Compounding Pharmacies and Outsourcing Facilities

Our experience spans litigation, regulatory strategy, government affairs, corporate transactions and compliance for compounding pharmacies and pharma sectors:

• Advising the Outsourcing Facilities Association in litigation against the Department of Health and Human Services and the FDA, urging agency action on nominations for active pharmaceutical ingredients used by outsourcing facilities.
• Representing FarmaKeio in high-profile litigation matters involving the FDA’s clinical need list and peptide regulation, addressing patient access to essential medications.
• Advocating for compounding pharmacies and outsourcing facilities at federal (FDA, DEA, HHS) agencies and state legislative and regulatory hearings.
• Providing strategic counsel in connection with an FDA consent decree, securing a favorable outcome without an upfront shutdown, mandatory on-site FDA oversight or product recall.
• Advising a global healthcare company on developing an enterprise-wide artificial intelligence (AI) and generative AI compliance framework, including FDA considerations.
• Representing multiple private equity sponsors in multimillion- and billion-dollar acquisitions of multi-state clinical networks and pharmacies, including regulatory diligence and execution.
• Counseling life sciences clients on the regulatory implications of cybersecurity incidents, including FDA and global compliance risks.