Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

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.  


Don't Get Caught Dazed and Confused: Another Florida Court Weighs in on Employer Obligations to Accommodate Medical Marijuana Use

A Florida trial court ruled in Giambrone v. Hillsborough County that employers may need to accommodate off-duty medical marijuana use under the Florida Civil Rights Act (FCRA). This contrasts with prior rulings and raises new compliance challenges for employers. With the case on appeal, now is the time to review workplace drug policies.

Corporate Transparency Act to be Re-evaluated

Recent federal rulings have impacted the enforceability of the Corporate Transparency Act (CTA), which took effect on January 1, 2024. While reporting requirements were briefly reinstated, FinCEN has now paused enforcement and is reevaluating the CTA. Businesses are no longer required to submit reports until further guidance is issued. For updates and legal counsel, contact BMD Member Blake Gerney.

Ohio Recovery Housing Operators Beware: House Bill 58 Seeks to Make Major Changes

Ohio House Bill 58 proposes significant changes to recovery housing oversight, granting ADAMH Boards authority to inspect and investigate recovery residences. The bill also introduces a Certificate of Need (CON) program, requiring state approval for major facility changes. OMHAS will assess applications based on cost, quality, accessibility, and financial feasibility. The bill also establishes a recovery housing residence fund to support inspections. For more information, contact BMD attorneys Daphne Kackloudis or Jordan Burdick.

January 2025 Notice of Proposed Rulemaking Brings Notable Changes to HIPAA Security Rule

In January 2025, the U.S. Department of Health and Human Services proposed amendments to the HIPAA Security Rule, aiming to enhance cybersecurity for covered entities (CEs) and business associates (BAs). Key changes include mandatory compliance audits, workforce training, vulnerability scans, and risk assessments. Comments on the proposed rule are due by March 7, 2025.

Corporate Transparency Act Effective Again

The federal judiciary has issued multiple rulings on the enforceability of the Corporate Transparency Act (CTA), which took effect on January 1, 2024. Previously, enforcement was halted nationwide due to litigation in Smith v. U.S. Department of the Treasury. However, on February 18th, the court lifted the stay, reinstating the CTA’s reporting requirements. Non-exempt entities now have until March 21, 2025, to comply. Businesses should act promptly to avoid civil penalties of $591 per day and potential criminal liability.