The Emergency Adoption of Rule 4729:9-1-01.2 of the Ohio Administrative Code by the State of Ohio Board of Pharmacy
WHEREAS, isotonitazene is considered one of the most persistent and prevalent new opioids in the United States; and
WHEREAS, isotonitazene is a synthetic opioid bearing structural resemblance to etonitazene, a synthetic opioid that is classified as a Schedule I controlled substance in Ohio and nationally; and
WHEREAS, isotonitazene is not approved for medical use by the United States Food and Drug Administration; and
WHEREAS, pharmacological data suggest that the group of synthetic opioids that includes isotonitazene (along with etonitazene, metonitazene, and clonitazene) has potency similar to or greater than fetanyl based on their structural modifications; and
WHEREAS, isotonitazene has been identified in at least 18 deaths in the United States; and
WHEREAS, data from the Ohio Bureau of Criminal Investigation funds that isotonitazene has been identified in the state at least 11 times since the start of 2020; and
WHEREAS, the toxicity of isotonitazene has not been extensively studied but recent association with drug user deaths lead forensic professionals to believe this new synthetic opioid retains the potential to cause widespread harm and is of public health concern; and
WHEREAS, Section 3719.45 of the Ohio Revises Code authorizes the State of Ohio Board of Pharmacy ("State Board of Pharmacy") to add to previously unscheduled compound, mixture, preparation, or substance to schedule I by emergency rule if the Board determines the compound has no accepted medical use in treatment in this state and poses an imminent hazard to the public health, safety, or welfare; and
WHEREAS, the State Board of Pharmacy has determined that isotonitazene has a high potential for abuse, has no accepted medical use in treatment in this state, and poses an imminent hazard to the public health, safety, or welfare of the citizens in this state; and
WHEREAS, Section 119.03 (G) of the Ohio Revised Code authorizes the Governor, on the request of the State agency, to suspend the normal rule making procedures with respect to specific rules when an emergency exists necessitating the immediate adoption, amendment, or recession of such rules. When such a determination is made, the agency may immediately adopt, amend, or rescind such rules. An emergency rule or amendment adding a substance to controlled substance schedule is only valid for one hundred and eighty (180) days; and
WHEREAS, the State Board of Pharmacy has requested a determination whether an emergency exists that requires the adoption of rule 4729:9-1-01.2 on an emergency basis and that would therefore permit the State Board of Pharmacy, pursuant to Section 3719.45 of the Ohio Revises Code, to make an immediate and necessary adoption of the rule.
NOW THERFORE, I, Mike DeWine, Governor of the State of Ohio, have determined, upon the reuest of the State Board of Pharmacy, that an emergency exists requiring the immediate adoption of rule 4729:9-1-01.2 of the Ohio Administrative Code.
I hereby order that the procedures prescribed be section 119.03 of the Ohio Revised Code with respect to the adoption of the specified rule be suspended and that the State Board of Pharmacy be permitted to adopt the rule immediately by filing it electronically with the Secretary of State, the Director of the Legislative Service Commission, and the Joint Committee on Agency Rule Review ("JCARR").
Furthermore, I hereby order that this Executive Order be filed in electronic form with the State Board of Pharmacy,the Secretary of State, the Director fo the Legislative Service Commission, and JCARR.
I signed this Executive Order on May 22, 2020, in Columbus, Ohio, and it will expire one hundred and eighty (180) days from the effective date of the emergency rule, or upon the adoption of the rule through the normal JCARR process, whichever is sooner.
Mike DeWine, Governor
Frank LaRose, Secretary of State