Chapter 4729:6-3 Disposal, Inspections and Corrective Actions

4729:6-3-01 Disposal of controlled substances.

(A) As used in this rule:

"Non-retrievable" means the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the dangerous drugs which are controlled substances unavailable and unusable for all practical purposes. The process to achieve a non-retrievable condition or state may be unique to a substance's chemical or physical properties. A dangerous drug which is a controlled substance is considered non-retrievable when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. The purpose of destruction is to render the controlled substance(s) to a non-retrievable state and thus prevent diversion of any such substance to illicit purposes.

(B) A person licensed in accordance with section 4729.52 of the Revised Code or this division of the Administrative Code shall dispose of controlled substance dangerous drugs in accordance with 21 C.F.R. 1317 (1/1/2016). The method of destruction must render the controlled substances to a state of non-retrievable. Records of controlled substance destruction that are required pursuant to 21 C.F.R. 1304 (1/1/2016) shall be maintained for a minimum of three years and made readily retrievable to the board of pharmacy upon request.

Replaces: 4729-9-06

Effective: 4/1/2018
Five Year Review (FYR) Dates: 04/01/2023
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.07, 4729.52
Prior Effective Dates: 07/01/1993, 02/01/1998, 03/01/1999, 04/27/2007, 10/27/2011

4729:6-3-03 Inspections and corrective actions.

(A) Pursuant to section 3719.13 of the Revised Code, an entity licensed by state board of pharmacy in accordance with section 4729.52 of the Revised Code or this divsion of the Administrative Code is subject to an on-site inspection by the board. An authorized board agent may, without notice, carry out an on-site inspection or investigation of an entity licensed by the board. Upon verification of the board agent's credentials, the agent shall be permitted to enter the licensed entity.

(B) Submission of an application for a license, in accordance with section 4729.52 of the Revised Code or this divison of the Administrative Code, with the state board of pharmacy constitutes permission for entry and on-site inspection by an authorized board agent.

(C) If an agent of the state board of pharmacy identifies a violation specified in paragraph (D) of this rule, the agent may provide written notice, in a manner determined by the board, of the nature of the observed violations to the responsible person on the license or application. The licensee or applicant may also be subject to disciplinary actions pursuant to Chapter 4729. of the Revised Code and this division of the Administrative Code.

(D) Violations may include any of the following:

(1) Violating any rule of the board;

(2) Violating any provision of Chapter 4729. of the Revised Code;

(3) Violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C. 301, or Chapter 3715. of the Revised Code;

(4) Violating any provision of the federal drug abuse control laws or regulations or Chapter 2925. or 3719. of the Revised Code.

(E) The licensee or applicant shall submit to the board within thirty days of a written notice provided in accordance with paragraph (C) of this rule, in a manner determined by the board, either of the following:

(1) The action(s) the licensee or applicant has taken to correct the violation(s) and the date of implementation of the corrective action(s); or

(2) An explanation disputing the observed violations.

Replaces: 4729-9-09

Effective: 4/1/2018
Five Year Review (FYR) Dates: 04/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.25, 3719.18, 3719.13
Prior Effective Dates: 02/17/2017

4729:6-3-04 [Effective 3/1/2019] 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 section, 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, 10/05/2015, 03/01/2017

4729:6-3-05 [Effective 3/1/2019] Suspicious Order Monitoring and Due Diligence.

(A) As used in this rule:

(1) "Customer" means a person located in this state that orders or seeks to order a reported drug from an Ohio licensed drug distributor and includes the following:

(a) A licensed terminal distributor of dangerous drugs; or

(b) A prescriber who possesses, or possesses for sale or sells, at retail, a dangerous drug.

(2) "Prescriber" has the same meaning as in section 4729.01 of the Revised Code.

(3) "Reported drug" means any dangerous drug whose sale is required to be reported to the drug database pursuant to agency 4729 of the Administrative Code.

(B) This rule only applies to the following drug distributors licensed in accordance with section 4729. 52 of the Revised Code:

(1) Wholesale distributors of dangerous drugs;

(2) Virtual wholesalers;

(3) Manufacturers of dangerous drugs; and

(4) Outsourcing facilities.

(C) Drug distributors listed in paragraph (B) of this rule shall design and operate a system to identify and report suspicious orders by customers for reported drugs. Suspicious orders shall include, but are not limited to, the following:

(1) Orders of unusual size;

(2) Orders deviating substantially from a normal pattern; and

(3) Orders of unusual frequency.

(D) Prior to any shipment of an order that a distributor has identified as suspicious, two persons designated by the distributor's responsible person must independently analyze the order. In order to proceed with the shipment and complete the sale, each of the two persons must determine that the order is not likely to be diverted from legitimate channels.

(E) All suspicious orders, regardless of actual sale, shall be submitted electronically in a manner and format determined by the board. The electronic submission of suspicious orders shall include all information as required by the board and shall be submitted within five days of the order being identified as suspicious by the drug distributor.

(F) All drug distributors listed in paragraph (B) of this rule shall submit a zero report, in a manner determined by the board, if no suspicious orders have been identified by the distributor in a calendar month. The zero report shall be submitted within fifteen days of the end of the calendar month.

(G)

(1) Except as provided in paragraph (G)(2) of this rule, a drug distributor listed in paragraph (B) of this rule shall exercise due diligence to identify customers ordering or seeking to order reported drugs to establish the normal and expected transactions conducted by those persons and to identify and prevent the sale of reported drugs that are likely to be diverted from legitimate channels. Such measures shall include, but are not limited to, the following which shall to be conducted prior to an initial sale and on an annual basis:

(a) Questionnaires and affirmative steps by the drug distributor to confirm the accuracy and validity of the information provided.

(b) For a customer who is a prescriber, confirmation of prescriber type (physician, dentist, veterinarian, etc.), specialty practice area (oncology, geriatrics, pain management, etc.) and if the prescriber personally furnishes reported drugs and the quantity personally furnished.

(c) Review of drug utilization reports.

(d) Obtaining and conducting a review of the following information:

(i) The methods of payment accepted (cash, insurance, medicaid, medicare) and in what ratios;

(ii) The ratio of controlled vs. non-controlled drug orders and overall sales;

(iii) Orders for reported drugs from other drug distributors made available by the United States drug enforcement administration's automation of reports and consolidated orders system; and

(iv) The proportion of out-of-state patients served compared to in-state patients.

(2) A drug distributor receiving a request for an initial sale for a reported drug may conduct the sale without complying with paragraph (G)(1) of this rule if all the following applies:

(a) The sale is to an institutional facility as defined in agency 4729 of the Revised Code that is a new customer of the distributor;

(b) The drug distributor documents that the order is to meet an emergent need; and

(c) The drug distributor completes the requirements set forth in paragraph (G)(1) of the rule no later than sixty days from the date of sale.

(H) Any customer that may be engaging in possible activities that may cause reported drugs to be diverted from legitimate channels, including those to whom a drug distributor refuses to sell, shall be electronically reported by the drug distributor in a manner and format determined by the board. The electronic submission of such customers shall include all information as required by the board and shall be submitted within five days of refusal, cessation or identification by the drug distributor.

(I) Within ninety days of the effective date of this rule, a drug distributor shall provide, in a manner and format determined by the board, information on all customers in this state the distributor has refused to sell to or has stopped selling to within the past three years because the distributor has identified the customer as engaging in possible activities that may cause reported drugs to be diverted from legitimate channels. The submission of information shall contain the customer's name, address, drug enforcement administration registration (if applicable), terminal distributor of dangerous drugs license number (if applicable), and a detailed explanation of why the distributor identified the customer as a possible diversion risk.

(J) All drug distributors described in paragraph (A) of this rule shall maintain and implement policies and procedures that include all the following:

(1) The design and operation of a suspicious order monitoring and reporting system.

(2) A system to collect the necessary information on customers in accordance with paragraph (G) of this rule.

(3) Mandatory training, to be conducted annually, for staff responsible for the processing of all orders for reported drugs that includes all the following:

(a) The drug distributor's suspicious order monitoring system;

(b) The process to collect all relevant information on customers in accordance with paragraph (G) of this rule;

(c) The process for submission of suspicious orders and customers who may be engaging in possible activities that may cause reported drugs to be diverted from legitimate channels to the board; and

(d) Information on submitting a confidential report of a suspicious order or customer engaging in possible activities that may cause reported drugs to be diverted from legitimate channels by using the board's online electronic complaint form that can accessed by visiting: www.pharmacy.ohio.gov. The training shall remind all employees that complaints and all information submitted that identifies a complainant shall remain confidential pursuant to section 4729.23 of the Revised Code.

(K) All policies and procedures maintained in accordance with paragraph (J) of this rule shall be reviewed and updated on an annual basis.

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2023
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.25, 4729.23, 4729.52

4729:6-3-06 [Effective 3/1/2019] Controlled Substances Inventory Requirements.

(A) All category III drug distributor licenses shall complete a controlled substances inventory in accordance with section 1304.11 of the Code of Federal Regulations (9/9/2014).

(B) The drug distributor's responsible person shall be responsible for completing and maintaining this inventory record.

(C) All inventory records shall be maintained for a period of three years from the completion date of the inventory and made readily retrievable.

(D) When a drug or compound is added to the schedule of controlled substances by state or federal law, rule or regulation, a drug distributor shall complete an inventory pursuant to paragraph (A) of this rule of all stocks of such substance no later than ten days after the drug is added to the schedule.

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.52

4729:6-3-07 [Effective 3/1/2019] Sales of dangerous drugs on-line.

(A) All persons selling or offering to sell dangerous drugs at retail or wholesale into, out of, or within Ohio must be appropriately licensed by the state board of pharmacy.

(B) All drug distributors licensed with the state board of pharmacy and who sell or offer to sell dangerous drugs on the internet to persons located in Ohio or any other state must make such sales only in compliance with all state and federal laws, rules and regulations governing the legal distribution of dangerous drugs.

(C) Websites owned and/or maintained by Ohio licensed dangerous drug distributors who sell or offer to sell dangerous drugs on the internet must provide the following information to the public:

(1) Name under which the dangerous drug distributor is licensed to do business as in Ohio.

(2) Full address of licensed location.

(3) Telephone number where the drug distributor may be contacted during regular business hours.

(4) A list of the states in which the dangerous drug distributor may legally sell dangerous drugs.

(5) The name, address and how the state licensing agency and the drug enforcement administration may be contacted in each state in which the person is authorized to do business. This may include a link to the agency's and the drug enforcement administration's website.

(D) Any Ohio licensed drug distributor requesting personal information from the public by way of the internet (questionnaire forms or e-mail) must provide for security and confidentiality of the information. This portion of the website must also provide information regarding how the personal information will be used, pursuant to all federal and state laws, rules, and regulations, and ensure that such information is not used for purposes not disclosed without the written informed consent of the patient or person submitting personal information.

Replaces: 4729-9-24

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28, 3715.69
Rule Amplifies: 3719.05, 3719.04, 4729.551, 4729.51
Prior Effective Dates: 03/01/1999, 01/01/2004, 01/01/2009

4729:6-3-08 [Effective 3/1/2019] Distributor of dangerous drugs samples and complimentary supplies.

(A) As used in this rule:

(1) "Sample" means a dangerous drug or pharmaceutical preparation that would be hazardous to health or safety if used without the supervision of a licensed health professional authorized to prescribe drugs, or a drug of abuse, and that, at one time, had been placed in a container plainly marked as a sample by a manufacturer. Except as provided in paragraph (E) of this rule, samples may only be provided to and furnished by a licensed prescriber as defined in rule 4729:5-1-02 of the Administrative Code in accordance with paragraph (B) of this rule.

(2) "Complimentary supply" also known as "starter packs," "initial dose packs," "starter stocks," "replacement programs," or any other similar supply means a drug or pharmaceutical preparation that is distributed without charge by licensed drug distributors to pharmacies licensed as terminal distributors of dangerous drugs or prescribers to assist patients in the initiation of drug therapy. A complimentary supply shall not contain the markings or labeling of a sample drug.

(B) No drug distributor or distributor's representative, including sales representatives, may sell or distribute a sample of a drug to a licensed prescriber unless requested by the prescriber and the entity:

(1) Is licensed as a distributor of dangerous drugs; and

(2) Maintains a record of such distribution for three years from the date of sale or distribution. Such records shall be made readily retrievable.

(C) Complimentary supplies are subject to the same requirements as stock shipments of dangerous drugs pursuant to agency 4729 of the Administrative Code and Chapters 4729., 3719., and 3715. of the Revised Code.

(D) A drug distributor shall comply with rule 4729:6-3-04 of the Administrative Code prior to the sale or distribution of complimentary supplies and samples.

(E) Nothing in this rule prohibits a pharmacist working, regardless of compensation, in a charitable pharmacy from dispensing a sample drug to a person in accordance with section 3719.811 of the Revised Code and agency 4729. of the Administrative Code.

(F) Paragraph (A)(1) of this rule does not permit a pharmacist who is authorized to manage drug therapy pursuant section 4729.39 of the Revised Code from ordering, dispensing or personally furnishing a sample within a pharmacy licensed as a terminal distributor of dangerous drugs.

Replaces: 4729-9-13

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2023
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.81
Prior Effective Dates: 09/10/1976, 02/01/1998, 03/01/1999, 09/15/2017