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The Ohio Board of Pharmacy released several new rules and proposed amendments to existing rules over the past month that will significantly impact pharmacy operations. Topics range from updates to the Terminal Distributor of Dangerous Drugs license to mobile clinics to mandatory rest breaks for pharmacists of outpatient pharmacies. A summary of the proposed changes is below, along with instructions for commenting on the rules. Your BMD healthcare attorney can help write comment letters and submit the comments on your behalf as well.

Rules Available for Stakeholder Comment

Comments on these proposed rules are due to the Ohio Board of Pharmacy by January 17, 2024, using the Board’s online form at: www.pharmacy.ohio.gov/comment.

Rule 4729:5-3-23: Mobile clinics or medication units (New)

• A nonprofit organization, corporation, or association may operate a mobile unit to dispense and administer prescription medications and devices.
• To legally operate, the mobile clinic will be required to register for a no-cost, satellite license that is affiliated with an existing terminal distributor of dangerous drugs (TDDD) license.
• The record-keeping and storage requirements for the mobile unit will mirror the requirements for a clinic with a TDDD license. For example, all mobile units must be dry, well lit, and well ventilated; maintained in a clean, sanitary, and orderly condition; and secured with suitable locks. Additionally, storage areas for dangerous drugs must be maintained at temperatures and conditions that will ensure the integrity of the drugs.
• When drugs are “dispensed” from the mobile clinic, a licensed pharmacist must be on the premises and the mobile unit must be under the control and management of the pharmacist.

Rule 4729:5-2-04: Procedure for discontinuing business as a terminal distributor of dangerous drugs (Amended)

• A TDDD that plans to discontinue business activities must file a notice with the Board of Pharmacy within thirty days of discontinuation of business.
• Additionally, a TDDD licensed as a pharmacy that is permanently closing must provide notification at least fifteen calendar days prior to closing to each patient who has filled a prescription within the previous six months. The notice must include (a) the last day the pharmacy will be open; (b) the name, address, and telephone number of the pharmacy or person that will take possession of the pharmacy records; (c) instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and (d) the last day a transfer may be initiated.

Rule 4729:5-5-15: Manner of issuance of a prescription (Amended)

• For outpatient prescriptions for minors (defined as people under the age of 18), all licensed prescribers must list the patient’s weight, for the outpatient prescription to be filled.

Rule 4729:5-5-18: Dispensing customized patient medication packages by an outpatient pharmacy (Amended)

• In lieu of dispensing two or more dangerous drugs in separate containers, a pharmacist practicing at an outpatient pharmacy may dispense a customized patient medication package. The quantity of the package dispensed may not be more than a sixty-day

Rule 4729:5-5-26: Outpatient Pharmacy Delivery Services (New)

• An outpatient pharmacy licensed as a TDDD providing delivery services must meet the following requirements pre-shipment: (1) contact the patient or patient’s caregiver for approval prior to any billing or delivery of a drug or device, except if the patient has provided general consent for delivery services; (2) notify the patient or patient’s caregiver of the delivery plan and expected arrival; (3) ensure that the drugs will be maintained within the temperature ranges recommended by the manufacturer until the delivery has been completed; and (4) enclose information informing the patient, if the patient's prescription is a temperature sensitive drug, that it is at risk for damage due to extreme hot or cold temperatures or moisture.
• Any drug or device that is compromised or lost must be replaced by the pharmacy at no additional cost to the patient.

Rule 4729:6-2-05: Change in description of a distributor of dangerous drugs (Amended)

• Any change in the ownership, business or trade name, category, or address of a distributor of dangerous drugs requires written notification to the Board, a new application, and a fee paid to the Board within thirty days of the change. However, the change no longer requires a new license, as it previously did.

Rules Ready for Public Hearing

The Board of Pharmacy also has several rules in the State Agency Rule Making process. These rules will have a public hearing on February 13, 2024, at 11:00 a.m. in the Board’s hearing room, 17th Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio. Stakeholders can submit their comments in person at the hearing or in writing to contact@pharmacy.ohio.gov prior to the hearing date.   

OAC Rule 4729:5-2-05: Notification of Accessible Services (New)

• Every outpatient pharmacy providing pharmacy services in Ohio must report to the Board within ninety days of the effective date of the rule the following information on the accessibility of services provided by the pharmacy:

1. The type of language translation services, including translated prescription labels, for patients who are of limited English proficiency;
2. The type of services available for patients who are hard of hearing; and
3. The type of services available for patients with low vision.

A pharmacy that reports that it offers accessible services will be required to provide those services to patients upon request, unless the pharmacy experiences a temporary software or equipment failure of the accessible service offered.

OAC Rule 4729:5-5-02: Minimum Standards for the Operation of an Outpatient Pharmacy (New)

• An outpatient pharmacy licensed as a TDDD must ensure that sufficient personnel are scheduled to work at all times to minimize fatigue, distraction, or other conditions that interfere with a pharmacist's ability to practice with reasonable competence and safety.
• An outpatient pharmacy should (1) store all drugs and devices in a suitable, well-lit, and well-ventilated room and (2) maintain them in a clean, sanitary, and orderly condition.
• Outpatient pharmacies should also provide pharmacy personnel with access to all current federal and state laws, regulations, and rules governing the practice of pharmacy and legal distribution of drugs in Ohio, including (1) a hard copy or internet access to appropriate pharmacy reference materials and (2) a telephone number of a poison control center.

OAC Rule 4729:5-5-02.1: Provision of Ancillary Services in an Outpatient Pharmacy (New)

• An outpatient pharmacy opened to the public and licensed as a TDDD must not establish any productivity or production quotas relating to the provision of ancillary services.
• For purposes of this rule, “ancillary services” mean services performed by pharmacy personnel that are not directly involved in the dispensation of dangerous drugs. Examples of such services include immunizations, drug administration, medication therapy management, disease state management, and refill reminders.

OAC Rule 4729:5-5-02.2: Mandatory Rest Breaks for Pharmacy Personnel (New)

• An outpatient pharmacy licensed as a TDDD may not require pharmacy personnel to work longer than thirteen (13) hours in any workday and must allow at least eight (8) hours of off time between consecutive shifts.
• Pharmacy personnel working longer than six (6) continuous hours per workday must be allowed to take a thirty-minute, uninterrupted rest break during that time. While the pharmacist is on a break, pharmacy personnel may only sell prescriptions that were dispensed by a pharmacist.

OAC Rule 4729:5-5-02.3: Requests for Additional Staff and Reports of Staffing Concerns in an Outpatient Pharmacy (New)

• An outpatient pharmacy should develop a process for pharmacy staff to communicate requests for additional staff or reports of staffing concerns. Requests for additional staff or reports of staffing concerns should be communicated and documented by the responsible person or pharmacist on duty to the terminal distributor.
• A written response to the request or report of concern should occur within fourteen (14) business days of submission and be communicated to the responsible person or pharmacy staff who submitted the request for additional staffing or report of concern.

OAC Rule 4729:5-5-02.4: Significant Delays in the Provision of Pharmacy Services (New)

• An outpatient pharmacy has a duty to properly dispense lawful prescriptions for dangerous drugs or devices without significant delay. For new prescriptions, "significant delay" means a prescription has yet to be dispensed within three (3) business days of receiving the prescription. For refill prescriptions not generated by a pharmacy auto-refill program, "significant delay" means a prescription has yet to be dispensed within three (3) business days of receiving the prescription. For refill prescriptions generated by a pharmacy auto-refill program, "significant delay" means a prescription has yet to be dispensed within five (5) business days of receiving the prescription.

OAC Rule 4729:5-5-02.5: Outpatient Pharmacy Access Points (New)

• An outpatient pharmacy open to the public must develop and implement an effective organizational policy that permits a pharmacist to limit the provision of ancillary services if, in the pharmacist’s professional judgment, the provision of such services (1) cannot be safely provided or (2) may negatively impact patient access to medications. Examples of ancillary services include immunizations, drug administration, medication therapy management, disease state management, and refill reminders. The pharmacy’s organizational policy should also limit pharmacy access points, if, in the pharmacist’s professional judgment, limiting such access points will minimize fatigue, distraction, or other conditions which interfere with a pharmacist's ability to safely and competently practice.
• In the absence of an organizational policy, an outpatient pharmacy shall defer to the on-duty pharmacist's decision (1) not to provide ancillary services and (2) to limit pharmacy access points.

If you have questions about these proposed rules, please contact your local BMD Healthcare Attorneys Ashley Watson at abwatson@bmdllc.com or Daphne Kackloudis at dlkackloudis@bmdllc.com.