Dr. Lunderville Unpacks The FDA’s Presentation at The Medical Spa Show by AmSpa

If you feel confused, you are not alone. At the American Med Spa Association (AmSpa) this past weekend in Las Vegas, I attended a special session by the FDA to discuss just this, and I want to break down what they said. They focused on two main areas: compounding regulations (for drugs like GLPs, peptides, hormones, if you use compounding) and the Drug Supply Chain Security Act (DSCSA), which applies to everything else we do (neurotoxin, fillers, generally dosed injectables).

The panel brought together key leaders in regulation and compliance: Aaron Weisbuch, Senior Regulatory Advisor at the FDA’s Center for Drug Evaluation and Research (CDER); Madison Dini, JD, Partner and General Counsel at Michelman & Robinson, LLP and Lynch Regenerative Medicine; Philip Bonforte, Lead Regulatory Counsel at the FDA and moderated by Alex Thiersch, JD, Founder and Chairman of AmSpa. Each speaker contributed a valuable perspective on how medspas must navigate increasing federal scrutiny.

A central theme of the discussion was clarifying the FDA’s role. The agency protects public health by enforcing federal laws that ensure the safety, quality, and integrity of drugs, devices, and products.It does not regulate the practice of medicine. That responsibility belongs to state medical boards. It also does not regulate pricing or insurance. This distinction is critical for medspa owners, as many compliance issues arise from misunderstanding the boundaries between federal and state oversight. They emphasized many times that state agencies are more likely to investigate, but that they help to uphold federal laws, and call on the FDA when needed. They also emphasized that the FDA will investigate with cause, meaning a complaint is filed or a bad outcome occurs that will trigger further action. 

FDA on Compounded Medications 

First, let’s chat about compounded medications, as it’s hard to get away from GLPs ads on my podcasts and billboards advertising them cheaper than ever from every corner. It feels like we live in a time where they might as well put them in the water. We often forget that most of these companies that heavily advertise are NOT FDA approved, and neither are the medspa versions most of us use.  However, while compounded drugs are not FDA-approved, they may still be lawful if they meet specific federal requirements, which is important for medspas and wellness companies to understand. The FDA has established an oversight framework, and failure to comply can result in violations of federal law. The FDA made a point that compounding in the U.S. has surged, but so has its regulation under Trump and RFK Jr as of September 2025 in their efforts to crack down in general on pharmaceutical direct-to-consumer advertising, a part of their larger MAHA campaign.

The rapid rise in compounded drug use in the United States is driven by several factors. 

1. Patient demand has increased significantly, particularly for treatments such as GLP-1 medications and peptides. 
2. Telemedicine has expanded access, making it easier than ever for patients to obtain these therapies. 
3. Drug shortages and high costs of FDA-approved medications have pushed patients to seek alternatives. 
4. Additionally, social media and online platforms have amplified awareness and normalized these treatments. Serena Williams recently went on Oprah just to share her GLP journey. I mean, if Serena is using it?! Why NOT ME?!

The FDA evaluates compounding compliance across three primary areas: the drug itself, promotion, and production. As a medspa, you are required to ensure that the GLP or peptide you’re selling at any time must meet the following:

For the drug itself, practices must demonstrate that the medication is prescribed for an individual patient, does not contain impermissible ingredients, is not essentially a copy of an FDA-approved drug that is commercially available, and has not been withdrawn from the market for safety reasons.

For promotion, the FDA assesses whether claims are truthful and supported by evidence, whether marketing implies FDA approval or equivalence, and whether the compounded nature of the product is clearly disclosed (this applies to your ads and social media!)

For production, oversight includes verifying that ingredients are sourced from registered suppliers, that preparation conditions prevent contamination, that processes ensure strength and quality, and that sterile practices are used for injectable products (please don’t answer those shady DMs; I will provide you with my approved pharmacy at the end of this article).

The panel emphasized that any entity that buys or sells compounded medications, including medspas, is responsible and liable for complying with these laws, aka you cannot blame the pharmacy or that you “did not know”. We often struggle with reps who swear it’s safe and a verified compliant pharmacy, but do not trust these reps! Check for yourself. Enforcement often begins when the FDA becomes aware of an issue, whether through adverse events, complaints, or suspicious practices that trigger an investigation.

“My sister and all my gym friends buy them online from a shady source. Why does my medspa need to be overly careful?”

When it comes to compounded medications like GLPs, state agencies and the FDA do look for specific behaviors from clinics and spas. Just because you think you’re flying under the radar does not mean you are immune from being investigated, shut down, or subject to criminal charges.

The FDA gave concrete examples of high-risk behavior, including offering noncompliant products such as retatrutide injections (they really do not like retatrutide), making promotional claims that imply FDA approval, and purchasing medications from unverified or contaminated sources. The guidance was clear. Avoid noncompliant peptides, be transparent that compounded products are not FDA-approved, and work only with properly registered pharmacies.

The current administration has recommitted to addressing deceptive drug advertising, expanding oversight across pharmaceutical companies, telehealth platforms, influencers, and medspas. Since then, more than 100 warning letters have been issued requesting documentation to demonstrate compliance, with a particular focus on social media marketing.

The FDA Also Gave Guidance on Non-Compounded Drugs That Medspas Regularly Prescribe

The second half of the discussion at AMSPA covered the Drug Supply Chain Security Act (DSCSA), which governs the distribution of FDA-approved drugs such as injectables, though it does not apply to compounded medications. Under this law, medspas are considered “distributors” and must meet requirements including product tracing, working with authorized trading partners (ATPs), maintaining product identifiers, and verifying suspect or illegitimate products.

One of my earliest memories of being in residency was the tenacity of the nurses who needed orders placed with subsequent lot numbers, expiration dates, and NDC codes for any medications I gave, even when I was on hour 25 of no sleep. They hunted me down at home sometimes, like it was an episode of CSI, leading me to fish out the empty bottles in my white coat to catch up on remotely recording every last dose given. I look back fondly on those nurses who taught me good principles of record keeping I keep to this day. Medspa nurses who have never worked in a hospital setting often lack the urgency and sanctity of these practices, but they are no less important in aesthetics. Let’s talk about why.

The Drug Supply Chain Security Act (DSCSA) establishes a closed, traceable supply chain for FDA-approved medications to prevent counterfeit, diverted, or contaminated products from reaching patients, and med spas are the last link in the chain before being administered to patients. Within this system, every entity that handles a drug plays a defined role, and medspas are dispensers that must also function as responsible downstream trading partners. This means we are required to purchase medications only from authorized, licensed wholesalers or manufacturers (if you are not obtaining directly from the manufacturer, it is on YOU to verify a wholesaler as an Authorized Trading Partner). Most of our products we get from the manufacturer, but in many cases, you are buying from a wholesaler, i.e., McKesson, Henry Shein, Crown Aesthetics are all examples of wholesalers.

In addition to verifying your ATP, you must ensure that each product you receive is accompanied by complete “transaction information,” including the National Drug Code (NDC), lot number, expiration date, and serial number.  These identifiers, embedded in a 2D data matrix barcode on the “smallest sellable unit” (think every vial of Botox has unique identifiers), allow the product to be traced back through every step of the supply chain. Medspas must verify that their suppliers are legitimate, maintain records of these transactions, and have processes in place to identify and quarantine any suspect or illegitimate products. If a product appears altered, lacks proper labeling, or cannot be traced, it must not be used and should be reported. While medspas are not typically responsible for full upstream tracing like manufacturers or wholesalers, they are critical gatekeepers at the point of patient administration. Your role as a medspa is to ensure that every injectable or prescription product administered is authentic, properly sourced, and fully traceable, thereby maintaining the integrity of the drug supply chain and protecting patient safety.

In practice, you must source medications like Botox and injectables only from authorized manufacturers or approved wholesalers and maintain complete documentation, including National Drug Codes (NDC), lot numbers, expiration dates, and serial numbers for traceability. AKA no shady third-party “cheap” products.

Using a Texas MedSpa as an example of what NOT to do

A case example highlighted by the FDA involved a Texas medspa where discrepancies between the purchased toxin from AbbVie and the documented amount of usage triggered a for-cause inspection, and they were found to have been buying third-party non-approved toxin (the FDA reported that they did, and often to, search the trash of these spas, finding counterfeit products). Investigators found multiple violations, including misbranded products that did not meet labeling requirements. The practice was cited for violations of DSCSA provisions and subject to seizure, fines, and shutdown in addition to criminal charges.

The overarching message was straightforward. If a deal seems too good to be true, it probably is. Avoid purchasing medications from overseas or suspicious online vendors. Maintain meticulous records, verify all product identifiers, and ensure licenses and supplier credentials are current. Although I love a follow, I always block accounts like @fillerlife_cheap4U, and you should too, as nothing is more important than integrity, protecting your license, and patient safety.

Key Takeaways Are Clear

DONT:

• Sell medications that fail federal requirements. 
• Rely solely on supplier or rep assurances
• Promote compounded drugs in a false or misleading manner, clearly state what is FDA approved, not FDA approved, and do not oversell or inflate results 

DO: 

• Verify suppliers independently. 
• Understand the regulatory status of every medication you prescribe
• Regularly review FDA warning letters and safety communications
• Stay current with guidelines; they change often 
• Follow available guides and resources (available at the end of this article)
• Maintain your state licensure

While the FDA may not frequently inspect medspas directly, state regulators actively enforce these standards. Compliance is not optional. It is essential for protecting both patient safety and your professional license.

I think it’s worth mentioning that the FDA appreciated that we attended a conference and lecture all about compliance, and that the “bad actors” in our industry, if you will, are probably not reading or studying compliance. We see them every day online advertising dirt-cheap “longevity” medications, and we see patients come in with complications from these products. These companies still face criminal charges if found non-compliant and should be reported to state and federal agencies. They appreciate that compliance is often so frustrating because it is a case-by-case application of various laws, and depends on the patient, the clinic, the state, and federal regulations. No one will probably ever get a 100% score on a compliance check, but doing your best, working with an experienced healthcare attorney, and keeping up with updates and conferences as much as you can will at least help protect you and your patients.

I think a helpful way to think about compliance is to compare it to practicing medicine itself. No physician can guarantee a 100% perfect outcome for every patient. There are variables, evolving data, and human factors. But the expectation is that you follow the standard of care, stay educated, document thoroughly, and make thoughtful, informed decisions. You may never achieve perfection, but by consistently striving for excellence, you practice safely and responsibly.

Comment with your questions or quandaries related to compliance! 

Dr. C’s preferred pharmacy for GLPs, peptides, compounding: MD Hayvn, where you can access education, protocols, and preferred pricing via an exclusive portal HERE.

FDA Resources

Verify annual reporting (to confirm ATP status)
https://www.accessdata.fda.gov/scripts/cder/wdd3plreporting

Verify State Licensure (to confirm ATP status)
https://www.fda.gov/drugs/drug-supply-chain-integrity/check-licensure-wholesale-drug-distributors-and-third-party-logistics-providers

Human Drug Compounding – https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

FDA’s DSCSA Resources – https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

Pharmacists: Utilize DSCSA Requirements to Protect Your Patients – https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/pharmacists-utilize-dscsa-requirements-protect-your-patients

Know Your Source: Protecting Patients from Unsafe Drugs – https://www.fda.gov/drugs/information-health-care-professionals-drugs/know-your-source-protecting-patients-unsafe-drugs

Internet Pharmacy Warning Letters – https://www.fda.gov/drugs/drug-supply-chain-integrity/internet-pharmacy-warning-letters

FDA Warning Letters- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters