4729-10-02 Licensure.

Each nonresident terminal distributor of dangerous drugs that sells dangerous drugs at retail in the state of Ohio shall obtain a terminal distributor of dangerous drugs license pursuant to sections 4729.54 and 4729.55 of the Revised Code and Chapter 4729-10 of the Administrative Code.

(A) Conditions of licensure. The nonresident terminal distributor of dangerous drugs shall provide the following information relative to the qualifications of a terminal distributor of dangerous drugs set forth in section 4729.55 of the Revised Code:

(1) Full name, address, and telephone number of the person who desires to be licensed as a nonresident terminal distributor of dangerous drugs.

(a) If incorporated, the application for licensure must include copies of the incorporation papers; and names, dates of birth, addresses, and social security numbers of the officers of the corporation and all stockholders holding more than ten percent of the stock.

(b) If a proprietorship, the application for licensure must include the name, address, date of birth, and social security number of the owner(s).

(c) If a partnership, the application for licensure must include the names, addresses, dates of birth, and social security numbers of the partners.

(d) If the entity applying for a license is a private investment group, the application for licensure must include the names, addresses, dates of birth, and social security numbers of the investors.

(2) Certification from the appropriate licensing authority that the applicant maintains at all times a valid, unexpired license, permit, or registration to properly carry on the business of a distributor of dangerous drugs in the state in which the facility is located and from where dangerous drugs are being sold at retail to residents in Ohio. The certification(s) must include licenses, permits, or registrations required to cover the categories of dangerous drugs which the nonresident terminal distributor of dangerous drugs will be selling at retail to persons in the state of Ohio (i.e., controlled substance drug products as well as noncontrolled substance drug products).

(3) A copy of the most recent inspection report, any warning notices, notice of deficiency reports, or any other related reports issued by the regulatory licensing agency and drug law enforcement agencies of the state in which it is located or any federal agencies regulating and enforcing laws governing the legal distribution of drugs.

(4) A narrative description of the type of business the nonresident terminal distributor of dangerous drugs conduct on within the category of licensure requested. The description shall include the type of professional services that will be provided in accordance with federal and state laws governing the legal distribution of drugs and professional pharmacy practice.

(5) If the nonresident terminal distributor is a pharmacy, the application shall be accompanied by:

(a) The name and license number of the responsible pharmacist (pharmacist-in-charge).

(b) Certification from the appropriate licensing authority that the responsible pharmacist's license is current and in good standing.

(c) The telephone number where the responsible pharmacist may be reached during normal business hours.

(d) A list of all pharmacists employed by the pharmacy who are dispensing dangerous drugs pursuant to prescriptions to residents of this state. The list shall include each pharmacist's license number and the date that the license will expire.

(e) A description of the following:

(i) Normal delivery protocols and times;

(ii) Any special packaging or procedures used in delivering temperature-sensitive drug products;

(iii) The procedure to be followed if the patient's prescription drug is not available at the nonresident pharmacy, or if delivery will be delayed beyond the normal delivery time;

(iv) The procedure to be followed upon receipt of a prescription for an acute illness that assures the patient the opportunity to obtain the medication immediately.

(v) The procedure to be followed that will ensure that the patient's medication therapy is not interrupted when the nonresident pharmacy has been advised by the patient or patient's caregiver that the patient's prescription medication has not been received within the normal delivery time.

(6) Nonresident terminal distributors of dangerous drugs where the responsible person is a prescriber shall submit the following information with their application:

(a) The name and license number of the responsible prescriber.

(b) Certification from the appropriate licensing authority that the responsible person's license is current and in good standing.

(c) The telephone number where the responsible prescriber may be reached during normal business hours.

(d) A list of all prescriber employed by the nonresident terminal distributor who are selling dangerous drugs at retail to residents of this state. The list shall include the license numbers and the date that the licenses to practice will expire.

R.C. 119.032 review dates: 03/17/2014 and 03/17/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54 , 4729.55 , 4729.551 , 4729.57
Prior Effective Dates: 8/16/94 (Emer), 12/15/94, 2/1/02