(A) As used in this section:
(1) "Category II" means any dangerous drug that is not included in category III.
(2) "Category III" means any controlled substance that is contained in schedule I, II, III, IV, or V.
(3) "Schedule I,""schedule II,""schedule III,""schedule IV," and "schedule V" have the same meanings as in section3719.01of the Revised Code.
(B)(1)(a) The state board of pharmacy shall license persons seeking to operate as any of the following, whether located within or outside this state:
(i) Wholesale distributors of dangerous drugs;
(ii) Manufacturers of dangerous drugs;
(iii) Outsourcing facilities;
(iv) Third-party logistics providers;
(v) Repackagers of dangerous drugs.
(b) When the board issues a license to a person identified in division (B)(1)(a) of this section, the license shall be issued according to one of the following categories, as the case may be for the person's business operations:
(i) Category II license. A category II license applies to a person whose business operations are located within this state. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category II.
(ii) Category III license. A category III license applies to a person whose business operations are located within this state. A person who obtains this license may possess, have custody or control of, and distribute the dangerous drugs described in category II and the controlled substances described in category III.
(iii) Nonresident license. A nonresident license applies to a person whose business operations are located outside this state. One of the following subcategories shall be designated by the board on the license, based on the license holder's business operations: wholesale distributor of dangerous drugs, manufacturer of dangerous drugs, outsourcing facility, third-party logistics provider, or repackager of dangerous drugs. A person who obtains a nonresident license may possess, have custody or control of, and distribute the dangerous drugs described in category II and the controlled substances described in category III.
(c) The board may adopt rules under section4729.26of the Revised Code to create classification types of any license issued pursuant to this section. Persons who meet the definitions of the classification types shall comply with all requirements for the specific license classification specified in rule.
(C) A person seeking a license issued under this section shall file with the executive director of the board a verified application containing such information as the board requires of the applicant relative to the licensure qualifications set forth in section4729.53of the Revised Code and the rules adopted under that section.
(D)(1) The board shall issue a category II or category III license, designated for a manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor as the case may be, to each applicant whose business operations are located within this state, if the applicant pays the required license fee and the board determines that the applicant meets the licensure qualifications set forth in section4729.53of the Revised Code and the rules adopted under that section.
(2) The board shall issue a nonresident license with the appropriate subcategory designation to an applicant whose business operations are located outside this state, if the applicant pays the required license fee and the board determines either of the following:
(a) That the applicant possesses a current and valid manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor license, or its equivalent, issued by another state in which that person's business operations are physically located, but only if that state has qualifications for licensure comparable to the licensure requirements in this state;
(b) That the applicant meets the requirements set forth by the board for issuance of a nonresident license, as verified by a state, federal, or other entity recognized by the board to perform such verification.
(E) All licenses issued or renewed pursuant to this section are effective for a period specified by the board in rules adopted under section4729.26of the Revised Code. The effective period for an initial or renewed license shall not exceed twenty-four months unless the board extends the period in rules to adjust license renewal schedules. A license shall be renewed by the board pursuant to this section, the standard renewal procedure of Chapter 4745. of the Revised Code, and rules adopted by the board under section4729.26of the Revised Code. A person seeking to renew a license shall submit an application for renewal and pay the required renewal fee before the date specified in the rules adopted by the board.
(F) Each license issued under this section shall describe not more than one establishment or place where the license holder may engage in the activities authorized by the license. No license shall authorize or permit the person named therein to engage in the sale or distribution of drugs at wholesale or to maintain possession, custody, or control of dangerous drugs for any purpose other than for the licensee's own use and consumption at any establishment or place other than that described in the license.
(G)(1) The category II license fee is one thousand nine hundred dollars and shall accompany each application for licensure. The license renewal fee is one thousand nine hundred dollars and shall accompany each renewal application.
(2) The category III license fee is two thousand dollars and shall accompany each application for licensure. The license renewal fee is two thousand dollars and shall accompany each renewal application.
(3) The nonresident license fee is two thousand dollars and shall accompany each application for licensure. The license renewal fee is two thousand dollars and shall accompany each renewal application.
(H)(1) Subject to division (H)(2) of this section, a license issued pursuant to this section that has not been renewed by the date specified in rules adopted by the board may be reinstated upon payment of the renewal fee and a penalty of three hundred dollars.
(2) If a complete application for renewal has not been submitted by the sixty-first day after the renewal date specified in rules adopted by the board, the license is considered void and cannot be renewed, but the license holder may reapply for licensure.
(I) Renewal fees and penalties assessed under division (G) or (H) of this section shall not be returned if the applicant fails to qualify for renewal.
(J) A person licensed pursuant to this section that fails to renew licensure in accordance with this section and rules adopted by the board is prohibited from engaging in manufacturing, repackaging, or compounding drugs, or distributing drugs as a third-party logistics provider or wholesale distributor, until a valid license is issued by the board.
(K) Holding a license issued pursuant to this section subjects the holder and the holder's agents and employees to the jurisdiction of the board and to the laws of this state for the purpose of the enforcement of this chapter and the rules of the board. However, the filing of an application for licensure under this section by or on behalf of any person, or the issuance of a license pursuant to this section to or on behalf of any person, shall not of itself constitute evidence that the person is doing business within this state.
(L) A person holding a license issued under this section shall designate, and shall have available at all times, a person to serve for the licensed location in a position to be known as "responsible person." A person may be designated and serve as a responsible person only if the person meets the requirements established in rules the board shall adopt under section4729.26of the Revised Code. Along with the license holder, a responsible person shall accept responsibility for the operation of the licensed location in accordance with all applicable state and federal laws and rules.
A license holder shall notify the board of the person who is designated to serve as the responsible person and, thereafter, shall notify the board each time a change is made in the designation. Notice to the board shall be provided in accordance with procedures established in rules that the board shall adopt under section4729.26of the Revised Code. For any change of responsible person, the board shall assess a fee of fifteen dollars.
(M) The board may enter into agreements with other states, federal agencies, and other entities to exchange information concerning licensing and inspection of any manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor located within or outside this state and to investigate alleged violations of the laws and rules governing distribution of drugs by such persons. Any information received pursuant to such an agreement is subject to the same confidentiality requirements applicable to the agency or entity from which it was received and shall not be released without prior authorization from that agency or entity. Any information received is also subject to section4729.23of the Revised Code.
Last updated August 8, 2025 at 8:47 AM