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.