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) "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.
Last updated April 25, 2022 at 8:28 AM