Hormones and Peptides: A Business Owner's Perspective on Risk, Regulation, and Revenue

The explosion of interest in peptide therapy and hormone replacement has created what appears to be a lucrative opportunity for medical aesthetics practices. Social media influencers tout miraculous results, patients are asking for these services by name, and the revenue potential seems substantial. However, every owner needs to understand the complete picture and not just the opportunity. The risks, regulatory complexities, and business implications are real and could make or break your practice.

After scaling a medical aesthetics franchise from a single location proof of concept to become a national brand and consulting with private practice owners and PE firms, I've learned that the difference between sustainable growth and catastrophic failure often comes down to one thing: knowing when to say yes, and more importantly, when to say no. This article will help you make that decision with your eyes wide open.

The Regulatory Landscape: Shifting Sand Beneath Your Feet

If you're considering adding peptides to your service offerings, you need to understand that you're entering a regulatory minefield that's actively being reshaped.

Here's what changed and why it matters to your business:

What's Banned: Many popular peptides including Ipamorelin, CJC-1295, BPC-157, and others are no longer FDA-approved for compounding as of 2023. These were cornerstone products for many wellness practices. You might ask, then why are peptides like BPC-157 available? This is the "gray market" risk. Practices, pharmacies, and etc are using a regulatory loophole.

The "Research Use Only" Loophole

The "research use" language is pervasive across the peptide space. Lawyers who work in the field say the language is an attempt to skirt FDA regulations. The agency does not oversee chemicals that aren't intended for human use.

What's Still Available: Not all peptides are banned—numerous peptides remain fully accessible to licensed healthcare providers via 503A and 503B regulated compounding pharmacies. However, the landscape continues to evolve.

The Gray Market Risk: The true danger lies in the gray market of "research peptides", purchasing peptides from unregulated online vendors labeled "for research use only," administering peptides that have not been approved for human use, or injecting/dispensing peptides sourced outside of licensed compounding pharmacies.

The Compounding Pharmacy Conundrum

Peptides that can be compounded at compound pharmacies must adhere to USP 797/795 and always align with local, state and federal laws and regulatory considerations.

This means:

• Source Verification: Any supplier must be listed with FDA as an API manufacturer and provide a Certificate of Analysis. Peptides that are 'research use only' (RUO) cannot be used in human or veterinary compounding.

• Quality Standards: Only pharmaceutical-grade peptides from licensed compounding pharmacies should be used—not "food grade" or research-only products.

• Legal Liability: If you're working with a compounding pharmacy that's cutting corners, you're exposed. Their compliance failures become your liability.

The Exception: FDA-Approved GLP-1 Medications

GLP-1 agonists like semaglutide (Ozempic/Wegovy) and tirzepatide (Zepbound) are FDA-approved medications with extensive clinical trial data proving 10-15% body weight reduction. These are on solid regulatory ground—but they come with their own set of clinical considerations and contraindications that we'll address later.

The Clinical Reality: What You Must Know Before You Prescribe

If you think you can simply add peptides to your service menu without implementing comprehensive patient screening protocols, you're setting yourself up for disaster—both clinically and legally. Here's what proper patient evaluation requires:

1. Comprehensive Medical History Review

A thorough medical evaluation (aka, good-faith exam)is the only way to ensure peptide therapy is safe. This includes a discussion of health goals, thorough review of medical history to identify any contraindications, and comprehensive lab work including hormone and vitamin panels.

2. Contraindications You Cannot Ignore

For GLP-1 medications alone, contraindications include:

• Personal or family history of medullary thyroid carcinoma (MTC)

• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

• Severe gastroparesis

• Active gallbladder disease

• History of pancreatitis

• Severe kidney disease (eGFR <30 mL/min/1.73m²)

• Pregnancy and breastfeeding

• Hypersensitivity to the medication

Each peptide has its own contraindication profile. Growth hormone-releasing peptides, for example, are contraindicated in patients with certain cancers where stimulating growth hormone could be dangerous.

3. Required Laboratory Testing

You cannot prescribe peptides or hormones responsibly without baseline and ongoing laboratory monitoring. Minimum requirements include:

• Comprehensive metabolic panel (CMP)

• Liver function tests

• Kidney function markers

• Hormone panels (testosterone, estradiol, FSH/LH as indicated)

• Thyroid function tests

• Complete blood count

• Cancer screening markers when indicated

4. Drug Interaction Assessment

Many peptides and hormones interact with common medications. Your clinical team must be qualified to identify and manage these interactions.

The Qualification Question

Here's the uncomfortable truth: not every provider in your practice is qualified to prescribe peptides and hormones.

These are not cosmetic injectables. They're systemic medications with profound physiological effects. Your injector who's excellent with Botox and fillers may not have the clinical background to:

• Interpret complex hormone panels

• Identify subtle contraindications

• Manage adverse effects

• Understand drug interactions

• Adjust dosing based on patient response

Ask yourself: Does your medical director have genuine expertise in hormone optimization and peptide therapy? If the answer is "we'll figure it out," you're already in trouble.

The Insurance Question: Are You Actually Covered?

This is where many med spa owners get blindsided. You've invested in training, established relationships with compounding pharmacies, implemented screening protocols—and then you discover your professional liability insurance doesn't cover these services.

What Professional Liability Policies Actually Cover

There has been an increase in overall claims for medical malpractice in general, claims development in certain procedures including hormone replacement therapy, and more rigid underwriting with decrease in limits of liability for procedures such as stem cell therapy and PRP.

The reality:

1. Standard med spa policies may explicitly exclude hormone therapy and peptide treatments—or limit coverage significantly

2. Regenerative medicine requires specialized coverage: Offering PRP, stem cells, exosomes, peptides, or biologics requires tailored policies that meet the needs of cutting-edge regenerative medicine clinics.

3. Training documentation matters: Claims exclusions may apply for lack of evidence of certified procedure training or signed patient consent forms.

Questions to Ask Your Insurance Broker

Before you launch peptide or hormone services, get explicit answers:

• "Are peptide therapies covered under my current policy?"

• "Are there specific peptides or protocols that are excluded?"

• "What are my policy limits for hormone replacement therapy?"

• "Do I need additional riders or a separate policy?"

• "What documentation and training certification do you require?"

• "What are the claims trends in this space, and how might that affect my premiums?"

Don't accept vague reassurances. Get it in writing.

The Cost of Getting It Wrong

Medical malpractice lawsuits can result in millions of dollars in liability, far beyond what most small businesses can afford. Without proper coverage, a single adverse event could bankrupt your practice—even if you did everything right clinically.

The Business Case: When Does It Make Sense?

Now that we've outlined the risks, let's talk about when it actually makes business sense to offer these services.

Peptide therapy and hormone replacement can generate significant recurring revenue:

• Monthly treatment costs: $300-800+ per patient

• Ongoing lab work: $200-500 per visit

• High patient retention: 6-18+ month treatment protocols

• Upsell potential: Complementary services and products

But this assumes you can:

1. Source products reliably and legally

2. Maintain proper clinical oversight

3. Keep patients safe and satisfied

4. Stay compliant with evolving regulations

When It Makes Sense

Based on my experience consulting with successful practices, peptides and hormones are a good fit when:

✓ You have genuine clinical expertise on staff

• Board-certified physicians with hormone optimization experience

• NPs or PAs with specialized training and appropriate supervision

• Commitment to ongoing education as the field evolves

✓ You're prepared for comprehensive patient management

• Robust intake and screening protocols

• Regular follow-up and monitoring

• Laboratory relationships and systems

• After-hours coverage for adverse events

✓ You have proper insurance and legal infrastructure

• Professional liability coverage that explicitly includes these services

• Solid relationships with compliant compounding pharmacies

• Legal counsel familiar with this space

• Comprehensive consent forms and documentation systems

✓ You can commit to operational excellence

• Investment in EHR systems that track complex protocols

• Staff training and competency assessment

• Quality assurance processes

• Willingness to walk away from patients who aren't appropriate candidates

When to Say No

You should not offer these services if:

✗ You're chasing trends without expertise "Patients are asking for it" is not a business strategy. Neither is “Everyone else is doing it”. That is essentially FOMO. When does making a decision based on that ever work out well? If you don't have clinical depth, you're gambling with people's health and your business.

✗ Your insurance is uncertain or inadequate Operating without proper coverage is financial suicide. Period.

✗ You can't source products compliantly If your compounding pharmacy is playing fast and loose with regulations, you will be held responsible when things go wrong. China is not a good alternative!

✗ You're not prepared for true medical practice These aren't add-on services. They require genuine medical oversight, comprehensive documentation, and ongoing patient management.

Hormone Replacement Therapy: A Parallel Consideration

Everything discussed about peptides applies equally—or even more intensely—to hormone replacement therapy (HRT).

Clinical Complexity:

• Testosterone therapy requires monitoring for cardiovascular effects, prostate health (in men), and blood count changes

• Estrogen replacement requires breast health screening and thrombosis risk assessment

• Pellet insertion has specific complications including extrusion, infection, and difficulty adjusting dosing

Insurance Scrutiny: Insurance carriers are showing increased claims development and more rigid underwriting specifically for hormone replacement therapy.

Regulatory Compliance:

• State-specific regulations on testosterone prescribing

• DEA requirements for Schedule III controlled substances

• REMS programs for certain hormones

The Patient Experience: HRT done right requires:

• Baseline and ongoing monitoring (every 3-6 months)

• Symptom tracking and dose adjustment

• Cardiovascular risk assessment

• Cancer screening appropriate to patient age and risk factors

Recommendations: A Framework for Decision-Making

After working with practices at every stage—from startups to established multi-location operators, here's my framework for deciding whether to offer these services:

Phase 1: Assessment (Before You Invest a Dollar)

1. Clinical Audit

   • Honestly assess your team's qualifications

   • Identify gaps in expertise

   • Determine if you can fill those gaps or if you need to bring in additional medical talent

2. Insurance Review

   • Meet with your broker with a specific list of services you're considering

   • Get written confirmation of coverage—or exclusions

   • Understand how adding these services will affect your premiums

3. Regulatory Research

   • Understand current FDA positions on the specific peptides you want to offer

   • Connect with compliant compounding pharmacies

   • Consult with healthcare legal counsel

4. Market Analysis

   • What's the actual demand in your market?

   • Who are your competitors in this space?

   • What's the realistic revenue potential?

   • What's your break-even on the required investment?

Phase 2: Infrastructure Development (If You Decide to Proceed)

1. Clinical Protocols

   • Develop comprehensive screening protocols

   • Create decision trees for peptide/hormone selection

   • Establish monitoring schedules

   • Define criteria for discontinuation

2. Operational Systems

   • EHR integration for complex treatment tracking

   • Laboratory partnerships and ordering systems

   • Medication storage and handling protocols

   • Staff training and competency validation

3. Risk Management

   • Informed consent documents reviewed by legal counsel

   • Adverse event reporting and management protocols

   • Regular chart review and quality assurance

   • Clear policies on who can and cannot be treated

4. Compliance Framework

   • Pharmacy compliance verification process

   • Documentation standards that exceed minimum requirements

   • Regular regulatory monitoring

   • Legal consultation relationship

Phase 3: Launch and Scaling (The Long Game)

1. Start Conservatively

   • Begin with FDA-approved medications (like semaglutide) where regulatory ground is firm

   • Treat only ideal candidates initially

   • Over-document everything

   • Establish your safety track record

2. Monitor Intensively

   • Track every adverse event, no matter how minor

   • Regular case review with your medical team

   • Patient satisfaction monitoring

   • Revenue and profitability analysis

3. Scale Thoughtfully

   • Don't expand services until you've mastered what you're offering

   • Add complexity only when systems are proven

   • Invest in staff education continuously

   • Stay connected to the evolving regulatory landscape

The Bottom Line: A Business Owner's Perspective

I've built businesses by knowing when to be aggressive and when to be cautious. In my experience scaling VIO Med Spa and consulting with practices and PE groups, I've learned that sustainable growth comes from doing fewer things excellently rather than many things marginally.

Peptides and hormone replacement represent genuine clinical opportunities. Patients need these services. The revenue potential is real. But the risks (clinical, legal, regulatory, and financial) are equally real.

My advice:

If you have deep clinical expertise, proper insurance, compliant sourcing, and commitment to operational excellence (which includes giving the patient the time they need and deserve), these services can be a valuable addition to your practice that enhances patient outcomes and generates strong recurring revenue.

If you're missing any of those elements, you're better off focusing on services where you can deliver exceptional results without the elevated risk profile.

All you have to do is open the closets of med spas across the country to realize that the medical aesthetics industry is full of operators who chased trends without doing the homework. Some got lucky. Many didn't. The ones who built sustainable, valuable businesses did so by being disciplined about what they offered and how they delivered it, as well as being focused on patient care and regulatory compliance.

Don't let FOMO drive your business strategy. Let clinical competence, proper risk management, and solid business fundamentals guide your decisions.

This article is for informational purposes only and does not constitute legal, medical, or business advice. Consult with qualified legal counsel, medical advisors, and insurance professionals before making decisions about adding new services to your practice.