Ohio Board of Pharmacy Issues New Guidance: 10 Compliance Pitfalls Putting Ohio Clinics and Medical Spas at Risk

The Ohio Board of Pharmacy (“Board”) released new guidance[1] identifying 10 common violations in prescriber clinics and medical spas. This guidance follows a recent surge in summary suspensions of Terminal Distributor of Dangerous Drug (TDDD) licenses, reflecting the Board’s increased focus on patient safety and the lawful possession, storage and administration of dangerous drugs. The guidance lists the following areas of noncompliance, frequently cited during recent inspections and enforcement actions[2]:

1. Purchasing from Unlicensed Sellers: Ohio law requires clinics to purchase drugs only from properly licensed wholesalers, manufacturers or pharmacies. Obtaining medications through informal channels, including online vendors, social media or other non-licensed sellers, exposes clinics to significant legal risk.
2. Purchasing Medications Marked for Research Purposes Only: Ohio and federal law prohibit possession of medications labeled “for research purposes only” or “not for human or animal consumption.” Any such products must be disposed of immediately, and patients should be advised to discontinue use.
3. Purchasing Non-FDA Approved Medications: Medications administered to patients must be legally marketed for use in the United States. Drugs intended for foreign markets or otherwise lacking FDA approval must be promptly removed from inventory and disposed of.
4. Failure to Comply with Compounding Standards: Prescribers engaged in sterile or non-sterile compounding must comply with the Board’s compounding regulations. Common violations include repackaging compounded drugs for at-home administration and failure to verify compounded drug products prior to administration.
5. Failure to Secure Controlled Substances: Ohio law prohibits unlicensed individuals from accessing controlled substances. Clinics must comply with the Board’s security requirements[3] to prevent unauthorized access.
6. Insanitary Preparation of Medications: The preparation of drug products must comply with Ohio Administrative Code 4729:7-3, including requirements related to environmental monitoring, engineering controls and routine cleaning procedures. 
7. Inadequate Recordkeeping: Common deficiencies in recordkeeping procedures include failure to maintain temperature monitoring systems for refrigerators and freezers used to store medications and inadequate drug inventory records.
8. Using Patient-Specific Drugs as Office Stock: A frequent violation involves pharmacies dispensing medications in the name of a clinic employee or individual patient and administering this same medication to other patients. Patient-specific drugs are the property of the patient, and pursuant to Ohio and federal law, cannot be administered to other persons.
9. Inadequate Labeling of Multi-Dose Vials: Multi-dose vials must be labeled with the date opened and/or the beyond-use date. Unlabeled vials must be disposed of immediately to avoid patient safety risks.
10. Expired Drugs in Active Drug Stock: Expired or adulterated drugs must be stored in a separate, secure area away from drugs used for dispensing, personal furnishing, compounding or administration. Commingling active and expired inventory increases the risk of accidental administration.

This guidance underscores the Board’s heightened scrutiny of prescriber clinics and medical spas. A compliance assessment is beneficial in many respects and can serve to reduce risk of Board sanction and the significant professional and business consequences which accompany such scrutiny.

Should you have questions regarding this guidance and your business compliance, please contact your Dinsmore Health Care attorney.