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 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, as defined in agency 4729 of the Administrative Code, 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.

(2) "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 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 five 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, as defined in section 5163.45 of the Revised Code, 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.

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: 3719.05, 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

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

4729:5-3-05 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