Current through all regulations passed and filed through September 16, 2024
As used in this division:
(A) "Abandoned application" means an
application for a registration pursuant to this division where the applicant
fails to complete all application requirements within thirty days after being
notified by the board. An applicant forfeits all fees associated with an
abandoned application. The board shall not be required to act on any abandoned
application and the application may be destroyed by board staff. If the
application is abandoned, the applicant shall be required to reapply for
registration, submit the required fee, and comply
with the registration requirements in effect at the time of reapplication.
(B) "Addicted to or
abusing alcohol or drugs" means the chronic and habitual use of alcohol or the
use of a drug of abuse as defined in section
3719.011 of the Revised Code by
an individual to the extent that the individual no longer can control the
individual's use of alcohol or drugs, the individual is physically or
psychologically dependent on alcohol or drugs, or the individual's use or abuse
of alcohol or drugs endangers the health, safety, or welfare of the individual
or others.
(C) "Board of pharmacy"
or "board" means the state board of pharmacy established under Chapter 4729. of
the Revised Code.
(D) "Business day"
means any day other than Saturday, Sunday or a holiday recognized by the state
of Ohio on which the offices of the board of pharmacy are not open for
business.
(E) "Certified pharmacy
technician" means a person who:
(1) Has
completed an approved training program pursuant to rule
4729:3-3-02 of the
Administrative Code or has complied with the
reciprocity requirements of 4729:3-2-01 of the Administrative
Code;
(2) Is registered with
the state board of pharmacy;
(3)
Practices in this state in accordance with rule
4729:3-3-04 of the
Administrative Code; and
(4)
Maintains a current pharmacy technician certification from an organization that
has been recognized by the board.
(F) "Compounding" has
the same meaning as defined in section
4729.01 of the Revised Code and
agency 4729 of the Administrative Code.
(G) "Controlled
substance" has the same meaning as in section
3719.01 of the Revised
Code.
(H) "Current pharmacy
technician certification from an organization that has been recognized by the
board" pursuant to division (B)(2)(d) of section
4729.90 of the Revised Code
means either:
(1) The ExCPT certification
provided by the national healthcareer association; or
(2) The pharmacy technician certification
board (PTCB) certification.
(I) "Dangerous drug"
has the same meaning as in section
4729.01 of the Revised
Code.
(J) "Disciplinary
action," unless otherwise stated in this division, means any of the following
by the drug enforcement administration or licensing agency of any state or
jurisdiction, regardless of whether the action occurred by formal proceeding,
consent, settlement, or other agreement:
(1)
An action to revoke, suspend, restrict, limit, or refuse to grant or renew a
license, registration, or certification;
(2) A summary or emergency suspension of a
license, registration or certification, of any length, and any subsequent
revision to the action;
(3) An
administrative fine or money penalty, taken as a result of a formal proceeding,
to include any fine or money penalty connected to the delivery of health care
services or taken in conjunction with other adverse licensure, registration or
certification actions, such as revocation, suspension, censure, reprimand, or
probation;
(4) An action to
reprimand or place the license, registration, or certification holder on
probation;
(5) The issuance of a
corrective action plan only if such issuance is in conjunction with other
adverse licensure, registration or certification actions, such as revocation,
suspension, reprimand, probation, or surrender;
(6) The withdrawal of a renewal application
for licensure, registration or certification while under
investigation;
(7) The non-renewal
of a license, registration or certification while under investigation or to
avoid an investigation;
(8) The
surrender or other relinquishment of a license, registration or certification
in lieu of a formal sanction against a person's license, registration, or
certificate, whether permanent or temporary;
(9) In lieu of an adverse licensure,
registration or certification action, a licensing agency issues a consent order
in which a person agrees not to re-apply for a license, registration, or
certification in the future;
(10)
An enforceable agreement not to practice or to be placed into inactive or other
equivalent status while under investigation or in exchange for not conducting
an investigation.
(K) "Direct
supervision" or "personal 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. The pharmacist providing personal supervision of a pharmacy
technician trainee, registered pharmacy technician, or certified pharmacy
technician shall:
(1) Be readily available to
answer questions of the technician or trainee;
(2) Make appropriate in-process and
end-process verifications of the activities of the technician or trainee;
and
(3) Be fully responsible for
the practice of the technician or trainee.
(L) "Entering
information into and retrieving information from a database or patient profile"
as used in section 4729.91 of the Revised Code
means to enter new or refill prescription information into a database or
patient profile.
(M)
"In good standing" means a pharmacist to which all the following apply:
(1) Has not been denied the privilege of
supervising pharmacy interns,
certified pharmacy technicians,
registered pharmacy technicians or
pharmacy technician trainees by the
board;
(2) Has not been denied a
license, registration or certificate by any public agency or licensing agency;
and
(3) Does not have a license,
registration or certificate limited, suspended, currently on probation, or
revoked by any public agency or licensing agency.
(N)
"Pharmacist" means an individual who holds a valid pharmacist license in
accordance with Chapter 4729. of the Revised Code.
(O) "Pharmacy
technician trainee" means a person who:
(1)
Intends to enroll or is enrolled in an approved training program pursuant to
rule 4729:3-3-02 of the
Administrative Code to obtain a registration as a registered or certified
pharmacy technician;
(2) Is
registered as a pharmacy technician trainee with the state board of pharmacy;
and
(3) Practices in this state in
accordance with rule
4729:3-3-01 of the
Administrative Code.
(P) "Place on
probation" means to take action against a license or registration, for a period
of time determined by the board, which imposes conditions or other
requirements, or suspends or otherwise restricts some or all of the activities
in which the licensee or registrant may engage.
(Q)
(1) "Positive identification" means a method
of identifying a person that does not rely solely 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, such as a password, for entry into a secure mechanical or
electronic system.
(R) "Refill
authorization" means authorization from a prescriber or prescriber's agent for
a new non-controlled substance prescription renewal, provided that the
prescription remains unchanged.
(S) "Refuse to grant or
renew" means to deny original or continued licensure or registration for a
period of at least twenty-four months. After twenty-four months, or such period
of time as the individual board order may require, a person licensed or
registered by the board or a person seeking to attain such status by licensure
or registration, and whose license or registration the state board of pharmacy
has refused to grant or renew, may make application to the board for issuance
of a new license or registration. A person that seeks to attain such status by
licensure or registration, whose license or registration the state board of
pharmacy has refused to grant or renew, must meet all requirements established
by the board in rule and as may be set forth in the person's board
order.
(T) "Registered
pharmacy technician" means a person who:
(1)
Has completed an approved training program pursuant to rule
4729:3-3-02 of the
Administrative Code or has complied with the
reciprocity requirements of 4729:3-2-01 of the Administrative
Code;
(2) Is registered with
the state board of pharmacy; and
(3) Practices in this state in accordance
with rule
4729:3-3-03 of the
Administrative Code.
(U) "Responsible
person" has the same meaning as defined in rule
4729:5-2-01 of the
Administrative Code.
(V) "Revoke" means to
take action against a license or registration rendering such license or
registration void and such license or registration shall not be reissued.
Revoke is an action that is permanent against the licensee or
registrant.
(W) "State" means a
state of the United States, the District of Columbia, the Commonwealth of
Puerto Rico or a territory or insular possession subject to the jurisdiction of
the United States.
(X)
(1) "Support personnel" means the following:
(a) An individual employed or performing
contracted services at a location licensed as a terminal distributor of
dangerous drugs, trained to perform clerical duties associated with the
practice of pharmacy, including pricing, cashiering, drug purchasing,
delivering, scheduling deliveries, answering non-professional telephone
inquiries, transportation of dispensed medications within a hospital,
documenting and processing third-party billing information for reimbursement,
or any other activity as determined by the board.
(b) An individual contracted by a terminal
distributor of dangerous drugs to perform drug inventories.
(2) Except for those responsible for the
delivery of dangerous drugs, support personnel shall not have unsupervised
access to dangerous drugs.
(3)
Except as provided in paragraphs (X)(4) and (X)(5) of this rule or as otherwise
authorized by the board in agency 4729 of the Administrative Code, support
personnel shall not perform the tasks of a pharmacist, pharmacy intern,
certified pharmacy technician, registered pharmacy technician, or pharmacy
technician trainee.
(4) Support
personnel may have access to or retrieve information from patient records,
including a database or patient profile to perform clerical duties associated
with the practice of pharmacy. Support personnel shall not enter prescription
information into a patient profile.
(5) Support personnel may perform the
following:
(a) Transporting dangerous drugs
from a loading dock, warehouse or other area that receives shipments from a
licensed wholesaler or other person licensed in accordance with section
4729.52 of the Revised Code;
(b) Stocking and retrieving from inventory
non-controlled dangerous drugs that are not dispensed by the
pharmacy.
(c)
Stocking of automated drug dispensing units and floor
stock with intravenous fluids that are non-controlled dangerous drugs and are
not dispensed by an institutional pharmacy.
(d)
Overwrapping or
placing in plastic dangerous drugs that have been compounded or dispensed and
appropriately labeled by a terminal distributor of dangerous
drugs.
(e)
Entering demographic and insurance information into an
electronic system to process prescription claims.
(f)
Place dangerous
drugs dispensed by a pharmacist into shipping containers or packages for
delivery if the terminal distributor of dangerous drugs complies with all the
following:
(i)
Uses barcode scanning and patient order information to
ensure the accuracy of the drugs placed into shipping containers or
packaging.
(ii)
Develops and implements a quality assurance program to
track the accuracy of the support personnel packaging the dangerous
drugs.
(6) The terminal distributor of dangerous
drugs shall be responsible for ensuring all support personnel comply with state
and federal requirements to ensure the confidentiality of patient health
records.
(7) Support personnel
shall not serve as a pharmacist's delegate pursuant to section
4729.80 of the Revised
Code.
(8) Support personnel are not
required to obtain licensure or registration under Chapter 4729. of the Revised
Code.
(Y) "Suspend" means to
take action against a license or registration rendering such license or
registration without force and effect for a period of time as determined by the
state board of pharmacy.
(Z) "Summary
suspension" means to take immediate action against a license or registration
without a prior hearing rendering such license or registration without force
and effect for a period of time as indicated in section
3719.121 of the Revised Code.
The board may suspend a license or registration issued pursuant to Chapter
4729. of the Revised Code by utilizing a telephone conference call to review
the allegations and take a vote.
(AA) "Veteran" means
anyone who is serving or has served under honorable conditions in any component
of the armed forces, including the national guard and reserve.
