Ohio Code 4729.55 – Terminal distributor license requirements
No license shall be issued to an applicant for licensure as a terminal distributor of dangerous drugs unless the applicant has furnished satisfactory proof to the state board of pharmacy that:
Terms Used In Ohio Code 4729.55
- Animal shelter: means a facility operated by a humane society or any society organized under Chapter 1717 of the Revised Code or a dog pound operated pursuant to Chapter 955 of the Revised Code. See Ohio Code 4729.01
- County dog warden: means a dog warden or deputy dog warden appointed or employed under section 955. 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
- Laboratory: means a laboratory licensed under this chapter as a terminal distributor of dangerous drugs and entrusted to have custody of any of the following drugs and to use the drugs for scientific and clinical purposes and for purposes of instruction: dangerous drugs that are not controlled substances, as defined in section 3719. 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
- Retail seller: means any person that sells any dangerous drug to consumers without assuming control over and responsibility for its administration. See Ohio Code 4729.01
- Rule: includes regulation. See Ohio Code 1.59
- state: means the state of Ohio. See Ohio Code 1.59
- Terminal distributor: 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 other person authorized by the state board of pharmacy. See Ohio Code 4729.01
(A) The applicant is equipped as to land, buildings, and equipment to properly carry on the business of a terminal distributor of dangerous drugs within the category of licensure approved by the board.
(B) A pharmacist, licensed health professional authorized to prescribe drugs, other person authorized by the board, animal shelter or county dog warden licensed under section 4729.531 of the Revised Code, or laboratory will maintain supervision and control over the possession and custody of dangerous drugs and controlled substances that may be acquired by or on behalf of the applicant.
(C) Adequate safeguards are assured to prevent the sale or other distribution of dangerous drugs by any person other than a pharmacist or licensed health professional authorized to prescribe drugs.
(D) Adequate safeguards are assured that the applicant will carry on the business of a terminal distributor of dangerous drugs in a manner that allows pharmacists and pharmacy interns employed by the terminal distributor to practice pharmacy in a safe and effective manner.
(E) If the applicant, or any agent or employee of the applicant, has been found guilty of violating section 4729.51 of the Revised Code, the “Federal Food, Drug, and Cosmetic Act,” 52 Stat. 1040 (1938), 21 U.S.C.A. 301, the federal drug abuse control laws, Chapter 2925., 3715., 3719., or 4729. of the Revised Code, or any rule of the board, adequate safeguards are assured to prevent the recurrence of the violation.
(F) If the application is made on behalf of an animal shelter or county dog warden, at least one of the agents or employees of the animal shelter or county dog warden is certified in compliance with section 4729.532 of the Revised Code.
(G) In the case of an applicant who is a retail seller of peritoneal dialysis solutions in original packages labeled as required by the “Federal Food, Drug, and Cosmetic Act,” 52 Stat. 1040 (1938), 21 U.S.C.A. 301, the applicant will maintain supervision and control over the possession, custody, and retail sale of the peritoneal dialysis solutions.
(H) In the case of an applicant who is a pain management clinic, the applicant meets the requirements to receive a license with a pain management clinic classification issued under section 4729.552 of the Revised Code.
Last updated October 4, 2023 at 11:32 AM