The Ohio Board of Pharmacy (BOP) requires all businesses including, medical clinics, urgent cares, veterinary clinics, medical spas, research facilities, processors, and many others (with few exceptions) who store, administer, or distribute “dangerous drugs,” to obtain a Terminal Distributor of Dangerous Drugs (TDDD) license. Obtaining this license allows the Board of Pharmacy to inspect the business at any time, with or without notice to the licensee, and imposes a biennial fee. Dangerous Drugs refers to all prescription drugs including saline, Botox, and anything else with a prescription label as well as prescription compounds like topical numbing creams.
Each licensee is subject to strict and numerous laws and regulations which dictate the storage, quantity, destruction, record-keeping, inventory logging, and the credentials and necessity of a Responsible Person. Except in the case of a Pain Clinic which requires the Responsible Person to be a State Medical Board certified physician, the Responsible Person must be a licensed healthcare professional who will be physically present to provide supervision and control of dangerous drugs on-site, will provide enough security and control of the drugs and have sufficient safeguards in place, will comply with laws regarding the drugs’ distribution, and will monitor subscriptions for suspicious orders and unusual usage and distribution. Like employment posters, the TDDD license must be posted in a visible area and must be available for inspection at any time. TDDD licensed facilities must always have a Responsible Person, and in case of a change in Responsible Person, the Board must be notified within 10 days of such a change.
Only a licensed healthcare professional may have access to the dangerous drug stock, which must be kept in an area with a physical barrier, which the BOP indicates can be in the form of a locked cabinet. While a full inventory is only required annually, a daily log must be kept of all dangerous drugs being accepted and leaving the stock. Administration, which is documented in patient records, as well as detailed and inspected invoices or shipment slips are generally sufficient for this requirement. Controlled and Hazardous substances require additional record-keeping, barriers, and safeguards. Disposal of any dangerous drug is also regulated, must be documented, must be witnessed by the patient and sometimes by another healthcare provider.
There are a few distinctions based upon the category of the licenses as well. For more information on whether your practices requires a TDDD license, the BOP has some guidance on its website: https://www.pharmacy.ohio.gov/Documents/Licensing/TDDD/General/Responsible%20Person%20Requirements%20for%20Licensure.pdf.
For additional information, consult with the experienced attorneys at SAPG Legal.