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VETERINARY PHARMACY

& PHARMACY LAW


C

Elizabeth Young, Pharm.D. FSVHP


Wasson Veterinary Pharmacy Resident
Purdue University Veterinary Teaching Hospital
January 11, 2018
Objectives
• Briefly review the Federal Food, Drug and Cosmetic Act and its amendments pertaining
to veterinary medicine

• Introduce the Veterinary Feed Directive and its implications on veterinary practice

• Discuss how antimicrobial resistance arises and how it can be prevented

• Introduce the Controlled Substances Act and the Drug Enforcement Agency

• List various controlled substances used in veterinary medicine and which schedules
they fall under
Background
• Pharmacology:
• The branch of medicine concerned with the uses, effects, and modes of action of drugs in the
body

• Pharmaceuticals are essential to veterinary medicine


• Keep in mind that all drugs work by altering a patient’s normal physiology  thus all
drugs have side effects.

• Pharmacy laws and regulations are important to understand in order to prevent misuse
and illegal dispensing/handling of medications
Veterinarians are often “pharmacists”
• In many community practices, veterinarians dispense and sell
medications.

• This can account for ~20% of a practice’s income.

• DVM’s can also write prescriptions for clients to take to retail


pharmacies (Walgreens, CVS, Walmart, etc.) or compounding
pharmacies
• Most retail pharmacies only carry human medications
Pharmacy Law and Veterinary
Medicine
The Veterinarian-Client-Patient-
Relationship
Veterinarians must have a valid
VCPR prior to prescribing prescription
drugs for animal patients

Agreement:
Examination: Follow-up:
Veterinarian accepts
Vet must have recently Vet agrees to be
responsibility for
examined the animal available for follow-up
treating the animal;
or documented a visit if a problem occurs
owner agrees to follow
to the farm with treatment
vet’s instructions
VCPR
• AVMA’s Principles of Veterinary Medical Ethics: Section III
• The veterinarian has assumed the responsibility for making medical judgments
regarding the health of the patient and the client has agreed to follow the
veterinarian's 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. This means that the
veterinarian is personally acquainted with the keeping and care of the patient by
virtue of:
• a timely examination of the patient by the veterinarian, or
• medically appropriate and timely visits by the veterinarian to the operation where the
patient is managed.
• 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.
VCPR
• IC 25-38.1-1-14.5"Veterinarian-client-patient relationship"
• Sec. 14.5. "Veterinarian-client-patient relationship" means a relationship between a
veterinarian and client that meets the following conditions:
• (1) The veterinarian has assumed the responsibility for making clinical judgments regarding
the health of the animal and the need for medical treatment, and the client has agreed to
follow the veterinarian's instructions.
• (2) The veterinarian has sufficient knowledge of the animal to initiate a diagnosis of the
medical condition of the animal. The veterinarian has recently seen and is personally
acquainted with the keeping and care of the animal by either of the following:
• (A) An examination of the animal.
• (B) By recently seeing and being personally acquainted with the keeping and care of representative
animals and associated husbandry practices by making medically appropriate and timely visits to
the premises where the animal is kept.
• (3) The veterinarian is readily available or has arranged for emergency coverage for follow-
up evaluation if there is an adverse reaction or failure of the treatment regimen.
• (4) When appropriate, the veterinarian has arranged for continuing care with another
licensed veterinarian who has access to the animal's medical record.
History of Important Laws
• Food and Drug Act of 1906 – prevention of mislabeling
• Products must contain what the label says it contains
• No safety testing required
• No efficacy testing required

• This only forbade fraudulent curative claims where it could be


proved the promoter intended to deceive the purchaser
History of Important Laws
• Food, Drug, and Cosmetic Act of 1938 –
requirements for safety testing

• Sulfanilamide disaster in 1937: “taste of raspberries,


taste of death”
• Sulfanilamide – used to treat strep throat (mainly
children)
>100 people died of renal failure

• Many amendments apply directly to animal drugs


Amendments to the Federal FDC Act
• AMDUCA = The Animal Medicinal Drug Use Clarification Act of 1994

• “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.

• Prior to it’s passage, extra-label drug use was illegal.


AMDUCA
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
• Alternatively if an approved animal drug exists but a veterinarian finds, within the context of a VCPR, that
the approved drug is clinically ineffective for its intended use, extra label use of an alternative medication
is permissible.

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.
Extra Label Drug Use (ELDU)
• Describes the use of an approved drug in a manner that is not in
accordance with the approved labeling.
What is approved labeling?
• It’s the 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
The Label The Package Insert
What is approved labeling?
• It’s the 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.
Extra Label Drug Use (ELDU)
• Describes the use of an approved drug in a manner that is not in
accordance with the approved labeling.

• ELDU of an FDA approved drug may be used 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
veterinary finds that the drug is clinically ineffective for its labeled use.
ELDU
• This can include use in another species, use for another
indication, or at a different dose or frequency, as well as a
different route of administration.
• Using Atopica for Cats (cyclosporine) solution – approved for cats  using it
in a dog
• Using an antibiotic for a UTI when it has only been approved for skin and soft
tissue infections
• Using Clavamox TID instead of it’s labeled BID dosing
• Using eye drops in the ear
ELDU
• FDA has the right to prohibit the extra label use of an approved new animal or human
drug or class of drugs in animals if the FDA determines:
• 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.
• The following drugs have been prohibited in food-producing animals

• Chloramphenicol • Sulfonamide drugs in lactating dairy cattle


• Clenbuterl (with exceptions)
• Diethylstilbestrol (DES) • Fluoroquinolones
• Dimetridazole • Glycopeptites
• Ipronidazole • Phenylbutazone in female dairy cattle 20
• Other nitroimidazoles months of age or older
• Furazolidone • Cephalosporin (excluding cephapirin) use in
• Nitrofurazone cattle, swine, chickens, and turkeys
• Others
Amendments to the Federal FDC Act
• Animal Drug Availability Act of 1996 (ADAA)
• 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
Veterinary Feed Directive (VFD)
• Background
• Antibiotics have in the past been available over the counter for
incorporation into feed
• Development of resistant bacteria linked to inappropriate use
of antibiotics in food animals
• Used for production purposes
• NOT used for prevention or treatment of a disease
• “Increase weight gain”, “improve feed efficiency”
Veterinary Feed Directive (VFD)
• So who cares about antibacterial resistance?
• Microbes are living organisms
• Constantly mutating
• It’s a global concern
• Increased medical costs
• Increased length of hospital stays
• Increased mortality rates
Veterinary Feed Directive (VFD)
• FDA’s Judicious Use Strategy
• 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.”
• This list represents the medically important antimicrobials approved for use in or on
animal feed that require a VFD, including those that transitioned from over-the-counter
(OTC) to VFD
• All feed uses of the following drugs, alone and in a combination with another drug(s),
require a VFD

apramycin avilamycin chlortetracycline (CTC)


chlortetracycline/sulfamethazine erythromycin florfenicol
hygromycin B lincomycin neomycin
oleandomycin oxytetracycline oxytetracycline/neomycin
sulfadimethoxine/ormetoprim sulfamerazine tilmicosin
tylosin tylosin/sulfamethazine tylvalosin
virginiamycin

• Note that some of these medications may not be marketed at this time
What does this mean?
• Veterinarian-Client-Patient Relationship (VCPR) required
• Written (nonverbal) statement from a licensed veterinarian
• Name of VFD drug
• Date of issuance, date of expiration (no more than 6 months from issuance)
• Veterinarian’s name, address, phone number, electronic or written signature
• Client’s name, address, phone number
• Location of animal/animals (i.e., a farm)
• Species and production class of animals to be fed
• Approximate number of animals to be fed
• Duration of use, Number of reorders authorized
• Indication
• WDT, special instructions and cautionary statements
• Statement: “ Use of feed containing this VFD drug in a manner other than as
directed on the labeling is not permitted”
Veterinary Feed Directive (VFD)
• Useful links:
• FDA’s Q&A on VFD Regulation:
• http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforce
ment/GuidanceforIndustry/UCM052660.pdf
• FDA’s Brochure on the VFD for veterinarians:
• https://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess
/UCM455480.pdf
Withdrawal Time (WDT)
• The WDT is the estimated time that tissues can be safely
consumed following the last dose of drugs in 99% of animals
treated.
• WDTs are expressed in days for meat and eggs, and hours for milk
• Meat: the animal cannot be slaughtered for food prior to that time
• Milk: the milk taken from the lactating cow must be discarded for that many
hours after the last dose of drug is given
• Drugs approved for use in food animals must contain WDT
information on their labeling
Food Animal Residue Avoidance
Database (FARAD)
• Supported by USDA

• A computer based decision support program to provide drug and pesticide WDTs for
producers, DVMs, and extension specialists
FARAD
• “The overarching goal of FARAD is to provide current and
accurate scientific information to veterinary practitioners and
thereby foster production of animal-derived human foods that
are devoid of unsafe chemical residues, including drugs,
pesticides, natural toxins and environmental contaminants.”

• http://www.farad.org/
Amendments to the Federal FDC Act
• MUMS = Minor Use/Minor Species Act of 2004
• Minor uses: disease affecting a small percentage of a species
• Minor Species: everything that’s not a major species

• Major Species:
• Cats
• Dogs
• Cattle
• Horses
• Pigs
• Chickens
• Turkeys
MUMS Approval Process
• CONDITIONAL APPROVAL: A sponsor can apply for “conditional approval,” which
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.

• DESIGNATION: Sponsors of “designated” new animal drugs are eligible to apply for
grants to support safety and effectiveness testing.

• INDEXING: In some cases, 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 of Legally
Marketed Unapproved New Animal Drugs for Minor Species (the Index). This provision
is limited to minor species that are not used as food for humans or other animals.
The Pathway to FDA Approval
•New Animal Drug Application (NADA)
• Full blown approval for pioneer drug

•Abbreviated New Animal Drug Application


(ANADA)
• Approval for generic of a pioneer approved drug
Who regulates you?
• Congress – pass the laws that govern drug use
• Food and Drug Administration (FDA) – regulations enforce
congressional laws
• Center for Veterinary Medicine (CVM) – subsection of the FDA
that oversees veterinary medical drugs
• Drug Enforcement Administration (DEA) – enforces use of
Controlled Substances
• Environmental Protection Agency (EPA) – enforces use of
topically applied anti - parasitic, sprays, and insecticides
• State and Local laws
FDA
• U.S. Food and Drug Administration

• Responsible for protecting the public by ensuring the


safety, efficacy, and security of human and veterinary
drugs, biological products, and medical devices.

• They also ensure the safety of the nations food supply


and cosmetics
Center for Veterinary Medicine
(CVM)
• Subsection of the FDA

• Assures that an animal drug is safe and effective before approval


• Monitors safety and effectiveness of animal drugs already on the market
• Monitors safety, manufacturing, and labeling of animal food/treats
• Assures the safety and effectiveness of food additives for use in food for
animals
• Conducts research
• Helps make more animal drugs legally available for minor species and minor
uses in major species.
USDA
• U.S. Department of Agriculture

• Regulates veterinary biologics


• Vaccines

• The Virus-Serum-Toxin Act of 1913 is the federal


legislation granting this regulatory authority to the
USDA
EPA
• Environmental Protection Agency Example:

• Topical flea and tick products, as well


as all other environmental and topical
pesticides, fungicides, and
rodenticides
• These products are covered by a set of
statutes known as the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA)
• If any substance in this category are
administered orally or parenterally,
they are then under FDA jurisdiction.
Drug Enforcement Administration (DEA)
• Enforces the controlled substances laws and regulations
of the United States
• The DEA 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
• They must also maintain accurate inventories, records, and security of
the controlled substances.
• Perform Inspections
CONTROLLED
SUBSTANCES
C
CSA
• Controlled Substances Act (CSA) of 1970
• Grants 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
CSA
• There are five schedules of medications that are used to classify drugs – these are
based on the abuse potential, medical applications, and safety.

• Schedule I: High abuse potential, NO accepted medical use


• Schedule II: High abuse potential, accepted medical use; use may lead to
psychological/physical dependence
• Schedule III: Lower abuse potential, accepted medical use; may lead to moderate
or low physical dependence or high psychological dependence
• Schedule IV: Low abuse potential, accepted medical use; may lead to limited
physical dependence or psychological dependence
• Schedule V: Low abuse potential, accepted medical use; may lead to limited
physical dependence or psychological dependence relative to the drugs in
schedule IV.
Why should I know this?
• Many medications used in veterinary medicine are controlled
substances
• Schedule II: hydromorphone, fentanyl, codeine, methadone
• Schedule III: ketamine, buprenorphine, pentobarbital (euthanasia)
• Schedule IV: tramadol, phenobarbital, butorphanol, benzodiazepines
(alprazolam, diazepam, etc.)
• Schedule V: diphenoxylate + atropine (Lomotil)
• Drug Diversion
• Use of a substance for a use other than what is prescribed
• Use of a substance by a person other than who it was prescribed for.
Why should I know this?
•As veterinarians, you will be administering,
dispensing, and writing prescriptions for these
medications!
• “A prescription for a controlled substance may be issued by one of the
following practitioners licensed in Indiana: physician, osteopathic physician,
veterinarian, podiatrist, advanced practice nurse, physician assistant … The
practitioner must hold an Indiana Controlled Substance Registration (CSR)
and a federal Drug Enforcement Agency (DEA) registration … in order to
prescribe a controlled substance.”
CSA Amendment
• Veterinary Medicine Motility Act of 2014

• Allows traveling veterinarians to transport/dispense controlled substances


across state lines without needed a new CSR number for each state
• You must still be licensed and have a CSR/DEA numbers in your original state
of business

• “A veterinarian shall not be required to have separate registration in order to transport


and dispense controlled substances in the usual course of veterinary practice at a site
other than the registrant’s registered principal place of business or professional
practice”
What are your responsibilities?
• Inventory
• “…a complete and accurate record of all controlled substances on hand
on the date the inventory is taken … maintained in written, typewritten or
printed form at the registered location” (at your practice)
• Initial inventory and at least biennially (every 2 years)

• Expired Controlled Substances


• Reverse distributors: handle unwanted, unusable, outdated controlled
substances (many times pharmaceutical companies will register for this)

• Some states have stricter regulations


References & Additional Readings
• FDA Website > Food, Drug and Cosmetic Act:
https://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDC
ActChapterVDrugsandDevices/default.htm
• FDA Website > AMDUCA:
https://www.fda.gov/regulatoryinformation/legislation/significantamendmentstothefdcact/animalmedi
cinaldruguseclarificationactamducaof1994/default.htm
• FDA Website > Brochure on the Veterinary Feed Directive > Requirements for Veterinarians 2015:
https://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/UCM455480.pdf
• Indiana Board of Pharmacy Website > Controlled Substance Prescriptions.
http://www.in.gov/pla/3016.htm
• Indiana Board of Pharmacy Website > Pharmacy Laws & Regulations. http://www.in.gov/pla/2545.htm
• DEA website > Controlled Substance Regulations. https://www.deadiversion.usdoj.gov/index.html
• DEA website > List of Controlled Substances. https://www.deadiversion.usdoj.gov/schedules/index.html
VETERINARY PHARMACY
& PHARMACY LAW
C

Elizabeth Young, Pharm.D. FSVHP


Wasson Veterinary Pharmacy Resident
Purdue University Veterinary Teaching Hospital