Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

The Ohio Board of Pharmacy’s Latest Batch of Rules: What Providers Should Know

Client Alert
January 15, 2024

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.

Ohio State Board of PharmacyDaphne KackloudisAshley WatsonJordan BurdickHealth Law
Client Alert

EEOC Provides Updated Guidance Regarding Employer COVID-19 Vaccine Policies

June 3, 2021On May 28, 2021, the U.S. Equal Employment Opportunity Commission updated its guidance regarding employer COVID-19 vaccination policies. The new guidance provides much-needed clarification of expectations for employers seeking to promote workplace safety and prevent the spread of COVID-19, including discussion of mandatory vaccination policies, voluntary vaccination incentives, and accommodation of employees based on disability or sincerely held religious beliefs. The full text of the update is found in Section K of the EEOC’s COVID Q&A document. You can also learn more about these and other developments from BMD's Bryan Meek and Monica Andress through the Employment Law After Hours YouTube channel, available here.Client Alert

What Telemedical Barriers Practices Face and How They Can Manage Them

May 28, 2021The onset of the COVID-19 pandemic has led to many businesses and industries having to rapidly adapt new practices in order to stay profitable, and the healthcare industry is no exception. Although telehealth tools and practices have existed and been used since the Vietnam War, the pandemic has caused many individual healthcare practices to heavily rely on telehealth as a large portion of their service mix in order to continue to provide care for patients. Because of this rapid adoption of telehealth practices in order to combat the restrictions of COVID-19, the telemedicine industry’s revenue has exploded in the last year. Experts predict that telehealth will continue to grow in use beyond the current pandemic, estimating the industry’s worth to be $25 billion by 2025. However, this rapid adoption of telehealth was prompted out of need and has not been without its own barriers that practices now face.Client Alert

Which Entity Should I Form When Starting a New Business?

May 21, 2021As a tax law attorney, friends and acquaintances ask me this question all the time: what type of entity should I form when starting a new business? With many business options available it can be confusing determining which business structure would be appropriate. Below is a general overview of each business structure and the tax responsibilities of each.Client Alert

IMPORTANT UPDATE: IRS Opens Portals for Advanced Child Tax Credit Payments 2021

May 20, 2021The American Rescue Plan Act (the “Act”) expands the Child Tax Credit for tax year 2021. In addition to expanding the Child Tax Credit, the Act provides for advance payments of the 2021 Child Tax Credit. Beginning in July, the IRS will automatically send Advanced Child Tax Credit payments to eligible taxpayers based on their 2020 tax return (or 2019 tax return if the 2020 tax return has not been filed and processed yet). The amount of the advanced payment will be up to $300 each month for each qualifying child under 6 years old at the end of 2021 and $250 each month for each qualifying child between 6 and 17 years old at the end of 2021. For example, if you have 2 qualifying children, one 4 years old and one 8 years old, you may receive up to $550 each month in advance child tax credit payments.Client Alert

Employment Law After Hours: CDC SAYS NO MORE MASKS FOR VACCINATED PEOPLE: What does this mean for employers and employees?

May 17, 2021This morning, ELAH published an emergency episode discussing the questions employers sent us since the CDC’s release of its revised mask guidance late last week. This episode explores questions such as whether an employer can allow vaccinated people to go without masks, while requiring unvaccinated people to wear a mask, whether employers can inspect an employee’s vaccine card, and it discusses the risks of liability an employer faces based on the decisions and policies it makes following the release of this CDC guidance, along with many other questions.
Older posts
Newer posts