The Compounding Pharmacy Crisis:
Why Your Access to Personalized Medications Is Under Threat
Curated By Nelson Vergel | ExcelMale.com | Updated February 2026
EXECUTIVE SUMMARY
The compounding pharmacy industry—which provides millions of Americans with affordable, customized medications including testosterone, hCG, hormone therapies, and erectile dysfunction treatments—faces an existential crisis. A coordinated assault from multiple directions threatens to eliminate or severely restrict patient access to these essential medications:
• FDA Regulatory Expansion: New "Demonstrable Difficulties for Compounding" lists could ban compounding of hormone therapies. The FDA is considering placing 11 bioidentical hormones—including testosterone and testosterone cypionate—on restricted lists. Proposed 90-day beyond-use dating rules would make many compounding operations economically unviable.
• Pharmaceutical Industry Litigation: Eli Lilly and Novo Nordisk have launched aggressive legal campaigns against compounding pharmacies, filing dozens of lawsuits and entering exclusive agreements with telehealth providers that prohibit working with compounders. If these pharmaceutical giants prevail, precedents could devastate the entire compounding industry.
• State Regulatory Fragmentation: States including Massachusetts, California, and Florida are implementing new licensure requirements, documentation mandates, and operational restrictions that create compliance nightmares and threaten to force smaller compounders out of business.
• Federal Legislation: The SAFE Drugs Act (HR 6509), introduced in December 2025, would significantly narrow the scope of lawful compounding while imposing new fees, inspections, and reporting requirements.
What's at stake for patients: Dramatic cost increases (compounded testosterone costs $50-100 vs. $200-400 commercial); loss of customization options (carrier oils, concentrations, combination therapies); elimination of medications with no FDA-approved alternatives (Trimix, testosterone for women, certain peptides); and restricted access to fertility treatments like hCG.
Why patient testimonials matter: Regulators and legislators need to hear directly from patients whose lives depend on compounded medications. Your story about how these treatments have transformed your health, preserved your fertility, or made therapy affordable is more powerful than any industry argument. The FDA's testosterone expert panel comment period closes February 9, 2026—your voice is needed now.
This article provides the full context of these threats and specific guidance on how to share your testimonial to help preserve access to compounded medications.
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What would happen if you suddenly lost access to the medications that have transformed your health?
For millions of Americans who rely on compounded medications—customized formulations of testosterone, hormone therapy, fertility treatments, erectile dysfunction medications, and weight management drugs—this isn't a hypothetical scenario. It's an emerging reality. A perfect storm of FDA regulatory expansion, aggressive pharmaceutical industry litigation, and inconsistent state pharmacy board actions threatens to eliminate or severely restrict access to compounded medications that patients have depended upon for decades.
The compounding pharmacy industry, which has served as a vital lifeline for patients whose medical needs cannot be met by mass-produced pharmaceuticals, now faces an uncertain future. Regulatory agencies are proposing new restrictions that could make it impossible for compounders to operate. Pharmaceutical giants are wielding their legal departments to suppress competition. And state boards of pharmacy are implementing increasingly burdensome requirements that threaten to drive smaller compounding pharmacies out of business.
This article examines the multi-front assault on compounding pharmacy and explains why patient voices are crucial in this fight. Your testimonials about how compounded medications have improved your life could be the most powerful weapon in preserving access to personalized medicine.
Understanding Compounding Pharmacy: Why It Matters
Compounding pharmacy is one of the oldest practices in medicine, dating back to the origins of pharmacy itself. In its simplest form, compounding involves a licensed pharmacist preparing a customized medication tailored to an individual patient's specific needs. This might include adjusting dosage strengths, changing delivery forms (from tablets to liquids or creams), removing allergens from formulations, or combining multiple medications into a single preparation.
Federal law recognizes that commercial pharmaceutical manufacturers cannot meet every patient need. Under Section 503A of the Federal Food, Drug, and Cosmetic Act, traditional compounding pharmacies (known as "503A pharmacies") may compound medications based on valid prescriptions for individual patients. Section 503B establishes a separate category for "outsourcing facilities" that can compound larger quantities under stricter FDA oversight.
For men's health specifically, compounding pharmacies provide crucial access to:
testosterone cypionate and enanthate in customized concentrations and carrier oils; human chorionic gonadotropin (hCG) for fertility preservation during TRT; personalized erectile dysfunction medications like Trimix; anastrozole and enclomiphene for estrogen management; and combinations of therapies unavailable from commercial manufacturers.
Compounding pharmacies typically offer these medications at significantly lower costs than commercially manufactured alternatives—often 50-75% less expensive. For many patients paying out-of-pocket for hormone therapy, this price difference determines whether treatment is financially sustainable.
The FDA's Expanding Regulatory Reach
The Food and Drug Administration has dramatically escalated its oversight of compounding pharmacies in recent years, implementing new rules and proposing regulations that could fundamentally reshape the industry.
The "Demonstrable Difficulties for Compounding" Lists
In March 2024, the FDA proposed a significant new rule creating "Demonstrable Difficulties for Compounding Lists" (DDC Lists). Any drug product placed on these lists would be prohibited from being compounded by either 503A pharmacies or 503B outsourcing facilities. The FDA has outlined six criteria for adding drugs to these lists, including "complex formulation," "bioavailability achievement complexity," and "compounding process complexity."
While the initial proposal targets only three narrow drug categories, the framework creates a mechanism for future restrictions on virtually any compounded medication. Industry observers believe the FDA is positioning itself to place hormone therapy formulations, peptides, and other commonly compounded medications on these restricted lists.
Bioidentical Hormone Therapy Under Threat
The FDA is currently considering placing eleven hormones used in Compounded Bioidentical Hormone Therapy (cBHT) on the "difficult to compound list." This would effectively ban compounding of estradiol, estrone, estradiol cypionate, estriol, progesterone, pregnenolone, testosterone, testosterone cypionate, and testosterone propionate in injections, creams, gels, pellets, and oral formulations.
The FDA previously attempted to ban compounded bioidentical hormone therapy in 2008 and 2018 without success. The current effort relies heavily on a controversial 2020 report from the National Academies of Science, Engineering, and Medicine (NASEM), which critics argue was fundamentally flawed—the study committee included no prescribers or pharmacists who compound hormones, featured members with pharmaceutical industry ties, and selectively reviewed only 13 studies while ignoring hundreds of others demonstrating cBHT safety and efficacy.
The GLP-1 Crackdown
The FDA's aggressive enforcement against compounded GLP-1 medications (semaglutide and tirzepatide) has provided a preview of how the agency may target other compounded drugs. When the FDA declared drug shortages "resolved" for tirzepatide in October 2024 and semaglutide in February 2025—decisions many industry observers disputed—compounders were given just 60-90 days to cease production.
In September 2025, the FDA issued approximately 80 warning letters to compounding pharmacies and telehealth companies, targeting their marketing of compounded GLP-1 products. FDA Commissioner Marty Makary announced a comprehensive "clampdown" on what the agency termed "illegal" compounders. This enforcement pattern demonstrates how quickly the regulatory landscape can shift against compounding pharmacies.
Beyond Use Dating Restrictions
The FDA has proposed limiting compounded medications to 90-day "beyond use dates" (BUDs), even when pharmacies can demonstrate longer stability through appropriate testing. Currently, the maximum BUD under USP conditions is one year, though most compounders use 3-6 month dating. A 90-day maximum would dramatically increase costs and potentially make many compounding operations economically unviable. As one pharmacist noted, "This will essentially put compounders out of business. There is zero scientific basis for this proposal—everyone suspects it's designed to hinder compounding."
Big Pharma's Legal Assault
Pharmaceutical manufacturers have launched an unprecedented legal campaign against compounding pharmacies, using intellectual property claims, consumer protection laws, and the Lanham Act to challenge competitors who operate entirely within federal law.
The Eli Lilly and Novo Nordisk Litigation Wave
Pharmaceutical giants Eli Lilly and Novo Nordisk—which dominate the lucrative GLP-1 market with Mounjaro, Zepbound, Ozempic, and Wegovy—have intensified litigation strategies that could devastate the compounding industry. On August 4, 2025, Novo Nordisk filed lawsuits against 12 defendants, including multiple pharmacies, marking a strategic shift in directly targeting compounders rather than just telehealth providers.
Eli Lilly filed suit against
Empower Pharmacy—one of the nation's largest 503A/503B compounding facilities—in the Southern District of Texas in July 2025, alleging "unlawful manufacturing and selling of untested, unapproved weight loss drugs on a large scale." These claims come despite the fact that compounding pharmacies operate under explicit federal authorization.
Compounders Fight Back
In January 2026, Arizona-based Strive Compounding Pharmacy filed a federal antitrust lawsuit against both Eli Lilly and Novo Nordisk, alleging a "coordinated effort to suppress competition and limit patient access to lawful compounded GLP-1 medications." The lawsuit details how the pharmaceutical companies entered exclusive agreements with telehealth providers that explicitly prohibited those providers from working with compounding pharmacies—"cutting off an essential channel between patients with prescriptions for personalized medicines and the pharmacies that could fill those prescriptions."
According to the complaint, both Eli Lilly and Novo Nordisk have "dedicated significant resources to disparaging compounded medicines" and "engaged in efforts to censor all statements about compounded medicines' potential benefits." The lawsuit alleges these actions expressly violate U.S. antitrust laws.
The Chilling Effect on Patient Access
If the pharmaceutical companies prevail in their litigation, it could set precedents with chilling effects throughout the compounding industry. Legal observers note that victory for Eli Lilly and Novo Nordisk could "stifle the compounding pharmacy industry, reducing patient options for personalized medications and hindering access to necessary therapies" for conditions far beyond weight management—including hormone optimization, fertility preservation, and erectile dysfunction.
State-Level Regulatory Fragmentation
While federal agencies and pharmaceutical litigation grab headlines, state boards of pharmacy are implementing a patchwork of regulations that create compliance nightmares for compounding pharmacies attempting to serve patients across state lines.
Massachusetts Licensure Requirements
Beginning May 1, 2025, Massachusetts requires all nonresident pharmacies and compounding pharmacies to hold specific state licenses before dispensing to patients within the Commonwealth. Pharmacies without appropriate licensure that dispense into Massachusetts after this date face prosecution and penalties. The grace period for license applications ended March 31, 2025, creating a compliance crunch for compounders serving Massachusetts patients.
California's "Essentially a Copy" Redefinition
California adopted new Board of Pharmacy rules in late 2025 that redefine when a compounded medication is considered "essentially a copy" of a commercially available drug. These regulations assign pharmacists an affirmative duty to verify and document patient-specific "clinically significant differences" before compounding—essentially requiring pharmacies to build individual case files justifying why each prescription requires compounding rather than a commercial alternative.
Florida's New Documentation Requirements
Florida's Senate Bill 860 and House Bill 877, introduced in late 2025, would impose stringent active pharmaceutical ingredient (API) sourcing and documentation conditions on compounded medications. Under these proposals, pharmacies must use APIs identical to those in FDA-approved drugs, source from FDA-registered facilities inspected within the preceding two years, and conduct independent quality-control testing before use. The administrative burden and cost of compliance could force smaller compounders to discontinue operations.
Federal Legislation Threatens Further Restrictions
In December 2025, Representatives Rudy Yakym and André Carson introduced the "Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act" (HR 6509), which would significantly narrow the scope of lawful compounding under federal law while imposing new reporting, inspection, and fee obligations on both 503A pharmacies and 503B outsourcing facilities. This legislation represents yet another front in the regulatory assault on compounding pharmacy.
What Patients Stand to Lose
For men relying on compounded medications for testosterone replacement therapy and related treatments, the potential consequences of these regulatory and legal developments are severe.
Dramatic Cost Increases
Compounded testosterone cypionate typically costs $50-100 for a 10mL vial—a 90-120 day supply for most patients. Commercial alternatives through retail pharmacies often cost $200-400 for equivalent supplies, even with insurance. For patients paying cash for long-term hormone therapy, this price differential can mean hundreds of dollars annually. The elimination of compounding alternatives would force patients into the more expensive commercial market, with no guarantee of continued availability.
Loss of Customization Options
Commercial testosterone products offer limited options—typically cottonseed oil carriers and standard concentrations. Compounding pharmacies can provide alternatives for patients allergic to specific carrier oils (using grapeseed, sesame, or MCT oil instead), custom concentrations for precise dosing (from 20mg/mL to 250mg/mL), combination formulations (such as cypionate/propionate blends for different release profiles), and preservative-free options for sensitive patients. These customizations are impossible with mass-produced pharmaceuticals.
Fertility Treatment Restrictions
The FDA has already restricted compounding of gonadotropin fertility compounds, classifying hCG, FSH, and HMG as "biologics" requiring FDA approval. For men on TRT seeking to preserve fertility, compounded hCG was often the most affordable and accessible option. Following these restrictions, prices at retail pharmacies skyrocketed—hCG (10,000 IU) increased from approximately $118 per vial to around $300 within six months.
Medications with No Commercial Alternatives
Some compounded medications have no FDA-approved equivalents whatsoever. There are no manufactured bioidentical testosterone products approved for women with female sexual dysfunction. Trimix injections for erectile dysfunction are only available through compounding. Specific peptide therapies, testosterone propionate (increasingly difficult to find even from compounders), and customized topical preparations exist solely in the compounding space. Eliminating compounding would eliminate patient access entirely.
The Power of Patient Testimonials
In regulatory and legislative battles, patient voices carry exceptional weight. Regulators making decisions in conference rooms can easily dismiss industry arguments as self-interested. What they cannot dismiss are compelling personal stories from individuals whose lives have been transformed by access to compounded medications.
Why Your Story Matters
Patient testimonials serve multiple critical functions in advocacy efforts. They humanize the debate by showing regulators and legislators that real people—voters and constituents—depend on these medications for their health and quality of life. They
demonstrate clinical necessity by providing evidence that compounded medications serve genuine medical needs that commercial products cannot meet. They
counter pharmaceutical industry narratives that attempt to paint all compounded medications as dangerous, unregulated, or unnecessary. They
create political pressure that elected officials and appointed regulators must consider when making decisions that affect patient access.
What to Include in Your Testimonial
Effective testimonials should be personal, specific, and compelling. Consider addressing:
Your diagnosis and health journey: What condition(s) do you manage with compounded medications? How long have you been on treatment?
Why compounding is medically necessary for you: Do you require specific dosing unavailable commercially? Are you allergic to ingredients in commercial products? Do you need a combination therapy only available through compounding?
The impact on your quality of life: How have compounded medications improved your energy, mood, relationships, work performance, or overall health?
Financial considerations: Would you be able to afford treatment if compounded options were eliminated? What would losing this access mean for your family's finances?
What losing access would mean: Be specific about the consequences—both health-related and personal—if compounded medications were no longer available to you.
Conclusion: Your Voice Is Essential
The compounding pharmacy industry faces existential threats from regulatory expansion, pharmaceutical litigation, and state-level restrictions. The outcome of these battles will determine whether millions of patients continue to have access to personalized, affordable medications—or whether they are forced into a pharmaceutical marketplace that cannot meet their individual medical needs.
For men relying on compounded testosterone, hCG, erectile dysfunction medications, and other hormone therapies, the stakes could not be higher. Losing access to compounding would mean dramatically increased costs, elimination of customization options, and for some patients, complete loss of access to medications with no commercial alternatives.
The pharmaceutical industry has billions of dollars at stake and armies of lobbyists advocating for their position. Compounding pharmacies have science, federal law, and patient need on their side—but they need your voice to make their case. Your testimonial about how compounded medications have transformed your health, preserved your fertility, restored your quality of life, or simply made treatment affordable is more powerful than any industry argument.
The time to act is now. Together, we can preserve patient access to the personalized medications that make health optimization possible.
Key References
FDA. (2024). Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B. Federal Register
FDA. (2025). Expert Panel on Testosterone Replacement Therapy for Men; Request for Information. Federal Register
Washington University Law Review. (2024). Compounding Inequities Through Drug IP and Unfair Competition. Read Article
Buchanan Ingersoll & Rooney PC. (2025). Major Update on GLP-1 Litigation involving Compounding Pharmacies. Read Analysis
Frier Levitt. (2024). Regulatory Update on Compounded Bioidentical Hormone Therapy (cBHT). Read Article
Frier Levitt. (2026). State and Federal Legislative Developments Affecting Drug Compounding. Read Article
Avalere Health. (2025). Navigating the Evolving World of Drug Compounding. Read Report
NCPA & APC. (2025). Joint Comments on Compounded Menopause Hormone Therapy. NCPA Website
National Academies of Sciences, Engineering, and Medicine. (2020). The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. NCBI Bookshelf
Medical Disclaimer
This article is provided for informational and educational purposes only and should not be considered medical advice. The information presented reflects regulatory and legal developments as of the publication date and is subject to change. Patients should not discontinue or modify any medication regimen without consulting their healthcare provider. If you have questions about your treatment, please discuss them with a qualified medical professional.
