Ohio’s Opioid Fight: Board of Pharmacy’s Regulation of Office-Based Opioid Treatment Clinics Axed

September 6, 2023Legal Alerts

Ohio’s Opioid Fight: Board of Pharmacy’s Regulation of Office-Based Opioid Treatment Clinics Axed

Ohio is eliminating the Ohio Board of Pharmacy’s (“BoP”) regulation of office-based opioid treatment (“OBOT”) clinics. Ohio law currently requires any clinic where a prescriber provides treatment for opioid dependence or addiction using a controlled substance, such as Suboxone or Subutex, to more than 30 individuals must possess a Terminal Distributor of Dangerous Drugs (“TDDD”) license with an OBOT classification.[i] House Bill 33 of the 135th General Assembly, also known as the Operating Budget, repeals[ii]  this requirement effective October 3, 2023, eliminating the BoP’s licensure of OBOT clinics, unless medications are maintained onsite for administration or furnishing to patients.[iii] The BoP released updated guidance for OBOT providers in response to the repeal.

Ohio’s prior TDDD with OBOT classification regulations originally went into effect in 2017 in response to regulatory concerns pertaining to OBOT ownership and operations. The laws enhanced the BoP’s ability to regulate clinics, similar to its enhanced regulation of Ohio pain management clinics following the “pill mill” epidemic. Though perhaps well-intentioned, members of the medical community worried that the 2017 regulations imposed on OBOT clinics would stifle and deter health care providers from entering into the field and providing much needed care to Ohioans suffering from opioid dependence or addiction. 

With the repeal of the TDDD with OBOT classification requirements, current OBOT operators are still required to follow the BoP’s rules relating to the general TDDD requirements for possession of dangerous drugs. Specifically, clinics that possess any dangerous drugs (i.e. medications that require a prescription) must obtain and maintain a Category 2 TDDD license. Clinics that possess dangerous drugs and controlled substances onsite will need a Category 3 TDDD license.[iv] OBOT clinics with medications such Vivitrol (a/k/a naltrexone) and/or antibiotics onsite will need to maintain a Category 2 TDDD license, while any OBOT that possesses controlled substances such as Buprenorphine, will need a Category 3 TDDD license. Notably, existing TDDD with OBOT classification clinics do not need to take any action, as the BoP will automatically convert their current OBOT classification to a Category 3 TDDD license on October 3, 2023.

In addition to changes to OBOT clinic licensure, Ohio eliminated TDDD licensure requirements for certain non-prescriber practices, effective July 11, 2023.[v] Such non-prescriber practices include the possession of nitrous oxide for maintenance of plumbing or heating, ventilation and air conditioning systems, as well as possession of medical oxygen, sterile water and sterile saline for direct administration to patients. These exemptions do not apply to entities that possess controlled substances or dangerous drugs used for compounding.

TDDD regulations are constantly changing, and Dinsmore health care attorneys can assist practices in ensuring compliance with Ohio law. Contact a Dinsmore health care attorney to learn more about our expertise and services.

[i] ORC 4729.355(B)(1)

[ii] See House Bill 33 of the 135th General Assembly, Section 105.01 at page 2772.

[iii] Ohio Legislative Commission analysis available here, page 494.

[iv] ORC 4729.54.

[v] The BoP issued an update to 4729.514(A), removing these non-prescribers from the licensure requirement. Although the effective date of the changes is October 3, 2023, the BoP has indicated it is honoring the rule change effective July 11, 2023.