As a compounding pharmacy that works closely with prescriber clinics and medical spas across the country, we’ve seen one theme repeat itself when enforcement actions occur: most violations are easily preventable.
In early 2025, the Ohio Board of Pharmacy suspended more than 30 clinics and med spas after determining their operations posed an immediate risk to patient safety. The issues cited weren’t obscure regulatory traps. They were operational missteps that often happen when clinics scale quickly, source medications inconsistently, or lack clear compliance guardrails.
At Vigor Compounding, our role goes beyond supplying medication. We see ourselves as a long-term partner to providers—helping you maintain compliant operations while delivering effective weight loss care through our compounded GLP-1 medications. Below is a practical overview of the ten most common violations identified by regulators, along with our perspective and guidance on how clinics like yours can reduce their exposure.
Common Prescriber Clinic and Medical Spa Violations
1. Buying From Unlicensed or Unverified Sellers
Every clinic is required to purchase medications from licensed wholesalers, manufacturers, and outsourcing facilities. Yet inspectors continue to find drugs sourced through social media, informal online sellers, or peer-to-peer transfers. Even one undocumented purchase from an unlicensed seller can place a clinic at risk. License verification must happen before the first order and be documented on an ongoing basis.
2. Possession of “For Research Use Only” Products
Drugs labeled “for research purposes only” or “not for human consumption” are unlawful to possess or administer—regardless of patient consent. This includes research-grade GLP-1 products and other substances that have not been reviewed for safety or approved for clinical use.
If these products are found onsite, regulators expect immediate disposal and patient discontinuation.
3. Improper Handling of APIs or Unfinished Drug Products
Some clinics mistakenly assume that reconstituting or diluting an active ingredient does not qualify as compounding. Under pharmacy law, it does. Any preparation of unfinished drug products or active pharmaceutical ingredients must comply with compounding regulations, including environmental controls, documentation, and staff training. Preparing these products outside required conditions is a frequent citation.
4. Use of Foreign or Non-FDA Authorized Medications
Foreign-labeled drugs, products marked for use outside the U.S., and medications sourced from international markets fall outside legitimate supply chains. Inspectors often identify these products by foreign language labeling or “export only” markings. This issue commonly appears with injectables, peptides, and neurotoxins. These products must be removed from inventory immediately.
5. Gaps in Prescriber Compounding Practices
Clinics and providers engaged in compounding activities must follow prescriber compounding rules. Common issues include clinics pre-filling syringes for later use, preparing doses for at-home administration, or administering compounded medications without proper verification. These standards exist to reduce contamination risk and protect patients.
6. Inadequate Control of Controlled Substances
Controlled substances must be secured so only licensed personnel can access them. Clinics are frequently cited for allowing unlicensed staff access to controlled inventory, including testosterone. Clear access controls and physical security measures are essential. Please reference state and federal laws because each one is different.
7. Incomplete Records and Temperature Monitoring
Accurate records are foundational to compliance. Regulators often cite clinics for missing inventory logs, incomplete documentation, or lack of daily temperature monitoring for refrigerated medications. Even when clinics are closed, temperature tracking is still required, whether through manual logs or automated systems.
8. Using Patient-Specific Prescriptions as Shared Inventory
Medications dispensed for a specific patient belong to that patient and cannot be used as office stock. Clinics may not administer one patient’s prescription to another or function as informal pickup locations without meeting strict criteria. This remains a common and high-risk violation.
9. Improper Labeling of Multi-Dose Vials
Multi-dose vials must be labeled with the date opened and a beyond-use date—typically 28 days, unless the manufacturer or compounder specifies less than 28 days. Unlabeled or expired vials are considered adulterated and must be discarded.
10. Storing Expired or Adulterated Drugs With Active Stock
Expired or compromised medications must be segregated from active inventory and stored in a secure area until disposal. Commingling these products creates unnecessary risk and is frequently cited during inspections.
How Our Compounding Pharmacy Can Support Compliance
Many compliance issues begin upstream, with sourcing decisions. Working with a licensed U.S. compounding pharmacy that follows federal and state standards reduces exposure to research-grade products, foreign-sourced medications, and undocumented handling practices. Our CEO, Edward Zatta, RPh, has over 30 years of experience and is highly respected for his expertise in FDA regulations and pharmacy compliance
At Vigor Compounding, we are a licensed 503A compounding pharmacy. Every batch of GLP-1 medication is produced using FDA-sourced APIs and undergoes third-party testing for sterility and endotoxins.
Our processes are designed to support clinics that want clarity, consistency, and confidence in their supply chain—without cutting corners. Compliance isn’t about reacting to inspections. It’s about building systems that support safe, sustainable care as your practice grows.
Partner With Vigor Compounding
If you’re evaluating your current medication sourcing or want a pharmacy partner that prioritizes compliance as much as growth, we’re here to help. Our team works directly with prescribers to support responsible operations and long-term success.
Contact Vigor Compounding today to learn how we support clinics with compliant GLP-1 sourcing through our dependable pharmacy partnership.
