Highlights of Medical Marijuana Proposed Rules for Ohio Dispensaries and Physicians
On December 15, 2016, the Ohio Board of Pharmacy posted its proposed rules governing the operation of medical marijuana dispensaries. The same day, the State Medical Board posted its proposed rules regulating the issuance of certificates to physicians wishing to recommend medical marijuana to their patients. Below are a few key points from each set of proposed rules.
- Licenses, Applications, Certificates. Initially, the state will allow up to 40 dispensary licenses until September 8, 2018 when it will consider offering additional licenses based on the state’s population, number of patients seeking to use medical marijuana, and the geographic distribution of dispensaries state-wide. The application fee for a dispensary license will be $5,000 and a certificate to operate the dispensary will be $80,000. Dispensary licensees must also renew the certificate to operate every two years and pay $80,000 for each renewal.
- Employee Training. Each dispensary will have an employee training program and each employee must receive a minimum of eight hours of training per year on topics such as the state’s drug database, the state’s inventory tracking system, dispensary confidentiality requirements, and instruction on the different medical marijuana strains.
- Clinical Director. Each dispensary will have to hire a clinical director who is either a licensed pharmacist, or one of the following licensed professionals authorized to prescribe drugs: a clinical nurse specialist or certified nurse practitioner, a physician, or physician assistant. The clinical director will be responsible for implementing a variety of employee trainings and overseeing the dispensary’s operations.
- Certificate to Recommend. Qualifying physicians will not “prescribe” medical marijuana to patients, instead, they will have to receive a certificate that will allow them to “recommend” its use. To receive a certificate to recommend, a physician will be required, amongst other things, to hold an active registration with the Drug Enforcement Agency, complete at least two hours of continuing medical education regarding medical marijuana, and not have any type of compensation arrangement with any medical marijuana licensed entity.
- Standard of Care. A physician recommending the use of medical marijuana will be required to maintain medical documentation with a patient that includes things like a description of the patient’s current medical condition and documented review of the patient’s current medication to identify possible drug interactions with opioids.
- Physician’s Duties. A physician recommending treatment with medical marijuana will have to ensure the patient is registered with the Ohio Board of Pharmacy’s medical marijuana patient registry and, if the patient is registered and has received a recommendation in the immediately preceding 90 days, no medical marijuana recommendation may be made.
Public comments to the proposed dispensary rules should be directed to firstname.lastname@example.org, and comments to the proposed physician rules should be directed to email@example.com. Comments will be accepted until 5:00 p.m. EST on January 13, 2017.
To view the original Frost Brown Todd Legal Update: Highlights of Medical Marijuana Proposed Rules for Ohio Dispensaries and Physicians
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Brian F. Higgins is an associate in FBT's regulated business group with a focus on health care, and he has a history as corporate counsel to Medpace, Inc., a pharmaceutical clinical research organization.