for Veterinary Medicine website is a good reference source to bookmark for keeping abreast of regulatory policies and issues pertaining to the regulation of animal drugs and feeds

Question 7

➢ The Freedom of Information (FOI)
Since 1967, the Freedom of Information Act (FOIA) has provided the public the right to request access to ______ from any ______ agency. It is often described as the law that keeps citizens in the know about their government.

Answer 7

➢ The Freedom of Information (FOI)
Since 1967, the Freedom of Information Act (FOIA) has provided the public the right to request access to records from any federal agency. It is often described as the law that keeps citizens in the know about their government.

Question 8

➢ New Animal Drug Application (NADAs)
It used to seek approval of a ______ animal drug.

Answer 8

➢ New Animal Drug Application (NADAs)
It used to seek approval of a new animal drug.

Question 9

➢ Abbreviated New Animal Drug Application
It used to seek approval of a _______ ____ animal drug which is a ____ of an approved new animal drug for which ______ or other periods of ________ are near expiration.

Answer 9

➢ Abbreviated New Animal Drug Application
It used to seek approval of a generic new animal drug which is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration.

Question 10

FDA/CVM regulates the _________ and ________ of drugs, food, additives, and medical devices used in veterinary species

Answer 10

FDA/CVM regulates the manufacturing and distribution of drugs, food, additives, and medical devices used in veterinary species

Question 11

Animal drugs: virtually all animal drugs are “_____ animal drugs” that are considered to be _______ unless there is an approval of a New Animal Drug Application (NADA) and unless the _____ of a drug and its _______ conform to the approved application.

Answer 11

Animal drugs: virtually all animal drugs are “new animal drugs” that are considered to be unsafe unless there is an approval of a New Animal Drug Application (NADA) and unless the use of a drug and its labeling conform to the approved application

Question 12

Veterinary biologics
The (4?) regulates veterinary biologics, which include (3?) (used to prevent, treat, or diagnose animal disease)

Answer 12

Veterinary biologics
The US Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services, Veterinary Biologics regulates veterinary biologics
→ Vaccines, antitoxins, and diagnostics (used to prevent, treat, or diagnose animal disease)

Question 13

Medical device
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, mitigation, treatment, or prevention of disease

Veterinary medical devices are subject to the general provisions of the Act that relate to
misbranding and adulteration (Sections 501 and 502 of the 1938 Federal Foods, Drugs
and Cosmetics Act, FFDCA)

Answer 13

Veterinary medical devices are subject to the general provisions of the Act that relate to
misbranding and adulteration (Sections 501 and 502 of the 1938 Federal Foods, Drugs
and Cosmetics Act, FFDCA)

Question 14

–> Pesticides
➢ The _____ regulates pesticides
→ including preparations for use in ______ objects (________)
→ ____________
→ ____________
➢ EPA regulates under the authority of the ______ Act (_____)
_____ and EPA work together through an informal agreement to determine whether
a product will be regulated as an animal drug or as a pesticide

Answer 14

–> Pesticides
➢ The Environmental Protection Agency (EPA) regulates pesticides
→ including preparations for use in inanimate objects (disinfectants)
→ rodenticides
→ insecticides
➢ EPA regulates under the authority of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA)
FDA and EPA work together through an informal agreement to determine whether
a product will be regulated as an animal drug or as a pesticide

Question 15

Question 16

Generic Animal Drug and Patent Term Restoration Act (GADPTRA) 1988
➢ The approval of generic copies of animal drug products that have been ___________
approved and shown to be safe and effective when used in accordance with their
___________.
➢ The GADPTRA provides for a period of ___ years of marketing exclusivity for a ______
use of an animal drug
→ the use requires reports of new ______ or ______ investigations for its approval
➢ The law also provides for a period of ____ years of marketing exclusivity for an animal drug that has _____ been previously approved in any new animal drug application

The Center for Veterinary Medicine has arranged for the publication of a list of animal
drugs products that are eligible to be copied as generics (Green Book)

Answer 16

Generic Animal Drug and Patent Term Restoration Act GADPTRA 1988
➢ The approval of generic copies of animal drug products that have been previously
approved and shown to be safe and effective when used in accordance with their
labeling
➢ The GADPTRA provides for a period of 3 years of marketing exclusivity for a new
use of an animal drug
→ the use required reports of new clinical or field investigations for its approval
➢ The law also provides for a period of 5 years of marketing exclusivity for an animal drug that has not been previously approved in any new animal drug application

The Center for Veterinary Medicine has arranged for the publication of a list of animal
drugs products that are eligible to be copied as generics (Green Book)

Question 17

The Animal Medicinal Drug Use Clarification Act of 1994
AMDUCA
* AMDUCA enabled veterinarians for the first time to use a human or animal drug in an ________ manner for animals under certain conditions
* Prior to the enactment of the AMDUCA of 1994, the FFDCA prohibited veterinarians from prescribing new animal drugs for any indications other than the specific conditions of use on the _________ labeling
* Prior to ______, the use of human drugs for treating animals was illegal

Implemented in _____ by the regulations in 21 CFR, Part 530 - Extralabel drug use (ELDU)

Answer 17

The Animal Medicinal Drug Use Clarification Act of 1994
AMDUCA
* AMDUCA enabled veterinarians for the first time to use a human or animal drug in an extralabel manner for animals under certain conditions
* Prior to the enactment of the AMDUCA of 1994, the FFDCA prohibited veterinarians from prescribing new animal drugs for any indications other than the specific conditions of use on the approved labeling
* Prior to 1994, the use of human drugs for treating animals was illegal

Implemented in 1996 by the regulations in 21 CFR, Part 530 - Extralabel drug use (ELDU)

Question 18

Answer 18

Question 19

The agency may establish _____ and _______ levels for residues for ELDU and may require development of _______ methods for residue detection. If after affording an opportunity for public comment, FDA finds that an extralabel animal drug use presents a risk to ______ health or that no _________ method has been developed and submitted, the agency may ________ the ELDU.

Answer 19

The agency may establish safe and violative levels for residues for ELDU and may require development of analytical methods for residue detection. If after affording an opportunity for public comment, FDA finds
that an extralabel animal drug use presents a risk to public health or that no analytical method has been developed and submitted, the agency may prohibit the ELDU.

Question 20

•ELDU is permitted only by or under the supervision of a _____________.
• ELDU is allowed only for ____-approved animal and human drugs.
• A valid ______ exists.
• ELDU is for the _________ purposes only (animal’s health is suffering or threatened), NOT for __________ use.
•Rules apply to dosage for drugs and drugs administered in ______. ELDU in _____ is prohibited.
•ELDU is not permitted if it results in a _______ food residue, or any residue that may present a risk to ______ health.

Answer 20

•ELDU is permitted only by or under the supervision of a veterinarian.
• ELDU is allowed only for FDA-approved animal and human drugs.
• A valid veterinarian/client/patient relationship (VCPR) exists.
• ELDU is for the therapeutic purposes only (animal’s health is suffering or threatened), NOT for production use.
•Rules apply to dosage for drugs and drugs administered in water. ELDU in feed is prohibited.
•ELDU is not permitted if it results in a violative food residue, or any residue that may present a risk to public health.

Question 21

Question 22

Additional provisions of the AMDUCA legislation require proper _______ and _______ of prescribed drugs for animals

Answer 22

Additional provisions of the AMDUCA legislation require proper dispensing and labeling of prescribed drugs for animals

Question 23

–> Record requirements for drugs dispensed for animals
1. Identify the animals, either as ________ or a _____
2. Animal ______ treated
3. ________ of animals treated
4. ________ being treated
5. The established ______ of the drug and ______ ingredient
6. Dosage _______ or ______
7. _________ of treatment
8. Specified ________, ________, or _____ time(s), if applicable, for _____, ____, ____, or _____-derived food
9. Keep records for ?
10. ____ may have access to these records to estimate risk to public health

Answer 23

–> Record requirements for drugs dispensed for animals
1. Identify the animals, either as individuals or a group
2. Animal species treated
3. Number of animals treated
4. Condition being treated
5. The established name of the drug and active ingredient
6. Dosage prescribed or used
7. Duration of treatment
8. Specified withdrawal, withholding, or discard time(s), if applicable, for meat,
milk, eggs, or animal-derived food
9. Keep records for 2 years
10.FDA may have access to these records to estimate risk to public health

Question 24

–> Label requirements for drugs prescribed for animals
1. ______ and ______ of the prescribing veterinarian
2. ___________ name of the drug
3. Any specified directions for use including the ___/____ or _______ of the animal or herd, flock, pen, lot, or other group; the dosage _____ and _____ of administration; and _______ of the therapy
4. Any _________ statements
5. Your specified ________, ________, or ______ time for meat, milk, eggs, or any food

Answer 24

–> Label requirements for drugs prescribed for animals
1. Name and address of the prescribing veterinarian
2. Established name of the drug
3. Any specified directions for use including the class/species or identification of the animal
or herd, flock, pen, lot, or other group; the dosage frequency and route of
administration; and duration of the therapy
4. Any cautionary statements
5. Your specified withdrawal, withholding, or discard time for meat, milk, eggs, or any food

Question 25

The purpose of the Animal Drug Availability Act of 1996 (ADAA) is to increase the _______ of animal drugs on the market and to reduce regulatory ________ on the animal health industry without undermining the _______ of animal drug products

Answer 25

The purpose of the Animal Drug Availability Act of 1996 (ADAA) is to increase the number of animal drugs on the market and to reduce regulatory burdens on the animal health industry without undermining the safety of animal drug products

Question 26

The Animal Drug Availability Act of 1996 (ADAA)
1. An amendment to the definition of substantial evidence that a new animal drug is effective → greater flexibility regarding the _________ and _______ of adequate and well-controlled studies
2. Greater direct interaction between animal drug _________ and the _______ during the drug development → the goal: to reach a common understanding regarding what data will be needed to establish ______ and _________
3. The ability to market an animal drug with a range of ________/__________ doses, rather than as ______ optimum dose. The law directs FDA to __________ the approval process → more animal drugs available to treat minor species
4. Creation a new category of drugs, “Veterinary Feed Directive Drugs” (VFD)
→ allows approval and use of new animal drugs in or on animal _____
→ it is limited to use under the professional supervision of a licensed veterinarian
→ a VFD is not a __________ drug

Answer 26

The Animal Drug Availability Act of 1996 (ADAA)
1. An amendment to the definition of substantial evidence that a new animal drug is effective → greater flexibility regarding the number and types of adequate and well-controlled studies
2. Greater direct interaction between animal drug sponsors and the FDA during the drug development → the goal: to reach a common understanding regarding what data will be needed to establish safety and effectiveness
3. The ability to market an animal drug with a range of acceptable/recommended doses,
rather than as one optimum dose. The law directs FDA to broaden the approval process
→ more animal drugs available to treat minor species
4. Creation a new category of drugs, “Veterinary Feed Directive Drugs” (VFD)
→ allows approval and use of new animal drugs in or on animal feed
→ it is limited to use under the professional supervision of a licensed veterinarian
→ a VFD is not a prescription drug

Question 27

FDA is responsible for determining the _________ status (prescription, over-the-counter, or VFD, etc.)

Answer 27

FDA is responsible for determining the marketing status (prescription, over-the-counter, or VFD, etc.)

Question 28

A chemical can be considered a drug if it meets one of the following criteria:
1. It is recognized in one of the official ________
2. It is intended for use in the 5? of
disease in people or animals
3. It is other than food indented to affect the _________ or any _________ of the body
4. It is intended to be used as a _________ of an items falling into one of the three categories above

Answer 28

A chemical can be considered a drug if it meets one of the following criteria:
1. It is recognized in one of the official compendia
2. It is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in people or animals
3. It is other than food indented to affect the structure or any function of the body
4. It is intended to be used as a component of an item falling into one of the five categories above

Question 29

VFD drugs
* It may be often necessary to use the oral dosing of drugs via ____
→ _______ number of animals
* This approach does not assure that a ______ dose of drug reaches each animal
→ drug dosage is a function of food __________
➢ Prior to this time, the FDA had only two options for regulating the distribution of
animal drugs
→ drug __________
→ _______

Answer 29

VFD drugs
* It may be often necessary to use the oral dosing of drugs via feed
→ large number of animals
* This approach does not assure that a specific dose of drug reaches each animal
→ drug dosage is a function of food consumption
➢ Prior to this time, the FDA had only two options for regulating the distribution of
animal drugs
→ drug prescription
→ OTC

Question 30

VFD drugs
It allows producers to acquire medicated ______ through traditional manufactures
→ a ____________ is not involved
→ it does not need to follow _____ pharmacy laws

Beginning in _____, all approved feed grade antibiotics used in food animal production
require VFD approval prior to use
➢ The ________ use of any VFD drugs is prohibited
→ lone exceptions: _________

Answer 30

VFD drugs
It allows producers to acquire medicated feeds through traditional manufactures
→ a pharmacist is not involved
→ it does not need to follow state pharmacy laws

Beginning in 2017, all approved feed grade antibiotics used in food animal production
require VFD approval prior to use
➢ The extralabel use of any VFD drugs is prohibited
→ lone exceptions: ionophores

Question 31

VFD drugs
Requirement for using a VFD medicated feed:
A valid _______-_______-______ relationship (VCPR)
➢ The _____ is responsible for making medical judgment: health and need for medical
treatment ✓the _______ agrees to follow the instructions
➢ There is sufficient knowledge of the animal(s) by the vet
The vet has _________ seen and is personally
__________ with the care of all animal(s) –>
Preliminary diagnosis of medical condition
➢ The veterinarian is readily available: for ________-___ in case of adverse reactions

Once the ________ diagnose has been made, the veterinarian can issue a _______ VFD on a preprinted, multipart form and gives to the producers → feed supplier

Answer 31

VFD drugs
Requirement for using a VFD medicated feed:
A valid veterinarian-client-patient relationship (VCPR)
➢ The vet is responsible for making medical judgment: health and need for medical
treatment ✓the client agrees to follow the instructions
➢ There is sufficient knowledge of the animal(s) by the vet
The vet has recently seen and is personally
acquainted with the care of all animal(s)
Preliminary diagnosis of
medical condition
➢ The veterinarian is readily available: for follow-up in case of adverse reactions
Once the initial diagnose has been made, the veterinarian can issue a signed VFD on a preprinted,
multipart form and gives to the producers → feed supplier

Question 32

VFD drugs
A VFD feed may not be distributed to a producer without a _______ VFD form
1. The person or firm supplying a VFD drug to a producer must receive and retain a copy of
the ______ VFD form issued by the veterinarian
2. Licensed feed manufactures and distributors must receive and retain a copy of
____________ stating that the VFD feed will be distributed only in accordance with FDA
3. All distributors and retailers who do not hold a feed mill ______ must notify the FDA within ____ days of their initial VFD feed shipment. VDF forms have to be retained for a minimum of ___ ______ by all three parties involved → the _________, the ________, and ________, It should be available for review by the FDA

Answer 32

VFD drugs
A VFD feed may not be distributed to a producer without a signed VFD form
1. The person or firm supplying a VFD drug to a producer must receive and retain a copy of
the signed VFD form issued by the veterinarian
2. Licensed feed manufactures and distributors must receive and retain a copy of
acknowledgement stating that the VFD feed will be distributed only in accordance with FDA
3. All distributors and retailers who do not hold a feed mill license must notify the FDA within 30 days of their initial VFD feed shipment VDF forms have to be retained for a minimum of 2 years by all three parties involved
→ the veterinarian, the producer, and feedmill, It should be available for review by the FDA

Question 33

The form for VFD products should be provided to the veterinarian by the _________ of the specific therapeutic agent. This form must be completed by the veterinarian and should include:
* _______ information
* _______, ________, ___ of animals being treated
* ______ of treatment
* Drug _____ and ___________ and
__________ of feed to be manufactured
* Directions for ________ and ________. ________ of feeding; ________ times; ______ date of the feed
* _________ information

Answer 33

The form for VFD products should be provided to the veterinarian by the manufacturer of the specific therapeutic
agent. This form must be completed by
the veterinarian and should include:
* Client information
* Species, location, number of animals being treated
* Date(s) of treatment
* Drug name and concentration and
amount of feed to be manufactured
* Directions for mixing and feeding. Duration of feeding; withdrawal times; expiration date of the feed
* Veterinarian’s information

Question 34

Over-The-Counter (“Nonprescription”) drugs
* OTC products can be found for animals in the same retail outlets as for ________ (pharmacies, markets) as well as in ___ and _____ stores

• These drugs have been recognized by experts as ____ and ______
• All OTC products must be used precisely as _______ (just as _______ drugs)
• Pharmacists must no make recommendations for use of ________ OTC drugs in animals → unless so directed by a ________

Answer 34

Over-The-Counter (“Nonprescription”) drugs
* OTC products can be found for animals in the same retail outlets as for humans (pharmacies, markets) as well as in pet and feed stores

• These drugs have been recognized by experts as safe and effective
• All OTC products must be used precisely as labeled (just as prescription drugs)
• Pharmacists must no make recommendations for use of human OTC drugs in animals → unless so directed by a veterinarian

Question 35

FDA approves veterinary OTCs:
* For ________ species
* For __________ indication(s)
* At approved ______
* By approved _______
* For approved ________

Answer 35

FDA approves veterinary OTCs:
* For target species
* For approved indication(s)
* At approved dose
* By approved route
* For approved duration

Question 36

Controlled substances
* Controlled substances are drugs under the jurisdiction of the ________ Controlled
Substances Act (CSA) of ______
* The _____ enforces the CSA through the regulations found in title ____, Code of Federal Regulation (CFR) part 1300 to end
* These drugs are strictly controlled by the ______ and _____ law. There are specific
requirements for _________, ________, and _________.
* Individual _______ are allowed to have _____ strict requirements than the federal DEA
scheduling

Answer 36

Controlled substances
* Controlled substances are drugs under the jurisdiction of the federal Controlled
Substances Act (CSA) of 1970
* The drug Enforcement Administration (DEA) enforces the CSA through the regulations
found in title 21, Code of Federal Regulation (CFR) part 1300 to end
* These drugs are strictly controlled by the federal and state law. There are specific
requirements for administering, dispensing, and prescribing.
* Individual states are allowed to have more strict requirements than the federal DEA
scheduling

Question 37

Schedules of controlled substances
The drugs are divided into five schedules based on _____ potential, _____, and accepted medical ____ in the United States

Answer 37

Schedules of controlled substances
The drugs are divided into five schedules based on abuse potential, safety, and accepted medical use in the United States

Question 38

• Schedule I: these substances have ____ current accepted medical use in the U.S. and
  have a ______ abuse potential → ______, _________
• Schedule II: these substances have a _____ abuse potential and an ______ medical
  use in the U.S → ________, ________
• Schedule III: these substances have an _______ medical use in the U.S. and _____
  abuse potential than schedule I and II → _______, ___________
• Schedule IV: these substances have a ________ potential for abuse relative to the
  schedule III substance → _________, ________, __________
• Schedule V: these substance have the _______ abuse potential of the controlled
  substances → _____ preparations - 200 mg/(100 ml or 100 gm)

Answer 38

• Schedule I: these substances have no current accepted medical use in the U.S. and
  have a high abuse potential → heroin, methamphetamine
• Schedule II: these substances have a high abuse potential and an accepted medical
  use in the U.S → morphine, fentanyl
• Schedule III: these substances have an accepted medical use in the U.S. and less
  abuse potential than schedule I and II → ketamine, buprenorphine
• Schedule IV: these substances have a lower potential for abuse relative to the
  schedule III substance → butorphanol, diazepam, phenobarbital
• Schedule V: these substance have the lowest abuse potential of the controlled
  substances → codeine preparations - 200 mg/(100 ml or 100 gm)

Question 39

Prescribing controlled substances
* A veterinarian who administers, dispenses, or prescribes controlled substances MUST register with the ?
* Practitioners must have a _______ registration for every practice site employed
* _____ regulations also must be followed → some states have stricter regulations

Answer 39

Drug Enforcement Authority (DEA)

separate

state

Question 40

–> Record keeping
* Prescribing controlled substances requires submission of appropriate forms and maintaining records for controlled substances
* Documentation must be made in the ______ medical record (including all administered _______ substances)
* Records must be stored in a readily retrievable manner for ___ years
* All schedule II records must be kept ______ from other records
* The practitioner should contact their regional _____ or their state’s ____ for disposal substances (unusable). Copies of all records documenting the ______ or ______ of controlled substances should be maintained for ___ years

Answer 40

–> Record keeping
* Prescribing controlled substances requires submission of appropriate forms and maintaining records for controlled substances
* Documentation must be made in the patient’s medical record (included all administered controlled substances)
* Records must be stored in a readily retrievable manner for 3 years
* All schedule II records must be kept separated from other records
* The practitioner should contact their regional DEA or their state’s BOP for disposal substances (unusable). Copies of all records documenting the return or disposal of controlled substances should be maintained for 3 years

Question 41

Prescribing controlled substances
Classification of Drugs
Requirements for writing a prescription for controlled substances
1. _____ or _____ name, ______, and ______ number of the licensed practitioner
2. _____ registration number of the licensed practitioner
3. _____ signature of the licensed practitioner followed by _____ name of the practitioner
4. _____ and ______ of drug
5. Direction for ____
6. Full name and address of _____
7. ______ statements including, if applicable, __________ time for food animals

No refills are allowed on schedule ___ prescriptions.
Refills are limited to ___ times or ___ months on prescriptions for drugs in schedules ____-___

Answer 41

Prescribing controlled substances
Classification of Drugs
Requirements for writing a prescription for controlled substances
1. Printed or stamped name, address, and telephone number of the licensed practitioner
2. DEA registration number of the licensed practitioner
3. Legal signature of the licensed practitioner followed by printed name of the practitioner
4. Name and strength of drug
5. Direction for use
6. Full name and address of client
7. Cautionary statements including, if applicable, withdrawal time for food animals

No refills are allowed on schedule II prescriptions.
Refills are limited to 5 times or 6 months on prescriptions for drugs in schedules III - V

Question 42

Inventory records
* All DEA 222 order forms for schedule ___ orders (+ commercial invoices) must be signed and dated
* Items must be ______, _____, and _______ in a readily retrievable file for __ years
* Schedule II records must be stored ______ from schedule III-V records
A complete and accurate inventory of all stocks must be taken every ___ years
➢ Requirements for writing an inventory
1. The name, address, and DEA registration number of the __________
2. The ____ and ____ the inventory is taken
3. The _______ of the person taking inventory
4. An indication that the inventory is maintained for at least __ years at the location
appearing on the __________
5. An indication that inventory and other records of schedule II drugs are maintained
_________ from other drugs

Answer 42

Inventory records
* All DEA 222 order forms for schedule II orders (+ commercial invoices) must be signed and dated
* Items must be counted, noted, and stored in a readily retrievable file for 3 years
* Schedule II records must be stored separately from schedule III-V records
A complete and accurate inventory of all stocks must be taken every 2 years
➢ Requirements for writing an inventory
1. The name, address, and DEA registration number of the registrant
2. The date and time the inventory is taken
3. The signature of the person taking inventory
4. An indication that the inventory is maintained for at least 2 years at the location
appearing on the registration
5. An indication that inventory and other records of schedule II drugs are maintained
separately from other drugs

Question 43

Ordering Schedule III through V by either
_______, _______, or ________ an order. Schedule II drugs must be ordered on special DEA form-____

Answer 43

Ordering Schedule III through V by either
phoning, faxing, or mailing an order. Schedule II drugs must be ordered on special DEA form-222

Question 44

Storage and security of controlled substances
* Controlled substances MUST be stored in a securely ______ constructed cabinet
* In case of loss or theft →upon discovery it, the registrant MUST immediately notify the region office of the ____. Complete DEA form ____ describing the loss
* If a theft is verified → local _____ department MUST be notified

Answer 44

Storage and security of controlled substances
* Controlled substances MUST be stored in a securely locked constructed cabinet
* In case of loss or theft →upon discovery it, the registrant MUST immediately
notify the region office of the DEA. Complete DEA form 106 describing the loss
* If a theft is verified → local police department MUST be notified

Question 45

Compounded drugs
* Mixture of approved dosage forms or drugs formulated from _____ chemicals
* Veterinarians may write prescriptions for ________ pharmaceutical ingredients (APIs) to
be used in preparing compounds by licensed pharmacists
* These active pharmaceutical ingredients (drugs) are recognized by FDA to be ________
in the treatment → ________ animals (nonfood animals)

Note
Some of the drugs may still compounded for nonfood animals but never for
_____ animals or _______

The FDA has published a “negative” list → drugs withdrawn for safety or efficacy reason

Answer 45

Compounded drugs
* Mixture of approved dosage forms or drugs formulated from bulk chemicals
* Veterinarians may write prescriptions for active pharmaceutical ingredients (APIs) to
be used in preparing compounds by licensed pharmacists
* These active pharmaceutical ingredients (drugs) are recognized by FDA to be essential
in the treatment → companion animals (nonfood animals)

Note
Some of the drugs may still compounded for nonfood animals but never for
food animals or humans

The FDA has published a “negative” list → drugs withdrawn for safety or efficacy reason

Question 46

Compounded drugs

On April 14, 2022, FDA issued Guidance for Industry #256 entitled:
“compounding Animal Drugs from Bulk drug Substances.”

• List of bulk drug substances for compounding office stock drugs for use in ________- producing animals
• List of bulk drug substances for compounding for use in _____-producing animals or _____-ranging wildlife species

Answer 46

Compounded drugs

On April 14, 2022, FDA issued Guidance for Industry #256 entitled:
“compounding Animal Drugs from Bulk drug Substances.”

• List of bulk drug substances for compounding office stock drugs for use in nonfood- producing animals
• List of bulk drug substances for compounding for use in food-producing animals or free- ranging wildlife species

Question 47

Compounded drugs
FDA intends to include a bulk drug substance on either of the Lists when:

1. There is no marketed FDA-approved, conditionally approved, or indexed animal drug(s) that can be used as labeled to treat the condition;
2. There is no marketed FDA-approved, conditionally approved, or indexed animal or human drug(s) with the same active ingredient(s) that could be used in an extralabel manner to treat the condition; and
3. FDA has not identified a significant safety concern specific to use of the bulk drug
   substance in animals.
4. Urgent treatment with the compounded drug is necessary to avoid animal suffering
   or death, or to protect public safety → use in nonfood-producing animals
5. There is sufficient scientific information for the prescribing veterinarian to determine
   appropriate withdrawal, withholding, or discard time(s) for meat, milk, eggs, or any
   food which might be derived from the treated animal(s)
   → for use as antidotes in food-producing animals or for use as sedatives or
   anesthetics for free-ranging wildlife species

Answer 47

Compounded drugs
FDA intends to include a bulk drug substance on either of the Lists when:

1. There is no marketed FDA-approved, conditionally approved, or indexed animal drug(s) that can be used as labeled to treat the condition;
2. There is no marketed FDA-approved, conditionally approved, or indexed animal or human drug(s) with the same active ingredient(s) that could be used in an extralabel manner to treat the condition; and
3. FDA has not identified a significant safety concern specific to use of the bulk drug
   substance in animals.
4. Urgent treatment with the compounded drug is necessary to avoid animal suffering
   or death, or to protect public safety → use in nonfood-producing animals
5. There is sufficient scientific information for the prescribing veterinarian to determine
   appropriate withdrawal, withholding, or discard time(s) for meat, milk, eggs, or any
   food which might be derived from the treated animal(s)
   → for use as antidotes in food-producing animals or for use as sedatives or
   anesthetics for free-ranging wildlife species

Question 48

Prescription (Rx) drugs
* Prescription drugs are dispensing by or upon the order of a ___________ prescriber
→ habit former
→ toxic
→ potential for harm
* Rx products must bear the legend:
“Caution: Federal law restricts this drug to use by or on the order of a __________ veterinarian.”
A valid ________ relationship (VCPR) is required!

Answer 48

Prescription (Rx) drugs
* Prescription drugs are dispensing by or upon the order of a licensed prescriber
→ habit former
→ toxic
→ potential for harm
* Rx products must bear the legend:
“Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
A valid veterinarian-client-patient relationship (VCPR) is required!

Question 49

Prescription (Rx) drugs

Requirements for writing a prescription for noncontrolled Substances
1. Printed or stamped name, address, and telephone number of the _________ _________
2. _________ signature of the licensed practitioner
3. _______ and ________ of the drug
4. Directions for ____
5. Full name and address of the ______
6. Animal identification (?)
7. _________ statements including, if applicable, withdrawal time for ______ animals
8. Number of _____, if any

Answer 49

Prescription (Rx) drugs

Requirements for writing a prescription for noncontrolled Substances
1. Printed or stamped name, address, and telephone number of
the licensed practitioner
2. Legal signature of the licensed practitioner
3. Name and strength of the drug
4. Directions for use
5. Full name and address of the client
6. Animal identification (name and/or species)
7. Cautionary statements including, if applicable, withdrawal time
for food animals
8. Number of refills, if any

Question 50