Ohio Admin. Code 4729:5-1-01 - Definitions - terminal distributors of dangerous drugs
As used in this division:
(A) "Terminal distributor of dangerous drugs"
or "terminal distributor" means a person who is engaged in the sale of
dangerous drugs at retail, or any person, other than a manufacturer,
repackager, outsourcing facility, third-party logistics provider, wholesale
distributor, or pharmacist, who has possession, custody, or control of
dangerous drugs for any purpose other than for that person's own use and
consumption.
(1) A terminal distributor of
dangerous drugs includes pharmacies, hospitals, nursing homes, and laboratories
and all other persons who procure dangerous drugs for sale or other
distribution by or under the supervision of a pharmacist, licensed health
professional authorized to prescribe drugs or any other person authorized by
the board of pharmacy.
(2) A
terminal distributor shall comply with the provisions set forth in this
division.
(B) "Abandoned
application" means an application submitted for licensure that meets the
criteria set forth in paragraph (B)(1) of this rule. 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 licensure, submit the required fee, and comply with the
licensure requirements in effect at the time of reapplication.
(1) An application shall be deemed abandoned
if any of the following apply:
(a) An
applicant fails to complete all application requirements within thirty days
after being notified of the incomplete application by the board.
(b) An applicant for a terminal distributor
of dangerous drugs that fails to demonstrate compliance with rule
4729:5-2-01 of the
Administrative Code. The applicant may submit a request to the
director of licensing
executive director or the director's designee for
a one-time, ninety-day extension.
(c) An applicant for a terminal distributor
of dangerous drugs that fails to demonstrate compliance with appropriate
security and control rules pursuant to this division of the Administrative
Code. The applicant may submit a request to the director of licensing
executive director or the director's designee for a
one-time, ninety-day extension.
(2) An application shall not be deemed
abandoned if the application is subject to any of the following:
(a) An administrative proceeding;
or
(b) If there is discipline
pending against the applicant.
(C) "Access to drug stock" includes not only
physical access, but also any influence over the handling of dangerous drugs
such as purchases, inventories, issuance of medical orders, etc. It does not
include employees or contractors such as maintenance, janitorial, IT or other
staff that may need limited supervised access to areas where dangerous drugs or
D.E.A. controlled substance order forms are kept.
(D) "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.
(E) "Adulterated drug"
includes a dangerous drug to which any of the following applies:
(1) A compounded dangerous drug if it exceeds
the assigned beyond-use date.
(2)
Meets any of the requirements described in section
3715.63 of the Revised
Code.
(3) Is beyond the expiration
date as stated by the manufacturer, repackager, or distributor in its labeling.
This does not apply to expired drugs that are donated pursuant to sections
3715.88 to
3715.92 of the Revised
Code.
(4) Is not stored, dispensed
or personally furnished according to the requirement of the federal act as
indicated in the product labeling.
(F) "Board of pharmacy" or "board" means the
state board of pharmacy established under Chapter 4729. of the Revised
Code.
(G) "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.
(H) "Campus," as used to describe a type of
terminal distributor of dangerous drugs license issued pursuant to section
4729.54 of the Revised Code,
means an establishment or place consisting of multiple buildings where
dangerous drugs are stored that are located on a contiguous plot of land. All
such buildings and stocks of dangerous drugs shall be under common ownership
and control.
(I) "Certified
diabetes educator," as used in Chapters 3719. and 4729. of the Revised Code,
means a person who has been certified to conduct diabetes education by the
"National Certification Board for Diabetes Educators" (NCBDE).
(J) "Controlled substance" has the same
meaning as in section
3719.01 of the Revised
Code.
(K) "Dangerous drug" has the
same meaning as in section
4729.01 of the Revised
Code.
(L) "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.
(M)
"Distributor of dangerous drugs" or "drug distributor" means the following
persons licensed in accordance with section
4729.52 of the Revised Code and
division 4729:6 of the Administrative Code:
(1) Wholesale distributors of dangerous
drugs, including:
(a) Brokers; and
(b) Virtual wholesalers.
(2) Manufacturers of dangerous
drugs.
(3) Outsourcing
facilities.
(4) Third-party
logistics providers.
(5)
Repackagers of dangerous drugs.
(N) "Inpatient" means any person who receives
drugs for use while within an institutional facility.
(O) "Outpatient" means any person who
receives drugs for use outside of an institutional facility.
(P) "Person" has the same meaning as in
division (S) of section
4729.01 of the Revised Code and
also includes any individual member, regardless of the percentage of ownership,
of any partnership, association, limited liability company, or
corporation.
(Q) "Personally
furnish" or "personally furnishing" means the final association of a drug with
a patient by a prescriber prior to providing the drug to a patient for use
outside the prescriber's practice setting.
(R) "Place on probation" means to take action
against a license 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 may engage.
(S) "Readily retrievable," means that records
maintained in accordance with this division 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.
(T) "Refuse to grant or renew" means to deny
original or continued licensure 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 by the board or a person seeking to attain such
status by licensure, and whose license the state board of pharmacy has refused
to grant or renew, may make application to the board for issuance of a new
license. A person that seeks to attain such status by licensure, whose license
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.
(U) "Revoke"
means to take action against a license rendering such license void and such
license shall not be reissued. Revoke is an action that is permanent against
the licensee.
(V) "Sale" or "sell"
includes any transaction made by any person, whether as principal proprietor,
agent, or employee, to do or offer to do any of the following: deliver,
distribute, broker, exchange, gift or otherwise give away, or transfer, whether
the transfer is by passage of title, physical movement, or both.
(W) "Sample" means a drug or pharmaceutical
preparation that would be hazardous to health or safety if used without the
supervision of a licensed health professional authorized to prescribe drugs, or
a drug of abuse, and that, at one time, had been placed in a container plainly
marked as a sample by a manufacturer.
(X) "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.
(Y) "Suspend" means to take
action against a license rendering such license without force and effect for a
period of time as determined by the state board of pharmacy. The board may
require that an individual whose license or registration has been suspended may
not be employed by or work in a facility licensed by the state board of
pharmacy to possess or distribute dangerous drugs during such period of
suspension.
(Z) "Summary
suspension" means to take immediate action against a license without a prior
hearing rendering such license without force and effect for a period of time as
indicated in section 4729.571 of the Revised Code.
The board may suspend a license issued pursuant to Chapter 4729. of the Revised
Code by utilizing a telephone conference call to review the allegations and
take a vote.
(AA) "Wholesale sale"
and "sale at wholesale" mean any sale in which the purpose of the purchaser is
to resell the article purchased or received by the
purchaser.
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26, 9.79
Rule Amplifies: 4729.54, 4729.55
Prior Effective Dates: 03/01/2019, 07/01/2019, 04/25/2022
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
As used in this division:
(A) "Terminal distributor of dangerous drugs " or "terminal distributor " means a person who is engaged in the sale of dangerous drugs at retail, or any person , other than a manufacturer, repackager, outsourcing facility, third-party logistics provider, wholesale distributor, or pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person 's own use and consumption.
(1) A terminal distributor of dangerous drugs includes pharmacies, hospitals, nursing homes, and laboratories and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist, licensed health professional authorized to prescribe drugs or any other person authorized by the board of pharmacy .
(2) A terminal distributor shall comply with the provisions set forth in this division.
(B) "Abandoned application " means an application submitted for licensure that meets the criteria set forth in paragraph (B)(1) of this rule. 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 licensure, submit the required fee, and comply with the licensure requirements in effect at the time of reapplication.
(1) An application shall be deemed abandoned if any of the following apply:
(a) An applicant fails to complete all application requirements within thirty days after being notified of the incomplete application by the board .
(b) An applicant for a terminal distributor of dangerous drugs that fails to demonstrate compliance with rule 4729:5-2-01 of the Administrative Code. The applicant may submit a request to the director of licensing for a one-time, ninety-day extension.
(c) An applicant for a terminal distributor of dangerous drugs that fails to demonstrate compliance with appropriate security and control rules pursuant to this division of the Administrative Code. The applicant may submit a request to the director of licensing for a one-time, ninety-day extension.
(2) An application shall not be deemed abandoned if the application is subject to any of the following:
(a) An administrative proceeding; or
(b) If there is discipline pending against the applicant.
(C) "Access to drug stock " includes not only physical access, but also any influence over the handling of dangerous drugs such as purchases, inventories, issuance of medical orders, etc. It does not include employees or contractors such as maintenance, janitorial, IT or other staff that may need limited supervised access to areas where dangerous drugs or D.E.A. controlled substance order forms are kept.
(D) "Act of moral turpitude" means an act or behavior that gravely violates moral sentiment or accepted moral standards of the community and is a morally culpable quality held to be present in some criminal offenses as distinguished from others.
(1) A compounded dangerous drug if it exceeds the assigned beyond-use date.
(2) Meets any of the requirements described in section 3715.63 of the Revised Code.
(3) Is beyond the expiration date as stated by the manufacturer, repackager, or distributor in its labeling. This does not apply to expired drugs that are donated pursuant to sections 3715.88 to 3715.92 of the Revised Code.
(4) Is not stored, dispensed or personally furnished according to the requirement of the federal act as indicated in the product labeling.
(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.
(1) Wholesale distributors of dangerous drugs, including:
(a) Brokers; and
(b) Virtual wholesalers.
(2) Manufacturers of dangerous drugs.
(3) Outsourcing facilities.
(4) Third-party logistics providers.
(5) Repackagers of dangerous drugs.
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26, 9.79
Rule Amplifies: 4729.54, 4729.55
Prior Effective Dates: 03/01/2019, 07/01/2019