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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.  


House Bill 249: Key Updates to Involuntary Hospitalization Law for Mental Health Providers

House Bill 249 (HB 249) proposes changes to Ohio Revised Code (ORC) Sections 5122.01 and 5122.10 to expand the conditions under which a person with a mental illness can be involuntarily hospitalized.

Starting an Advanced Practice Provider Practice

Advanced practice providers (APPs), which includes non-physician providers such as nurse practitioners, physician assistants, and nurse anesthetists, commonly start their own healthcare practices. Practices may provide, for example, service offerings such as primary care, anesthesiology, mental health, and aesthetics (medical spas). However, there are a number of considerations and steps that must be taken for APPs to compliantly function independently.

FTC Increases Targeting of Companies Lacking Cyber Protection

The Federal Trade Commission (FTC) recently released a comprehensive cybersecurity report outlining key findings and recommendations based on emerging threats, trends in data breaches, and strategies for businesses to enhance their cybersecurity posture observed over the last year.

New Federal Medical Conscience Rule and Its Implications

The Department of Health and Human Services Office for Civil Rights issued a Final Rule to clarify protections for healthcare providers who refuse services based on religious or moral beliefs. This includes protection against discrimination for refusing procedures like assisted suicide or abortion. The OCR can receive complaints, conduct investigations, and enforce these protections. Entities are encouraged to update policies accordingly and display a model notice provided by the OCR.

Marijuana Reclassification and APRN/PA Prescribing

Marijuana is expected to be reclassified by the Drug Enforcement Administration (DEA) from a Schedule I controlled substance to a Schedule III controlled substance as a result of efforts by the Biden administration.