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.
