This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
universities.
| Rule |
Rule 4729:5-5-01 | Definitions - outpatient pharmacies.
Effective:
December 1, 2020
As used in Chapter 4729:5-5 of the Administrative
Code: (A) "Audit trail" means all
materials and documents required for the entire processing of a prescription,
which shall be sufficient to document or reconstruct the origin of the
prescription and authorization of subsequent modifications of that
prescription. (B) "Dispense" means the final association of a
drug with a particular patient pursuant to a prescription, drug order, or other
lawful order of a prescriber and the professional judgment of and the
responsibility for interpreting, preparing, compounding, labeling, and
packaging a specific drug. (C) "OARRS report" means a report of information
related to a specific person generated by the drug database established and
maintained pursuant to section 4729.75 of the Revised Code. (D) "Original prescription" means any of the
following issued in accordance with division 4729:5 of the Administrative
Code: (1) A prescription issued
by a prescriber in writing; (2) An oral prescription
transcribed by a pharmacist, pharmacy intern, or certified pharmacy
technician; (3) An electronically
transmitted prescription; or (4) A prescription
transmitted by use of a facsimile machine. (E) "Personal supervision" or "direct
supervision" means a pharmacist shall be physically present in the
pharmacy, or in the area where the practice of pharmacy is occurring, to
provide personal review and approval of all professional
activities. (F) "Pharmacy," except when used in a context
that refers to the practice of pharmacy, means any area, room, rooms, place of
business, department, or portion of any of the foregoing where the practice of
pharmacy is conducted. (G) "Pharmacist" means an individual who holds a
current pharmacist license pursuant to Chapter 4729. of the Revised
Code. (H) "Outpatient pharmacy" means any pharmacy,
including a clinic pharmacy, where drugs are dispensed for outpatient use. It
does not include institutional pharmacies or institutional facilities, as
defined in agency 4729 of the Administrative Code, where drugs are dispensed
for use by inpatients. An outpatient pharmacy shall comply with all
requirements set forth in this chapter. (I) (1) "Positive
identification" means a method of identifying a person that does not rely
on the use of a private personal identifier such as a password, but must use a
secure means of identification that includes any of the following: (a) A manual signature on a hard copy record; (b) A magnetic card reader; (c) A bar code reader; (d) A biometric method; (e) A proximity badge reader; (f) A board approved system of randomly generated personal
questions; (g) A printout of every transaction that is verified and
manually signed within a reasonable period of time by the individual who
performed the action requiring positive identification. The printout must be
maintained for three years and made readily retrievable; or (h) Other effective methods for identifying individuals
that have been approved by the board. (2) A method relying on a
magnetic card reader, a bar code reader, a proximity badge reader, or randomly
generated questions for identification must also include a private personal
identifier for entry into a secure mechanical or electronic
system. (J) "Practice of pharmacy" has
the same meaning as in division (B) of section 4729.01 of the Revised
Code. (K) "Readily retrievable" means
that records maintained in accordance with this chapter shall be kept in such a
manner that, upon request, they can be produced for review no later than three
business days to an agent, officer or inspector of the board. (L) "Responsible person" has
the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and
is responsible for the supervision and control of dangerous drugs as required
in division (B) of section 4729.55 of the Revised Code, adequate safeguards as
required in division (C) of section 4729.55 of the Revised Code, security and
control of dangerous drugs, and maintaining all drug records otherwise
required.
Last updated August 2, 2024 at 4:53 PM
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Rule 4729:5-5-02 | Minimum standards for an outpatient pharmacy.
Effective:
December 1, 2020
(A) Library (1) All pharmacists
working in a pharmacy must be able to access all current federal and state
laws, regulations, and rules governing the legal distribution of drugs in Ohio,
including internet access to the following: (a) The board's website; (b) LAWriter Ohio laws and rules
(http://codes.ohio.gov/); (c) The code of laws of the United States of America
(variously abbreviated to Code of Laws of the United States, United States
Code, U.S. Code, U.S.C., or USC); and (d) The code of federal regulations. (2) The pharmacy shall
have access to and utilize the references necessary to conduct a pharmacy in a
manner that is in the best interest of the patients served and to comply with
all state and federal laws, this shall include hard copy or internet access to
appropriate pharmacy reference materials. (3) All pharmacists
working in a pharmacy shall have access to the telephone number of a poison
control center. (B) Equipment The pharmacy shall carry and utilize the
equipment necessary to conduct a pharmacy in a manner that is in the best
interest of the patients served and to comply with all state and federal
laws. (C) Stock of drugs The stock of drugs shall include such chemicals,
drugs, and preparations sufficient to compound and prepare all types of
prescriptions offered by the pharmacy. (D) Prescription containers The stock of prescription containers shall
include such containers as are necessary to dispense drugs in accordance with
federal and state laws, including the provisions of the federal Poison
Prevention Act of 1970 and compendial standards, or as recommended by the
manufacturer or distributor for non-compendial drug products. (E) Space and fixtures (1) The library and
equipment shall be housed in a suitable, well-lit and well-ventilated room or
department and maintained in a clean, sanitary and orderly
condition. (2) All areas where drugs
and devices are stored and prepared shall be dry, well-lit, well-ventilated,
and maintained in a clean, sanitary and orderly condition. Storage areas shall
be maintained at temperatures and conditions which will ensure the integrity of
the drugs prior to their dispensing or administering as stipulated by the
USP/NF and/or the manufacturer's or distributor's
labeling. (3) All storage areas
shall provide adequate security for all dangerous drugs in accordance with the
requirements of agency 4729 of the Administrative Code. A pharmacy shall
maintain the current contact information for the pharmacy's security
system vendor. (F) Pharmacy hours Notice to the public of operating hours of the
pharmacy department must be posted. (G) Personnel (1) The pharmacy shall be
appropriately staffed to operate in a safe and effective manner pursuant to
section 4729.55 of the Revised Code. (2) An employee of a
pharmacy must be identified by a name tag that includes the employee's job
title.
Last updated March 27, 2024 at 11:26 AM
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Rule 4729:5-5-02.1 | Provision of Ancillary Services in an Outpatient Pharmacy.
(A) As used in this rule, "ancillary
services" are services performed by pharmacy personnel that are performed
in addition to, or outside of, the dispensation of dangerous
drugs. (1) Ancillary services include, but are not limited to,
immunizations, drug administration, medication therapy management, disease
state management, and refill reminders. (2) Ancillary services do not include services provided by
an outpatient pharmacy to patients upon discharge from an institutional
facility as defined in Chapter 4729:5-9 of the Administrative
Code. (B) In accordance with division (D) of
section 4729.55 of the Revised Code, an outpatient pharmacy licensed as a
terminal distributor of dangerous drugs shall not establish any quotas relating
to the provision of ancillary services. (1) For purposes of this
rule, "quota" means a fixed number or formula related to the duties
of pharmacy personnel, against which the pharmacy or its agent measures or
evaluates the number of times either an individual performs tasks or provides
services while on duty. (2) For purposes of this
rule, "quota" does not mean any of the following: (a) A measurement of the revenue earned by a pharmacy not
calculated in relation to, or measured by, the tasks performed, or services
provided by pharmacy personnel. (b) Any evaluation or measurement of the competence,
performance, or quality of care provided to patients of pharmacy personnel if
the evaluation does not use quotas. (c) Any performance metric required by state or federal
regulators. (C) This rule does not apply to
outpatient pharmacies that are not open to the public (e.g., closed door
pharmacies).
Last updated May 1, 2024 at 8:40 AM
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Rule 4729:5-5-02.2 | Mandatory Rest Breaks for Pharmacy Personnel.
(A) An outpatient pharmacy licensed as a
terminal distributor of dangerous drugs shall not require pharmacy personnel to
work longer than thirteen hours in any workday and shall allow at least eight
hours of off time between consecutive shifts. (1) A pharmacist may volunteer to work longer than thirteen
continuous hours. (2) The pharmacy must document and date the amount of time
worked beyond the thirteen hour limit along with the reason and make it
available in the pharmacy for immediate inspection for at least three years
from the date it was created. (B) Pharmacy personnel working longer than six continuous
hours per workday shall be allowed during that time to take a thirty-minute,
uninterrupted rest break. (1) Unless as provided in paragraph (B)(2) of this rule, a
pharmacist that takes a break in accordance with this rule shall remain on the
premises of the pharmacy during the meal/rest break and shall be available for
emergencies. (2) The requirement in paragraph (B)(1) of this rule does
not apply in either case: (a) There are two or more
pharmacists working in the pharmacy and the pharmacists stagger their rest
breaks so that the pharmacy is not left without a pharmacist on
duty. (b) The pharmacy closes
for the required rest break. If a pharmacy closes for a required rest break,
the pharmacy shall implement a regular break schedule and communicate the break
schedule to customers wherever pharmacy hours are publicly posted or
communicated. (C) The requirements of paragraph (B) of this rule do not
apply to outpatient pharmacies that are not open to the public (e.g., closed
door pharmacies). An outpatient pharmacy that is not open to the public shall
still be required to allow all pharmacy personnel working longer than six
continuous hours to take a thirty-minute, uninterrupted rest period and meal
break. (D) Only prescriptions dispensed by a pharmacist pursuant
to this chapter of the Administrative Code may be sold when the pharmacist is
on break. An offer to counsel any person filling a prescription shall be
offered pursuant rule 4729:5-5-09 of the Administrative Code. Persons who
request to speak to the pharmacist shall be told that the pharmacist is on
break and that they may wait to speak with the pharmacist or provide a
telephone number for the pharmacist to contact them upon return from break.
Pharmacists returning from break shall immediately attempt to contact persons
who requested counseling. (E) An outpatient pharmacy shall not retaliate or
discipline a pharmacist for refusing to work longer than thirteen hours or
pharmacy personnel that opt to take breaks in accordance with this rule. As
used in this rule, retaliation or discipline of an employee includes, but is
not limited to, the following: (1) Removing or suspending the employee from
employment; (2) Withholding from the employee salary increases or
employee benefits to which the employee is otherwise entitled; (3) Transferring or reassigning the employee; (4) Denying the employee a promotion that otherwise would
have been received; (5) Reducing the employee in pay or position.
Last updated May 1, 2024 at 8:40 AM
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Rule 4729:5-5-02.3 | Requests for additional staff and reports of staffing concerns in an outpatient pharmacy.
(A) An outpatient pharmacy shall develop
a process for pharmacy staff to communicate requests for additional staff or
reports of staffing concerns. Requests for additional staff or reports of
staffing concerns shall be communicated and documented by the responsible
person or pharmacist on duty to the terminal distributor. (B) Executed requests for additional
staffing or reports of staffing concerns shall be provided to the immediate
supervisor of the responsible person or pharmacist on duty, with one copy
maintained in the pharmacy for three years for immediate inspection by an
agent, inspector, or employee of the board. (C) Outpatient pharmacies licensed as
terminal distributors of dangerous drugs shall review all requests and reports
of concern submitted in accordance with this rule and shall resolve any issues
listed in a timely manner to ensure a safe working environment for pharmacy
staff as required by section 4729.55 of the Revised Code. A written response to
the request or report of concern shall occur within fourteen business days of
submission and be communicated to the responsible person or pharmacy staff who
submitted the request for additional staffing or report of concern. A copy of
this response shall be maintained in the pharmacy for three years for immediate
inspection by an agent, inspector, or employee of the board. (D) An outpatient pharmacy shall not
retaliate or discipline pharmacy personnel who, in good faith, make a request
for additional staff or report staffing concerns in accordance with this rule.
As used in this rule, retaliation or discipline of an employee includes, but is
not limited to, the following: (1) Removing or
suspending the employee from employment; (2) Withholding from the
employee salary increases or employee benefits to which the employee is
otherwise entitled; (3) Transferring or
reassigning the employee; (4) Denying the employee
a promotion that otherwise would have been received; (5) Reducing the employee
in pay or position.
Last updated July 25, 2024 at 8:25 AM
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Rule 4729:5-5-02.4 | Significant Delays in the Provision of Pharmacy Services.
(A) An outpatient pharmacy has a duty to
properly dispense lawful prescriptions for dangerous drugs or devices without
significant delay. (1) For purposes of this
rule, "significant delay" means a prescription that was submitted to
the pharmacy for processing by a prescriber, patient, or caregiver and has yet
to be dispensed (e.g., final verification) by a pharmacist as
follows: (a) For new prescriptions: within three business days of
receiving the prescription. (b) For refill prescriptions not generated by a pharmacy
auto-refill program: within three business days of receiving the
prescription. (c) For refill prescriptions generated by a pharmacy
auto-refill program: within five business days of receiving the
prescription. (2) Receipt of the
prescription as described in paragraph (A)(1) of this rule is said to
occur: (a) For new prescriptions: receipt occurs on the day when
the prescription is transmitted or submitted to the pharmacy. (b) For refills on existing prescriptions: receipt occurs
on the day when a refill request is submitted to the pharmacy by a patient,
caregiver, or prescriber or when a refill request is generated as part of a
pharmacy's auto-refill program. (3) For purposes of this
rule, "significant delay" does not mean any of the
following: (a) A prescription that has been submitted to the pharmacy
but where there is a documented drug shortage, or the pharmacy documents the
drug is not available from the pharmacy's drug distributor. (b) A prescription that has been submitted to the pharmacy
that requires clarification or consultation by the issuing
prescriber. (c) A prescription that has been submitted to the pharmacy
that requires prior authorization or is otherwise delayed because of the
patient's prescription insurance coverage. (d) A prescription that is for a compounded drug
product. (e) A prescription that the pharmacist, using their
professional judgement, determines is of questionable, doubtful, or suspicious
origin. (f) A prescription that, in the pharmacist's
professional judgment, if dispensed, cannot be safely provided or may
negatively impact patient care. (g) A prescription where the prescriber indicates a
"do not fill until" date or similar designation. (h) A prescription where the patient, caregiver, or issuing
prescriber has communicated to the pharmacy that dispensing may occur beyond
the period described in paragraph (A)(1) of this rule. (i) A prescription where the patient, caregiver, or issuing
prescriber has requested a transfer to another pharmacy. (j) A prescription where the pharmacy has experienced any
of the following: (i) A natural disaster
(fire, flood, etc.), civil unrest, or human made disaster; (ii) An outbreak of a
pandemic illness or the declaration of a state or federal public health
emergency; (iii) A loss of power;
or (iv) An unplanned
information technology system outage. (k) Any other circumstance as determined by the
board. (B) Each prescription that experiences a
significant delay, as defined in paragraph (A) of this rule, shall be
considered a violation of this rule and shall subject the outpatient pharmacy
to disciplinary action in accordance with rule 4729:5-4-01 of the
Administrative Code. (C) Immediately upon discovery or at the
request of an agent, inspector, or employee of the board, a pharmacy
experiencing a significant delay shall implement one or more of the following
remediation measures to dispense all prescriptions that are experiencing a
significant delay: (1) Limiting pharmacy
hours (e.g., dark hours); (2) Transferring
prescriptions to another pharmacy, upon patient consent; (3) Increasing pharmacy
staff; or (4) Any other strategy
that is mutually agreed upon by the outpatient pharmacy and the agent,
inspector, or employee of the board. (D) As part of the remediation process
required in paragraph (C) of this rule, the outpatient pharmacy shall implement
a process that triages lifesaving and life-sustaining medications that are
experiencing a significant delay. (E) As used in this rule, "business
day" means any day, excluding holidays, where the pharmacy is open for
business. (F) An outpatient pharmacy shall only
provide auto-refills of a prescription upon the authorization of the patient or
the patient's caregiver. (1) The pharmacy shall
maintain documentation indicating the patient or the patient's caregiver
has enrolled in the pharmacy's auto-refill program. (2) Consent for
enrollment in the pharmacy's auto-refill program may be captured
electronically, verbally by pharmacy staff, or in writing. (3) The pharmacy shall
maintain a record of consent in the patient's profile, or another system
maintained by the pharmacy, in a readily retrievable manner. As part of this
record, the pharmacy shall document the date the patient or caregiver consented
to enrollment in the pharmacy's auto-refill program. (4) The pharmacy shall
discontinue enrollment in an auto-refill program upon the request of the
patient or the patient's caregiver.
Last updated May 1, 2024 at 8:41 AM
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Rule 4729:5-5-02.5 | Outpatient Pharmacy Access Points.
(A) As used in this rule,
"ancillary services" are those services performed by pharmacy
personnel that are not directly involved in the dispensation of dangerous
drugs. Examples of such services include, but are not limited to,
immunizations, drug administration, medication therapy management, disease
state management, and refill reminders. (B) Except as provided for in paragraph
(C) of this rule, a pharmacy shall develop and implement an effective
organizational policy that permits a pharmacist to do all the
following: (1) Limit the provision
of ancillary services if, in the pharmacist's professional judgment, the
provision of such services cannot be safely provided or may negatively impact
patient access to medications. The pharmacy's policy shall include an
offer by pharmacy staff to make an appointment for a patient or refer a patient
to another location offering immunizations and other ancillary
services. (2) Limit pharmacy access
points, if, in the pharmacist's professional judgment, limiting such
access points will minimize fatigue, distraction, or other conditions which
interfere with a pharmacist's ability to practice with reasonable safety
and competence. (C) In the absence of an organizational
policy described in paragraph (B) of this rule, an outpatient pharmacy shall
not override the control of the pharmacist on duty as follows: (1) A pharmacist's
decision not to administer or supervise immunizations or provide other
ancillary services if, in the pharmacist's professional judgment, the
provision of such services cannot be provided safely or may negatively impact
patient access to medications. The pharmacy staff shall offer to make an
appointment for the patient or may refer the patient to another location
offering immunizations and other ancillary services. (2) A pharmacist's
decision to limit pharmacy access points if, in the pharmacist's
professional judgment, limiting such access points will minimize fatigue,
distraction, or other conditions which interfere with a pharmacist's
ability to practice with reasonable safety and competence. Such limitations
shall not interfere with a patient's ability to drop off or receive
dispensed prescriptions during the pharmacy's posted hours of
operation. (D) Organizational policies developed in
accordance with paragraph (A) of this rule shall be maintained in the pharmacy
for immediate inspection by an agent, inspector, or employee of the
board. (E) This rule does not apply to outpatient pharmacies that
are not open to the public (e.g., closed door pharmacies). (F) An outpatient pharmacy shall not
retaliate or discipline a pharmacist who, in good faith, acts in accordance
with this rule. As used in this rule, retaliation or discipline of an employee
includes, but is not limited to, the following: (1) Removing or
suspending the employee from employment; (2) Withholding from the
employee salary increases or employee benefits to which the employee is
otherwise entitled; (3) Transferring or
reassigning the employee; (4) Denying the employee
a promotion that otherwise would have been received; (5) Reducing the employee
in pay or position.
Last updated May 1, 2024 at 8:41 AM
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Rule 4729:5-5-03 | Filing and storage of prescriptions.
Effective:
December 1, 2020
All original outpatient prescriptions shall be
filed in the following manner: (A) Prescriptions for schedule II controlled substances shall be
maintained in a separate prescription file for schedule II
prescriptions. (B) Prescriptions for schedule III, IV, and V controlled
substances shall be maintained in a separate prescription file for schedule
III, IV, and V prescriptions. (C) Prescriptions for non-controlled substances shall be
maintained in a separate prescription file for non-controlled
prescriptions. (D) Prescriptions containing multiple drug orders shall be filed
in the most restrictive file. (E) All non-controlled hard copy prescriptions, including
facsimiles, maintained pursuant to this rule may be electronically maintained,
provided that the system creates and maintains electronic records in accordance
with the following: (1) All hard copy prescriptions for
non-controlled dangerous drugs may be electronically filed and then destroyed
after one hundred and eighty days from the date of creation or receipt.
Disposal of the hard copy shall use a secure method of destruction to ensure
privacy and confidentiality of the contents. (2) All hard copy prescriptions electronically
filed in accordance with this rule shall be scanned front and back in full
color (i.e. retains color information and/or color graphics in the document)
via technology designed to capture information in one form and reproduce it in
an electronic medium presentable and usable to an end user. Prior to scanning,
the written or faxed prescription shall be clearly notated to indicate it has
been received by the pharmacy in a manner that does not destroy any of the
original information contained on the prescription but prevents the
unauthorized duplication of the prescription. (3) A record or image once created shall be
unalterable but may be annotated as necessary so long as the original record or
image is still available for review and the individual that made the annotation
is noted. (4) The electronic form shows the exact and legible image of the
original hard copy prescription. (5) All hard copy prescriptions filed electronically in
accordance with this rule shall be deemed the original prescription.
(F) All electronically transmitted prescriptions, including faxed
prescriptions received in an electronic format, shall be electronically stored
and maintained in accordance with this rule. (G) All electronic systems used to maintain prescription images
or data shall: (1) Contain security features to prevent
unauthorized access to the records; and (2) Contain daily back-up functionality to
protect against loss of records. (H) All prescription
records stored in accordance with this rule shall be uniformly maintained for a
period of three years. (I) An outpatient pharmacy
shall ensure that original prescriptions are properly filed in compliance with
this rule and rule 4729:5-5-13 of the Administrative Code.
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Rule 4729:5-5-04 | Record keeping.
Effective:
December 1, 2020
(A) There shall be positive
identification of the licensed or registered individuals responsible for
performing the following activities authorized under Chapter 4729. of the
Revised Code and agency 4729 of the Administrative Code: (1) Prescription
information entered into the record keeping system. This provision shall take
effect one-year from the effective date of this rule. (2) Verification by the
pharmacist of the prescription information entered into the record keeping
system. (3) Prospective drug
utilization review, which shall be captured as a standalone action or as part
of either: (a) The pharmacist verification of prescription information
in paragraph (A)(2) of this rule; or (b) The dispensing process in paragraph (A)(4) of this
rule. (4) Dispensing. (5) Compounding. (6) Administering
immunizations pursuant to section 4729.41 of the Revised Code. (7) Administering
injectable drugs pursuant to section 4729.45 of the Revised Code. (8) Prescription
information transcribed from an order received by telephone, facsimile, or
recording device. (9) Any changes or
annotations made to a prescription. (B) All records maintained in accordance
with this rule shall be uniformly maintained for a period of three
years. (C) Record keeping systems shall provide immediate
retrieval via digital display and hard copy printout or other mutually
agreeable transfer medium of information for all prescriptions dispensed within
the previous twelve months and shall provide, in a manner that is readily
retrievable, information on all prescriptions dispensed beyond the previous
twelve months but within the previous three years. This information shall
include, at a minimum, the following data: (1) The original
prescription number; (2) Date of issuance of
the original prescription order by the prescriber; (3) Full name 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; (4) Residential address, including the
physical street address and telephone number of the patient or
owner; (5) Full name and address of the
prescriber, including the physical address of the prescriber's practice
location; (6) The prescriber's credential (MD,
DDS, DVM, etc.), if indicated on the prescription; (7) Directions for use; (8) The brand name, if any, or the
generic name and the name of the manufacturer or distributor or national drug
code of the drug or device dispensed; (9) The strength, dosage form, and
quantity of the drug or device dispensed; (10) The prescriber's federal drug
enforcement administration number, if applicable; (11) The positive identification of the
persons performing specific actions pursuant to paragraph (A) of this
rule; (12) The total number of refills
authorized by the prescriber; (13) The date of dispensing; (14) The refill history of the
prescription, including all of the following: (a) The prescription number; (b) The brand name, if any, or the generic name and the
name of the manufacturer or distributor or national drug code of the drug or
device dispensed; (c) The date(s) of dispensing; and (d) The quantity dispensed. (D) A pharmacy that utilizes a computerized system to
dispense dangerous drugs that is unable to electronically document positive
identification in accordance with paragraph (A) of this rule shall be required
to maintain hard copy documentation. Hard copy documentation shall be provided
by each registered or licensed individual who makes use of such system by one
of the following methods: (1) A hard copy printout
of each day's prescription data. (a) The printout shall include, at a minimum, the following
data: (i) Date of
dispensing; (ii) Prescription
number; (iii) Patient
name; (iv) Name, strength, and
quantity of drug dispensed; (v) Identification of the
pharmacist or pharmacy personnel responsible for any activity described in
paragraph (A) of this rule; (vi) Identification of
the pharmacy; and (vii) Identification of controlled substances. (b) The printout must be verified, dated, and signed by
each individual responsible for any activity described in paragraph (A) of this
rule. The printout must be verified and manually signed by the individual
within a reasonable timeframe to ensure the accuracy of the record.
(c) If the printout is prepared at a location other than
where the drug was dispensed, the printout must be provided to the licensed
location within three business days of the date on which the drugs were
dispensed. Such printouts must be verified and signed by each individual
responsible for any activity described in paragraph (A) of this rule within
twenty-four hours of the date the printout is received by the
individual. (d) The printout must be readily retrievable and maintained
in chronological order in a separate file at the licensed location where the
drug was dispensed for a period of three years from the date of
dispensing. (e) The signed printout may be stored electronically in
accordance with paragraph (E) of this rule. (2) A tamper evident log
book. (a) Each individual pharmacist involved in dispensing drugs
must enter into a tamper evident log book the following data for each
prescription dispensed: (i) Date of
dispensing; (ii) Prescription
number; (iii) Patient
name; (iv) Name, strength and
quantity of drug dispensed; (v) Identification of the
pharmacist and pharmacy personnel responsible for any activity described in
paragraph (A) of this rule; (vi) Identification of
controlled substances. (b) Each individual responsible for any activity described
in paragraph (A) of this rule shall review this information at the end of each
day, or at the end of the individual's shift, and must
either: (i) Manually sign a
statement in the log book attesting to the fact that the prescription
information entered into the computer that day and recorded in the log book has
been reviewed by the individual and is correct as shown; or (ii) Manually initial
each entry of the log book to indicate that the prescription information
entered into the computer that day and recorded in the log book has been
reviewed by the individual and is correct as shown. (c) The log book must be readily retrievable and maintained
at the licensed location where the drug was dispensed for a period of three
years from the date of dispensing. (E) A signed printout that is maintained in accordance with
paragraph (D) of this rule may be electronically created and maintained,
provided the system creates and maintains the printout in accordance with the
following: (1) All information in
the printout shall be scanned in full color (i.e. retains color information
and/or color graphics in the document) via technology designed to capture
information in one form and reproduce it in an electronic medium presentable
and usable to an end user; (2) A record or image
once created shall be unalterable but may be annotated as necessary so long as
the original record or image is still available for review and the individual
that made the annotation is noted; (3) Contains security
features to prevent unauthorized access to the records; (4) Contains daily
back-up functionality to protect against record loss. (F) In addition to the immediate retrieval and production
of prescription information required by paragraph (C) of this rule, an
outpatient pharmacy that utilizes a computerized record keeping system shall
comply with the following: (1) Make readily
retrievable the following information: (a) An electronic record in a character-delimited or
fixed-width ASCII text file or other mutually acceptable format that contains
any requested data fields the pharmacy is responsible for maintaining pursuant
to all federal and state laws, rules and regulations; and (b) A hard copy printout sorted by any requested data
fields that the pharmacy is responsible for maintaining pursuant to all federal
and state laws, rules, and regulations. (2) Make readily
available upon request by an individual authorized by law to access such
records any of the following: (a) A printout; or (b) An electronic record and a definition file describing
the file layout and column width, if applicable. (3) All computerized
record keeping systems shall be able to capture records edited by authorized
personnel and maintain an audit trail. (G) In the event that a pharmacy utilizes a computerized
record keeping system that experiences an outage, the pharmacy must have an
auxiliary procedure which will be used for documentation of refills of
prescription orders. This auxiliary procedure must ensure that refills are
authorized by the original prescription order, that the maximum number of
refills has not been exceeded, and that all of the appropriate data is recorded
and retained. Nothing in this paragraph shall preclude a pharmacist from
dispensing a refill if, in the exercise of the pharmacist's professional
judgement, failure to dispense or sell the drug to the patient could result in
harm to the health of the patient. (H) Prescriptions entered into a computer system that are
not dispensed shall meet all of the following requirements: (1) The complete
prescription information must be entered in the computer system; (2) The information must
appear in the patient's profile; (3) There is positive
identification of the person who is responsible for entering the prescription
information into the system and the pharmacist responsible for verifying the
prescription information in accordance with paragraph (A) of this rule;
(4) The prescription must
be assigned a prescription number; and (5) The original
prescription is filed according to rule 4729:5-5-03 of the Administrative
Code. (I) Records shall be maintained for three years and made
readily retrievable for all immunizations administered in accordance with
section 4729.41 of the Revised Code and rules 4729:1-3-02 and 4729:2-3-03 of
the Administrative Code and shall include the following
information: (1) Full name and address
of the patient; (2) Patient's date
of birth or age; (3) Patient's applicable allergy
information; (4) Date of administration; (5) Name, strength, and dose of the
immunization administered; (6) Lot number and expiration date of the
immunization; (7) Route of administration; (8) Location of the injection
site; (9) Positive identification of the
administering pharmacist or the administering pharmacy intern and supervising
pharmacist; (10) Identification of the patient,
parent, or legal guardian of the patient who gives informed consent to
administer the immunization. (J) Immunization records may be electronically created and
maintained if done so in accordance with the standards set forth in paragraph
(E) of this rule. (K) A pharmacist may document the pharmacist's own
administration of an immunization or an immunization administered by a pharmacy
intern the pharmacist is personally supervising on a prescription form, which
may be assigned a number for record keeping purposes. (L) Records shall be maintained for three years and made
readily retrievable for all dangerous drugs administered in accordance with
section 4729.45 of the Revised Code and rule 4729:1-3-03 of the Administrative
Code and shall include the following information: (1) Full name and address
of the patient; (2) Patient's date
of birth or age; (3) Patient's
applicable allergy information; (4) Date of
administration; (5) Name, strength, and
dose of the drug administered; (6) Lot number and
expiration date of the drug; (7) Route of
administration; (8) Location of the
injection site; (9) Documentation of test
results required prior to the administration of an opioid antagonist in
accordance with rule 4729:1-3-03 of the Administrative Code; (10) Required physician
notification pursuant to rule 4729:1-3-03 of the Administrative
Code; (11) Positive
identification of the administering pharmacist; and (12) Identification of
the person who provides permission to administer the dangerous drug pursuant to
rule 4729:1-3-03 of the Administrative Code. (M) Dangerous drug administration records may be
electronically created and maintained if done so in accordance with the
standards set forth in paragraph (E) of this rule.
Last updated August 2, 2024 at 4:53 PM
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Rule 4729:5-5-05 | Prescription format requirements.
Effective:
December 1, 2020
(A) Except as provided in paragraph (E)
of this rule, no pharmacist shall dispense dangerous drugs pursuant to a
written outpatient prescription unless the following conditions are
met: (1) The prescription is
issued in compliance with rule 4729:5-5-15 of the Administrative
Code. (2) If handwritten,
typewritten, or computer-generated hard copy, there are no more than three
non-controlled substance prescription orders per prescription
form. (3) If preprinted with
multiple drug names or strength combinations: (a) There are no controlled substances among the
choices; (b) There is only one prescription order selected per
form. (B) Except as provided in paragraph (E)
of this rule, no pharmacist shall dispense controlled substances pursuant to a
written outpatient prescription unless the following conditions are
met: (1) The prescription has
been issued in compliance with rule 4729:5-5-15 of the Administrative
Code. (2) The prescription
contains only one prescription order per prescription form, whether
handwritten, typewritten, computer-generated hard copy, or
preprinted. (3) The quantity has been
written both numerically and alphabetically. (4) If preprinted, there
is only one drug and strength combination printed on the form. (C) A prescription for a controlled
substance issued by a medical intern, resident, or fellow as described in rule
4729:5-1-02 of the Administrative Code may not be dispensed unless the
prescription is issued in accordance with this rule and complies with the
requirements for drug enforcement administration (D.E.A.) registration numbers
for hospital and other institution employed prescribers pursuant to agency 4729
of the Administrative Code. (D) A prescription for a controlled
substance issued by a staff prescriber of a hospital or other institution may
not be dispensed unless the prescription is issued in accordance with this rule
and complies with either: (1) The requirements for
D.E.A. registration numbers for hospital or other institution employed
prescribers pursuant to agency 4729 of the Administrative Code; or (2) Includes the
prescriber's D.E.A. registration number. (E) For purposes of preprinted outpatient prescription
forms for hospice care programs, the following conditions apply: (1) Preprinted
prescription forms may contain multiple orders on one form and the prescriber
may select as many drug orders as necessary. Additional prescriptions may be
manually added to the form. (2) Preprinted forms
shall not contain prescription orders for schedule II controlled substances.
Schedule II controlled substances may be manually added to the preprinted forms
and signed by the prescriber. (3) The prescriber shall
indicate on each preprinted form the drug orders authorized on the form by
either: (a) Manually indicating the total drug orders authorized on
the form; or (b) Manually initialing each drug order. (4) All written drug
orders must be signed by the prescriber. (5) All signed
prescriptions may be faxed from the prescriber or the hospice location to the
pharmacy. (6) At the direction of
the prescriber, verbal drug orders may be transmitted to the pharmacy by the
prescriber's agent, including a hospice nurse, except for schedule II
controlled substances. (7) All schedule II
controlled substance prescriptions shall comply with 21 C.F.R. 1306.11
(3/31/2010).
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Rule 4729:5-5-06 | Labeling of drugs dispensed on prescription.
(A) No drug may be dispensed by
outpatient prescription unless a label is affixed to the container in which
such drug is dispensed, and such label includes: (1) The name or
"doing business as" (DBA) name and address of the pharmacy as it
appears on the terminal distributor of dangerous drugs license; (2) The contact phone number of the dispensing pharmacy or
a location where a pharmacist is employed or contracted by the dispensing
pharmacy who has full access to the dispensing pharmacy's patient
records; (3) 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;
(4) The full name of the prescriber or
the first initial of the prescriber's first name and the full last name of
the prescriber; (5) Directions for use of the
drug; (6) The date of dispensing; (7) Any cautions which may be required by
federal or state law; (8) The serial number of the
prescription; (9) 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.
The dispensing pharmacist may omit the name and strength of the drug only if
the prescriber specifically requests omission and such request is documented;
and (10) The quantity of drug
dispensed. (B) The term "affix" means the
prescription label must be attached or fastened to the drug's
container. (C) A label meeting the requirements in paragraph (A) of this
rule may be placed on the packaging of a commercially manufactured dangerous
drug product.
Last updated April 2, 2024 at 9:04 AM
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Rule 4729:5-5-07 | Patient profiles.
Effective:
December 1, 2020
All outpatient pharmacies shall maintain a patient
profile system which shall provide for immediate retrieval of information
regarding those patients who have received prescriptions from the
pharmacy. (A) All patient profile systems shall
maintain, at a minimum, the following data: (1) The patient's
data record, which shall contain all the following information: (a) Full name 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. (b) Residential address, including the physical street
address and telephone number of the patient or owner. (c) Patient's date of birth. (d) Patient's gender. (e) A list of current patient-specific data consisting of
at least the following, if made known to the pharmacist or agent of the
pharmacist: (i) Drug related
allergies; (ii) Previous drug
reactions; (iii) History of or
active chronic conditions or disease states; and (iv) Other drugs,
including nonprescription drugs, devices, and nutritional supplements used on a
routine basis. (f) The pharmacist's comments relevant to the
patient's drug therapy, including any other necessary information unique
to the specific patient or drug. (2) The patient's
drug therapy record, which shall contain the following information for all
prescriptions dispensed by the pharmacy within the last twelve
months: (a) The original prescription number. (b) Date of issuance of the original prescription by the
prescriber. (c) Full name and address of the prescriber, including the
physical address of the prescriber's practice location. (d) The prescriber's credential (MD, DDS, DVM, etc.),
if indicated on the prescription. (e) Directions for use. (f) The brand name, if any, or the generic name and the
name of the manufacturer or distributor or national drug code of the drug or
device dispensed. (g) The strength, dosage form, and quantity of the drug or
device dispensed. (h) The prescriber's federal drug enforcement
administration registration number, if applicable. (i) The total number of refills authorized by the
prescriber. (j) The date of dispensing. (k) The refill history of the prescription, including all
the following: (i) The prescription
number; (ii) The brand name, if
any, or the generic name and the name of the manufacturer or distributor or
national drug code of the drug or device dispensed; (iii) The date(s) of
dispensing; and (iv) The quantity
dispensed. (B) A pharmacist or an agent of the
pharmacist shall make a reasonable effort to obtain a patient's medical
history necessary to conduct a prospective drug utilization review. An agent of
the pharmacist described in this paragraph shall be limited to the following
persons: a pharmacy intern, certified pharmacy technician, registered pharmacy
technician or pharmacy technician trainee. (C) The patient profile shall be
maintained for a period of not less than one year from the date of the last
entry in the profile record. This record may be a hard copy or maintained as a
part of computerized system.
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Rule 4729:5-5-08 | Prospective drug utilization review.
Effective:
November 15, 2022
(A) Prior to dispensing any prescription,
a pharmacist shall review the patient profile for the purpose of identifying
the following: (1) Over-utilization or
under-utilization; (2) Therapeutic
duplication; (3) Drug-disease state
contraindications; (4) Drug-drug
interactions; (5) Incorrect drug
dosage; (6) Drug-allergy
interactions; (7) Abuse/misuse; (8) Inappropriate
duration of drug treatment; and (9) Food-nutritional
supplements-drug interactions. (B) Upon identifying any issue listed in
paragraph (A) of this rule, a pharmacist, using professional judgment, shall
take appropriate steps to avoid or resolve the potential problem. These steps
may include, but shall not be limited to, the following: (1) Requesting and
reviewing an OARRS report or another state's prescription drug monitoring
report; (2) Consulting with the
prescriber; or (3) Counseling the
patient. (C) Prospective drug utilization review
shall be performed using predetermined standards consistent with, but not
limited to, any of the following: (1) Peer-reviewed medical
literature (i.e. scientific, medical, and pharmaceutical publications in which
original manuscripts are rejected or published only after having been
critically reviewed by unbiased independent experts); (2) American hospital
formulary service drug information; and (3) United States
pharmacopeia drug information. (D) Prior to dispensing an outpatient
prescription for a controlled substance dangerous drug or a drug containing
gabapentin, at a minimum, a pharmacist shall request and review an OARRS report
covering at least a one year time period in any of the following
circumstances: (1) A patient adds a new
or different controlled substance dangerous drug or a drug containing
gabapentin to the patient's therapy that was not previously
included; (2) An OARRS report has
not been reviewed for that patient during the preceding twelve months, as
indicated in the patient profile; (3) A prescriber is
located outside the usual pharmacy geographic area; (4) A patient is from
outside the usual pharmacy geographic area; (5) A pharmacist has
reason to believe the patient has received prescriptions for controlled
substance dangerous drugs or a drug containing gabapentin from more than one
prescriber in the preceding three months, unless the prescriptions are from
prescribers who practice at the same physical location; (6) Patient is exhibiting
signs of potential abuse or diversion. This includes, but is not limited to,
over-utilization, early refills, appears overly sedated or intoxicated upon
presenting a prescription for a controlled substance dangerous drug, or an
unfamiliar patient requesting a reportable drug by specific name, street name,
color, or identifying marks. (E) In the event an OARRS report is not
immediately available, the pharmacist shall use professional judgment in
determining whether it is appropriate and in the patient's best interest
to dispense the prescription prior to reviewing a report. (F) A pharmacist may use a delegate
licensed or registered in accordance with Chapter 4729. of the Revised Code to
request an OARRS report. (G) Based upon information obtained
during a prospective drug utilization review, a pharmacist shall use
professional judgment when making a determination about the legitimacy of a
prescription. A pharmacist shall not dispense a prescription of doubtful,
questionable, or suspicious origin.
Last updated November 15, 2022 at 9:07 AM
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Rule 4729:5-5-09 | Patient counseling.
Effective:
December 1, 2020
(A) A pharmacist or the pharmacist's
designee shall verbally offer to provide the service of counseling pursuant to
paragraph (B) of this rule to a patient or caregiver whenever any prescription,
new or refill, is dispensed. A pharmacist or pharmacy intern under the personal
supervision of a pharmacist 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. If the patient or caregiver is not
physically present, the offer to counsel shall be made by telephone or in
writing on a separate document accompanying the dispensed drug or incorporated
as part of documentation, in a conspicuous manner, that is included with the
dispensed drug. 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. (B) In the event a patient or caregiver
accepts an offer to counsel or requests counseling, a pharmacist, or a pharmacy
intern under the personal supervision of a pharmacist, shall counsel the
patient or caregiver. Such counseling may include, but is not limited to, the
following: (1) The name and
description of the drug; (2) The dosage form,
dose, strength, frequency, route of administration, and duration of drug
therapy; (3) The intended use of
the drug and the expected action; (4) Special directions
and precautions for preparation, administration, handling, storage, disposal,
and use by the patient; (5) Common adverse
effects or interactions and therapeutic contraindications that may occur,
including possible methods to avoid them, and the action required if they
occur; (6) Techniques for
self-monitoring drug therapy; (7) Proper storage and
disposal; (8) Prescription refill
information; (9) Action to be taken in
the event of a missed dose; and (10) The
pharmacist's comments relevant to the patient's drug therapy,
including other necessary information unique to the patient or
drug. (C) Other forms of information may be
used when appropriate to supplement the counseling by the pharmacist or intern.
Examples of forms that may be used include, but are not limited to, drug
product information leaflets, pictograph labels, and video
programs. (D) Notwithstanding any other rule of agency 4729 of the
Administrative Code, "personal supervision," as used in paragraph (B)
of this rule, means that a pharmacist is on the premises at all times and is
aware of all counseling activities performed by the pharmacy intern. A
pharmacist who has accepted responsibility for the supervision and training of
a pharmacy intern is responsible for all acts performed by the pharmacy intern
working under the pharmacist's supervision.
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Rule 4729:5-5-10 | Manner of processing a prescription.
Effective:
December 1, 2020
(A) A prescription, to be valid, must be
issued for a legitimate medical purpose by an individual prescriber acting in
the usual course of the prescriber's professional practice. The
responsibility for the proper prescribing is upon the prescriber, but a
corresponding responsibility rests with the pharmacist who dispenses the
prescription. An order purporting to be a prescription issued not in the usual
course of bona fide treatment of a patient is not a prescription and the person
knowingly dispensing such a purported prescription, as well as the person
issuing it, shall be subject to the penalties of law. (B) A pharmacist dispensing an outpatient
prescription shall comply with the requirements of this chapter, including, but
not limited to, the following: (1) Ensure that patient
information is profiled pursuant to rule 4729:5-5-07 of the Administrative
Code; (2) Perform prospective
drug utilization review pursuant to rule 4729:5-5-08 of the Administrative
Code; and (3) Ensure that the drug
is labeled pursuant to rule 4729:5-5-06 of the Administrative
Code. (C) Prescriptions: (1) The front of hard copy prescriptions for controlled
substance dangerous drugs shall be clearly notated to indicate receipt by the
pharmacy in a manner that does not destroy any of the original information
contained on the prescription but prevents the unauthorized duplication of the
prescription. (2) When a pharmacist dispenses a drug
pursuant to an original prescription, the pharmacist must record the date of
such dispensing and the pharmacist's positive identification. (3) When a pharmacist dispenses a drug
pursuant to an authorized refill of a prescription, the pharmacist must record
the date of such dispensing and the pharmacist's positive
identification. (D) Oral prescriptions: (1) A pharmacist shall
make a record of the full name of the prescriber and, if transmitted by the
prescriber's agent, the full name of the agent. The pharmacist is
responsible for ensuring the validity of the source of the oral
prescription. (2) Upon receiving a
prescription from a recording device or voice mail service, a pharmacist shall
transcribe the information. The pharmacist must document on the original
prescription the full name of the prescriber and, if transmitted by the
prescriber's agent, the full name of the agent. The pharmacist is
responsible for ensuring the validity of the prescription removed from the
recording device or voice mail service. (3) A licensed pharmacy
intern may receive telephone prescriptions and remove prescriptions from a
recording device or voice mail service if the pharmacist on duty who is
personally supervising the activity of the intern determines that the intern is
competent to perform this function. (a) The intern shall immediately transcribe the
prescription, document the full name of the prescriber and, if transmitted by
the prescriber's agent, the full name of the agent and shall review the
prescription with the pharmacist on duty. Prior to dispensing, positive
identification of the intern and the pharmacist on duty shall be recorded to
identify the responsibility for the receipt of the oral order. (b) The pharmacist on duty is responsible for the accuracy
of the prescription. (c) The pharmacist on duty must be immediately available to
answer questions or discuss the prescription with the prescriber or the
prescriber's agent. (4) A certified pharmacy
technician may receive telephone prescriptions and remove prescriptions from a
recording device or voice mail service for non-controlled drugs in accordance
with rule 4729:3-3-04 of the Administrative Code. (E) Facsimile prescriptions: A facsimile shall only be valid as a prescription
if a pharmacy retains a printed copy of a facsimile prescription or an
electronic copy of the facsimile prescription in accordance with rule
4729:5-5-03 of the Administrative Code. The facsimile prescription shall comply
with the requirements of rule 4729:5-3-11 of the Administrative Code. (F) Electronic
prescriptions: (1) A pharmacy receiving electronic prescriptions directly
into its computer system shall ensure original prescription information
received from the prescriber is maintained in accordance with rule 4729:5-5-03
of the Administrative Code. (2) A pharmacy computer
system receiving electronic prescriptions shall: (a) Comply with the applicable provisions of 21 C.F.R. 1311
(05/01/19); and (b) Have the capability to receive an ICD-10-CM medical
diagnosis code for all controlled substance prescriptions pursuant to rule
4729:5-5-15 of the Administrative Code. (G) Except as provided for in section
4729.46 of the Revised Code, a pharmacist shall not dispense a dangerous drug
for the first time beyond six months from the date of issuance of a
prescription. (H) The quantity prescribed shall be
considered the quantity dispensed, unless the quantity dispensed meets any of
the following: (1) If the dispensed
prescription is less than the quantity prescribed, the pharmacist shall note
the quantity dispensed on the original prescription or within a computerized
recordkeeping system. (2) If the quantity
dispensed on a prescription is greater than the quantity prescribed, the
pharmacist shall record on the original prescription or within a computerized
recordkeeping system the name of the authorizing prescriber, the full name of
the agent of the prescriber, if applicable, the quantity authorized to be
dispensed, and the date that the authorization was obtained. (3) A prescription
dispensed in accordance with section 4729.40 of the Revised Code. The
pharmacist shall note the quantity dispensed on the original prescription or
within a computerized recordkeeping system. (I) Where a prescription is written using
a generic name, or where the pharmacist dispenses an equivalent drug product
pursuant to the provisions of sections 4729.38 and 4729.381 of the Revised
Code, the brand name or drug name and name of the manufacturer or distributor
of the drug or the national drug code (NDC) number of the drug dispensed must
be recorded in the record of dispensing by the pharmacist. (J) (1) A prescription issued
by a prescriber who experiences a change of status, as defined in paragraph
(J)(2) of this rule, that precludes a continued prescriber-patient relationship
may be dispensed by a pharmacist in accordance with the following: (a) In the exercise of the pharmacist's professional
judgment: (i) The drug is essential
to sustain the life of the patient or continue therapy for a chronic condition
of the patient; or (ii) Failure to dispense
the drug to the patient could result in harm to the health of the
patient. (b) The prescription was issued prior to the
prescriber's change of status, as defined in paragraph (J)(2) of this
rule, and in accordance with all applicable provisions of state and federal
laws, rules and regulations. (c) For a non-controlled substance prescription, a
pharmacist may dispense up to a thirty-day supply as provided in the
prescription or, if the standard unit of dispensing for the drug exceeds a
thirty-day supply, the amount of the drug dispensed shall not exceed the
standard unit of dispensing. The pharmacist shall exercise professional
judgment in determining the amount of the drug to be dispensed. (d) For a controlled substance prescription, a pharmacist
may dispense up to a seventy-two-hour supply as provided in the prescription.
The pharmacist shall exercise professional judgment in determining the amount
of the drug to be dispensed. (2) A change of status
includes, but is not limited to, the following: death, incapacity, suspension,
surrender or revocation of the prescriber's license or registration, or
permanent relocation. (3) A prescription for a
dangerous drug dispensed in accordance with paragraph (J)(1) of this rule is
considered void after the initial dispensing and may not be dispensed again.
Following the initial dispensing of the drug, a pharmacist shall utilize a
manual or electronic method for invalidating the prescription to prevent
further dispensing.
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Rule 4729:5-5-11 | Prescription copy.
Effective:
December 1, 2020
(A) An outpatient pharmacy may send or
receive copies of prescriptions in accordance with the following: (1) Copies of
prescriptions shall be transferred only between pharmacists, except as
follows: (a) Pharmacy interns in accordance with paragraph (G) of
this rule; and (b) Certified pharmacy technicians in accordance with rule
4729:3-3-04 of the Administrative Code. (2) Copies of
prescriptions for controlled substances shall be communicated directly between
two pharmacists and, except as provided in paragraph (A)(3) of this rule, shall
be transferred only one time. (3) Pharmacies electronically sharing a
real time, online database may transfer a controlled substance prescription up
to the maximum number of refills permitted by law and the prescriber's
authorization. (4) The copy transferred shall be an
exact duplicate of the original prescription, except that it shall also include
the following: (a) Serial prescription number assigned to the
prescription; (b) Name, address and, if a controlled substance
prescription, the drug enforcement administration (D.E.A.) registration number
of the pharmacy transferring the copy; (c) Date of issuance of the prescription; (d) Date of last refill; (e) Number of valid refills or quantity remaining;
and (f) The full name of the transferring pharmacist or, if
transferred by a pharmacy intern or certified pharmacy technician, the full
name of the transferring pharmacy intern or certified pharmacy technician and
the pharmacist on duty who is supervising the activity of the intern or
technician. (5) A pharmacist transferring a copy of a
controlled substance prescription shall: (a) Write the word "VOID" on the face of the
invalidated prescription in a manner that does not destroy any of the original
information contained on the prescription; for electronic prescriptions,
information that the prescription has been transferred must be added to the
prescription record. (b) Record on the reverse of the invalidated prescription
the name, address, and the D.E.A. registration number of the pharmacy to which
it was transferred and the first and last name of the pharmacist receiving the
prescription information; for electronic prescriptions, such information must
be added to the prescription record. (c) Record the date of the transfer and the name of the
pharmacist transferring the information. (d) Ensure copies of controlled substance prescriptions may
only be transferred if the prescription record in the system is invalidated to
prevent further dispensing at the original pharmacy. (6) A pharmacist, pharmacy intern, or
certified pharmacy technician transferring a copy of a non-controlled substance
prescription shall: (a) Utilize a manual or electronic method for invalidating
the prescription to prevent further dispensing at the original
pharmacy. (b) Record the name and address of the pharmacy to which it
was transferred. (c) If transferred
orally, the first and last name of the pharmacist or authorized pharmacy
personnel receiving the prescription information. (d) Record the date of the transfer and the name of the
pharmacist, pharmacy intern, or certified pharmacy technician transferring the
information. (7) A pharmacist, pharmacy intern, or
certified pharmacy technician receiving a copy of a prescription must comply
with the following: (a) Exercise reasonable diligence to determine the validity
of the copy. (b) Transcribe an oral prescription by recording all the
information transferred. The oral prescription shall include all information
required in paragraph (A)(4) of this rule and the pharmacist, pharmacy intern,
or certified pharmacy technician shall write the word "transfer" on
the face of the prescription or indicate the prescription was transferred
within a computerized record keeping system. (c) Record date of transfer on the face of the prescription
or within a computerized record keeping system. (d) Prior to dispensing, positive identification of the
receiving pharmacist shall be recorded to identify who is responsible for the
receipt of the copy. For pharmacy interns, positive identification shall be
documented in accordance with paragraph (G)(5) of this rule. For certified
pharmacy technicians, positive identification shall be documented in accordance
with rule 4729:3-3-04 of the Administrative Code. (B) A prescription copy may be
transferred electronically between pharmacies if the pharmacies are accessing
the same prescription records in a centralized database or the pharmacies'
computers are linked in any other manner. The computer systems must be able to
comply with the requirements of paragraphs (A)(4) and (A)(5)(d) of this rule.
This shall include invalidation of the prescription record in the system to
prevent further dispensing at the original pharmacy and, if a controlled
substance prescription, the canceling of the original written prescription as
required in paragraphs (A)(5)(a) and (A)(5)(b) of this rule. (C) A prescription copy may be
transferred by the use of a facsimile machine. A facsimile shall be considered
a copy of the prescription if it meets the requirements of paragraph (A) of
this rule, including invalidation of the original prescription. Facsimile
copies must be recorded in writing pursuant to section 4729.37 of the Revised
Code or stored in such a manner that will allow retention of the prescription
record for three years from the date of the last transaction. (D) Information on a prescription is the
property of the patient and is intended to authorize the dispensing of a
specific amount of medication for use by the patient. (1) If the pharmacy is
not able to provide the medication when needed by the patient pursuant to an
authorized refill, the pharmacy shall, upon the request of the patient or
patient's caregiver, transfer the prescription information to a pharmacy
designated by the patient. (2) Unless otherwise
prohibited by law, no pharmacy shall refuse to transfer information about a
prescription to another pharmacy when requested by the patient or
patient's caregiver. Prescription information shall be transferred in
accordance with this rule as soon as possible to ensure that the patient's
drug therapy is not interrupted. (3) A prescription may
only be transferred upon the request or consent of the patient or
patient's caregiver. (E) Prescriptions entered into a computer
system but not dispensed shall be transferred to another pharmacy, at the
request of the patient or patient's caregiver, if all of the following
conditions are met: (1) The complete
prescription information has been entered into the computer
system. (2) The information is
displayed on the patient's profile. (3) There is positive
identification of the individual responsible for entering the prescription
information into the system and the pharmacist responsible for verification of
the information entered into the system. (4) The original
prescription is filed in accordance with rule 4729:5-5-03 of the Administrative
Code. (5) The prescription is
assigned a prescription number. (6) All requirements of
this rule are met for the transfer of the prescription. (7) The transfer is
conducted in accordance with all state and federal laws, rules and
regulations. (8) A pharmacist may
transfer an unfilled electronic prescription for a controlled substance to
another pharmacist in accordance regulations or policies adopted by the United
States drug enforcement administration. (F) Transfer of prescription information
between two pharmacies which are accessing the same real time, online database
pursuant to the operation of a licensed central fill pharmacy shall not be
considered a prescription copy and, therefore, is not subject to the
requirements of this rule. (G) A licensed pharmacy intern may send
or receive copies of prescriptions in accordance with the
following: (1) The pharmacist on
duty who is supervising the activity of the intern determines if the intern is
competent to send or receive a prescription copy. (2) The pharmacist on
duty who is supervising the activity of the intern is responsible for the
accuracy of a prescription copy that is sent or received by an
intern. (3) The pharmacist on
duty must be immediately available to answer questions or discuss the
prescription copy that is sent or received by an intern. (4) The pharmacist or
intern receiving a prescription copy from an intern must document the full
names of the sending intern and the intern's supervising
pharmacist. (5) The intern receiving
a prescription copy shall immediately transcribe the prescription and shall
review the prescription with the pharmacist on duty. Prior to dispensing,
positive identification of the intern and the supervising pharmacist on duty
shall be recorded to identify who is responsible for the receipt of the
copy. (6) The pharmacist or intern sending a
prescription copy to an intern must document the full names of the receiving
intern and the pharmacist on duty. (7) The intern shall not send or receive
a prescription copy for a controlled substance. (8) The intern and the pharmacist on duty
shall comply with all the requirements of this rule.
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Rule 4729:5-5-12 | Partial dispensing of schedule II controlled substances.
Effective:
December 1, 2020
(A) A valid prescription for a schedule
II controlled substance may be partially dispensed as follows: (1) For a terminally ill
patient or a patient residing in a long-term care facility, compliance with 21
C.F.R. 1306.13 (03/31/2010). (2) For a patient who is
not terminally ill or residing in a long-term care facility, the following must
be observed: (a) The partial dispensing shall be requested by the
patient or the prescriber that issued the prescription; (b) The total quantity dispensed in all partial dispensings
shall not exceed the total quantity prescribed; and (c) The remaining portions of a partially dispensed
schedule II controlled substance prescription shall be filled not later than
thirty days after the date on which the prescription is written. (B) The partial dispensing of a schedule
II controlled substance prescription can only occur at the pharmacy where the
original prescription is on file. (C) At the time of partial dispensing of
a schedule II controlled substance, the following must be noted on the back of
the original prescription or within a computerized record keeping system
pursuant to rule 4729:5-5-04 of the Administrative Code: the date dispensed,
quantity dispensed, remaining quantity authorized to be dispensed, prescription
number of the partial dispensing if different, and the manual initials or other
form of positive identification of the dispensing pharmacist. (D) If a computerized record keeping
system is being used and the system will not permit refills of schedule II
controlled substances, a new prescription number for the partial dispensing
must be assigned. (1) A notation must also
be made in the record keeping system that identifies the new prescription
number as a partial dispensing and provides the serial number of the original
prescription. (2) A prescription
bearing the new serial number must be placed in the schedule II file. The
prescription for each partial filling must also show the serial number of the
original prescription and all previous partial fills.
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Rule 4729:5-5-13 | Serial numbering of prescriptions.
Effective:
December 1, 2020
All outpatient prescriptions must be serially
numbered when entered into a computer system or when dispensed under a manual
system. (A) The serial number must appear on the
original prescription. (B) There must be a complete accounting
of all numbers used in the serial numbering system. (C) All prescriptions that cannot be
refilled, either because of the dispensing of all refills or the length of time
since issuance, shall be assigned a new serial number upon an authorization for
additional dispensing by a prescriber or prescriber's agent.
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Rule 4729:5-5-14 | Prescription pick-up station.
Effective:
December 1, 2020
(A) No pharmacist shall accept
prescriptions obtained from a place which offers, in any manner, its services
as a "pick-up station" or intermediary for the purpose of having
prescriptions filled unless such place is a pharmacy as defined in section
4729.01 of the Revised Code and all of the following apply: (1) The site is licensed
as a terminal distributor of dangerous drugs pursuant to Chapter 4729. of the
Revised Code; (2) The receipt, storage,
control, and distribution of prescriptions are in the full and actual charge of
a pharmacist licensed pursuant to Chapter 4729. of the Revised
Code; (3) A record keeping
system is in place that will provide accountability for proper receipt,
delivery, disposal and return of all prescriptions; (4) There is a documented
method in place to ensure compliance with rule 4729:5-5-09 of the
Administrative Code. (B) No pharmacist shall dispense
dangerous drugs to a place which offers, in any manner, its services as a
"pick-up station" or intermediary for the purpose of having
prescriptions filled or delivered unless such place is a pharmacy as defined in
section 4729.01 of the Revised Code or, if not a pharmacy, all of the following
apply: (1) The site is licensed
as a terminal distributor of dangerous drugs pursuant to Chapter 4729. of the
Revised Code, unless exempted pursuant to section 4729.541 of the Revised Code
or a waiver is granted by the board. (2) There is clear and
convincing evidence that delivery of a prescription medication directly to the
patient would result in: (a) Danger to public health or safety; or (b) Danger to the patient without increased involvement by
a health care professional in the patient's drug therapy. (3) The receipt, storage,
control, and distribution of dangerous drugs are in the full and actual charge
of a health care professional licensed pursuant to Chapter 4715., 4723., 4729.,
4730., 4731., or 4741. of the Revised Code. (4) A record keeping
system is in place that will provide accountability for proper receipt,
delivery, disposal and return of all prescription medications. Unless donated
to a drug repository program pursuant to section 3715.87 of the Revised Code, a
dangerous drug that is not distributed to a patient shall either: (a) Be returned to the dispensing pharmacy for disposal;
or (b) If the pick-up station is licensed a terminal
distributor of dangerous drugs, be disposed of in accordance the applicable
rules set forth in this division of the Administrative Code. (5) There is a documented
method in place to ensure compliance with rule 4729:5-5-09 of the
Administrative Code. (C) The state board of pharmacy may
restrict a site from acting as a pick-up station if it has clear and convincing
evidence that the activities of the pick-up station present the
following: (1) Danger to public
health or safety; or (2) Danger to the
patient.
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Rule 4729:5-5-15 | Manner of issuance of a prescription.
Effective:
December 1, 2020
(A) A prescription, to be valid, must be
issued for a legitimate medical purpose by an individual prescriber acting in
the usual course of the prescriber's professional practice. The
responsibility for the proper prescribing is upon the prescriber, but a
corresponding responsibility rests with the pharmacist who dispenses the
prescription. An order purporting to be a prescription issued not in the usual
course of bona fide treatment of a patient is not a prescription and the person
knowingly dispensing such a purported prescription, as well as the person
issuing it, shall be subject to the penalties of law. (B) All outpatient prescriptions issued
by a prescriber shall: (1) Be dated as of and on
the day when issued. (2) Contain the manually
printed, typewritten, or preprinted full name, professional title, and address
of the prescriber. The prescriber's address shall include the physical
address of the prescriber's practice location. (3) Indicate a telephone
number where the prescriber can be contacted during normal business
hours. (4) Indicate the full name and residential address of the
patient; 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. The patient or
owner's residential address shall include a physical street
address. (5) Indicate the drug
name and strength. (6) Indicate the quantity
to dispense. (7) Indicate the
appropriate and explicit directions for use. (8) Specify the number of
times or the period of time for which the prescription may be refilled. If no
such authorization is given, the prescription may not be refilled except in
accordance with section 4729.281 of the Revised Code. (a) Prescriptions for non-controlled substance dangerous
drugs bearing "PRN," "Ad lib," or other similar
prescription refill designation permitting the pharmacist to refill the
prescription as needed by the patient, shall be refilled only in keeping with
the number of doses ordered and according to the directions for use, and, in no
instance, shall such prescription be refilled beyond one year from the date of
issue. The prescription shall not be refilled out of context with the dosage
schedule indicated in the directions for use unless specifically authorized by
the prescriber. (b) Prescriptions for controlled substance dangerous drugs
bearing "PRN," "Ad lib," or other similar prescription
refill designation are not considered a valid refill
authorization. (9) Not authorize any
refills for schedule II controlled substances. (10) Authorize refills
for schedules III and IV controlled substances only as permitted by section
3719.05 of the Revised Code. (11) Not authorize a
refill beyond one year from the date of issuance for schedule V controlled
substances and for dangerous drugs that are not controlled substances.
(12) Identify the trade
name or generic name of the drug(s) in a compounded prescription. (13) Not be coded in such
a manner that it cannot be dispensed by any pharmacy of the patient's
choice. (14) For a controlled
substance: (a) Indicate the drug enforcement administration
registration number of the prescriber pursuant to 21 CFR 1306.05
(3/31/2010). (b) Except for veterinarians licensed pursuant to Chapter
4741. of the Revised Code, indicate either: (i) The ICD-10-CM medical
diagnosis code of the primary disease or condition that the controlled
substance is being used to treat. The code shall, at a minimum, include the
first four alphanumeric characters of the ICD-10-CM medical diagnosis code,
sometimes referred to as the category and the etiology (ex. M
16.5). (ii) For dentists
licensed pursuant to Chapter 4715. of the Revised Code, the Code on Dental
Procedures and Nomenclature (CDT Code), as published by the American dental
association, of the dental treatment requiring the controlled substance
prescription. (15) Except for
veterinarians licensed under Chapter 4741. of the Revised Code, for all
controlled substances and products containing gabapentin: indicate the
prescriber's intended days' supply of the prescription. (16) For a managing
pharmacist acting as an agent of a physician pursuant to section 4729.39 of the
Revised Code and Chapter 4729:1-6 of the Administrative Code, the prescription
shall include the full name of the managing pharmacist. (17) Be issued in
compliance with all applicable federal and Ohio laws, rules, and
regulations. (C) Failure of a prescription to contain
the requirements set forth in paragraphs (B)(14)(b) and (B)(15) of this rule or
of the pharmacist to obtain the information set forth in paragraphs (B)(14)(b)
and (B)(15) of this rule shall not render the prescription, if dispensed in
good faith, to be invalid. (D) All prescriptions issued on paper to
a patient by a prescriber shall be: (1) Manually signed on
the day issued by the prescriber in the same manner as the prescriber would
sign a check or legal document. (2) Issued in compliance
with rule 4729:5-5-05 of the Administrative Code. (E) When forms are used that create
multiple copies of a prescription issued to a patient by a prescriber, the
original prescription that includes the actual signature of the prescriber must
be issued to the patient for dispensing by a pharmacist. (F) Pursuant to section 4729.38 of the
Revised Code, a pharmacist shall not select a generically equivalent drug or
interchangeable biological product if either of the following
applies: (1) In the case of a
written or electronic prescription, including a computer- generated
prescription, the prescriber handwrites or actively causes to display on the
prescription "dispense as written," "D.A.W.," "do not
substitute," "brand medically necessary," or any other statement
or numerical code that indicates the prescriber's intent to prevent
substitution. Such a designation shall not be preprinted or stamped on the
prescription, but a reminder to the prescriber of the designation procedure may
be preprinted or displayed on the prescription form or electronic system the
prescriber uses to issue the prescription. (2) In the case of an
oral prescription, the prescriber or the prescriber's agent specifies that
the drug as prescribed is medically necessary or otherwise indicates the
prescriber's intent to prevent substitution. (G) Pursuant to section 4729.40 of the
Revised Code, a pharmacist shall not dispense a quantity or amount of drug that
varies from the quantity or amount of the drug that otherwise would be
dispensed unless all the conditions are met in accordance with that section and
either of the following applies: (1) The prescriber
includes "dispense as written" or another phrase having a similar
meaning on the prescription. Such a designation shall not be preprinted or
stamped on the prescription, but a reminder to the prescriber of the
designation procedure may be preprinted or displayed on the prescription form
or electronic system the prescriber uses to issue the
prescription. (2) When issuing a
prescription electronically or orally, the prescriber specifies that the
quantity or amount of the drug to be dispensed may not vary from the quantity
or amount specified in the prescription. (H) Pursuant to section 4729.382 of the
Revised Code, a pharmacist shall not make the substitution of an epinephrine
autoinjector if either of the following applies to the
prescription: (1) In the case of a
written or electronic prescription, including a computer-generated
prescription, the prescriber handwrites or actively causes to display on the
prescription "dispense as written," "D.A.W.," "do not
substitute," "medically necessary as prescribed," or any other
statement or numerical code that indicates the prescriber's intent to
prevent substitution. Such a designation shall not be preprinted or stamped on
the prescription, but a reminder to the prescriber of the designation procedure
may be preprinted or displayed on the prescription form or electronic system
the prescriber uses to issue the prescription. (2) In the case of an
oral prescription, the prescriber specifies that the epinephrine autoinjector
as prescribed is medically necessary or otherwise indicates the
prescriber's intent to prevent substitution. (I) A patient or patient's caregiver shall have the
exclusive right to freedom of choice for any pharmacy to dispense
prescriptions. (J) A pharmacist may dispense a prescription from a
prescriber practicing outside of Ohio, if all the following apply: (1) The prescriber who
issued the prescription would ordinarily be entitled to issue prescriptions
under Ohio law and the state where the prescription was issued; (2) The prescription
meets all the requirements of this rule, including whether the prescription is
for a legitimate medical purpose in accordance with paragraph (A) of this
rule. (3) The prescription is
transmitted in accordance with rule 4729:5-3-11 of the Administrative Code;
and (4) For a controlled
substance prescription, the prescriber holds a valid drug enforcement
administration registration number in the state of origin of the
prescription.
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Rule 4729:5-5-16 | Pharmacist modifications to a prescription.
Effective:
December 1, 2020
(A) For a schedule II controlled
substance prescription: (1) A pharmacist shall
not make changes to the drug prescribed, except for substitution permitted by
law, the prescriber's signature, or the patient's name. (2) Any other
modification, except for substitution permitted by law, may only be made after
consultation with and agreement of the prescriber. (B) For a schedule III-V controlled
substance prescription: (1) Except as provided
for in paragraph (D) of this rule, a pharmacist shall not make changes to the
drug prescribed, except for substitution permitted by law, the
prescriber's signature, or the patient's name. (2) Any other
modification, except for substitution permitted by law, may only be made after
consultation with and agreement of the prescriber or the prescriber's
agent. (C) For a non-controlled substance
dangerous drug prescription: (1) Except as provided
for in paragraphs (D) and (E) of this rule, a pharmacist shall not make changes
to the drug prescribed, except for substitution permitted by law, the
prescriber's signature, or the patient's name. (2) Any other
modification, except for substitution permitted by law or in accordance with
paragraph (E) of this rule, may only be made after consultation with and
agreement of the prescriber or the prescriber's agent. (D) Except for a schedule II controlled
substance prescription, a pharmacist may correct a patient's name on a
prescription after consultation with and agreement of the prescriber or the
prescriber's agent. (E) For a non-controlled substance
prescription, a pharmacist may change the dosage form, drug strength, drug
quantity, and directions for use without consultation with and agreement of the
prescriber or agent of the prescriber in accordance with the
following: (1) The drug selected
must be the same drug indicated on the prescription; (2) The drug selected
must have the same frequency and duration of therapy as the drug indicated on
the prescription; (3) The prescription is
for a human patient; (4) No modifications
shall be made pursuant to this paragraph if "dispense as written" or
another phrase or indicator having a similar meaning is indicated on the
prescription; (5) The pharmacist who
selects the drug to be dispensed pursuant to this paragraph shall assume the
same responsibility for selecting the dispensed drug as would be incurred in
filling a prescription for a drug using the prescribed form; and (6) The pharmacist shall
not substitute between long-acting and short-acting forms of the
drug. (F) A pharmacist may dispense a quantity
of a drug in a manner that varies from the prescription in accordance with
paragraph (H) of rule 4729:5-5-10 of the Administrative Code or rule
4729:5-5-12 of the Administrative Code and all applicable federal and state
laws, rules, and regulations. (G) All consultations and corresponding changes performed
in accordance with this rule shall be noted by the pharmacist on the
prescription or in the patient's profile and shall be communicated to the
patient or patient's caregiver.
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Rule 4729:5-5-17 | Drugs repackaged or relabeled by a pharmacy.
Effective:
December 1, 2020
(A) As used in this rule,
"repackaging" means the act of taking a finished drug product from
the container in which it was distributed by the original manufacturer and
placing it into a different container without further manipulation of the drug.
Repackaging also includes the act of placing the contents of multiple
containers (e.g., vials) of the same finished drug product into one container,
as long as the container does not include other ingredients. If a drug is
manipulated in any other way, including if the drug is reconstituted, diluted,
mixed, or combined with another ingredient, that act is not considered
repackaging. (B) The following rule applies to
dangerous drugs repackaged by an outpatient pharmacy. The rule does not apply
to any of the following: (1) Repackaging drug
products for use in animals; (2) Repackaging
non-dangerous drug products; (3) Radiopharmaceuticals
as defined in Chapter 4729:5-6 of the Administrative Code; (4) Repackaging conducted
by outsourcing facilities or repackagers licensed in accordance with section
4729.52 of the Revised Code; (5) Removing a drug
product from the original container at the point of care (e.g., patient's
bedside) for immediate administration to a single patient after receipt of a
valid patient-specific prescription or order for that patient (e.g., drawing up
a syringe to administer directly to the patient); (6) Upon receipt of a
valid patient-specific prescription or medication order, a licensed pharmacy
removing from one container the quantity of non-sterile drug products (e.g.,
oral dosage forms) necessary to fill the prescription and placing it in a
different container to dispense directly to the patient; and (7) Investigational new
drugs being studied under an investigational new drug application.
(C) Drugs repackaged by an outpatient
pharmacy shall comply with the following: (1) "Repackaging of Certain Human Drug Products by
Pharmacies and Outsourcing Facilities" guidance issued by the United
States food and drug administration (January 2017) and any other subsequent
repackaging guidance issued by the food and drug administration that is
approved by the board; (2) For sterile compounded drug preparations, United States
pharmacopeia chapter <797> as referenced in rule 4729:7-1-01 of the
Administrative Code. (D) Labels of drugs repackaged by and stored within a
pharmacy prior to being dispensed shall contain, but not be limited to, the
following: (1) Name of drug,
strength, and dosage form; (2) National drug code or
universal product code, if applicable, which may be embedded in a bar code or
quick response (QR) code on the label; (3) The identification of
the repackager by name or by the final seven digits of the terminal distributor
of dangerous drugs license number; (4) Pharmacy control
number; (5) The beyond-use date
of the repackaged drug in accordance with the guidance listed in paragraph (C)
of this rule. (E) All drugs dispensed for outpatient
use shall also be labeled in accordance with rule 4729:5-5-06 of the
Administrative Code. (F) A record of all drugs repackaged and stored within a
pharmacy prior to being dispensed shall be kept in a readily retrievable manner
for at least three years or one year past manufacturer's expiration date,
whichever is greater. This record shall include the following: (1) Name of drug,
strength, dosage form, and quantity; (2) National drug code or
universal product code, if applicable, which may be embedded in a bar code or
quick response (QR) code on the label; (3) Manufacturer's
or distributor's control number; (4) Manufacturer's
or distributor's name, if a generic drug is used; (5) Pharmacy control
number; (6) Manufacturer's
or distributor's expiration date; (7) The pharmacy's
beyond-use date in accordance with the guidance listed in paragraph (C) of this
rule; (8) The positive
identification of the individual responsible for the repackaging of the drug;
and (9) The positive
identification of the pharmacist conducting the final verification of the
repackaged drug to confirm the accuracy of the drug and conformity to the
requirements of this rule prior to dispensing or distribution. (G) A pharmacy that uses supplemental labels that contain a
bar code or QR code for the purpose of identifying a repackaged drug shall
capture the positive identification of the pharmacist responsible for the
following: (1) Association of the
bar code to the drug product; and (2) Association of the
label to the drug product.
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Rule 4729:5-5-18 | Dispensing customized patient medication packages by an outpatient pharmacy.
Effective:
October 1, 2024
In lieu of dispensing two or more dangerous drugs
in separate containers, a pharmacist practicing at an outpatient pharmacy may
dispense a customized patient medication package. A customized patient
medication package is a package for a specific patient comprising a series of
containers and containing two or more prescribed solid oral dosage forms that
complies with the following requirements: (A) The package is designed, or each
container is labeled, to indicate the day and time or period of time when the
contents within each container are to be taken by the patient. (B) The number of drugs placed in each
container cannot exceed the capability of the container to prevent damage to
the dosage forms. (C) The quantity of the package dispensed
may not be more than a ninety-day supply. (D) The labels must be of sufficient size
to properly and clearly label a ninety-day or less supply with all information
required in accordance with this chapter of the Administrative Code, including
the use of accessory labels. (E) The package must include an
expiration date or beyond-use date, which shall not exceed the expiration date
on the manufacturer's container or six months from the date the drug was
originally packaged, whichever date is earlier. If multiple manufacturer
containers are used, the expiration date shall not exceed the expiration date
on the manufacturer's container that will expire first or six months from
the date the drug was originally repackaged, whichever date is
earlier. (F) Dangerous drugs which have been
dispensed in a customized patient medication package may only be returned to
stock or re-dispensed in accordance with all the following: (1) The drugs have not
been in the possession of the ultimate user; and (2) The drugs have not
been placed in the same container with another dangerous drug (i.e. did not
come into direct contact with a different drug within the same
container). (G) The containers of a package are
sealed or secured in such a way that access to the drugs stored within is not
possible without leaving visible proof that such access has been attempted or
made. (H) Any pharmacy dispensing customized
patient medication packages in accordance with this rule must implement
policies and procedures that will exclude drugs having any of the following
characteristics from such packaging: (1) The U.S.P. monograph
or official labeling requires dispensing in the original container, unless
there is documentation from the manufacturer stating otherwise; (2) The drugs or dosage
forms are incompatible with packaging components or each other; (3) The drugs are
therapeutically incompatible when administered simultaneously; (4) The drugs require
special packaging.
Last updated October 1, 2024 at 9:20 AM
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Rule 4729:5-5-19 | Central fill pharmacies.
Effective:
February 1, 2022
(A) As used in this chapter: (1) "Central fill
pharmacy" means a pharmacy licensed as a terminal distributor of dangerous
drugs acting as an agent of an originating pharmacy to fill or refill a
prescription. A central fill pharmacy may also be the originating pharmacy
pursuant to paragraph (D) of this rule. (2) "Originating
pharmacy" means an outpatient pharmacy licensed as a terminal distributor
of dangerous drugs that uses a central fill pharmacy to fill or refill a
prescription. (B) A central fill pharmacy and
originating pharmacy may process a request for the filling or refilling of a
prescription received by an originating pharmacy only pursuant to the following
requirements: (1) The central fill
pharmacy either has the same owner as the originating pharmacy or has 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. The contract shall expressly
state who is responsible for performing the patient counseling requirements in
accordance with rule 4729:5-5-09 of the Administrative Code. (2) The central fill
pharmacy shall maintain a record of all originating pharmacies, including name,
address, terminal distributor of dangerous drugs license number, and, if
applicable, drug enforcement administration registration number, for which it
processes a request for the filling or refilling of a prescription received by
the originating pharmacy. The record shall be made readily retrievable and
maintained for a period of three years. (3) 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 prescription. (4) The originating
pharmacy shall comply with the minimum required information for a patient
profile pursuant to rule 4729:5-5-07 of the Administration Code prior to
sending a prescription to the central fill pharmacy. (5) The originating
pharmacy shall remain responsible for compliance with the dangerous drug
dispensing requirements of this chapter and the compounding requirements of
Chapter 4729:7-2 of the Administrative Code that are not assumed in writing by
the central fill pharmacy. (6) 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. (7) 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.
(8) The originating pharmacy shall
maintain the original of all prescription orders received for purposes of
filing and recordkeeping as required by state and federal law, rules, and
regulations. (9) The central fill pharmacy shall
maintain all original fill and refill requests received from the originating
pharmacy and shall treat them as original and refill prescription orders for
purposes of filing and recordkeeping as required by state and federal law,
rules, and regulations. (10) The central fill pharmacy and
originating pharmacy shall each maintain records to capture the positive
identification of the licensed or registered individuals responsible for
performing respective activities in accordance with paragraph (A) of rule
4729:5-5-04 of the Administrative Code. (11) 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. (C) Dangerous drugs may be returned by
the originating pharmacy to the central fill pharmacy that originally filled
the prescription for the express purpose of being returned to the central fill
pharmacy's stock shelves in accordance with the following: (1) The central fill
pharmacy complies with the requirements of rule 4729:5-3-16 of the
Administrative Code; and (2) The originating and
central fill pharmacy are under common ownership and control. (D) An originating pharmacy may return
dangerous drugs received by a central fill pharmacy to stock shelves in
accordance with rule 4729:5-3-16 of the Administrative Code. (E) A central fill pharmacy may dispense
a prescription directly to a patient pursuant to the following
requirements: (1) A prospective drug
utilization review is conducted pursuant to a written contract or agreement in
accordance with rule 4729:5-5-08 of the Administrative Code; (2) Patient counseling is
provided pursuant to a written contract or agreement in accordance with rule
4729:5-5-09 of the Administrative Code; (3) The dispensing is
conducted in accordance with all other applicable state and federal laws,
regulations and rules, including those specified in 68 CFR 37405
(7/24/2003). (F) All written documentation required by
this rule shall be maintained for three years from the date of execution or
review and shall be made readily retrievable. (G) Drugs that are repackaged or
relabeled by a central fill pharmacy shall comply with the requirements of rule
4729:5-5-17 of the Administrative Code.
Last updated February 1, 2022 at 9:15 AM
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Rule 4729:5-5-20 | Remote outpatient prescription processing.
Effective:
November 30, 2021
(A) As used in this rule: (1) "Remote
prescription processing" means the processing of a prescription for an
outpatient pharmacy licensed as a terminal distributor of dangerous drugs by a
remote pharmacist. Remote prescription processing does not include the
dispensing of a drug, but may include receiving, interpreting, evaluating,
clarifying and approval of prescriptions. Additionally, remote prescription
order processing may include order entry, other data entry, performing
prospective drug utilization review, interpreting clinical data, performing
therapeutic interventions, and providing drug information services. The
requirements of this rule shall be limited to the processing of outpatient
prescriptions dispensed in or into this state. (2) "Remote
pharmacy" means either: (a) A pharmacy licensed as a terminal distributor of
dangerous drugs that dispenses dangerous drugs; or (b) A pharmacy licensed as a limited category II terminal
distributor of dangerous drugs that does not stock, own, or dispense any
dangerous drugs and whose sole business consists of entry, review, and/or
verification of prescriber orders and consulting services under contract for
outpatient pharmacies in this state. (3) "Remote
pharmacist" means any of the following: (a) If performing remote prescription processing in this
state: an Ohio licensed pharmacist, either employed or a contract employee of
an outpatient pharmacy or remote pharmacy, who either processes prescriptions
from a remote site, which may include the pharmacist's residence or other
location where the pharmacist and the outpatient or remote pharmacy can ensure
the confidentiality and integrity of patient information, or on the premises of
a remote pharmacy or outpatient pharmacy; or (b) If performing remote prescription processing outside of
this state: a pharmacist licensed or registered in the state where the remote
prescription processing is occurring, either employed or a contract employee of
an outpatient pharmacy or remote pharmacy who holds a nonresident pharmacy
license in accordance with Chapter 4729:5-8 of the Administrative Code, who
either processes prescriptions from a remote site, which may include the
pharmacist's residence or other location where the pharmacist and the
outpatient or remote pharmacy can ensure the confidentiality and integrity of
patient information, or on the premises of a remote pharmacy or outpatient
pharmacy. A pharmacist shall only be permitted to
conduct remote prescription processing within the United States, to include the
District of Columbia, the Commonwealth of Puerto Rico or a territory or insular
possession subject to the jurisdiction of the United States. (B) An outpatient pharmacy may outsource
prescription processing to a remote pharmacy provided the pharmacies are under
common ownership or control or the outpatient pharmacy has entered into a
written contract or agreement with a pharmacy that outlines the services to be
provided and the responsibilities and accountabilities of each party to the
contract or agreement in compliance with federal and state statutes and
regulations. (C) The outpatient pharmacy and remote
pharmacy must maintain a copy of the contract or agreement in a readily
retrievable manner for inspection and review by an agent, inspector, or
employee of the board. (D) An outpatient pharmacy utilizing
remote prescription processing shall ensure that all remote pharmacists
providing such services have been trained on the outpatient pharmacy's
policies and procedures relating to prescription processing. The training of
each pharmacist shall be documented. (1) Such training shall
include, but is not limited to, policies on drug and food allergy
documentation, abbreviations, substitution, and prospective drug utilization
review requirements in accordance with rule 4729:5-5-08 of the Administrative
Code. The outpatient pharmacy and the remote pharmacy shall jointly develop a
procedure to communicate changes in policies and procedures related to
prescription processing. (2) A terminal
distributor of dangerous drugs may utilize one training program for all
outpatient pharmacies under the terminal distributor's common ownership
and control. (E) An outpatient pharmacy utilizing
remote pharmacists shall maintain or have access to a record of the name and
address of each pharmacist, evidence of current pharmacist licensure in the
state where the pharmacist is performing remote order processing, and the
address of each location where the pharmacist will be providing remote
prescription processing services. (F) The outpatient pharmacy shall ensure
that any remote pharmacist shall have secure electronic access to the
outpatient pharmacy's patient information system and to other electronic
systems that the on-site pharmacist has access to when the pharmacy is
open. (G) The remote pharmacist must be able to
contact the prescriber issuing a prescription to discuss any concerns
identified during the pharmacist's review of patient information and the
order. A procedure must be in place to communicate any problems identified with
the prescriber and the outpatient pharmacy. (H) Each remote entry record must comply
with all recordkeeping requirements for outpatient pharmacies, including
capturing the positive identification of the remote pharmacist involved in the
review and verification of the prescription. (I) An outpatient pharmacy utilizing
remote prescription processing is responsible for maintaining records of all
prescriptions entered into their information system, including orders entered
by a remote pharmacist. The system shall have the ability to audit the
activities of the remote pharmacists. (J) An outpatient pharmacy utilizing
remote prescription processing services shall develop and implement a policy
and procedure manual. A remote pharmacy shall maintain a copy of those portions
of the policy and procedure manual that relate to the remote pharmacy's
operations. Each manual shall include all the following: (1) Outline the
responsibilities of the outpatient pharmacy and the remote
pharmacy; (2) Include a list of the
names, addresses, telephone numbers, and all license numbers of the
pharmacies/pharmacists involved in remote prescription processing; and
(3) Include policies and
procedures for: (a) Protecting the confidentiality and integrity of patient
information; (b) Ensuring that no patient information is duplicated,
downloaded, or removed from the outpatient pharmacy's patient information
system; (c) Maintaining appropriate records of each pharmacist
involved in prescription processing; (d) Complying with federal and state statutes and
regulations; (e) Reviewing written policies and procedures at least
every three years, or upon the implementation of a significant change of
written policies and procedures, and documentation of the review;
and (f) Annually reviewing the competencies of pharmacists
providing remote prescription processing services.
Last updated November 30, 2021 at 8:28 AM
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Rule 4729:5-5-22 | Return to stock in an outpatient pharmacy.
Effective:
December 1, 2020
(A) As used in this rule: (1) "Pharmacy
delivery agent" means an employee of the pharmacy, United States postal
service, or common or contract carrier who delivers dangerous drugs that have
been dispensed. (2) "Psychiatric
outpatient facility" means a facility where psychiatric evaluation and
treatment is provided on an outpatient basis. (B) An outpatient pharmacy may return
dangerous drugs to stock shelves that have been dispensed, but have never left
the pharmacy (i.e. never picked up by a patient or caregiver) or the control of
a pharmacy delivery agent (i.e. never delivered to a patient or caregiver), if
the pharmacy complies with all of the following: (1) The pharmacy has the
capability to place the expiration date, as required by this rule, on the
prescription label. (2) The expiration date
on the label shall not exceed the expiration date on the manufacturer's
container or one year from the date the drug was originally dispensed and
placed in the prescription vial, whichever date is earlier. If multiple
manufacturer containers are used, the expiration date shall not exceed the
expiration date on the manufacturer's container that will expire first or
one year from the date the drug was originally dispensed and placed in the
prescription vial, whichever date is earlier. If the prescription container is
the manufacturer's original sealed packaging, the expiration date is the
expiration date listed on the packaging. (3) The dangerous drug
products returned to stock shelves shall be maintained in the container in
which they were filled and shall maintain their original prescription label
containing the original expiration date assigned. The label on the container
shall not be removed, altered, or replaced with another label or have any other
label added, except as follows: (a) Adding to or modifying the existing label, if the drug
name, dose, and original expiration date are maintained. (b) Adding a new label over the existing label on the
container. In this instance, the drug shall be verified by a pharmacist or an
electronic verification system following the application of the new label. The
new label shall include the expiration date assigned on the original
label. (c) A prescription label may be removed if the prescription
container is the manufacturer's original sealed packaging and the removal
of the label does not remove or otherwise cause to make unreadable the
expiration date and lot number on the manufacturer's
packaging. (4) The contents of a
prescription vial or container shall not be returned to the manufacturer's
stock bottle. (5) When dispensing a
dangerous drug that was previously returned to stock to another patient, a new
container shall be used or, in the case of unit dose or unit of use products,
all previous patient information shall be removed. (6) Drugs returned to
stock shelves shall be stored in accordance with rule 4729:5-5-02 of the
Administrative Code. The pharmacy shall develop and implement a policy to
ensure that drugs are maintained by pharmacy delivery agents within
temperatures as stipulated by the USP/NF and/or the manufacturer's or
distributor's labeling. (7) In the case of
recalls, any drugs returned to stock shelves containing the drug affected by
the recall shall be removed from the shelves immediately, unless the lot number
can be determined. (8) A dangerous drug that
leaves the prescription department of the pharmacy in the custody of a pharmacy
delivery agent may only be returned to stock shelves if the drug meets either
of the following prior to initially leaving the prescription
department: (a) Each dangerous drug prescription is dispensed in a
tamper evident container or package prior to leaving the pharmacy;
or (b) The dangerous drug prescription is dispensed in the
manufacturer's original tamper evident packaging. (9) A dangerous drug that
is dispensed and shows any signs of tampering or adulteration shall not be
returned to stock shelves. (C) A dangerous drug that exceeds its
assigned expiration date, as described in paragraph (B) of this rule, shall be
removed from the area for the storage of drugs used for dispensing and
administration in accordance with rule 4729:5-3-06 of the Administrative
Code. (D) Non-controlled drugs dispensed by a
government entity and delivered for outpatients to a psychiatric outpatient
facility or to any service provider licensed as a terminal distributor of
dangerous drugs may be returned to stock if all the following
apply: (1) The drugs are
packaged in unopened, single-dose or tamper-evident containers;
and (2) The drugs have not
been in the possession of the ultimate user. (E) This rule does not apply to drugs
dispensed for inpatients pursuant to agency 4729 of the Administrative Code.
Drugs dispensed for inpatients may be returned to stock in accordance with the
applicable provisions of agency 4729 of the Administrative Code. (F) A pharmacy may transfer dangerous
drugs that are returned to stock shelves that meet the requirements of this
rule to another pharmacy if the transfer is conducted in accordance with
paragraph (E) of rule 4729:5-3-09 of the Administrative Code.
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Rule 4729:5-5-23 | Security, control and storage of dangerous drugs in an outpatient pharmacy.
Effective:
December 1, 2020
(A) The following applies to an
outpatient pharmacy licensed as a terminal distributor of dangerous
drugs: (1) Except as provided in
paragraph (A)(6) of this rule, a pharmacist shall provide supervision of the
dangerous drugs, hypodermics, D.E.A. controlled substance order forms, all
records relating to the distribution of dangerous drugs, except where the board
has granted permission for such records to be stored at a secure off-site
location in accordance with this chapter of the Administrative Code, at all
times in order to deter and detect theft or diversion. (2) The pharmacy shall be
separated from the merchandising or public areas. (3) The pharmacist or
pharmacists on duty: (a) Shall be physically present at the licensed location
and responsible for the security of the pharmacy and supervision of pharmacy
personnel. (b) If the pharmacy is located within a store or business,
shall ensure that all dangerous drugs, controlled substances, and hypodermics
that are delivered onto the premises of the store or business are immediately
placed and secured in the pharmacy under the physical control of the pharmacist
or pharmacists on duty or secured in a designated area in accordance with
paragraph (A)(6)(i) of this rule. (4) No person, other than
a licensed pharmacist, may enter the pharmacy unless the person is on business
directly concerning the operation, maintenance or repair of the pharmacy and a
pharmacist employed by the pharmacy is physically present at the same
time. (5) All schedule II
controlled substance dangerous drugs shall be stored in a securely locked,
substantially constructed cabinet or safe and shall not be dispersed through
the stock of dangerous drugs. The cabinet or safe shall remain locked and
secured when not in use. Schedule III through V controlled substance dangerous
drugs may be stored with Schedule II controlled substance dangerous
drugs. (6) Whenever a pharmacist
cannot meet the supervision requirements in paragraph (A)(3)(a) of this rule,
security of the pharmacy must be provided in accordance with the
following: (a) The pharmacy must be secured by either: (i) A physical barrier
(i.e. barricade) with suitable locks approved by the board. Except for
extraordinary circumstances beyond the pharmacy's control, a pharmacy
shall notify the board of any installation or modification to a physical
barrier prior to implementation. (ii) An alarm system
approved by the board that is monitored by a central station for control and
can detect unauthorized access to the pharmacy. The alarm system shall be
tested on a biannual basis. The pharmacy or the entity that manages security
for the pharmacy shall maintain testing records for three years from the date
of testing and shall make such records readily retrievable. The pharmacy shall
be responsible for obtaining testing records if such records are maintained by
a third-party. Except for extraordinary circumstances beyond the
pharmacy's control, a pharmacy shall notify the board of any installation
or modification to an alarm system prior to implementation. This notification
requirement does not apply if a pharmacy also utilizes an approved physical
barrier in accordance with paragraph (A)(6)(a)(i) of this rule. (b) Except as provided in paragraph (A)(6)(i) of this rule,
the pharmacy must contain all dangerous drugs, hypodermics, and D.E.A.
controlled substance order forms and every other item or product that requires
the supervision or sale by a pharmacist. (c) Only a licensed pharmacist may have access to keys or
other methods of gaining access to the pharmacy. (i) Keys to the pharmacy
that are not in the possession of a licensed pharmacist that are maintained
on-site shall be secured to prevent unauthorized access. (ii) All combinations or
access codes, including alarm codes, shall be changed upon termination of
employment of an employee having knowledge of the combination or access
code. (d) All records relating to the distribution of dangerous
drugs must be maintained in the pharmacy, except as follows: (i) The board has granted
permission for such records to be stored at a secure off-site location in
accordance with this chapter of the Administrative Code; or (ii) Any designated area
outside the pharmacy used to store records that complies with paragraph
(A)(6)(i) of this rule. (e) No item, product, record, or equipment that must be
accessible to anyone other than a pharmacist may be stored in the
pharmacy. (f) Only a pharmacist may have access to the pharmacy or
stock of dangerous drugs or assume responsibility for the security of dangerous
drugs, hypodermics, and any other item or product that requires the supervision
or sale by a pharmacist. (g) No prescription, dangerous drug, hypodermic, nor any
other item or product that requires the supervision or sale by a pharmacist may
be sold, given away, or disposed of at any time the pharmacy is
closed. (h) New or refill prescription orders may be deposited into
a secured area within the building where the pharmacy is located when a
pharmacist is not present. Only a pharmacist may have access to this secured
area. (i) Any designated area outside the pharmacy at the
location licensed as a terminal distributor of dangerous drugs intending to be
used for the storage of dangerous drugs, D.E.A. controlled substance order
forms, hypodermics, and records relating to the distribution of dangerous
drugs, except where the board has granted a permission for such records to be
stored at a secure off-site location pursuant to this chapter of the
Administrative Code, and every other item or product that requires the
supervision or sale by a pharmacist shall meet the following
requirements: (i) The designated area
shall be secured by an approved physical barrier with suitable locks to detect
unauthorized entry. Except for extraordinary circumstances beyond the
pharmacy's control, a pharmacy shall notify the board of any installation
or modification to a physical barrier prior to implementation. (ii) No item, product,
record, or equipment that must be accessible to anyone other than a pharmacist
may be stored in the designated area, unless authorized by the board of
pharmacy. (iii) Authorized
personnel may have access if there is supervision by a pharmacist. (iv) No controlled
substances may be stored outside of the pharmacy, except as authorized under
division 4729:10 of the Administrative Code. (j) If an outpatient pharmacy provides services by means of
a drive-through facility, the drive-through facility shall be constructed and
maintained in a manner, and with materials, that secures the premises of the
pharmacy from unauthorized access. (B) Refrigerators and freezers used for
the storage of dangerous drugs shall comply with the following: (1) Maintain either of
the following to ensure proper refrigeration and/or freezer temperatures are
maintained: (a) Temperature logs with, at a minimum, daily
observations; or (b) A temperature monitoring system capable of detecting
and alerting staff of a temperature excursion. (2) The terminal
distributor shall develop and implement policies and procedures to respond to
any out of range individual temperature readings or excursions to ensure the
integrity of stored drugs. (3) The terminal
distributor shall develop and implement a policy that no food or beverage
products are permitted to be stored in refrigerators or freezers used to store
dangerous drugs. (C) Upon the initial puncture of a
multiple-dose vial containing a drug, the vial shall be labeled with a
beyond-use date or date opened. The beyond-use date for an opened or entered
(e.g., needle punctured) multiple-dose container with antimicrobial
preservatives is twenty-eight days, unless otherwise specified by the
manufacturer. A multiple-dose vial that exceeds its beyond-use date shall be
deemed adulterated.
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Rule 4729:5-5-24 | Drug inventory records and other record keeping provisions.
Effective:
August 19, 2022
(A) Records of receipt shall contain the
name, strength, dosage form, and quantity of the dangerous drugs received, the
name and address of the seller, the name and address of the recipient, and the
date of receipt. (B) Temperature logs maintained in
accordance with paragraph (B) of rule 4729:5-5-23 of the Administrative Code
shall include either: (1) The date and time of
observation, the full name or the initials of the individual performing the
check, and the temperature recorded; or (2) For automated systems
that provide temperature monitoring, either of the following: (a) A report that provides, at a minimum, the date and time of
observation and the temperature recorded; or (b) A report that provides temperature excursions, if any, and
the date, time, temperature recorded, and length of the noted
excursion. (C) Records of dangerous drugs disposed
from inventory, other than controlled substances, shall contain the name,
strength, dosage form, and quantity of the dangerous drug disposed, the date of
disposal, the method of disposal, and the positive identification of the
licensed or registered health care professional that performed the
disposal. (D) Records of controlled substance drug
disposal shall comply with the requirements of rule 4729:5-3-01 of the
Administrative Code. (1) If the disposal of
controlled substance drug inventory is performed on-site, records shall also
include the positive identification of two licensed or registered healthcare
professionals conducting and witnessing the disposal, one of whom shall be a
pharmacist. (2) If conducting the
disposal of an unused portion of a controlled substance resulting from
administration to a patient, records shall also include the positive
identification of two licensed or registered healthcare professionals
conducting and witnessing the disposal. (E) Records of transfer or sale conducted
in accordance with rule 4729:5-3-09 of the Administrative Code shall contain
the 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. (F) All records maintained pursuant to
this rule may be electronically created and maintained, provided that the
system that creates and maintains the electronic record does so in accordance
with the following: (1) Complies with the
requirements of this rule; (2) All paper records
maintained electronically shall be scanned in full color via technology
designed to capture all information in the paper record in one form and
reproduce it in an electronic medium presentable and usable to an end
user; (3) Contains security
features to prevent unauthorized access to the records; and (4) Contains daily
back-up functionality to protect against record loss. (G) All records maintained in accordance with this chapter shall
be readily retrievable and uniformly maintained for a period of three
years. (H) (1) Except as provided
for in paragraph (H)(2) of this rule, all records maintained in accordance with
this chapter shall be maintained on-site. (2) An outpatient
pharmacy located in this state intending to maintain records at a location
other than the location licensed by the state board of pharmacy shall send a
request in a manner determined by the board. The board will provide written or
electronic notification to the outpatient pharmacy documenting the approval or
denial of the request. A copy of the board's approval shall be maintained
at the licensed location. Any such alternate location used to store records
shall be secured and accessible only to authorized representatives or
contractors of the terminal distributor of dangerous drugs. (I) All records required in accordance
with this chapter shall comply with the following: (1) Be maintained under
appropriate supervision and control to restrict unauthorized access, including
security features to prevent unauthorized access to computerized records;
and (2) All computerized
records shall contain daily back-up functionality to protect against record
loss. (J) Controlled substance inventory
records shall be maintained in accordance with rule 4729:5-3-07 of the
Administrative Code.
Last updated August 19, 2022 at 8:12 AM
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Rule 4729:5-5-25 | Remote prescription entry - technician.
Effective:
November 30, 2021
(A) As used in this rule: (1) "Direct
supervision" and "personal supervision" have the same meaning as
in rule 4729:3-1-01 of the Administrative Code. (2) "Remote
prescription entry" means the entry of prescriptions for an outpatient
pharmacy licensed as a terminal distributor of dangerous drugs by a remote
technician under the direct supervision or remote supervision of a pharmacist.
Remote prescription entry does not include dispensing, interpreting,
evaluating, or approval of prescriptions or any other activities not permitted
by state or federal laws, rules, and regulations. Remote prescription entry may
include clarifying prescriptions and other data entry, including the processing
of insurance coverage. The requirements of this rule shall be limited to the
entry of prescriptions dispensed in or into this state. (3) "Remote
pharmacy" means either: (a) A pharmacy licensed as a terminal distributor of
dangerous drugs that dispenses dangerous drugs; or (b) A pharmacy licensed as a limited category II terminal
distributor of dangerous drugs which does not stock, own, or dispense any
dangerous drugs, and whose sole business consists of entry, review, and/or
verification of prescriber orders and consulting services under contract for
outpatient pharmacies in this state. (4) "Remote
supervision" means that a pharmacist directs and controls the actions of
remote technicians through the use of technology that ensures a supervising
pharmacist can meet the requirements listed in this paragraph. A pharmacist
providing remote supervision shall: (a) Be readily available to answer questions of a remote
technician; and (b) Be fully responsible for the practice and accuracy of
the remote technician. (5) "Remote
technician" means any of the following: (a) If performing remote prescription entry in this state:
an Ohio registered certified pharmacy technician, registered pharmacy
technician, or pharmacy technician trainee, either employed or a contract
employee of an outpatient pharmacy or remote pharmacy, who either conducts
prescription entry from a remote site, which may include the technician's
residence or other location where the technician and the outpatient or remote
pharmacy can ensure the confidentiality and integrity of patient information,
or on the premises of a remote pharmacy or outpatient pharmacy; or (b) If performing remote
prescription entry outside of this state: a pharmacy technician who meets the
following criteria: (i) The pharmacy technician is licensed or registered in
the state where the remote prescription entry is occurring, or if working in a
state that has not yet implemented a technician registration process, has
received training and is working as a pharmacy technician in accordance with of
the laws and regulations of their state of practice; and (ii) The pharmacy technician is either employed or a
contract employee of an outpatient pharmacy or remote pharmacy who holds a
nonresident pharmacy license in accordance with Chapter 4729:5-8 of the
Administrative Code, who either conducts prescription entry from a remote site,
which may include the technician's residence or other location where the
technician and the outpatient or remote pharmacy can ensure the confidentiality
and integrity of patient information, or on the premises of a remote pharmacy
or outpatient pharmacy. (c) A nonresident
pharmacy shall be responsible for ensuring all actions performed by an
unregistered technician comply with the applicable requirements for conducting
remote prescription entry. (d) A remote technician shall only be permitted to conduct
remote prescription entry within the United States, to include the District of
Columbia, the Commonwealth of Puerto Rico or a territory or insular possession
subject to the jurisdiction of the United States. (B) An outpatient pharmacy may outsource
prescription entry to a remote pharmacy provided the pharmacies are under
common ownership or control or the outpatient pharmacy has entered into a
written contract or agreement with a pharmacy that outlines the services to be
provided and the responsibilities and accountabilities of each party to the
contract or agreement in compliance with federal and state statutes and
regulations. (C) The outpatient pharmacy and remote
pharmacy must maintain a copy of the contract or agreement in a readily
retrievable manner for inspection and review by an agent, inspector, or
employee of the board. (D) An outpatient pharmacy utilizing
remote prescription entry shall ensure that all remote technicians providing
such services have been trained on the outpatient pharmacy's policies and
procedures relating to prescription entry. (1) The training of each
remote technician shall be documented. The outpatient pharmacy and the remote
pharmacy shall jointly develop a procedure to communicate changes in policies
and procedures related to prescription entry. (2) A terminal
distributor of dangerous drugs may utilize one training program for all
outpatient pharmacies under the terminal distributor's common ownership
and control. (E) An outpatient pharmacy utilizing
remote technicians shall maintain or have access to a record of the name and
address of each technician, evidence of current licensure or registration, and
the address of each location where the technician will be providing remote
prescription entry services. (F) The outpatient pharmacy shall ensure
that any remote technician shall have secure electronic access to the
outpatient pharmacy's patient information system and to other electronic
systems that an on-site technician has access to when the pharmacy is
open. (G) Each remote entry record must comply
with all recordkeeping requirements for outpatient pharmacies, including
capturing the positive identification of the remote technician involved in the
entry of the prescription. (H) An outpatient pharmacy utilizing
remote prescription entry is responsible for maintaining records of all
prescriptions entered into their information system, including prescriptions
entered by a remote technician. (I) An outpatient pharmacy utilizing
remote prescription entry services shall develop and implement a policy and
procedure manual. A remote pharmacy shall maintain a copy of those portions of
the policy and procedure manual that relate to the remote pharmacy's
operations. Each manual shall include all the following: (1) An overview of the
responsibilities of the outpatient pharmacy and the remote
pharmacy; (2) A list of the names,
addresses, telephone numbers, and all license numbers of the pharmacies and
remote technicians involved in remote prescription entry; and (3) Policies and
procedures for: (a) Protecting the confidentiality and integrity of patient
information; (b) Ensuring that no patient information is duplicated,
downloaded, or removed from the outpatient pharmacy's patient information
system; (c) Maintaining appropriate records of each technician
involved in prescription entry; (d) Complying with federal and state statutes and
regulations; and (e) Reviewing written policies and procedures at least
every three years or upon the implementation of a significant change of written
policies and procedures and documentation of the review. (J) A pharmacy intern that is licensed in
this or any other state may engage in remote prescription entry pursuant to the
requirements of this rule.
Last updated November 30, 2021 at 8:28 AM
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