Tag: Ohio

Ohio Votes for the Decriminalization of Marijuana

On November 7, 2023 Ohio voters approved the Issue 2 ballot initiative, which will make substantial revisions to Ohio’s cannabis laws[1] and make Ohio the 24th state[2] to legalize recreational marijuana. Issue 2 was introduced by the Coalition to Regulate Marijuana Like Alcohol which, according to the group, sought to legalize and regulate the cultivation, manufacturing, testing and sale of marijuana and marijuana products to adults and also legalize home grow for adults. Reports suggest over two million Ohioans voted to approve Issue 2, a relatively high turnout given 2023 was an off-year election.[3]

Passage of Issue 2 creates Chapter 3780 in the Ohio Revised Code, which makes several changes to how Ohio law addresses marijuana, including:

  • Empowering a division within the Ohio Department of Commerce to regulate, investigate and penalize cannabis operators and laboratories;
  • Legalizing and regulating the cultivation, manufacture, testing and sale of cannabis;
  • Decriminalizing the cultivation and growing of up to six plants per person and 12 plants per residence;
  • Permitting the sale of cannabis products in the form of plant material and seeds, live plants, clones, extracts, drops, lozenges, oils, tinctures, edibles, patches, smoking or combustible product, vaporization of product, beverages, pills, capsules, suppositories, oral pouches, oral strips, oral and topical sprays, salves, lotions or similar cosmetic products and inhalers;
  • Providing for a 10% adult use tax—which is separate from the sales tax—on the sale of cannabis, the proceeds of which will be deposited in the Adult Use Tax Fund and further distributed to four newly created funds:
    • 36% to the Cannabis Social Equity and Jobs Fund
    • 36% to the Host Community Cannabis Fund
    • 25% to the Substance Abuse and Addiction Fund
    • 3% to the Division of Cannabis Control and Tax Commissioner Fund;
  • Establishing the cannabis social equity and jobs program, which will focus on addressing historically disproportionate enforcement of marijuana-related laws through efforts such as licensing and financial assistance;
  • Authorizing landlords and employers to prohibit the use of cannabis in certain circumstances;
  • Creating a program for cannabis addiction services; and
  • Designating Franklin County, Ohio courts as the venue for any court actions related to Chapter 3780.

The law becomes effective 30 days after passage of Issue 2.

The passage of Issue 2 will not be a carte blanche to cultivate, sell and possess marijuana/cannabis. Criminal penalties will also be enforced, including minor misdemeanors for the use of cannabis in public areas, criminal sanctions for fraudulent purchase by those under 21 years old, application of O.R.C. § 4511.19 (“OMVI”) against persons operating a vehicle or bike while using or under the influence of cannabis and application of O.R.C. § 2925.11 (“Possession of controlled substances”) against anyone possessing a greater amount of cannabis than authorized.[4]  Unless cannabis is reclassified as a Schedule I Controlled Substance, it remains illegal under federal law.

People and entities seeking to operate as a cultivation facility or adult use dispensary will be required to apply for, and be granted, a certificate of operation. Licensure will occur through the Ohio Department of Commerce.[5]

Legally, Issue 2 was an “initiated statute”[6] that amended the Ohio Revised Code rather than amending the Ohio Constitution,[7] meaning the Ohio General Assembly could pass laws to modify the changes implemented under the ballot initiative. As such, the regulatory details of the legalization and sale of marijuana in Ohio is far from set in stone.

Passage of Issue 2 presents a new and lucrative opportunity for Ohio entrepreneurs and businesses and Dinsmore attorneys have extensive experience in licensure and regulatory compliance of such facilities. If you have questions about applying for a certificate of operation, or whether your activities will comport with Ohio’s new laws, please contact a Dinsmore attorney.

[1] According to the ballot initiative text, “adult use cannabis, cannabis, and marijuana are all defined to mean marihuana” as defined in O.R.C. § 3179.01.

[2] The District of Columbia, Guam, and the Northern Mariana Islands have also legalized recreational marijuana.

[3] Final Issue 2 count available here.

[4] See O.R.C. §§ 3780.99(A)-(C), 3780.36(D)(1).

[5] O.R.C. § 3780.03.

[6] According to the Ohio Secretary of State, “initiated statutes” allow citizens to submit a proposed law to the people of Ohio for a statewide vote if that citizen feels that an issue is not addressed properly in the Ohio Revised Code.

[7] On November 7, Ohio also voted on amendment of the Ohio Constitution relating to abortion and other reproductive decisions

© 2023 Dinsmore & Shohl LLP. All rights reserved.

Article by Daniel S. Zinsmaster , Christopher B. Begin of Dinsmore & Shohl LLP

For more articles on Cannabis, visit the NLR Biotech, Food, Drug section.

Wendy’s E. Coli Outbreak Lawsuits

Health Department officials are investigating over one hundred cases of E. coli poisoning in Michigan, Ohio, Indiana and Pennsylvania. People have been diagnosed with food poisoning in Michigan, Ohio, Pennsylvania, and Indiana. The majority of these people claim that they ate sandwiches topped with lettuce at a Wendy’s Restaurant within the week before their food poisoning diagnosis.

Public health officials in Michigan have confirmed 43 cases of E. Coli that match the strain in a multi-state outbreak. A number of similar cases have been identified in Ohio. The specific source of the food poisoning has not been officially determined, but one possible source is romaine lettuce used to top hamburgers and sandwiches at Wendy’s restaurants.

The illness onset dates range from late July through early August 2022. The sickness and harm have ranged from mild to very severe. Many victims have required extensive hospitalization and medical care. Four cases of hemolytic uremic syndrome (HUS) have been diagnosed and suspected to be related to the contaminated lettuce at Wendy’s Restaurants.

  • E. Coli outbreak cases have been reported in the following counties: Allegan, Branch,Clinton, Genesee, Gratiot, Jackson, Kent, Macomb, Midland, Monroe, Muskegon, Oakland, Ogemaw, Ottawa, Saginaw, Washtenaw, and Wayne and the City of Detroit. Public health departments in those counties are closely monitoring patients and working hard to determine the source of the poisoning.

E. coli is a bacterium that lives in the digestive tracks of animals and humans. Most varieties are harmless, but some can cause severe illness. Common sources of E. coli include:

  • Raw milk or dairy products that are not pasteurized.
  • Raw fruits or vegetables, such as lettuce, that have come into contact with infected animal feces.

Symptoms of E. Coli poisoning are very serious. They include severe stomach cramps, diarrhea, and vomiting. Some people experience high fevers and many develop life-threatening conditions.

E. coli infections often require hospitalization and expensive medical care, the damages from this food poisoning can be extensive.

The Wendy’s food poisoning claims are just at their initial stages.  Very few lawsuits have been filed to date, but it is expected dozens will be filed in courthouses shortly.  At this time, there are no reported Wendy’s food poisoning settlements.

In general, food poisoning settlements include money payment for pain and suffering, mental anguish, and the physical injuries caused by the food contamination. In addition, claims for economic losses and damages are also demanded in a food poisoning lawsuit. These are financial losses and include payment of medical bills and expenses, as well as lost wages and income resulted from missed time at work.

If you ate food at a Wendy’s Restaurant that contained romaine lettuce in July or August and were diagnosed or hospitalized with E. coli poisoning, you may benefit from speaking to a food poisoning attorney.

Article By Lawrence J. Buckfire of Buckfire Law

For more personal injury legal news, click here to visit the National Law Review.

Buckfire & Buckfire, P.C. 2022

Ohio Court of Appeals Affirms $30 Million Libel Verdict Against Oberlin College

The Ohio Court of Appeals affirmed a judgment in excess of $30,000,000 against Oberlin College, holding that Oberlin was responsible for libelous statements made during the course of a student protest. Gibson Bros., Inc. v. Oberlin College, 2022 WL 970347 (Ohio Ct. App. March 31, 2022). The court’s rationale, if followed elsewhere, could lead to significantly broader institutional and corporate liability for statements by students and employees.

The case arose out of an incident in which an employee of the Gibson Brothers Bakery and Food Mart accused a black student of shoplifting, and then pursued and held the student until police arrived. Over the next few days, large groups of student protestors gathered outside the bakery and among other things handed out a flyer describing the incident as an “assault,” and stating that the bakery had a “long account of racial profiling and discrimination.” The day following the incident, the student senate passed a resolution calling for a boycott. It likewise described the incident as an assault on the student and stated that the bakery had a “history of racial profiling and discriminatory treatment of students….” The resolution was emailed to the entire campus and posted on the senate bulletin board, where it remained for over a year. The court found the statements to be factually untrue, because the student pled guilty to the shoplifting charge and admitted racial profiling did not occur, and the College presented no evidence of any past racial profiling or instances of discrimination at the bakery.

The court acknowledged that there was no evidence that Oberlin participated in drafting the flyer or the student senate resolution. Instead, the court found Oberlin liable on the theory that one who republishes a libel, or who aids and abets the publication of a libelous statement, can be liable along with the original publisher. As to the flyer, the court cited the following as evidence sufficient to support a jury finding that Oberlin had either republished or aided and abetted its publication:

  • Oberlin’s Dean of Students attended the protests as part of her job responsibilities;
  • the Dean of Students handed a copy of the flyer to a journalist who had not yet seen it and told students they could use a college copier to make more copies of the flyer;
  • the associate director of a multicultural resource center was seen carrying a large number of flyers, which he appeared to be distributing to others to redistribute to the public; and
  • the College provided a warming room with coffee and pizza at a site near the protests.

As to the student senate resolution, the court cited:

  • the senate was an approved organization;
  • the College created the senate’s authority to adopt and circulate the resolution;
  • the senate faculty moderator was the Dean of Students; and
  • despite having knowledge of the content of the resolution, neither the President nor the Dean of Students took any steps to require or encourage the student senate to revoke the resolution or to remove it from the bulletin board.

The court then held that despite the publicity the bakery received once the dispute arose, at the time of the protests and resolution the bakery and its owners were private persons, not public figures. Thus, the bakery only had to show that Oberlin had been negligent, rather than that it acted with reckless indifference as to the truth or falsity of the statements published.

Particularly in these polarized times, university administrators should be aware of and take steps to manage legal risks when external disputes become the subject of campus discussion and activism. Student organizations, faculty and administrators should be reminded that, to the extent they participate in protests or other public commentary outside their official roles, they should make clear they are acting for themselves and not the institution. Institutional responses to causes espoused by students or faculty need to be carefully vetted to assure that any factual assertions about third parties are accurate.

Article By Barry P. Kaltenbach and Robert T. Zielinski of Miller Canfield

For more litigation legal news, click here to visit the National Law Review.

© 2022 Miller, Canfield, Paddock and Stone PLC

One Less Way for Ohio Landowners to Challenge Royalty Severances

On February 15, 2022, the Ohio Supreme Court issued a significant decision in Peppertree Farms, L.L.C. v. Thonen establishing that, unless expressly stated otherwise, an oil and gas royalty interest retained in a deed executed prior to 1925 is not limited to the lifetime of the grantor. In so holding, the Ohio Supreme Court cut off one of the only grounds, other than the Dormant Minerals Act and Marketable Title Act, for landowners to quiet title and eliminate past oil and gas severances.

Ohio follows a legal tradition under which the default rules of English “common law” were adopted and then adapted by statute to form the basis of our legal system. At common law, a conveyance of real property had to include “words of inheritance” (i.e., an express statement that the royalty interest would last in perpetuity and be inheritable) or the interest being conveyed would be limited to the lifetime of the grantee (a life estate). Additional complications arose when a grantor sought to retain an interest by deed. If the grantor was retaining a right which had already been conveyed to him in perpetuity, then the retention qualified as a “technical exception” of a pre-existing right and additional words of inheritance were not required. However, if the grantor was creating and then retaining a new right, the retention qualified as a “technical reservation” and was limited to a life estate.

As new modes of production and corresponding property rights were discovered, it became unclear exactly what rights pre-existed a severance and the whole system of distinctions fell apart. In 1925, the General Assembly passed a law establishing that all future conveyances of real property were presumed perpetual unless stated otherwise. While eliminating this issue as to future deeds, the General Assembly did not settle the issue as to deeds executed before 1925 or clarify whether the retention of an oil and gas royalty was a “technical exception” or “technical reservation.”

In the Peppertree Farms case, Plaintiffs Peppertree Farms, Jay Moore and Amy Moore (collectively, “Peppertree”) sought to quiet title to certain lands in Monroe County, Ohio, against a severed oil and gas royalty interest (the “Royalty Interest”) originally retained by the grantor under a 1921 deed. In addition to a claim for extinguished under Ohio’s Marketable Title Act, Peppertree asserted that the Royalty Interest did not include words of inheritance and was therefore a newly created right which terminated upon the death of the grantor under the 1921 deed. Conversely, the defendant royalty owners (“Royalty Owners”) argued that the Royalty Interest was a pre-existing right which the grantor already held, and therefore could retain, in perpetuity without words of inheritance.

While Peppertree was able to convince both the trial and appellate court that the Royalty Interest was a newly created interest which was limited to a life estate, it was unsuccessful with the Ohio Supreme Court. Reasoning that a royalty was nothing more than the retention of part of the right to receive the proceeds of oil and gas production, the Court ultimately found that the Royalty Interest was a “technical exception” which survived the lifetime of the grantor. As a result, Peppertree was limited to its claims for extinguishment under the Marketable Title Act and Ohio surface owners lost another means to challenge ancient royalty reservations.

©2022 Roetzel & Andress
For more articles on local state litigation, visit the NLR Litigation section.

Physicians Face Regulatory Exposure for Prescribing COVID-19 Drugs Cited by President Trump

Physicians and medical professionals throughout the world are facing and attempting to treat one of the most serious and deadly viruses that has affected the world in our lifetime. Medical professionals are on the front lines and in a position, despite their best efforts to protect themselves, to contract the disease. Medical professionals do not only fear for their own lives but also for the lives of their family members if they unintentionally bring this disease home.

In light of safety concerns for their family members, over the past few weeks, there have been reports claiming physicians throughout Ohio have prescribed chloroquine and hydroxychloroquine, frequently cited by President Donald Trump, to family members and friends. In some reported instances, prescriptions were issued even when such individuals did not exhibit signs or symptoms of the coronavirus.

In order to preserve the stockpile of medications for patients, on March 22, 2020, the Ohio Board of Pharmacy issued an emergency rule (OAC 4729-5-30.2) that prohibits a pharmacist from filling prescriptions for chloroquine or hydroxychloroquine without a valid COVID-19 diagnosis and positive test result.

On March 30, 2020, the Ohio Attorney General’s Office issued the following statement, which highlighted the Pharmacy Board’s new emergency rule and advised physicians to self-report to the State Medical Board of Ohio if they prescribed these medications improperly:

“It has come to my attention that physicians may be abusing their privilege to prescribe medications by writing prescriptions for chloroquine and hydroxychloroquine for themselves, their friends and their families without any legitimate medical need for the medication. As Attorney General, I am very concerned with these reports and will work vigorously with Ohio’s regulatory boards and agencies to address any illegal or prohibited conduct. I encourage anyone who has written a prescription of this type improperly to self-report to their respective regulatory authority.”

The State Medical Board of Ohio is also on record stating that it takes allegations of inappropriate prescribing very seriously, and that it will be actively investigating complaints as they come in and working with the Ohio Attorney General on any necessary enforcement actions for bad prescribing.[i]

In addition to state regulators, the U.S. Attorney’s Office for the Northern and Southern Districts of Ohio have set up a COVID-19 Task Force. One of its responsibilities is to investigate and criminally prosecute physicians who have egregiously prescribed chloroquine and hydroxychloroquine to themselves, family members, or friends without a legitimate medical purpose. The Task Force is comprised of representatives of the United States Attorney’s Office, Ohio Attorney General’s Office, State Medical Board, and the Pharmacy Board.[ii]

Physicians who recently prescribed chloroquine and hydroxychloroquine and who are considering whether they should self-report to the Medical Board should first contact experienced legal counsel to determine the implications of a possible self-report, including the potentiality of license discipline and/or criminal charges.

[i] See:  https://clt945532.bmeurl.co/A27E486

[ii] See: https://www.dispatch.com/news/20200324/feds-yost-will-prosecute-doctors-who-abuse-power-with-personal-coronavirus-prescriptions

© 2020 Dinsmore & Shohl LLP. All rights reserved.

For more COVID-19 developments, see the dedicated National Law Review Coronavirus News page.

PTSD Compensation for First Responders without Associated Physical Injury Revisited by Ohio Legislature in New House Bill

With the recent proliferation of mass shootings and other deadly incidents, several states have taken on the issue of allowing mental and/or emotional impairments caused by post-traumatic stress disorder (PTSD) to be a compensable workers’ compensation condition for first responders without the requirement of a physical injury.

In June 2019, House Bill 80, the budget bill for the Ohio Bureau of Workers’ Compensation, included such a proposal. After the bill passed the House, the Senate stripped the policy provisions on the mental-only diagnosis issue out of the proposed budget. Senate leaders indicated while there may be a reason for a special circumstance, it should be studied and debated separately from the workers’ compensation budget. In July 2019, leadership vowed to consider the legislation later in the year.

True to their word, the issue was revived in September 2019 by Representative Thomas Patton. House Bill 308 reintroduced the issue of PTSD coverage for first responders exposed to traumatic events in the course and scope of their employment. Two hearings on the bill have already occurred, most recently on Oct. 22, 2019. Proponent testimony was offered by several organizations and individuals. The statements reiterated concerns first responders are not able to pursue avenues for compensation under the law set forth by the Supreme Court of Ohio in Armstrong v. John R. Jurgensen Co. Interestingly, one of the organizations offering proponent testimony was the Ohio State Medical Association.

The business community remains opposed to any legislation that would allow for a “mental-mental” avenue for claimants. Rob Brundrett, director of public policy for the Ohio Manufacturers Association, provided testimony on House Bill 80 earlier this summer. Beyond merely the increased cost to employers, if a mental-only diagnosis were allowed, Mr. Brundrett noted the potential expansion of workers’ compensation beyond first responders could be required.

“If we erode the physical-injury requirement for peace offers, firefighters, and emergency medical workers, it may be difficult to justify not doing the same for other professionals who seek equal treatment,” Mr. Brundrett said in his testimony.

How such a proposal would be funded is also a concern of employers. Mr. Brundrett, who is closely following House Bill 308, has indicated that several discussions in the Senate have occurred in recent weeks on a potential bill that would provide PTSD coverage for first responders outside of the Bureau of Workers’ Compensation system. This proposal would, of course, be the preference of the business community.

While passage of this issue in the past has been unsuccessful, the August 2019 mass shooting in Dayton and its impact on first responders may result in this bill moving through the legislature. Dinsmore’s workers’ compensation group will continue to monitor this bill, as its passage would have a profound impact on employers.

If you wish to see the proponent testimony and follow the bill, you can obtain more information here.

© 2019 Dinsmore & Shohl LLP. All rights reserved.

For more on mental health, see the National Law Review Health Law & Managed Care page.

Payment Processor Held Accountable by FTC

The Federal Trade Commission and the Ohio attorney general recently initiated legal action against a payment processor arising from alleged activities that enabled its customers to defraud consumers.

According to the FTC, the defendants generated and processed remotely created payment orders (“RCPOs”) or checks that allowed unscrupulous merchants, including deceptive telemarketing schemes, to withdraw money from their victims’ bank accounts.

The FTC’s Telemarketing Sales Rules specifically prohibits the use of RCPOs in connection with telemarketing sales.  RCPOs are created by the processor and result in debits to consumers’ bank accounts without a signature.

“To execute their payment processing scheme, Defendants open business checking accounts under various assumed names with banks and credit unions, the majority of which are local institutions,” according to the complaint.  Within the last five years, the defendants opened at least 60 business checking accounts at 25 different financial institutions, mainly in Texas and Wisconsin, to enable their activity, the regulators said. “Defendants often misrepresent to the financial institution the type of business for which they open the account, and routinely fail to disclose the real reason for which they open the account—processing consumer payments for third-party merchants via RCPOs.  Red flags about Defendants’ practices have led at least 15 financial institutions to close accounts opened by Defendants.  When that happens, Defendants typically open new accounts with different financial institutions.  ”

According to the Ohio AG and FTC lawyers, the defendants specifically market their RCPO payment processing service to high risk merchants.  The complaint also alleges that the defendants are aware that some of their largest merchant- clients sell their products or services through telemarketing.

The FTC and Ohio AG also allege that the defendants violated the TSR by charging consumers advance fees before providing any debt relief service, failing to identify timely and clearly the seller of the purported service in telemarketing calls, and failing to pay to access the FTC’s National Do Not Call Registry.

The Ohio AG previously had previously filed suit against the defendants for similar violations.

According to the FTC CID attorneys, the telemarketing operations that defendants supported included, among others, student debt relief schemes, and a credit interest reduction scheme.  The FTC and Ohio allege that using RCPOs, the defendants have withdrawn more than $13 million from accounts of victims of these telemarketing operations since January 2016.

“The FTC will continue to pursue such schemes aggressively, and hold accountable payment processors that are complicit in the illegal conduct,” FTC lawyer Andrew Smith said in a statement about the case.

The complaint alleges violations of the FTC Act and Ohio state law, and seeks injunctive relief plus disgorgement of alleged ill-gotten gains.

At the same time, the FTC and state of Ohio filed another enforcement action against one of the processor’s biggest clients based in Canada and the Dominican Republic.

Federal and state regulators have evidenced a willingness to both go after merchants that engage in unfair and deceptive practices that are injurious to consumers, as well as the payment processors that enable merchants to engage in such conduct.

© 2019 Hinch Newman LLP

Fore more FTC finance enforcement actions, see the National Law Review Financial Institutions & Banking law page.

Cincinnati City Council Passes Ordinance Prohibiting Salary History Inquiries

In a thinly veiled attempt to steal the spotlight from Cleveland, the new destination city for the National Football League, on March 13, 2019, the Cincinnati City Council passed Ordinance No. 83-2019, titled Prohibited Salary History Inquiry and Use, barring employers from inquiring about or relying on job applicants’ salary histories. It is scheduled to become effective in March 2020, and it applies to private employers with 15 or more employees in the city of Cincinnati.

The ordinance makes it “an unlawful discriminatory practice for an employer or its agent to:

    1. Inquire about the salary history of an applicant for employment; or
    2. Screen job applicants based on their current or prior wages, benefits, other compensation, or salary histories, including requiring that an applicant’s prior wages, benefits, other compensation or salary history satisfy minimum or maximum criteria; or
    3. Rely on the salary history of an applicant in deciding whether to offer employment to an applicant, or in determining the salary, benefits, or other compensation for such applicant during the hiring process, including the negotiation of an employment contract; or
    4. Refuse to hire or otherwise disfavor, injure, or retaliate against an applicant for not disclosing his or her salary history to an employer.”

The ordinance does not limit employers from asking applicants “about their expectations with respect to salary, benefits, and other compensation, including but not limited to unvested equity or deferred compensation that an applicant would forfeit or have cancelled by virtue of the applicant’s resignation from their current employer.” Ordinance No. 83-2019 requires that, following a conditional offer of employment, upon request, the employer must provide the conditional offeree the pay scale for the position. The ordinance provides a private right of action to enforce the law. Remedies for violating the ordinance include “compensatory damages, reasonable attorney’s fees, the cost of the action, and such legal and equitable relief as the court deems just and proper.”

Ordinance No. 83-2019 is designed to “ensure that . . . job applicants in Cincinnati are offered employment positions and subsequently compensated based on their job responsibilities and level of experience, rather than on prior salary histories.” In reality, it reaches well beyond Cincinnati, as state and local salary history bans are proliferating. Many municipalities, cities, and states across the country have passed laws limiting salary inquiries, and legislation is pending in numerous other jurisdictions around the country.

 

© 2019, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.
Read more on Equal Pay issues on the National Law Review’s Labor and Employment page.

New Board of Pharmacy Regulations Significantly Narrow the Sole Proprietor Exemption and Impose New Compounding Standards

New regulations from the Ohio State Board of Pharmacy now require any prescriber who will possess, have custody or control of, or distribute dangerous drugs that are compounded or used for the purpose of compounding to be licensed as a Terminal Distributor of Dangerous Drugs (TDDD). This new requirement is particularly noteworthy for physicians, dentists, and others who have previously operated under the “sole proprietor” exemption from licensure as a TDDD. That exemption has been widely used in Ohio and has traditionally permitted practitioners who 1) operate as sole proprietor, sole shareholder of a corporation or professional association, or sole member of a limited liability company; and 2) are the sole authorized prescribers in the practice to be exempt from the TDDD licensure requirements. These new regulations narrow this exemption by now requiring that all prescribers who “compound” or use “compounded” drugs become licensed as a TDDD, even if those prescribers had previously qualified under the “sole proprietor” exemption.

The scope of what constitutes “compounding” is broad – likely broader than what is commonly believed. Ohio law defines “compounding” as the preparation, mixing, assembling, packaging, and labeling of one or more drugs and also includes the reconstitution of drugs in accordance with the manufacturer’s instructions.1 Under the new regulations, any “compounding” activity, possession, or administration of a compounded drug requires TDDD licensure, even by a previously exempt “sole proprietor.”

Additionally, these same new regulations impose new standards for compounding sterile products, non-sterile products, and hazardous drugs and more stringent rules governing purchase of compounded drugs from in-state pharmacies, out-of-state pharmacies, and outsourcing facilities.2 These regulations were imposed in order to bring Ohio into compliance with the 2013 Drug Quality and Security Act, a federal law passed in response to the deadly outbreak of fungal meningitis in 2012 that was linked to the New England Compounding Center.

Article By Eric J. Plinke, Sarah C. Persinger, PharmD, RPh & Daniel S. Zinsmaster

© 2016 Dinsmore & Shohl LLP. All rights reserved.

1 Hazardous Drug Compounding by Prescribers
2 http://codes.ohio.gov/oac/4729-16

Ohio Following National Trend in Clarifying Permissible Telemedicine Activities

On April 15, 2016, the State Medical Board of Ohio (Ohio Board) released proposed rules outlining the requirements for practitioners to prescribe or cause a prescription drug to be provided to a person who is at a location remote from the practitioner and for whom the practitioner has never conducted a physical examination. The proposed rules were a result of Ohio Revised Code Section 4731.74, enacted March 23, 2016, which tasked the Ohio Board with developing clear standards for practitioners who treat patients through telemedicine platforms. The proposed rules will replace Ohio Administrative Code Rule 4731-11-09.

Ohio defines “the practice of telemedicine” as “the practice of medicine in this state through the use of any communication, including oral, written, or electronic communication, by a physician located outside of this state.”i While this definition only references physicians, the Ohio Board has indicated that the proposed rule will also be applicable to podiatrists and physician assistants who have prescriptive authority. Any practitioner who treats a patient located in Ohio through telemedicine must be licensed by the Ohio Board or possessing a limited Ohio telemedicine certificate issued by the Ohio Board.

With regard to non-controlled substances, the proposed rules will authorize a practitioner to establish a practitioner-patient relationship by the use of appropriate technology in a manner consistent with the minimal standard of care for in-person treatment by a practitioner. This encompasses a medical evaluation and the collection of relevant clinical history as needed to establish a diagnosis, identify any underlying conditions, and identify any contraindications to the treatment recommended or provided. This information must be documented in the patient’s medical record along with confirmation of the patient’s identity, the patient’s physical location, and the patient’s informed consent for treatment through remote examination.

In accordance with the proposed rules, controlled substances may only be prescribed by a practitioner who has met the steps outlined above for authorizing non-controlled substances and one of the following situations exists:

  • The person is an “active patient” of a health care provider who is a colleague of the practitioner and the controlled substances are provided through an on call or cross coverage arrangement between the health care providers. Note that “active patient” means that within the previous 24 months, the practitioner conducted at least one in-person medical evaluation.

  • The person has been admitted as an inpatient or resident of an institutional facility such as a hospital, nursing home, or psychiatric facility.

  • The practitioner is appropriately engaged in the practice of telemedicine as defined in 21 C.F.R. 1300.04.

The Ohio Board’s proposed rules follow similar recent developments from other state licensing agencies, including Indiana, West Virginia and Washington State. The Ohio Board is accepting comments regarding the intended regulations through Thursday, May 12, 2016. For more information on the proposed rules and/or submitting comments about the rules, please contact a Dinsmore health care attorney.

Article By Daniel S. Zinsmaster & Jenna Moran ofDinsmore & Shohl LLP

© 2016 Dinsmore & Shohl LLP. All rights reserved.

1 Ohio Revised Code Section 4731.296.