Ohio Code 4729.53 – Registration requirements
(A) The state board of pharmacy shall not license any person as a manufacturer of dangerous drugs, outsourcing facility, third-party logistics provider, repackager of dangerous drugs, or wholesale distributor of dangerous drugs unless the applicant for licensure furnishes satisfactory proof to the board that all of the following conditions are met:
Terms Used In Ohio Code 4729.53
- 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
- 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) If the applicant has committed acts that the board finds violate any federal, state, or local law, regulation, or rule relating to drug samples, manufacturing, compounding, repackaging, wholesale or retail drug distribution, or distribution of dangerous drugs, including controlled substances, or constitute a felony, or if a federal, state, or local governmental entity has suspended or revoked any current or prior license of the applicant for the manufacture, compounding, repackaging, distribution, or sale of any dangerous drugs, including controlled substances, the applicant, to the satisfaction of the board, assures that the applicant has in place adequate safeguards to prevent the recurrence of any such violations.
(2) The applicant’s past experience in the manufacture, compounding, repackaging, or distribution of dangerous drugs, including controlled substances, is acceptable to the board.
(3) The applicant is properly equipped as to land, buildings, equipment, and personnel to properly carry on its business, including providing adequate security for and proper storage conditions and handling for dangerous drugs, and is complying with the requirements under this chapter and the rules adopted pursuant thereto for maintaining and making available records to properly identified board officials and federal, state, and local law enforcement agencies.
(4) Personnel employed by the applicant have the appropriate education or experience, as determined by the board, to assume responsibility for positions related to compliance with this chapter and the rules adopted pursuant thereto.
(5) The applicant has designated the name and address of a person to whom communications from the board may be directed and upon whom the notices and citations provided for in section 4729.56 of the Revised Code may be served.
(6) Adequate safeguards are assured to prevent the sale of dangerous drugs other than in accordance with section 4729.51 of the Revised Code.
(7) With respect to criminal records checks, the applicant has done both of the following and the board has decided that the results of the criminal records checks do not make the applicant ineligible for a license issued pursuant to section 4729.52 of the Revised Code:
(a) Complied with sections 4776.01 to 4776.04 of the Revised Code;
(b) Required any person who is seeking to serve as the responsible person on the license, who has an ownership interest, or who is a corporate officer, as set forth in rules adopted under division (C) of this section, to submit to a criminal records check in accordance with section 4776.02 of the Revised Code and send the results of the criminal records check directly to the board.
(8) The applicant meets any other requirement or qualification the board, by rule adopted under division (C) of this section, considers relevant to and consistent with the public safety and health.
(B) In addition to the causes described in section 4729.56 of the Revised Code for refusing to grant or renew a license, the board may refuse to grant or renew a license if the board determines that the granting of the license or its renewal is not in the public interest.
(C) The board shall adopt rules in accordance with Chapter 119 of the Revised Code that do all of the following:
(1) For purposes of division (A)(7)(b) of this section, define “responsible person” and specify the persons with ownership interests and the corporate officers who are required to submit to criminal records checks;
(2) For purposes of division (A)(8) of this section, specify other requirements or qualifications, if any, that an applicant must meet to receive a license;
(3) Address any other matter the board considers appropriate to implement this section.