The Ohio Board of Pharmacy has suspended more than 30 clinics and med spas in 2025 after determining there is clear and convincing evidence they pose a danger of immediate and serious harm to others.

The board has since developed guidance listing the top ten common violations identified at prescriber clinics and med spas based on citations issued, in an effort to educate current and future licensees.

Take note of these common violations to make sure your aesthetic practice is operating in compliance with guidance for Terminal Distributors of Dangerous Drugs (TDDDs).

1)Purchasing from Unlicensed Sellers

Pharmacies, clinics and healthcare facilities must purchase from licensed drug distributors, which can include wholesalers, manufacturers and outsourcing facilities, and from licensed pharmacies.

Stay compliant: Verify that your seller is licensed with your state pharmacy board. Do not purchase from social media, unlicensed internet sellers, or from other clinics or prescribers.

2)Purchasing Medications Marked “For Research Purposes Only (RUO)”

Drugs labeled “for research purposes only” or “not for human or animal consumption of any kind” have not been approved by the U.S. Food and Drug Administration (FDA) and have not been found safe and effective for any condition. Prescriber clinics and med spas cannot order, possess or administer any medications marked as such. Further, they cannot be used in compounding.

As GLP-1s grew in popularity, for example, the FDA put out a warning against using unapproved versions, including salt forms of semaglutide and those labeled “for research purposes” or “not for human consumption.”

Stay compliant: Immediately dispose of any drug labeled “for research purposes only” and advise patients to discontinue use.

3)Insanitary Preparation of Medications Marked “Unfinished Drug Products” or Active Pharmaceuticals Ingredients (API)

Adding bacteriostatic saline and reconstituting unfinished drug products is considered compounding, so clinics must comply with all federal and state laws on drug compounding.

Most botulinum toxin formulations come as a vacuum-dried powder form, which is combined with sterile, normal saline (sodium chloride) as a diluent to create a clear solution of neurotoxin ready for injection. When prepared in accordance with manufacturer’s labeling, reconstituting neurotoxins is not considered prescriber compounding.

Stay compliant: Comply with all federal and state laws on drug compounding when preparing unfinished drug products or API. This may include measures such as environmental monitoring, a hood, temperature-monitored storage, regular cleaning and disinfection, and personnel and training requirements. Follow manufacturer instructions with proper equipment.

4)Purchasing Non-FDA Approved Medications Including Foreign-Sourced Drugs or Drugs Not Permitted for Compounding

Medications must be approved for use in the U.S.: medications labeled in foreign languages or with labeling indicating the drug is only approved for use in other countries may not be used in prescriber clinics or medical spas. Using equivalent drugs from another country would be called parallel importation. Med spas also cannot purchase drugs that are not permitted for compounding, such as those not authorized by the FDA for use in the U.S.

Stay compliant: Purchase FDA approved medications from legitimate supply chains. Dispose of unapproved drugs and any drugs with foreign labeling or indication that they are intended for foreign markets, such as the UK, EU, Turkey or South Korea.

5)Failure to Comply with Compounding Standards

Compounding requirements prevent bacterial contamination, with measures to make sure compounded drugs are prepared in a sterile environment and are verified products.

Stay compliant: Review your state’s prescriber compounding regulations.

6)Failure to Secure Controlled Substances

Unlicensed staff must not have access to controlled substances, including hormones, that are maintained by the clinic or med spa.

Stay compliant: Follow state-specific security requirements for controlled substances.

7)Inadequate Record Keeping

Med spas need to maintain temperature monitoring systems and logs for all refrigerators/freezers used to store drugs, and must keep a record of all dangerous drugs received, administered, personally furnished, disposed, sold or transferred.

Stay compliant: Read up on compounding record keeping requirements and maintain all logs, daily observation and inventory records accordingly.

8)Patient-Specific Drugs Used as Office-Stock (Pick-Up Station)

Clinics have been cited for using patient-specific drugs dispensed by a pharmacy as office-stock.

Stay compliant: Clinics cannot administer medication in the name of one patient to any other person. To act as a prescription pick-up station (store a patient’s medication), your clinic would need to produce “clear and convincing evidence that delivery of a prescription medication directly to the patient would result in danger to public health or to the patient without increased involvement by a health care professional,” per the guidance.

9)Labeling Multi-Dose Vials

Instead of single-use vials, it’s often efficient and economical for clinics to purchase multi-dose vials. When a multiple-dose vial is first opened, it must be labeled with a beyond-use date or date opened. For multiple-dose containers with antimicrobial preservatives, the beyond-use date is 28 days unless specified by the manufacturer.

Note for neurotoxins: Labels that say a drug ”should be used within 24 hours of preparation” mean that that drug can only be used within 24 hours. If there is no beyond-use date on a neurotoxin label, the Ohio pharmacy board advises the drug must be used within six hours of preparation.

Stay compliant: Label all multi-dose vials and dispose of any vials that exceed their beyond-use date; this prevents bacterial growth and protects your patients.

10)Expired/Adulterated Drugs in Active Drug Stock

Expired and adulterated drugs need to be removed from the active drug stock so they are not inadvertently administered to patients. Keep them separate from drugs used for dispensing, personally furnishing, compounding, and administration. 

Stay compliant: Store these drugs in a separate and secure area; carefully maintain and monitor inventory.

Read full guidance from the Ohio Board of Pharmacy.

AmSpa Members have the support of leading aesthetic and healthcare law firm ByrdAdatto. Schedule your annual consultation for a personalized check into your compliance with patient safety regulations from your state’s boards. Explore your legal resources.

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