Board of Pharmacy Compliance
What You Need to Know
2017 Midwest Veterinary Conference
Cameron McNamee, MPP
Director of Policy and Communications
Sheri Zapadka, Pharm.D., R.Ph.
Compliance Specialist
Objectives
▪ Define licensing requirements for veterinary clinics and animal
shelters
▪ Review updates and pending updates to administrative rules.
▪ Review dangerous drug destruction requirements
▪ Review systems of security and control of dangerous drugs
▪ Examine dangerous drug record keeping requirements
▪ Identify veterinary requirements for compounded dangerous
drugs
▪ Describe requirements for personally furnishing dangerous drugs
to veterinary clients
Definitions
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.
▪ 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.
Licensure
▪ Terminal Distributor of Dangerous Drug licenses
(TDDDs) allow business entities to purchase, possess
and distribute dangerous drugs at a specific address
for distribution to patient.
▪ Distribution includes administration of drugs on-site
and providing drugs to patients for at-home use
(personally furnishing).
▪ Wholesalers cannot not sell to anyone other than an
individual prescriber (not a prescriber
practice/business), a TDDD, or other
wholesalers/manufacturers.
Licensure
▪ A separate license is required for each location
where dangerous drugs are received, stored,
used or distributed.
▪ TDDD license may transfer drugs between TDDDs
under common ownership (intra-company
sales/transfers). (OAC 4729-9-12).
Licensure
Who is exempt from TDDD licensure requirements?
▪ Health care professionals authorized by law to prescribe
drugs or dangerous drugs who practice as a sole proprietor
under their professional license and, who DOES NOT meet
the aforementioned licensing requirements.
▪ Prescriber businesses (S-corporations, LLC, professional
associations) if the business practice has a sole shareholder
who is a licensed health professional authorized to
prescribe drugs and to provide the professional services
offered by the practice, and who DOES NOT meet the
aforementioned licensing requirements.
www.pharmacy.ohio.gov/prescribertddd
Licensure
Who Must Obtain a TDDD?
▪ Business practices which are group practices where
there are multiple owners, shareholders or members
(prescribers or non-prescribers).
PREVIOUSLY LISTED EXEMPTIONS DO NOT APPLY
FOR:
▪ All prescriber practices that purchase and possess
dangerous drugs that are compounded or used for the
purpose of compounding (Effective April 1, 2017).
▪ All prescriber practices that purchase and possess
controlled substances (Effective April 6, 2017).
Licensure – Responsible Person
Ohio Administrative Code 4729-5-11
▪ A location licensed as a terminal distributor of
dangerous drugs must have a responsible
person at all times.
▪ Responsible person must be a veterinarian.
▪ Any change of responsible person must be
reported to the Board within 10 days, and a
new controlled substance inventory must be
conducted.
Licensure – Responsible Person
Ohio Administrative Code 4729-5-11
▪ A responsible person must be physically present at the
location for a sufficient amount of time to provide
supervision and control of dangerous drugs on-site.
▪ Responsible for ensuring the terminal distributor of
dangerous drugs requirements are met, including, but
not limited to, supervision and control of dangerous
drugs, adequate safeguards, security and control of
dangerous drugs and maintaining all records relating
to the distribution dangerous drugs.
Licensure
Drug Enforcement Administration
▪ 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
Licensure
Legal Questions
▪ On the TDDD application, there are
questions pertaining to criminal and
disciplinary history of employees of the
practice.
▪ To better clarify the Board’s
expectations a guidance document was
issued: www.pharmacy.ohio.gov/legal
Recently Updated Rules /Pending
Rules
Ohio Administrative Code 4729-16-12
▪ In-office compounding for veterinary use.
▪ A compounding pharmacy shall only provide a “limited
quantity” compounded drug products that are not
commercially available. In the following circumstances:
– To treat an emergency situation;
– For an unanticipated procedure or treatment for which a time delay
would negatively affect a patient outcome;
– For diagnostic purposes.
Recently Updated Rules /Pending
Rules
Ohio Administrative Code 4729-16-12
▪ “Limited quantity" means a quantity of a
compounded drug that meets the following:
▪ Is sufficient for that veterinarian's office use consistent with
the beyond use date of the product;
▪ Is reasonable considering the intended use of the
compounded medication and nature of the veterinarian's
practice; and
▪ The pharmacist who provides the veterinarian with a
compounded drug exercises their professional judgment as
to whether the quantity of the drug is appropriate.
Recently Updated Rules /Pending
Rules
Ohio Administrative Code 4729-16-12
▪ A veterinarian may personally furnish up to a seven
day supply of a compounded drug to a patient when,
in their professional judgment, failure to provide the
drug would result in potential harm to the patient.
▪ Veterinarians shall not:
– Sell a compounded drug to another prescriber;
– Sell a compounded drug to a pharmacy; or
– Return a compounded drug to the supplying pharmacy, unless
there is a documented error or recall.
Pick-Up Stations
Ohio Administrative Code 4729-5-10
▪ Effective February 19, 2017, rule 4729-5-10 of the Ohio
Administrative Code, which permits entities (known as pick-up
stations) to receive patient-specific prescription medication on
behalf of the end user/patient, removes the requirement that a
pharmacy or entity serving as a pick-up station submit notification
to the Board of Pharmacy.
▪ A dangerous drug that is not distributed to a patient shall either:
– Be returned to the dispensing pharmacy for disposal; or
– If the pick-up station is licensed a terminal distributor of
dangerous drugs, be disposed of in accordance with rules 47299-17 or 4729-9-06 of the Administrative Code.
Avoiding Illegal Purchases
Ohio Revised Code 4729.51
No licensed terminal distributor of dangerous
drugs shall purchase for the purpose of resale
dangerous drugs from any person other than a
registered wholesale distributor of dangerous
drugs.
Avoiding Illegal Purchases
Ohio Administrative Code 4729-9-12
▪ Before a terminal distributor of dangerous drugs may make a
purchase of dangerous drugs at wholesale, the purchaser must
obtain from the seller or the board's online registry the
wholesale distributor registration number.
▪ If no registration number of the wholesale distributor is obtained
or furnished before the purchase, both the purchaser and the
seller shall be considered to be in violation of section 4729.60 of
the Revised Code.
Avoiding Illegal Purchases
Avoiding Illegal Purchases
Drug Security
Proposed Changes to 4729-9-05
NOTE: NOT EFFECTIVE
▪ A veterinarian may maintain a supply of dangerous drugs
obtained from a licensed terminal distributor of dangerous drugs
in order to treat current or prospective patients that cannot be
reasonably treated at the location licensed as a terminal
distributor of dangerous drugs.
▪ The dangerous drugs shall be maintained in accordance with the
manufacturer’s instructions. A veterinarian shall maintain personal
supervision and control over the dangerous drugs and any
hypodermics removed from the terminal distributor.
▪ If personal supervision is not provided, the dangerous drugs and
any hypodermics shall be physically secured in a manner to
prevent unauthorized access and shall be stored at temperatures
which will ensure the integrity of the drugs.
Drug Security
Ohio Administrative Code 4729-9-11, 4729-9-05
▪ Dangerous drugs, exempt narcotics, uncompleted prescription
blank(s), hypodermics, and poisons must be stored in an area
secured by either a physical barrier with suitable locks, and/or an
electronic barrier to deter and detect unauthorized access.
▪ Records relating to dispensing, distribution, personally furnishing
and sale of dangerous drugs shall be maintained on-site under
appropriate supervision and control to restrict unauthorized access,
unless permission for off-site storage has been granted by the
Board.
▪ Responsible person must monitor purchases, usage, and
disposition.
▪ Only individuals authorized under state laws or rules shall have
unsupervised access to dangerous drugs.
Drug Security
Ohio Administrative Code 4729-9-11, 4729-9-05
• During non-business hours, hypodermics
shall be stored in an area secured by a
physical barrier with suitable locks.
• During normal business hours, hypodermics
shall not be stored in areas where members
of the public are not supervised by
individuals authorized to administer
injections.
Theft or Loss
Ohio Administrative Code 4729-9-15
Ohio Revised Code 2921.22
REQUIRED to report:
– Suspected theft
– 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: [email protected]
www.pharmacy.ohio.gov/theftorloss
Record Keeping
OAC 4729-9-22
▪ Each prescriber/TDDD must keep a record of dangerous
drugs received, administered, dispensed, personally
furnished, distributed, sold, destroyed or used.
▪ Prescribing, administering, dispensing and destroying of
dangerous drugs must be documented with the positive
identification of the responsible individual.
▪ Upon request records must be provided to the Ohio State
Board of Pharmacy within three (3) working days.
Record Keeping
Ohio Administrative Code 4729-5-01 – Positive Identification
▪
A method of identifying an individual who prescribes, administers,
or dispenses (personally furnishes) a dangerous drug.
▪
Method must also include a secure means of identification:
o Manual signature on hard copy record
o Magnetic Card Readers (with password/private personal
identifier)
o Bar Code Readers (with password/private personal identifier)
o Biometrics
o Proximity Badge
o Pharmacy Board approved randomly generated questions
o Manually signed transaction printout
Record Keeping
Records of receipt must include:
–
–
–
–
Drug name/description
Quantity received
Date received
Name/address of persons from whom received
Records of prescribing/administration/dispensing must include:
–
–
–
–
–
Drug name/description
Quantity administered, sold, dispensed, used
Name and address of the person for whom drugs were
used/dispensed
Identification of the animal
Positive identification of the person
prescribing/administering/dispensing
Recordkeeping
OAC 4729-9-14, ORC 3719.07
▪
A physical inventory of controlled substances must be taken annually at each
licensed location.
o
o
o
o
▪
▪
▪
▪
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
Note: Inventories and records of controlled substances in schedule I and II
must be maintained separately from all other records. Inventories and records
of controlled substances schedule III-V must be maintained separately from all
other records or in a form that the information is readily retrievable from
ordinary business records (21 CFR 1304.04)
Record Keeping
Discontinuing Business
▪
Must file written notice with the Board 14 days in advance of proposed
date of discontinuing business.
▪
Notice must include:
– Name/address and TDDD number discontinuing business
– Name/address and TDDD number of location where drug stock will be
transferred
– Name/address of the secured location where drug records will be
stored
– Proposed date of discontinuation of business
▪
A complete inventory of controlled substances being transferred must be
conducted and both parties must retain a copy in the records
▪
The registrant shall return to the Board of Pharmacy the TDDD license
Drug Compounding
▪ Ohio Administrative Code (OAC) 4729-16-04,
Drugs Compounded by a Prescriber does not
apply to a prescriber who is a veterinarian.
▪ Veterinary practices preparing or handling
compounded hazardous drugs must comply
with OAC 4729-16-11.
Drug Compounding
OAC 4729-16-11 Hazardous Drugs Compounded by a Prescriber
▪ Rule 4729-16-11 does not differentiate between
reconstitution and compounding for hazardous drugs.
▪ What is a hazardous drug?
▪ The National Institute for Occupational Safety and Health maintains a
list of hazardous drugs used in healthcare settings. The list can be
accessed here: https://www.cdc.gov/niosh/docs/2016-161/.
Guidance Document: www.pharmacy.ohio.gov/hazardous
Drug Compounding
OAC 4729-16-11 Hazardous Drugs Compounded by a Prescriber
▪
▪
▪
▪
▪
▪
▪
▪
▪
Must be licensed as a TDDD
Must have policies and procedures
Must meet physical requirements for compounding
Must maintain environmental quality and control
Must require personal protective equipment to be worn and safety
techniques to be followed during drug receipt and handling
Must require appropriately fitted respiratory protection
Must ensure appropriate disposal of personal protective
equipment
Must provide personnel training at least annually and when new
equipment/drugs are used
Compounding areas must be restricted to authorized staff only
Drug Compounding
OAC 4729-16-11 Hazardous Drugs Compounded by a Prescriber
▪
Materials used for packaging and transport must maintain the physical
integrity, stability and sterility of hazardous drugs during transport.
▪
Records of hazardous drugs must be kept pursuant to OAC 4729-1606
▪
Hazardous drugs personally furnished are labeled in accordance with
OAC 4729-5-17
▪
Hazardous drugs shall not be compounded in anticipation of need
▪
A licensed prescriber must perform the final check of a finished
hazardous drug compound prior to it being personally furnished or
administered to a patient unless the drug is administered to a patient
in the facility by a licensed health professional in accordance with
their applicable scope of practice, and at least two licensed healthcare
personnel complete the required checks.
Drug Disposal
▪ Adulterated drugs must be stored in a
separate and secure area apart from
the storage of drugs used for
dispensing, personally furnishing,
administration and compounding.
▪ Adulterated drugs must not be stored
longer than 1 year from the date of
adulteration or expiration.
Drug Disposal
▪ Dangerous drugs that are NOT controlled substances
may be destroyed utilizing proper methods of disposal
to prevent the possession of the drugs by
unauthorized persons.
▪ Records of dangerous drug destructions must contain:
Drug name, strength, dosage form
Quantity of drug destroyed
Date destroyed
Method of destruction
Positive identification of the prescriber or person
responsible for performing the destruction, and positive
identification of the witness to the destruction if a
witness was used.
– Records must be retained for a period of 3 years at the
place the dangerous drugs are located.
–
–
–
–
–
Drug Disposal
▪ Dangerous drugs which are controlled substances must be
disposed of in accordance with 21 C.F.R. 1317 / OAC 47299-06.
▪ Records of controlled substances destroyed must be
recorded on DEA Form 41 and must be maintained for a
minimum of 3 years, and made available to the Board of
Pharmacy upon request.
▪ Methods of destruction must be sufficient to render all
controlled substances non-retrievable and may include:
– Transfer to a person registered to accept controlled substances for the
purpose of destruction
– Transport to a registered location
– Transport to a non-registered location
– On-site destruction
Drug Disposal
▪ Only persons authorized by DEA may
collect controlled substances from
ultimate users and non-registrants for
destruction.
▪ Law enforcement may collect controlled
substances from ultimate users or
persons lawfully entitled to dispose of
an ultimate user decedent’s property.
Drug Disposal
Non-retrievable
▪
Non-retrievable means the condition or state to which a controlled
substance shall be rendered following a process that permanently alters
that controlled substance’s physical or chemical condition or state through
irreversible means and thereby rendering the dangerous drugs that are
controlled substances unavailable and unusable for all practical purposes.
▪
The process to achieve a non-retrievable condition or state may be unique
to a substance’s chemical or physical properties. A dangerous drug which
is 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 controlled substance analog.
▪
Does not include sewering.
Drug Disposal
• The Board and the DEA do not evaluate
technologies to determine if they meet the
non-retrievable definition.
• For disposal methods other than
incineration or use of a DEA registered
reverse distributor, the Board recommends
having proper documentation from the
manufacturer demonstrating how such
method meets the definition of nonretrievable.
Personally Furnishing Dangerous Drugs
OAC 4729-5-17
▪ Personally furnish means the distribution of drugs by
a prescriber to the prescriber’s patients for use
outside the prescriber’s practice setting.
▪ No prescriber may personally furnish to a patient to
whom there is no valid prescriber patient relationship,
pursuant to applicable state and federal laws,
regulations, and rules.
▪ This may include a requirement for a documented
patient encounter pursuant to each individual
healthcare licensing board.
Personally Furnishing Dangerous Drugs
OAC 4729-5-17
▪ Dangerous drugs (other than samples)
personally furnished to patients must be
labeled with:
– Name/address of prescriber
– Name of pet owner + identification of the
animal
– Name and strength of the drug
– Directions for use
– Date furnished
– Statement “Compounded Drug Product” or
similar statement, if applicable
Personally Furnishing Dangerous Drugs
OAC 4729-5-17
▪ Prescribers may designate health care
professionals (veterinary tech) acting within
the scope of their professional practice, and
under the supervision of the prescriber to
prepare and package a dangerous drug to
be personally furnished by the prescriber.
▪ The prescriber shall perform the final
verification of the dangerous drug prior to
personally furnishing and document the
verification with positive ID.
Personally Furnishing Dangerous Drugs
OAC 4729-5-17
▪ A prescriber or the prescriber's designee shall
personally offer to provide the service of
counseling pursuant to of this rule to the
patient or caregiver whenever any dangerous
drug is personally furnished. A prescriber shall
not be required to counsel a patient or
caregiver when the patient or caregiver refuses
the offer of counseling or does not respond to
the written offer to counsel.
▪ Verification of offer to counsel documentation
not required for veterinarians.
Personally Furnishing Dangerous Drugs
OAC 4729-5-17
▪ A prescriber may delegate an individual or individuals to
distribute dangerous drugs personally furnished by a
prescriber if either of the following apply:
▪ A prescriber authorized to personally furnish dangerous
drugs provides on-site supervision AND The designated
individual offers counseling to the patient or caregiver to be
provided by the on-site prescriber in accordance with
paragraph of this rule; OR
▪ A non-controlled dangerous drug is provided to the patient
by a health care professional (registered veterinary
technician), acting within the scope of the professional's
practice, and a prescriber authorized to personally furnish
dangerous drugs is available for counseling by means of
electronic communication during normal hours of operation.
Questions?
www.pharmacy.ohio.gov/contact
www.pharmacy.ohio.gov/update