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Protect your pharmacy and your future — with legal counsel that understands the complex and evolving regulatory landscape of compounding peptides and GLP-1s like semaglutide, tirzepatide, liraglutide, and more.
Legal support for every phase of your 503A compounding pharmacy or 503B outsourcing facilities, active pharmaceutical ingredient (API) manufacturers/importers, telehealth companies, wholesalers, 3PLs, brokers, MSOs, physician practices, wellness clinics and spas.
Our team brings a proven record of success, including a pharmacist-attorney with decades of hands-on experience in FDA 503A and 503B compounding regulations. Speak with attorney Martha Rumore, PharmD, today.
Whether you're launching a new compounding operation, or facing action from the FDA, DEA, a State Board of Pharmacy or a pharmaceutical manufacturer, you need a compounding attorney who knows how to:
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Former Government Regulators on Your Side – our team of healthcare defense specialists is spearheaded by former federal and state prosecutors who understand how the government and its contractors use data mining and proprietary algorithms to identify potential Fraud, Waste & Abuse (FWA) for audits and investigation. Because we understand how the government builds cases, we use their playbook to beat them.
Healthcare Specialty Attorneys and Consultants – Health Law Alliance specializes in healthcare law and is dedicated to defending healthcare providers and their licenses from overreach. Our founding partner previously served as a top for the biggest companies in healthcare, including McKesson, Relay Health, CoverMyMeds, United Health Group, Optum, and United Healthcare. We know the tricks insurance companies use to deny claims, and now use that inside information against them.
Proven Track Record – Some clients turn to us when stakes are the highest, when their businesses are threatened, when their license is challenged, and when their options are limited. Our demonstrated track record of successes against the most aggressive government regulators and industry giants can be reviewed HERE. Many more clients, however, turn to us at the first sign of potential trouble, when we can neutralize the problem before it grows. Either way, we have your back from beginning to end.
What does a compounding pharmacy attorney do?
A compounding pharmacy attorney helps you navigate the complex and constantly changing regulations that govern 503A and 503B pharmacies. That includes licensing and permits, FDA and DEA compliance, GLP-1 and peptide risk management, PBM and board audits, and defending your pharmacy if you’re facing federal or state action.
Can you help with GLP-1 medications like semaglutide and tirzepatide?
Yes. We advise on the full lifecycle of GLP-1s and related therapies, including:
Our goal is to help you offer these therapies while minimizing regulatory and enforcement risk.
What types of compliance and licensing issues do you handle?
We handle a wide range of compounding-specific issues, including:
If your question involves compounding, GLP-1s, peptides, or controlled meds, we likely cover it.
I received a PBM audit notice, warning letter, or Board complaint. Can you help?
Yes. We regularly defend pharmacies in:
We focus on protecting your license and limiting financial and reputational damage while working toward a practical resolution.
Do you work with both 503A pharmacies and 503B outsourcing facilities, and in multiple states?
Yes. We advise 503A pharmacies and 503B outsourcing facilities across a variety of practice models, including telehealth, mail-order, and out-of-state compounding. We can assist with:
If you’re growing or changing your compounding model, we can help you do it compliantly.
How do I get started and what happens in a strategy session?
Start by scheduling a confidential 30-minute strategy session. During that call we will:
Call us at (800) 345 - 4125 to book your consult and protect your compounding practice, your license, and your livelihood.
Speak to an experienced attorney today at no-cost to evaluate your situation and discuss how we can help.
