Ohio State Board of Pharmacy
Compliance in Veterinary
Practice
2015 Midwest Veterinary Conference
Greater Columbus Convention Center, Columbus, Ohio
February 19-22, 2015
Steven Schierholt, ESQ
Executive Director
Ohio State Board of Pharmacy
614-466-4143
Sheri Zapadka, PharmD, R.Ph.
Compliance Specialist
Ohio State Board of Pharmacy
[email protected]
614-433-4143
Topics
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Definitions
Licensure
Security
Recordkeeping
Drug Destruction
Theft or loss
Personally Furnished Medications
Labeling
Prescription Requirements
Euthanasia
Compounding
Pick-Up Station
© Ohio State Board of Pharmacy
Definitions
Ohio Revised Code 4729.01 (F)
Dangerous Drug
 All prescription drugs are Dangerous Drugs
 Caution: Federal Law Prohibits Dispensing Without a Prescription.
 Caution: Federal Law restricts this drug to the use by or on the
order of a licensed veterinarian.
 Rx Only.
 Any drug intended for administration by injection into the human
body other than through a natural orifice of the human body.
 Animal vaccines are not dangerous drugs, they are regulated by the
U.S. Department of Agriculture, not the FDA.
 Statements such as : Sold only to Veterinarians, Exclusively for
Veterinary use do not define products as Dangerous Drugs.
© Ohio State Board of Pharmacy
Definitions
Ohio Revised Code 4729.01
(J) Sale and Sell:
 Include delivery, transfer, barter, exchange, or gift or offer
therefor, and each such transaction made by any person,
whether as principal proprietor, agent or employee.
(K) Wholesale Sale:
 Means any sale in which the purpose of the purchaser is to
resell the article purchased or received by the purchaser.
© Ohio State Board of Pharmacy
Licensure
Terminal Distributor of Dangerous Drugs Licenses (TDDDs)
allow business entities to purchase and possess dangerous
drugs at a specific address for distribution to patients.
 Distribution includes on-site administration and providing
medications to patients for use at home.
 Registered Wholesalers may not sell to anyone other than:
 Individual health care professionals authorized to
prescribe dangerous drugs in the course of practice
 Terminal Distributors of Dangerous Drugs
 Wholesale Distributors of Dangerous Drugs
 Manufacturers
© Ohio State Board of Pharmacy
Licensure
Businesses that DO NOT require a TDDD License
 A business practice that is a corporation, limited
liability company or professional association if the
business has a SOLE SHAREHOLDER who is a licensed
health professional authorized to prescribe drugs.
 Also defined as: a business practice with a single
prescriber (DVM), who is the sole shareholder, member
or owner of the practice, including Sole Proprietors.
© Ohio State Board of Pharmacy
Licensure
Terminal Distributor Licenses for Compounded Drugs
and On-Site Compounding: ORC 4729.541
 Effective April 1, 2015
 Business entities who possess, have custody of
control of, and distribute dangerous drugs that are
compounded or used for the purpose of
compounding must hold a license as a Terminal
Distributor of Dangerous Drugs.
www.pharmacy.ohio.gov/TDDDCompounding
© Ohio State Board of Pharmacy
Licensure
 Who:
 Business entities that are corporations, limited liability
companies, or professional associations, if the entity has a
sole shareholder who is a licensed health professional
authorized to prescribe drugs.
 Limited liability companies, partnerships, or limited
liability partnerships or professional associations, if to be
a shareholder, member or partner, an individual is
required to be licensed, or certified to perform the
professional service provided by the entity, and each such
individual is a licensed health professional authorized to
prescribe drugs.
© Ohio State Board of Pharmacy
Licensure
Exceptions:
A prescriber who practices as a sole proprietor is
exempt form licensure as a Terminal Distributor of
Dangerous Drugs.
© Ohio State Board of Pharmacy
Licensure
DEA License
 DEA registration is required for all practitioners who possess,
distribute, or prescribe controlled substances.
 One registration is required for each address where controlled
substances are located. Multiple practitioner offices require separate
registration if controlled substances are stored at each location.
 Offices located in different states must be individually registered
with the DEA.
 Individual practitioners within the same practice must maintain a
DEA registration in order to write prescriptions to be dispensed
outside the practice. 21 CFR 1301.22
© Ohio State Board of Pharmacy
Drug Security
Ohio Administrative Code 4729-9-11, 4729-9-05
 All Dangerous Drugs must be secured and provide
adequate safeguards to prevent diversion.
 Dangerous Drugs must be secured in a manner that
detects and deters unauthorized access.
 Responsible person must monitor purchases,
usage, and disposition.
© Ohio State Board of Pharmacy
Recordkeeping
Ohio Administrative Code 4729-9-22, 4729-9-14, 4729-5-01
 A record of all dangerous drugs received, administered,
dispensed, distributed, sold, destroyed or used, must be
kept on file for 3 years at the place where dangerous
drugs are stored.
 Upon request, records must be provided to the Ohio
State Board of Pharmacy within 3 working days.
 Records of prescribing, administering, dispensing and
destroying must be documented with the positive
identification of the responsible individual.
© Ohio State Board of Pharmacy
Recordkeeping
Ohio Administrative Code 4729-5-01
Positive Identification
 A method of identifying an individual who prescribes, administers,
or dispenses a dangerous drug.
 Method must also include a secure means of identification:
 Manual signature on hard copy record
 Magnetic Card Readers (with password/private personal
identifier)
 Bar Code Readers (with password/private personal identifier)
 Biometrics
 Proximity Badge
 Pharmacy Board approved randomly generated questions
 Manually signed transaction printout
© Ohio State Board of Pharmacy
Recordkeeping
Ohio Administrative Code 4729-9-14 (Controlled Substances)
 A physical inventory of Controlled Substances must be taken
annually.
 Date of Inventory
 Name, strength and finished form of substance
 Number of units or volume of each finished form in each commercial
container
 Total quantity
 Schedule I or II substances require an exact count.
 Schedule III, IV or V may make an estimated count unless the
container holds more than 1000 tables/capsules.
 Zero inventory is required if no Controlled Substances are on
hand.
© Ohio State Board of Pharmacy
Drug Destruction
Ohio Administrative Code 4729-9-06, 4729-9-22
 Ohio licensed sites require written permission from the Board of
Pharmacy to destroy controlled substances. Non-licensed sites must
follow DEA requirements.
 Use DEA Form 41 to generate a record of drugs destroyed. Ohio
licensed sites must upload DEA 41 to the OSBP website within 30
days of the completion of destruction. (www.pharmacy.ohio.gov)
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Destruction record must include:
 Drug name
 Drug strength
 Drug dosage form
 Quantity destroyed
 Date destroyed
 Method of destruction
 Positive identification of the person destroying
 Positive identification of the witness to destruction for controlled substances
© Ohio State Board of Pharmacy
Drug Destruction
Ohio Administrative Code 4729-9-17
 Adulterated drugs may not be stored longer than 1 year from the date of
adulteration/expiration.
 Methods of disposal shall prevent the possession of the drugs by
unauthorized persons.
 Per DEA, “Non-retrievable” means the condition or state to which a
controlled substance shall be rendered following a process that
permanently alters that controlled substances physical or chemical
condition or state through irreversible means, and thereby renders the
controlled substance unavailable and unusable. A controlled substance is
considered non-retrievable when it cannot be transformed into a
physical or chemical condition or state as a controlled substance or a
controlled substance analog.
© Ohio State Board of Pharmacy
Theft or Loss
Ohio Administrative Code 4729-9-15
Ohio Revised Code 2921.22
REQUIRED to report:
Suspected theft
Confirmed (significant) loss
Report upon discovery immediately by telephone to the Ohio
State Board of Pharmacy and local law enforcement
Complete DEA form 106:
Electronically file with the DEA
Email to the Board within 30 days at
[email protected]
© Ohio State Board of Pharmacy
Personally Furnish
Ohio Revised Code 4729.29, 4729.291
 A licensed health professional authorized to prescribe may personally
furnish patients with dangerous drugs in the scope of their professional
practice.
 Drugs must be labeled and packaged in accordance with state and
federal drug laws.
 Records must be kept in accordance with state and federal drug laws.
 Positive Identification of the veterinarian furnishing the drug must be
recorded. No refills are permitted.
 Medications may only be furnished when the veterinarian is on-site.
Anyone can prepare and pass out medications provided the veterinarian
checks the preparation prior to release.
© Ohio State Board of Pharmacy
Labeling
Ohio Administrative Code 4729-5-17
 The label of drugs personally furnished to patients
must include:
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Name and address of veterinarian
Name of client and identification of the animal
Drug name and strength
Directions for use
Date dispensed
Any cautionary statements
 Child Resistant Closures?
© Ohio State Board of Pharmacy
Manner of Issuance of a
Prescription
Ohio Administrative Code 4729-5-30
 Prescriptions must be issued for a legitimate medical purpose by a
practitioner acting in the usual course of their professional practice.
 Requirements:
 Prescriber name, title, address and phone number
 Date issued
 Name and address of patient (ID of animal or herd/flock)
 Drug name and strength
 Quantity (numerically and alphabetically if controlled)
 Directions for use – Be specific!
 Number of refills
 DEA # if controlled substance
 Manual signature of prescriber
© Ohio State Board of Pharmacy
Euthanasia of Animals
Ohio Administrative Code 4729.531, 4729.532
Limited License to Animal Shelters for Euthanasia
 Animal shelters may apply for a Limited Terminal
Distributor of Dangerous Drugs License for the
purpose of purchasing, possessing, and
administering combination drugs that contain
pentobarbital and at least one other non-controlled
substance, in a manufactured dosage form whose
only indication is for euthanizing animals.
© Ohio State Board of Pharmacy
Euthanasia of Animals
 License holders are not permitted to distribute these drugs to
any person.
 Licensure requires that an agent or employee of an animal
shelter, other than a registered veterinary technician, has
successfully completed a euthanasia technician certification
course.
 Euthanasia methods include:
 Intravenous Injection
 Intraperitoneal Injection
 Intracardial Injection (only on sedated/unconscious
animals)
 Solution or Powder added to food
© Ohio State Board of Pharmacy
Euthanasia of Animals
 Registered veterinary technicians or certified
euthanasia technicians may perform euthanasia by
lethal injection.
 Euthanasia technician certification courses must be
approved by the state Veterinary Medical Licensing
Board.
 Animal Shelter agents/employees may not perform
euthanasia by lethal injection unless the facility is
licensed with the State Board of Pharmacy.
© Ohio State Board of Pharmacy
Compounding
Definition:
The preparation , mixing, assembling, packaging, and
labeling of one or more drugs pursuant to a
prescription issued by a licensed health professional
authorized to prescribe drugs, or pursuant to a
request made by a licensed health professional for
the purpose of direct administration to patients in the
course of professional practice.
© Ohio State Board of Pharmacy
Compounding
Who may compound?
 A pharmacist- pursuant to a valid prescription
 A veterinarian- to provide to his/her own patients
 Veterinary practices properly licensed by the Ohio State Board
of Pharmacy
What Can I compound?
 Non-commercially available products.
 Unique dosages/dosage forms specific to the animal
population.
 Compounding from approved animal or human drugs under
the conditions set forth in 21 CFR 530.13.
© Ohio State Board of Pharmacy
Compounding
Compounding should be limited to:
1. Individual patients which no other method or
route of drug delivery is practical.
2. Drugs for which safety, efficacy and stability have
been demonstrated in the specific compounded
form for the specific animal.
3. Disease conditions for which a quantifiable
response to therapy or drug concentration can be
monitored.
© Ohio State Board of Pharmacy
Compounding
Compounding Records:
 Master Formula – inspect and approve the compounding
process
 Compounding Worksheet
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Patient name
Drug name/strength/dose
Quantity added to each container
Disposition of unused drugs
Manufacturers name (if generic) lot #, expiration date
Date of compounding
Beyond Use date of compounded product
Documentation of compounder
Positive identification of the Veterinarian performing the final
check of the finished product
© Ohio State Board of Pharmacy
Compounding
 Compounding does not include mixing,
reconstituting, or other such acts performed in
accordance with directions contained in approved
labeling provided by a products manufacturer
 Compounded products must be assigned a BeyondUse date in accordance with USP 795/797, drug
product testing, or published peer reviewed
literature
For more information see: CPG Sec. 608.400 – Compounding of Drugs for
Use in Animals (FDA)
© Ohio State Board of Pharmacy
Compounding Pharmacies
 Must be licensed by the Ohio State Board of
Pharmacy
 May compound patient specific drugs pursuant to a
valid prescription.
 Must provide prescriptions directly to the
patient/caregiver
 Veterinary Compounding training courses are
available but not required.
© Ohio State Board of Pharmacy
Prescription Pick-Up Station
Ohio Administrative Code 4729-5-10
 A Pick-Up Station permits an entity to receive patient-specific
prescription medications on behalf of the end user/patient.
 In order to be a pick-up station, a request must be submitted
electronically to the Pharmacy Board.
www.pharmacy.ohio.gov
 Facilities receiving prescription medication on behalf of a
patient who does not live at the facility must become a PickUp station.
www.pharmacy.ohio.gov/pickup
© Ohio State Board of Pharmacy
Prescription Pick-Up Station
Requirements of a Pick-Up Station:
 Site must be appropriately licensed.
 Delivery of the prescription medication directly to the patient
would result in:
 A danger to public health or safety.
 A danger to the patient without increased involvement
from the health care professional.
 The receipt, storage, control, and distribution of prescriptions
or drugs are in the full and actual charge of a health care
professional.
 Appropriate recordkeeping systems are in place to account
for the receipt, delivery and return of all prescription
medications.
© Ohio State Board of Pharmacy
Questions?
© Ohio State Board of Pharmacy