Current through all regulations passed and filed through September 16, 2024
A nonresident terminal distributor of
dangerous drugs shall:
(A)
Maintain the following records of all dangerous drugs
dispensed or personally furnished to persons in this state:
(1)
Name, strength,
dosage form, the serial number of the prescription, and quantity of the
dangerous drug dispensed or personally furnished;
(2)
Full name and
date of birth of the patient for whom the drug is intended; or, if the patient
is an animal, the last name of the owner, name of animal (if applicable), and
species of the animal or animals; and
(3)
Residential
address, including the physical street address and, if provided, the telephone
number of the patient or owner.
(B)
Maintain the
following records of transfer or sale conducted in accordance with rule
4729:5-3-09 of the
Administrative Code for drugs sold or transferred into this state: name,
strength, dosage form, national drug code, and quantity of the dangerous drug
transferred or sold, the address of the location where the drugs were
transferred or sold, and the date of transfer or sale.
(C)
Maintain all
records and documents required by this chapter for a period of three years in a
readily retrievable manner.
(D)
Label all drugs
dispensed or personally furnished into this state with the following minimum
information:
(1)
The name or "doing business as" (DBA) name, or other legal
or contractually affiliated name and address of the terminal
distributor.
(2)
The full name of the patient for whom the drug is
prescribed; or, if the patient is an animal, the last name of the owner, name
of animal (if applicable), and species of the animal or
animals.
(3)
The full name of the prescriber or the first initial of
the prescriber's first name and the full last name of the
prescriber.
(4)
Directions for use of the drug.
(5)
The date of
dispensing.
(6)
Any cautions which may be required by federal or state
law.
(7)
The serial number of the prescription.
(8)
The proprietary
name, if any, or the generic name and the name of the distributor or national
drug code of the drug dispensed, and the strength, if more than one strength of
the drug is marketed.
(9)
The quantity of drug dispensed.
(10)
If the licensee
is an institutional central fill pharmacy as defined in rule
4729:5-9-02.13 of the
Administrative Code, the prescription label attached to the container shall
contain the name and address of the originating pharmacy and the name of the
central fill pharmacy. If applicable, the date on which the medication order
was dispensed shall be the date on which the central fill pharmacy filled the
order.
(11)
If the licensee is a central fill pharmacy as defined
in rule
4729:5-5-19 of the
Administrative Code, the prescription label attached to the container shall
contain the name and address of the originating pharmacy. The date on which the
prescription was dispensed shall be the date on which the central fill pharmacy
filled the prescription.
(a)
If the originating pharmacy and the central fill
pharmacy are not under common ownership, either of the following shall
apply:
(i)
The
name of the central fill pharmacy shall be included on the prescription label
or an auxiliary label; or
(ii)
A statement is
included on the prescription information accompanying the dangerous drug that
indicates a central fill pharmacy was used to fill the prescription and
includes the name of the central fill pharmacy.
(b)
The originating
pharmacy shall provide, upon the request of a patient or caregiver, the name
and address of the central fill pharmacy and a contact phone number where the
patient or caregiver can receive further assistance regarding prescriptions
filled by a central fill pharmacy.
(E)
Comply with all
the statutory requirements of the state of Ohio set forth in Chapters 4729.,
3719., 3715., and 2925. of the Revised Code for all drugs sold, dispensed or
personally furnished into this state, unless the licensee can demonstrate that
such compliance would cause the nonresident terminal distributor of dangerous
drugs to violate either the statutory or regulatory requirements of the state
in which it is located or federal statutory or regulatory
requirements.
(F)
Comply with the following regulatory requirements of
the state of Ohio, unless the licensee can demonstrate that such compliance
would cause the nonresident terminal distributor of dangerous drugs to violate
either the statutory or regulatory requirements of the state in which it is
located or federal statutory or regulatory requirements:
(1)
The requirements
set forth in this chapter;
(2)
The requirements
in Chapters 4729:5-1 and 4729:5-2 of the Administrative Code;
(3)
Theft or
significant loss reporting requirements in rule
4729:5-3-02 of the
Administrative Code for all drugs sold, dispensed or personally furnished into
this state;
(4)
Inspection and corrective action requirements in rule
4729:5-3-03 of the
Administrative Code;
(5)
Licensure verification requirements in rule
4729:5-3-04 of the
Administrative Code for all drugs sold, dispensed or personally furnished into
this state;
(6)
Patient confidentiality requirements in rule
4729:5-3-05 of the
Administrative Code;
(7)
Internet sales requirements in rule
4729:5-3-08 of the
Administrative Code for all drugs sold, dispensed or personally furnished into
this state;
(8)
Occasional sale and drug transfer requirements in rule
4729:5-3-09 of the
Administrative Code for all drugs sold, dispensed or personally furnished into
this state;
(9)
Remote medication order processing requirements in rule
4729:5-9-02.14 of the
Administrative Code and remote outpatient prescription processing requirements
in rule
4729:5-5-20 of the
Administrative Code.
(10)
The following central fill pharmacy requirements set
forth in Chapters 4729:5-5 and 4729:5-9 of the Administrative Code:
(a)
If the central
fill pharmacy does not have the same owner as the originating pharmacy, the
central fill pharmacy shall have a written contract with the originating
pharmacy outlining the services to be provided and the responsibilities of each
pharmacy in fulfilling the terms of the contract in compliance with federal and
state law, rules and regulations. For central fill pharmacies dispensing
outpatient prescriptions, the contract shall also expressly state who is
responsible for performing the patient counseling requirements in accordance
with paragraph (L) of this rule.
(b)
The central fill
pharmacy shall maintain a record of all originating pharmacies, including name,
address, terminal distributor number, and, if applicable, drug enforcement
administration registration number, for which it processes a request for the
filling or refilling of a medication order or prescription received by the
originating pharmacy.
(c)
The central fill pharmacy and originating pharmacy
shall have access to common electronic files as part of a real time, online
database or have appropriate technology to allow secure access to sufficient
information necessary or required to dispense or process the medication order
or prescription.
(d)
The central fill pharmacy and originating pharmacy
shall adopt a written quality assurance program for pharmacy services designed
to objectively and systematically monitor and evaluate the quality and
appropriateness of patient care, pursue opportunities to improve patient care,
resolve identified problems, and ensure compliance with this rule. The quality
assurance plan shall be reviewed and updated annually.
(11)
If
engaged in the provision of medication therapy management, as defined in rule
4729:5-12-01 of the
Administrative Code, for patients residing in this state the requirements set
forth in Chapter 4729:5-12 of the Administrative
Code.
(G)
Submit to the applicable disciplinary actions set forth
in section 4729.57 of the Revised Code and
rule 4729:5-4-01 of the
Administrative Code.
(H)
Operate in compliance with all applicable laws,
regulations and standards set forth by the United States food and drug
administration and the United States drug enforcement
administration.
(I)
Nonresident terminal distributors of dangerous drugs
who are pharmacies shall dispense prescriptions into this state issued by
either:
(1)
An
Ohio prescriber who is authorized pursuant rule
4729:5-1-02 of the
Administrative Code; or
(2)
A nonresident prescriber whose license is current and
in good standing and who is authorized to issue prescriptions for dangerous
drugs in the course of the prescriber's professional practice in a state other
than Ohio.
(J)
Supply, within three business days of a request, all
information needed by the board of pharmacy to carry out its responsibilities
as a licensing, regulatory, and drug law enforcement agency of the state of
Ohio.
(K)
Supply, within three business days of a request, all
information needed by the board of pharmacy and any local, state, or federal
agency to carry out its responsibilities in enforcing the federal and state
laws governing the distribution of drugs in the state of Ohio.
(L)
If the
nonresident terminal distributor is a pharmacy, there must be an offer to
counsel the patient issued with every prescription dispensed. The offer shall
be made by telephone or in writing on a separate document and shall accompany
the prescription. A written offer to counsel shall include the hours a
pharmacist is available and a telephone number where a pharmacist may be
reached. The telephone service must be available at no cost to the pharmacy's
primary patient population. The pharmacy shall have sufficient telephone
service to provide access to incoming callers.
(M)
Nonresident
terminal distributors shall permit properly identified and authorized state
board of pharmacy agents and federal, state, and local law enforcement
officials to enter and inspect their premises and delivery vehicles. A
nonresident terminal distributor of dangerous drugs shall be responsible for
all costs incurred by board of pharmacy agents in conducting an inspection.
Upon completion of the inspection, the nonresident terminal distributor of
dangerous drugs shall have ninety days to reimburse all inspection costs
incurred after being notified, electronically or in writing, by the
board.
In lieu of an inspection by the board,
a nonresident terminal distributor of dangerous drugs may submit any of the
following:
(1)
Inspection reports by a state licensing agency
demonstrating compliance with the requirements of this rule.
(2)
Inspection
reports demonstrating compliance with the requirements of this rule by one of
the following organizations:
(a)
The national association of boards of pharmacy's
verified pharmacy program (VIPP);
(b)
An organization
approved by the board.
(N)
Comply with all
drug database reporting requirements pursuant to Chapter 4729. of the Revised
Code and division 4729:8 of the Administrative Code.
(O)
Unless approved
by the board's executive director, a nonresident terminal distributor of
dangerous drugs that is not a pharmacy shall not be permitted to sell or
personally furnish controlled substances to patients residing in this
state.
Replaces: 4729:5-8-03
