(A) As used in this section:

Terms Used In Ohio Code 4729.52

  • Another: when used to designate the owner of property which is the subject of an offense, includes not only natural persons but also every other owner of property. See Ohio Code 1.02
  • Compounding: means the preparation, mixing, assembling, packaging, and labeling of one or more drugs in any of the following circumstances:

    (1) Pursuant to a prescription issued by a licensed health professional authorized to prescribe drugs;

    (2) Pursuant to the modification of a prescription made in accordance with a consult agreement;

    (3) As an incident to research, teaching activities, or chemical analysis;

    (4) In anticipation of orders for drugs pursuant to prescriptions, based on routine, regularly observed dispensing patterns;

    (5) Pursuant to a request made by a licensed health professional authorized to prescribe drugs for a drug that is to be used by the professional for the purpose of direct administration to patients in the course of the professional's practice, if all of the following apply:

    (a) At the time the request is made, the drug is not commercially available regardless of the reason that the drug is not available, including the absence of a manufacturer for the drug or the lack of a readily available supply of the drug from a manufacturer. See Ohio Code 4729.01

  • Drug: means :

    (1) Any article recognized in the United States pharmacopoeia and national formulary, or any supplement to them, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

    (2) Any other article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

    (3) Any article, other than food, intended to affect the structure or any function of the body of humans or animals;

    (4) Any article intended for use as a component of any article specified in division (E)(1), (2), or (3) of this section; but does not include devices or their components, parts, or accessories. See Ohio Code 4729.01

  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
  • Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
  • manufacturer: means a person, other than a pharmacist or prescriber, who manufactures dangerous drugs and who is engaged in the sale of those dangerous drugs. See Ohio Code 4729.01
  • 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. See Ohio Code 4729.01
  • Person: includes any individual, partnership, association, limited liability company, or corporation, the state, any political subdivision of the state, and any district, department, or agency of the state or its political subdivisions. See Ohio Code 4729.01
  • repackager: means a person that repacks and relabels dangerous drugs for sale or distribution. See Ohio Code 4729.01
  • Rule: includes regulation. See Ohio Code 1.59
  • state: means the state of Ohio. See Ohio Code 1.59
  • 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. See Ohio Code 4729.01
  • wholesale distributor: means a person engaged in the sale of dangerous drugs at wholesale and includes any agent or employee of such a person authorized by the person to engage in the sale of dangerous drugs at wholesale. See Ohio Code 4729.01

(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 section 3719.01 of the Revised Code.

(B)(1)(a) The state board of pharmacy shall license the following persons:

(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) There shall be two categories for the licenses identified in division (B)(1)(a) of this section. The categories are as follows:

(i) Category II license. 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 person who obtains this license may possess, have custody or control of, and distribute, the dangerous drugs described in category II and category III.

(c) The board may adopt rules under section 4729.26 of 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 identified in division (B)(1)(a) of 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 section 4729.53 of the Revised Code and the rules adopted under that section.

The board shall license as a category II or category III manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor each applicant who has paid the required license fee, if the board determines that the applicant meets the licensure qualifications set forth in section 4729.53 of the Revised Code and the rules adopted under that section.

(D) The board may issue to a person who does not reside in this state a license identified in division (B)(1)(a) of this section if the person pays the required licensure fee and meets either of the following:

(1) 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 is physically located, but only if that state has qualifications for licensure comparable to the licensure requirements in this state;

(2) Meets the requirements set forth by the board for issuance of a license identified in division (B)(1)(a) of this section, 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 section 4729.26 of 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 section 4729.26 of 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)(a) 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.

(b) 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.

(c)(i) Subject to division (G)(1)(c)(ii) 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.

(ii) 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.

(2) Renewal fees and penalties assessed under division (G)(1) of this section shall not be returned if the applicant fails to qualify for renewal.

(3) 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, compounding, or distributing as a third-party logistics provider or wholesale distributor until a valid license is issued by the board.

(H) 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.

(I) 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 section 4729.23 of the Revised Code.

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