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Compliance is vital when operating a MedSpa that holds a Terminal Distributor of Dangerous Drugs (“TDDD”) license or an IV Therapy Clinic. The Ohio Board of Pharmacy (“BOP”) regularly conducts inspections to confirm compliance, and has recently released guidance regarding MedSpas, IV Therapy Clinics, and TDDD licenses. Understanding BOP guidance and implementing appropriate changes can help ensure that your practice is ready for a potential BOP inspection. The following gives insight into the recent BOP guidance.

GLP-1 Guidance:

• Currently, compounding copies of Tirzepatide and Semaglutide is prohibited.  
• Retatrutide and Cagrilintide are not permitted to be used in compounding and are not components of any FDA-approved drugs. The BOP states that “all inventory containing Retatrutide or Cagrilintide must be disposed of immediately.”  
• If a drug is commercially available, it cannot be copied through compounding. There is an exception if the drug is not commercially available, or if the compounded drug “includes a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the commercially available product.” The asserted change must be sufficiently documented on the prescription or order.

Compounded Drug Guidance:

• Prescribers must inspect and approve the compounding process.
• Using protocols or standing orders for the recommendation, compounding, and administration of IV medication is not authorized.
• Compounded drug preparation must be appropriately labeled, and should list patient identification information, the name and quantity of each ingredient, the date and time prepared, the beyond use date, and the name and initials of the person who prepared the compounded drug preparation.
• Compounded drug preparation that is not used by the beyond use date cannot be administered to patients and must be appropriately disposed.
• Needles used for compounding should never be used for patient administration.

TDDD License Guidance:  

• In general, practices engaged in drug compounding are required to have a valid and current TDDD license.
• Before purchasing dangerous drugs, a terminal distributor must verify that a drug wholesaler is licensed to engage in the sale of dangerous drugs in accordance with ORC 4729.52, or that the seller is licensed to engage in the occasional sale or distribution of dangerous drugs at wholesale in accordance with OAC Rule 4729:5-3-09.  
• Any change in the ownership, business or trade name, category, or address of a TDDD requires a new application, required fee, and license. The new application and required fee must be submitted within thirty days of any change in the ownership, business or trade name, category, or address.
• Records of dangerous drug administration must be maintained for at least three years from the date of last administration.   
• Controlled substances must be stored in a securely locked, substantially constructed cabinet or safe. The cabinet or safe cannot be in an area readily accessible to the public, must remain locked and secured when not in use, and must be stored in an area with a physical barrier and suitable locks during non-business hours. The method of accessing the cabinet or safe should prevent unauthorized access.  

To learn more about MedSpa, IV Therapy Clinic, and TDDD license compliance, please contact BMD Member Jeana Singleton at jmsingleton@bmdllc.com or 330-253-2001.