Protect your pharmacy and your future - with legal counsel that understands the complex and evolving regulatory landscape of compounding, peptides, GLP-1s like semaglutide, terzepatide, liraglutide, and more.
Legal Support for Every Phase of Your Compounding Pharmacy
Whether you're launching a new compounding operation or facing action from the FDA, DEA, or your State Board of Pharmacy, you need a pharmacy attorney who knows:
How to interpret and defend federal and state regulations
The intricacies of 503A and 503B compounding
The risks and opportunities around semaglutide, terzepatide, liraglutide, ketamine, and peptide therapies
Licensing & Permits
• New pharmacy setup
• Multi-state pharmacy licensing
• Out-of-state compounding permit assistance
Regulatory Compliance
• FDA inspections
• DEA investigations
• DSCSA, HIPAA & DQSA compliance audits
• GLP-1 medication handling: semaglutide, terzepatide, liraglutide
• Controlled substances (including ketamine)
Audit Defense & Investigations
• PBM audits
• FDA/DEA warning letters
• State Board of Pharmacy complaints
• 483s and consent decrees
Peptide & GLP-1 Compliance Consulting
• Strategy for marketing GLP-1s (semaglutide, terzepatide)
• Off-label compounding and patient consent strategies
• Packaging, labeling & advertising risk mitigation
Facing a Federal or State Investigation?
We’ve helped pharmacies avoid license suspension, negotiate with the DEA, and resolve FDA compliance issues discreetly and efficiently.
Don’t wait for the board to make the next move - let us help you protect your practice, your license, and your livelihood.
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Recent Wins
Win over Optum
- PBM audit uncovered 25,000 unit discrepancy of Zegerid and other violations.
- PBM referred "fraud" to Massachusetts Attorney General—Medicaid Fraud Control Unit (MFCU).
- MFCU indicted Pharmacy & Owner on numerous criminal charges, including False Claims & Larceny.
- After HLA was retained, State dropped all charges before trial and abandoned the prosecution.
- Owner admitted no wrongdoing and was not excluded; Pharmacy avoided all network sanctions.
Win over CVS
- PBM audit uncovered $6.5 million inventory shortfall in compound cream APIs.
- PBM referred "fraud" to U.S. Attorney's Office for the Eastern District of Pennsylvania, FBI, and HHS-OIG.
- After HLA was retained, federal prosecutors declined to bring criminal charges against Owner.
- Client settled case for $2.5 million, or less than 40% of the government's claimed loss on claims paid.
- Owner admitted no wrongdoing, was not excluded, and suffered no licensing or other consequences.
Win over ESI
- PBM audit uncovered $600,000 inventory shortfall in brand and generic medications.
- PBM referred "fraud" to Pennsylvania Attorney General—Medicaid Fraud Control Unit (MFCU).
- MFCU opened grand jury investigation against Pharmacy and Owner for Medicaid Fraud and Theft.
- After HLA was retained, State declined to bring criminal charges against Owner.
- MFCU charged the Pharmacy, a corporate entity, instead.
