Chapter 4729:5-3 Disposal of Controlled Substances

4729:5-3-01 Disposal of controlled substances.

(A) As used in this rule:

(1) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(2) "Controlled substance proof-of-use sheet" means a record that captures, at a minimum, the following information:

(a) Date;

(b) Patient name;

(c) Drug name;

(d) Drug strength;

(e) Quantity; and

(f) The positive identification of the individuals authorized by this rule who are responsible for removing the dangerous drugs from the medication cart, or other storage area, and transferring the drugs to the secure storage area.

(3) "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.

(4)

(a) "Positive identification" means a method of identifying a person that does not rely solely on the use of a private personal identifier such as a password, but must also include a secure means of identification such as the following:

(i) A manual signature on a hard copy record;

(ii) A magnetic card reader;

(iii) A bar code reader;

(iv) A biometric method;

(v) A proximity badge reader;

(vi) A board approved system of randomly generated personal questions;

(vii) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who performed the action requiring positive identification. The printout must be maintained for three years and made available on request to those individuals authorized by law to review such records; or

(viii) Other effective methods for identifying individuals that have been approved by the board.

(b) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system.

(5) "State or local correctional facility" means any of the following:

(a) A "state correctional institution," as defined in section 2967.01 of the Revised Code;

(b) A "local correctional facility," as defined in section 2903.13 of the Revised Code.

(B) A terminal distributor of dangerous drugs 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.

(1) If a long term care facility uses a method of destruction pursuant to 21 C.F.R. 1317 (1/1/2016), the controlled substances transferred to a collection receptacle or mail-back envelope must be completed by the director of nursing and witnessed by a nurse licensed in accordance with Chapter 4723. of the Revised Code. The amount of controlled substances transferred to the receptacle or mail-back envelope and the method of disposal used must be documented with the positive identification of both individuals on the corresponding controlled substance proof-of-use sheet.

(C) If a pharmacy is servicing a long term care facility or a consultant pharmacist is employed by a long term care facility and is having a pharmacist engage in the on-site destruction of ultimate user (i.e. patient-owned) controlled substances in the custodial care of nursing staff, the pharmacy or consultant pharmacist shall have policies and procedures in place to ensure compliance with and shall comply with all the following:

(1) Upon discontinuation of a patient's controlled substance medication, a nurse and director of nursing, or other pharmacy or pharmacist-approved supervisory nurse, must document the removal of the patient's dangerous drugs from the medication cart or storage area and record the transfer of the drugs to a secure storage area for disposal.

(2) The record of the controlled substances removed from the medication cart, or other area of storage, for disposal shall be made on a controlled substance proof-of-use sheet.

(3) An Ohio licensed pharmacist or the director of nursing and another pharmacy or pharmacist-approved supervisory level nurse, may destroy ultimate user controlled substances using an on-site method at the location licensed as a terminal distributor of dangerous drugs. Both individuals shall personally witness and document the destruction of the controlled substance medication pursuant to paragraph (C)(4) of this rule. The on-site method does not have to meet the definition of non-retrievable but must render the drug unavailable and unusable.

(4) A record of controlled substances destroyed shall be made containing the date of destruction, patient name, drug name, drug strength, quantity, method of destruction and the positive identification of the two individuals listed in paragraph (C)(3) of this rule responsible for the destruction.

(5) The record of controlled substance destruction pursuant to paragraph (C)(4) of this rule shall be maintained on-site at the location licensed as a terminal distributor of dangerous drugs for a minimum of three years from the date of destruction and made readily retrievable to the board of pharmacy upon request.

(6) Controlled substances shall be destroyed pursuant to this paragraph no later than ten days from the date the patient's controlled substance medication is removed from the medication cart or storage area in accordance with paragraph (C)(1) of this rule.

(D) A state or local correctional facility may engage in the on-site destruction of ultimate user (i.e. patient-owned) controlled substances in the custodial care of nursing staff, as follows:

(1) The correctional facility shall be licensed as a category III terminal distributor of dangerous drugs.

(2) The responsible person shall have policies and procedures in place to ensure compliance with and shall comply with all the following:

(a) Upon discontinuation of a patient's controlled substance medication, the responsible person, director of nursing or a licensed pharmacist and another responsible person-approved nurse or corrections officer, must document the removal of the patient's dangerous drugs from the medication cart or storage area and record the transfer of the drugs to a secure storage area for disposal.

(b) The record of the controlled substances removed from the medication cart, or other area of storage, for disposal shall be made on a controlled substance proof-of-use sheet.

(c) The responsible person, director of nursing or a licensed pharmacist and another responsible person-approved nurse or corrections officer, may destroy ultimate user controlled substances using an on-site method at the location licensed as a terminal distributor of dangerous drugs. Both individuals shall personally witness and document the destruction of the controlled substance medication pursuant to paragraph (D)(2)(d) of this rule. The on-site method does not have to meet the definition of non-retrievable but must render the drug unavailable and unusable.

(d) A record of controlled substances destroyed shall be made containing the date of destruction, patient name, drug name, drug strength, quantity, method of destruction and the positive identification of the two individuals listed in the paragraph (D)(2)(c) of this rule responsible for the destruction. The record of controlled substance destruction shall be maintained on-site at the location licensed as a terminal distributor of dangerous drugs for a minimum of three years from the date of destruction and made readily retrievable to the board of pharmacy upon request.

(e) Controlled substances shall be destroyed no later than ten days from the date the patient's controlled substance medication is removed from the medication cart or storage area in accordance with paragraph (D)(2)(a) this rule.

(E) The unused portion of a controlled substance resulting from administration to a patient from a licensee's stock or emergency supply may be destroyed using an on-site method by any person legally authorized under Chapters 3719. and 4729. of the Revised Code to possess controlled substance dangerous drugs. The on-site method does not have to meet the definition of non-retrievable but must render the drug unavailable and unusable. A record of such destruction shall be made in accordance with 21 C.F.R. 1304 (1/1/2016) and shall be maintained for a minimum of three years from the date of destruction and made readily retrievable to the board of pharmacy upon request.

Effective: 3/1/2019
Five Year Review (FYR) Dates: 4/1/2023
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.05, 3719.06, 3719.07
Prior Effective Dates: 09/10/1976, 07/01/1993, 02/01/1998, 03/01/1999, 04/27/2007, 10/27/2011, 02/01/2017, 04/01/2018

4729:5-3-02 Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents.

(A) A terminal distributor of dangerous drugs shall notify the following upon discovery of the theft or significant loss of any dangerous drug or controlled substance, including drugs in transit that were either shipped from or to the licensed location:

(1) The state board of pharmacy, by telephone or other method determined by the board, immediately upon discovery of the theft or significant loss;

(2) If a controlled substance, the drug enforcement administration (DEA) pursuant to 21 C.F.R. 1301.76 (1/21/2016);

(3) Law enforcement authorities pursuant to section 2921.22 of the Revised Code.

(B) The theft or significant loss of controlled substances shall be reported by a licensee using the federal DEA report form regardless if the controlled substances are subsequently recovered and/or the responsible parties are identified and action is taken. Information reported in the federal form regarding such theft or significant loss shall be filed with the state board of pharmacy, in a manner determined by the board, by the licensee within thirty days following the discovery of such theft or significant loss.

(1) An exemption may be obtained upon sufficient cause if the federal form cannot be filed within thirty days.

(2) A request for a waiver of the thirty-day limit must be requested in a manner determined by the board.

(C) The theft or significant loss of non-controlled dangerous drugs shall be reported to the state board of pharmacy, in a manner determined by the board, by the licensee within thirty days following the discovery of such theft or significant loss of non-controlled dangerous drugs. The report shall be filed regardless if the dangerous drugs are subsequently recovered and/or the responsible parties are identified and action is taken.

(1) An exemption may be obtained upon sufficient cause if the form cannot be filed within thirty days.

(2) A request for a waiver of the thirty-day limit must be requested in a manner determined by the board.

(D) A terminal distributor of dangerous drugs shall, immediately upon discovery, notify the state board of pharmacy, in a manner determined by the board, and law enforcement authorities of any theft or loss of uncompleted prescription blank(s) used for writing a prescription, written prescription order(s) not yet dispensed and original prescription order(s) that have been dispensed.

(E) A terminal distributor of dangerous drugs shall, immediately upon discovery, notify the state board of pharmacy, in a manner determined by the board, law enforcement authorities and the drug enforcement administration (DEA) pursuant to 21 C.F.R. 1305.12 (1/21/2016) of the theft or loss of any official written order form(s) as defined in division (Q) of section 3719.01 of the Revised Code.

Replaces: 4729-9-15

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 3719.07, 4729.55
Prior Effective Dates: 4/1/78, 02/15/1982, 07/01/1990, 02/15/1995, 01/17/1997, 03/01/1999, 01/01/2006, 01/01/2011

4729:5-3-03 Inspections and corrective actions.

(A) Pursuant to section 3719.13 of the Revised Code, an entity licensed by the state board of pharmacy as a terminal distributor of dangerous drugs 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 as a terminal distributor of dangerous drugs 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 divsion 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

4729:5-3-04 Verification of licensure prior to sale or purchase.

(A) Before a terminal distributor of dangerous drugs may purchase dangerous drugs at wholesale, the terminal distributor shall query the board's online roster (available on the board's website: www.pharmacy.ohio.gov) to confirm any of the following:

(1) The seller is licensed to engage in the sale of dangerous drugs in accordance with section 4729.52 of the Revised Code; or

(2) The seller is licensed to engage in the occasional sale or distribution of dangerous drugs at wholesale in accordance with rule 4729:5-3-09 of the Administrative Code.

(B) If no documented query is conducted before a purchase is made, it shall be presumed that the purchase of dangerous drugs by the terminal distributor is in violation of section 4729.51 of the Revised Code.

If a licensed terminal distributor of dangerous drugs conducts a documented query at least annually and relies on the results of the query in purchasing dangerous drugs, the terminal distributor shall be deemed not to have violated section 4729.51 of the Revised Code in making the purchase.

(C) Before a terminal distributor of dangerous drugs may make a sale of dangerous drugs pursuant to rule 4729:5-3-09 of the Administrative Code, the terminal distributor shall query the board's online roster (available on the board's website: www.pharmacy.ohio.gov) 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 terminal 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 in accordance with division 4729:6 of the

Administrative Code.

(D) Paragraph (C) of this rule does not apply when a terminal distributor sells or distributes dangerous drugs at wholesale to any of the following:

(1) A terminal distributor, manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor that is located in another state, is not engaged in the sale of dangerous drugs within this state, and is actively licensed to engage in the sale of dangerous drugs by the state in which the distributor conducts business; or

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

(E) A terminal distributor of dangerous drugs may make a sale of a dangerous drug to any of the exempted persons described in section 4729.541 of the Revised Code in accordance with rule 4729:5-3-09 of the Administrative Code and shall ensure the purchaser meets the exemption criteria. To confirm a purchaser meets the exemption criteria, the terminal drug distributor shall comply with the all the following:

(1) Provide the purchaser, in a manner determined by the board, the requirements in

Ohio law of when a purchaser shall hold a license as a terminal distributor of dangerous drugs;

(2) If the purchaser is a prescriber, verify the prescriber is appropriately licensed in this state to prescribe drugs or dangerous drugs or drug therapy related devices in the course of the individual's professional practice;

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

(4) Ensure that all attestations are maintained by the terminal distributor for a period of three years following the date the attestation is signed by the purchaser.

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.60, 4729.37, 4729.55

4729:5-3-05 Confidentiality of patient records.

(A) Records relating to the practice of pharmacy, the administration of drugs, or any patient specific drug transaction are not a public record. A person having custody of, or access to, such records shall not divulge the contents thereof, or provide a copy thereof, to anyone except:

(1) The patient, or owner if the patient is an animal, for whom the prescription or medication order was issued.

(2) The prescriber who issued the prescription or medication order, or a subsequent treating prescriber.

(3) Licensed health care personnel who are responsible for the care of the patient.

(4) A member, inspector, agent, or investigator of the state board of pharmacy or any federal, state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug.

(5) An agent of an Ohio licensing agency that is responsible for the licensure or registration of a health professional authorized to prescribe drugs as defined in section 4729.01 of the Revised Code when enforcing that agency's chapter of the Revised Code.

(6) A state or federal agency charged with the responsibility of providing medical care (i.e. medicaid, medicare, workers' compensation, etc.) for the patient upon a written request by an authorized representative of the agency requesting such information.

(7) An agent of a medical insurance company who provides prescription insurance coverage to the patient upon authorization and proof of insurance by the patient or proof of payment by the insurance company for those medications whose information is requested.

(8) An agent who contracts with the terminal distributor of dangerous drugs as a "business associate" in accordance with the regulations promulgated by the secretary of the United States department of health and human services pursuant to the federal standards for privacy of individually identifiable health information.

(9) Any person, other than those listed in paragraphs (A)(1) to (A)(8) of this rule, only when the patient has given consent for such disclosure in writing. Any consent must be signed by the patient and dated. Any consent for disclosure is valid until rescinded by the patient.

In an emergency, the terminal distributor of dangerous drugs may disclose the information when, in the professional judgment of the pharmacist or healthcare provider, it is deemed to be in the best interest of the patient. A pharmacist or healthcare provider making an oral disclosure in an emergency situation must prepare a written memorandum showing the patient's name, the date and time the disclosure was made, the nature of the emergency, and the names of the individuals by whom and to whom the information was disclosed.

(B) Testimonial privilege is not waived for any communication between a prescriber, a pharmacist, and a patient pursuant to section 2317.02 of the Revised Code.

(C) Records relating to the practice of pharmacy, the administration of drugs, or any patient specific drug transaction which may be required as evidence of a violation shall be released, upon request, to a member, inspector, agent, or investigator of the state board of pharmacy or any state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug. Such person shall furnish a receipt to the person having legal custody of the records. If the record is a prescription, the receipt shall list the following information:

(1) Prescription identification number; or, if an order for medication, the name of the patient;

(2) The drugs prescribed or ordered;

(3) Quantity of drugs prescribed, dispensed, administered or personally furnished;

(4) Name of the prescriber;

(5) Date, name of agency, and signature of person removing the records.

(D) All such records, including consents, memoranda of emergency disclosures, and written requests pursuant to paragraph (A)(9) of this rule, shall be kept on file at the terminal distributor of dangerous drugs for a period of three years in a readily retrievable manner.

(E) All patient records maintained by a terminal distributor of dangerous drugs shall be maintained in accordance with the following:

(1) For human patients, the Health Insurance Portability and Accountability Act of 1996 (HIPAA); and

(2) All state and federal laws, rules and regulations.

Replaces: 4729-5-29

Effective: 4/1/2018
Five Year Review (FYR) Dates: 04/01/2023
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.05, 3719.07, 3719.13, 3719.27, 4729.27, 4729.37, 4729.39
Prior Effective Dates: 03/01/1999, 02/01/2002, 04/27/2007, 01/01/2009, 03/03/2017

4729:5-3-06 Storage of adulterated drugs.

To prevent their use, adulterated drugs, as defined in agency 4729 of the Administrative Code, shall be stored in a separate and secure area apart from the storage of drugs used for dispensing, personally furnishing, compounding and administration.

(A) Adulterated drugs shall be stored no longer than one year from the date of adulteration or expiration by those holding a terminal distributor of dangerous drugs license. Adulterated drugs shall be stored in a manner that prohibits access by unauthorized persons.

(B) Dangerous drugs, other than controlled substances, may be destroyed utilizing proper methods of disposal and following the record keeping requirements noted in agency 4729 of the Administrative Code, or may be donated to a pharmacy school pursuant to sections 3715.88 to 3715.92 of the Revised Code. Methods of disposal of non-controlled dangerous drugs shall prevent the possession or use of the drugs by unauthorized persons.

(C) Dangerous drugs that are controlled substances shall be disposed of pursuant to rule 4729:5-3-01 of the Administrative Code.

Replaces: 4729-9-17

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26, 3715.91
Rule Amplifies: 3715.88, 3715.89, 3715.90, 3715.92, 3719.05, 3719.06, 4729.53, 4729.55
Prior Effective Dates: 3/21/88, 7/1/93, 1/1/09, 03/01/2017

4729:5-3-07 Controlled substances inventory requirements.

(A) Unless otherwise stated in this division of the Administrative Code, all category III terminal distributor licensees shall complete a controlled substances inventory in accordance with 21 CFR 1304.11 (9/9/2014).

(B) All controlled substance inventories performed in accordance with this rule shall be conducted on an annual basis. The annual inventory may be taken on any date which is within thirteen months of the previous inventory date.

(C) The terminal distributor's responsible person shall be responsible for completing and maintaining this inventory record at the location licensed as a terminal distributor of dangerous drugs.

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

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

(F) In the event a terminal distributor of dangerous drugs commences business with no controlled substances on hand, this fact shall be recorded as the initial inventory.

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.54, 4729.55

4729:5-3-08 [Effective until 6/1/2019] Sales of dangerous drugs on-line.

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

(B) All terminal distributors of dangerous drugs who sell or offer to sell dangerous drugs at retail 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) Except as provided in paragraph (F) of this rule, all terminal distributors of dangerous drugs who sell or offer to sell dangerous drugs at retail on the internet to persons located in Ohio shall maintain accreditation as a verified internet pharmacy practice site from the national association of boards of pharmacy.

(D) Websites owned and/or maintained by a terminal distributor of dangerous drugs who sell or offer to sell dangerous drugs at retail on the internet to persons located in Ohio or any other state must provide the following information to the public:

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

(2) Full address of the licensed location.

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

(4) A list of the states in which the terminal 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.

(E) Any Ohio licensed terminal distributor requesting personal information from the public by way of the internet (questionnaire forms, e-mail, etc.) 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.

(F) A veterinarian, licensed under Chapter 4741. of the Revised Code, may sell or offer to sell dangerous drugs via the internet only when the internet pharmacy, that fulfills the dangerous drug prescription or facilitates the sale of the dangerous drug maintains accreditation as a verified internet pharmacy practice site from the national association of boards of pharmacy.

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.54, 4729.55

4729:5-3-08 [Effective 6/1/2019] Sales of dangerous drugs on-line.

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

(B) All terminal distributors of dangerous drugs who sell or offer to sell dangerous drugs at retail 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) Except as provided in paragraph (F) of this rule, all terminal distributors of dangerous drugs who sell or offer to sell dangerous drugs at retail on the internet to persons located in Ohio shall maintain accreditation as a verified internet pharmacy practice site from the national association of boards of pharmacy.

(D) Websites owned and/or maintained by a terminal distributor of dangerous drugs who sell or offer to sell dangerous drugs at retail on the internet to persons located in Ohio or any other state must provide the following information to the public:

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

(2) Full address of the licensed location.

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

(4) A list of the states in which the terminal 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.

(E) Any Ohio licensed terminal distributor requesting personal information from the public by way of the internet (questionnaire forms, e-mail, etc.) 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.

(F) A veterinarian, licensed under Chapter 4741. of the Revised Code, may sell or offer to sell dangerous drugs via the internet only when the internet pharmacy, that fulfills the dangerous drug prescription or facilitates the sale of the dangerous drug maintains accreditation as a verified internet pharmacy practice site from the national association of boards of pharmacy.

Effective: 6/1/2019
Five Year Review (FYR) Dates: 06/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.54, 4729.55

4729:5-3-09 Occasional sale and drug transfers.

(A) The term "occasional sale" as used in section 4729.51 of the Revised Code means a wholesale sale of a commercially manufactured dangerous drug to a person licensed in accordance with section 4729.52 of the Revised Code, terminal distributor of dangerous drugs or any entity or person exempted from licensure as a terminal distributor of dangerous drugs by either:

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

(2) A licensed terminal distributor of dangerous drugs that is not a pharmacy, but only as authorized in section 4729.51 of the Revised Code.

(B) The dosage units of all dangerous drugs distributed by the pharmacy pursuant to this rule shall not exceed five per cent of the total dosage units dispensed by the pharmacy during the same calendar year.

(C) The limits set forth in this rule do not apply to the following:

(1) A licensed terminal distributor of dangerous drugs as described in paragraph (A)(2) of this rule; and

(2) Pharmacies that are also licensed to conduct sales of dangerous drugs in accordance with section 4729.52 of the Revised Code.

(D) The requirements of this rule do not apply to the transfer of dangerous drugs pursuant to paragraph (E) of this rule.

(E) A licensed terminal distributor of dangerous drugs having more than one licensed location may transfer or deliver dangerous drugs from one licensed location to another licensed location owned by that terminal distributor if the license issued for each location is in effect at the time of the transfer or delivery. Such transfer or delivery includes either of the following:

(1) Intracompany sales, which includes any transaction or transfer between any division, subsidiary, parent or affiliated or related company under the common ownership and control.

(2) The sale, purchase, or transfer of a drug or an offer to sell, purchase, or transfer of a drug among hospitals or other health care entities that are under common control. Common control means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise.

(F) Occasional sales by a licensed terminal distributor shall comply with the reporting requirements set forth in division 4729:8 of the Administrative Code.

(G) "Drug shortage," with respect to an occasional sale, means a drug on the United States food and drug administration's drug shortage list that 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 or wholesaler.

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.51, 4729.541

4729:5-3-10 Employment of individuals with felony convictions.

(A) Pursuant to 21 C.F.R. 1301.76 (9/9/2014), a terminal distributor of dangerous drugs that is a United States drug enforcement administration registrant shall not employ in a position which allows access to controlled substances any person who has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for drug enforcement administration registration denied, revoked, or surrendered for cause.

"For cause" means surrendering a registration in lieu of, or as a consequence of, any federal or state administrative, civil, or criminal action resulting from an investigation of the individual's handling of controlled substances.

(B) Paragraph (A) of this rule does not apply if a waiver is obtained by a licensee pursuant to 21 C.F.R. 1307.03 (3/9/2010).

Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.54, 4729.55