Ohio Admin. Code 4729:5-5-26 - [Effective 6/30/2025] Outpatient pharmacy delivery services

(A) As used in this rule:

(1) "Business day" means any day, excluding holidays, where the pharmacy is open for business.

(2) "Common carrier" means a person holding itself out to the general public to provide transportation for compensation.

(3) "Contract carrier" means a person providing transportation for compensation under continuing agreements with one person or a limited number of persons.

(4) "Pharmacy delivery agent" means the United States postal service or common carrier, contract carrier, or employee of the terminal distributor of dangerous drugs who delivers dangerous drugs that have been dispensed to a patient or agent of the patient.

(5) "Temperature sensitive drug" means any drug that is required to be stored at temperatures outside of controlled room temperature (fifty-nine degrees Fahrenheit to eighty-six degrees Fahrenheit).

(B) An outpatient pharmacy licensed as a terminal distributor of dangerous drugs providing delivery services of dispensed drugs and devices in this state shall comply with the following:

(1) Contact the patient or patient's caregiver for consent prior to any billing or delivery of a drug or device, except if the patient has provided general consent for delivery services. Consent may be provided in writing, electronically, or verbally. In lieu of contacting the patient or patient's caregiver to obtain consent, the pharmacy shall provide a refund if the patient or patient's caregiver notifies the pharmacy that a dispensed drug or device was unneeded or unwanted.

(2) In accordance with the patient's communication preferences, make available to the patient or patients caregiver the date shipped, method of delivery (e.g., mail, courier, drone, etc.), and expected arrival. This information can be provided by electronic, telephonic, or any other manner that allows the patient to access the information required pursuant to this paragraph.

(3) Take all appropriate measures to ensure that temperature sensitive drugs will be maintained within the temperature ranges recommended by the manufacturer until the delivery has been completed.

(4) If the patient's prescription is a temperature sensitive drug, provide notification to the patient of the timeliness in addressing proper storage of the medication.

(5) Arrange for any controlled substances to require proof of delivery, which may include the signature of the receiving party.

(6) Assist patients with arranging access to medication from a local pharmacy if unable to deliver medications in the expected timeframe.

(7) Provide a method by which the patient or patient's caregiver can notify the pharmacy as to any irregularity in the delivery of the drug or device, including all of the following:

(a) Timeliness of delivery.

(b) Condition of the drug or device upon delivery.

(c) Failure to receive the proper drug or device.

(8) Ensure there is a process to inform the patient or patient's caregiver within two business days of being notified of the delay if the scheduled delivery of the patient's prescription will be interrupted or late.

(C) Upon notification of the dispensing pharmacy by the patient or patient's caregiver, any drug or device which is compromised or lost in transit shall be replaced at no additional cost to the patient. If the timeliness of the replacement will lead to an interruption in therapy, the outpatient pharmacy shall take all available steps to mitigate patient harm.

(D) Any drug or device that has been delivered to a patient or is no longer in the possession of a pharmacy delivery agent shall not be returned to stock in accordance with rule 4729:5-5-22 of the Administrative Code.

(E) An outpatient pharmacy shall maintain the following records for all drugs and devices delivered in accordance with this rule:

(1) Patient name;

(2) Patient address;

(3) Prescription number of drug or device being delivered;

(4) Name (brand name or generic) and dosage of each drug or device being delivered;

(5) Name of the pharmacy delivery agent who performed, or attempted to perform, the delivery as follows:

(a) For the United State postal service (USPS) or a common carrier, the record shall indicate either the USPS or the name of the common carrier.

(b) For a contract carrier, the record shall indicate the name of the contract carrier and the individual conducting the delivery on behalf of the contract carrier.

(c) For an employee of the terminal distributor of dangerous drugs, the record shall include the full name of the employee.

(F) All records maintained in accordance with this rule shall be readily retrievable and uniformly maintained for a period of three years.

(G) Except for deliveries performed by the United States postal service or common carrier, an outpatient pharmacy that utilizes a third-party to deliver drugs and devices shall enter into a contract with the third-party to ensure the following:

(1) The required records in paragraph (E) of this rule are provided to the contracting pharmacy; and

(2) The third-party entity agrees to cooperate with all investigations regarding the theft or significant loss of drugs and devices and produce required records listed in paragraph (E) of this rule within three business days of a request by an agent, officer, or employee of the board.

(H) Theft or significant loss of any dangerous drugs shall be reported to the board in accordance with rule 4729:5-3-02 of the Administrative Code.

Notes

Ohio Admin. Code 4729:5-5-26

Effective: 6/30/2025
Five Year Review (FYR) Dates: 06/30/2030
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.551, 4729.54, 4729.55