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Top Compliance Risks for Ohio Med-Spas in 2025

Client Alert

Do you own a med-spa with a Terminal Distributor of Dangerous Drugs (“TDDD”) license? If so, it is important that you and your practice comply with applicable Board of Pharmacy rules and regulations.  

The Ohio Board of Pharmacy (“BOP”) conducts regular inspections and is finding that many med-spas are not complying with Ohio laws. In 2025 alone, the overwhelming majority of TDDD summary suspensions involved med-spas. As a result of non-compliance, inspected practices are subjected to BOP enforcement actions. A review of recent BOP enforcement actions shows that the following are some of the top inspection violations committed by Ohio med-spas:  

  • Purchasing and administering drugs that are not approved by the Food and Drug Administration (“FDA”), including those labeled “for research purposes only”;
  • Purchasing and administering drugs from unlicensed sellers and drug distributors;
  • Improper drug storage, such as storing drugs in areas open to the public, in unlocked offices or cabinets, at the incorrect temperature, and keeping expired drugs in active stock;
  • Insufficient drug records and drug labeling, such as not keeping drug destruction records, temperature logs, drug administration records, and storing compounded drugs without a beyond use date (“BUD”);     
  • Lack of necessary prescriber oversight, such as the Responsible Person not being physically present for a sufficient amount of time, and prescribers not conducting applicable final checks of compounded drugs;     
  • Storing and utilizing pre-drawn syringes that do not adhere to immediate use, non-hazardous sterile compounding rules;  
  • Operating in unsanitary conditions, such as using single-dose vials on more than one patient; and
  • Operating as pick-up stations in violation of OAC Rule 4729:5-5-14.

The BOP applies various penalties for these violations, including summary suspensions of TDDD licenses, permanent revocations of TDDD licenses, monetary penalties, probation periods, continued pharmacy education requirements, and written reprimands from the BOP.     

To learn more about Ohio med-spa compliance and how Ohio Board of Pharmacy inspections can impact your practice, please contact BMD Member Jeana Singleton at jmsingleton@bmdllc.com or 330-253-2001.  


Corporate Transparency Act Update

The Corporate Transparency Act (“CTA”), with an effective date of January 1, 2024, is set to impose strict reporting guidelines on business owners throughout the country. The following provides a brief update on two aspects of the CTA ahead of its effectiveness next week.

The Second Wave of UnitedHealthcare's Prior Authorization Cuts Started in November

In August 2023, UnitedHealthcare released its plan to eliminate roughly one-fifth of its then-current prior authorization requirements. The first round of prior authorization cuts took effect on September 1, 2023. In that round, UnitedHealthcare eliminated the necessity for some prior authorizations for UnitedHealthcare Medicare Advantage, UnitedHealthcare commercial, UnitedHealthcare Oxford and UnitedHealthcare Individual Exchange plan members. The second and final round of prior authorization cuts began on November 1, 2023. The November 2023 Prior Authorization Cuts apply to the same plans as well as community plans (i.e., Medicaid managed care plans).

Legal Uncertainties Remain Following Passage of Issue 1 in Ohio

In the November 2023 General Election, Ohio voters passed Issue 1 which, among other things, “[e]stablish[es] in the Constitution of the State of Ohio an individual right to one’s own reproductive medical treatment, including but not limited to abortion”. Despite passage of Issue 1, questions persist about how its codification on December 7 affects previously passed legislation restricting abortion and related pending court cases.

NLRB Issues Final Rule on Joint-Employer Status

On October 26, 2023, the National Labor Relations Board (NLRB) issued its final rule on determining joint-employer status, departing from its prior 2020 standard. The final rule provides that two or more entities may be considered “joint employers” if each entity has an employment relationship with employees and if the entities share or codetermine one or more employees’ essential terms and conditions of employment. The final rule goes into effect on December 26, 2023, and will only be applied to cases filed after the effective date.

WEBINAR SERIES RECAP | Employment & Labor

BMD Partner and Co-Chair of the Employment & Labor Law Group, Bryan Meek, presented this four-part webinar series on trending topics in employment law.