Ohio Administrative Code|Rule 4729:6-1-01 | Definitions.

                                                
As used in this division:
(A) "Distributor of dangerous
		  drugs" or "drug distributor" means the following persons
		  licensed in accordance with section 4729.52 of the Revised 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.
(B) "Abandoned application"
		  means an application submitted for licensure in accordance with this division
		  that meets the criteria 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 demonstrate compliance with rule
				4729:6-2-01 of the Administrative Code and the applicable licensing rules
				pursuant to this division within ninety days of receipt of a completed
				application. The applicant may submit a request to the director of licensing
				for a one-time, ninety-day extension.
(b) An applicant fails to complete all application requirements
				within thirty days after being notified of the incomplete application by the
				board.
(c) An applicant 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, information technology or other staff that may need limited
		  supervised access to areas where dangerous drugs or drug enforcement
		  administration controlled substance order forms are stored.
(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.
(E) "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.
(F) "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.
(G) "Board of pharmacy" or
		  "board" means the state board of pharmacy established under Chapter
		  4729. of the Revised Code.
(H) "Broker" means any person engaged in the
		  marketing, offering, or contracting for wholesale distribution and sale of
		  dangerous drugs in or into Ohio who does not take physical possession of the
		  dangerous drugs. A broker shall be licensed as a wholesale distributor pursuant
		  to section 4729.52 of the Revised Code with a broker
		  classification.
(I) "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.
(J) "Dangerous drug" has the same meaning as in
		  section 4729.01 of the Revised Code.
(K) "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.
(L) "Manufacturer of dangerous drugs" or
		  "manufacturer" means a person, other than a pharmacist or prescriber,
		  that meets the following criteria:
(1) Meets the definition
			 of a manufacturer pursuant in section 21 U.S. Code Section 360 eee
			 (11/27/2013); and
(2) Manufactures
			 dangerous drugs and who is engaged in the sale or distribution of dangerous
			 drugs in or into Ohio.
(M) "Outsourcing facility" means a facility that
		  is engaged in the compounding and sale of sterile drugs and is registered as an
		  outsourcing facility with the United States food and drug
		  administration.
(N) "Person" has the same meaning as in division
		  (S) of section 4729.01 of the Revised Code and includes any individual member,
		  regardless of the percentage of ownership, of any partnership, association,
		  limited liability company or corporation.
(O) "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.
(P)  
(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 of positive
			 identification 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.
(Q) "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.
(R) "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.
(S) "Repackager of dangerous drugs" or
		  "repackager" means a person that meets the following:
(1) Repacks and relabels
			 dangerous drugs for sale or distribution; and
(2) Is required to
			 register with the United States food and drug administration to engage in the
			 repackaging or relabeling of dangerous drugs.
(T) "Reverse distribute" or "reverse
		  distribution" means to acquire dangerous drugs for the purpose of any of
		  the following: 
(1) Return to a
			 manufacturer or entity authorized by the manufacturer to accept returns on the
			 manufacturer's behalf; or
(2) Destruction or
			 disposal.
(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.
The shipment of dangerous drugs to a reverse
		  distributor in this state licensed as a wholesale distributor of dangerous
		  drugs in accordance with section 4729.52 of the Revised Code for the sole
		  purpose of destruction or disposal of dangerous drugs, does not constitute a
		  sale and does not require the person, if located outside of the state of Ohio,
		  shipping the dangerous drugs to the reverse distributor to possess an Ohio
		  license in accordance with Chapter 4729. of the Revised Code.
(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) "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.
(Y) "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 4729.561 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. 
(Z) "Third-party logistics provider" means a
		  person that provides or coordinates warehousing or other logistics services
		  pertaining to dangerous drugs including distribution, on behalf of a
		  manufacturer, wholesale distributor, or terminal distributor of dangerous
		  drugs, but does not take ownership of the drugs or have responsibility to
		  direct the sale or disposition of the drugs.
(AA) "Virtual wholesaler" or "virtual
		  wholesaler distributor" means any person engaged in wholesale distribution
		  of dangerous drugs in or into Ohio who has title but does not take physical
		  possession of the dangerous drugs. A virtual wholesale distributor shall be
		  licensed as a wholesale distributor pursuant to section 4729.52 of the Revised
		  Code with a virtual wholesale distributor classification.
(BB) "Wholesale distributor of dangerous drugs" or
		  "wholesale distributor" means a person engaged in the sale of
		  dangerous drugs at wholesale or the reverse distribution of dangerous drugs and
		  includes any agent or employee of such a person authorized by the person to
		  engage in the sale of dangerous drugs at wholesale.
(CC) "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.


Last updated January 12, 2022 at 3:04 PM