4729:6-3-04. Verification of licensure prior to sale or purchase

(A) As used in section 4729.60 of the Revised Code and in this rule, "roster" means any of the following:

(1) The online roster maintained as part of the board's elicensing system (available on the board's website: www.pharmacy.ohio.gov);

(2) An electronic list of licensees and registrants if maintained by the board; and

(3) Any other format capable of meeting the requirements of section 4729.60 of the Revised Code and this rule that has been approved by the board.

(B) Before a drug distributor may sell or distribute dangerous drugs to any person in this state, except as provided in paragraph (C) of this rule, the distributor shall conduct a documented query of a roster maintained by the board to determine if the purchaser is licensed as either:

(1) A terminal distributor of dangerous drugs. For a limited terminal distributor of dangerous drugs license, a drug distributor shall also review a current version of the licensee's drug list to ensure the purchaser is authorized to possess the drugs ordered.

(2) A distributor of dangerous drugs.

(C) Paragraph (B) of this rule does not apply when a drug distributor sells or distributes dangerous drugs to any of the following:

(1) A person specified in division (B)(4) of section 4729.51 of the Revised Code; or

(2) Any of the exempted persons listed in section 4729.541 of the Revised Code

(D) A distributor of dangerous drugs may make a sale of a dangerous drug to any of the exempted persons listed in section 4729.541 of the Revised Code and shall ensure the purchaser meets the exemption criteria.

(1) To confirm a purchasing prescriber meets the exemption criteria pursuant to section 4729.541 of the Revised Code, the drug distributor shall comply with all the following:

(a) Provide the prescriber the requirements in Ohio law of when a prescriber is required to hold a license as a terminal distributor of dangerous drugs;

(b) Verify the prescriber is appropriately licensed in this state to prescribe dangerous drugs or drug therapy related devices in the course of the individual's professional practice;

(c) Require the prescriber who claims an exemption to the terminal distributor of dangerous drug licensing requirement to attest in writing, which may include an electronic signature, that the prescriber meets the licensing exemptions in section 4729.541 of the Revised Code on an annual basis; and

(d) Ensure that all attestations are maintained by the drug distributor for a period of three years after the sale or distribution of the dangerous drug.

(2) To confirm any other person purchasing dangerous drugs meets the exemption criteria pursuant to section 4729.541 of the Revised Code, the drug distributor shall comply with all the following:

(a) Provide the person the requirements in Ohio law of when a person is required to hold a license as a terminal distributor of dangerous drugs;

(b) Require the person who claims an exemption to the terminal distributor of dangerous drug licensing requirement to attest in writing, which may include an electronic signature, that the person meets the licensing exemptions in section 4729.541 of the Revised Code on an annual basis; and

(c) Ensure that all attestations are maintained by the drug distributor for a period of three years after the sale or distribution of the dangerous drug.

(E) Except as provided in paragraph (F) of this rule, before a drug distributor located in this state may purchase or receive dangerous drugs, the distributor shall conduct a documented query of a roster maintained by the board to determine if the seller is licensed as a distributor of dangerous drugs. If a licensed drug distributor conducts a documented query at least annually and relies on the results of the query in purchasing dangerous drugs, the distributor shall be deemed not to have violated this rule.

(F) A third party logistics provider is exempt from the requirements of paragraph (B) of this rule if the licensee has access to documentation indicating the entity responsible for directing the sale or disposition of the drugs has complied with the requirements of this rule.

Replaces: 4729-9-12

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2023
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.541, 4729.60, 3719.04, 4729.51, 4729.54
Prior Effective Dates: 10/01/1971, 03/19/1987, 07/01/1991, 03/13/1995, 01/10/1996, 03/01/1999, 1/1/09, 10/05/2015, 03/01/2017