Compounding Pharmacies and Outsourcing Facilities

Continued innovation in personalized medicine, wellness therapies and patient care has increased both the opportunities and regulatory complexities facing compounding pharmacies and outsourcing facilities. Our cross-practice team brings in-depth, practical experience in pharmacy operations, reimbursement, Food and Drug Administration (FDA) regulatory matters and healthcare transactions and they are prepared to advise clients on maintaining compliance, scaling operations and mitigating risk in a highly regulated environment.

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

Advocated before the FDA’s Pharmacy Compounding Advisory Committee (PCAC) on behalf of the American Academy of Peptide Medicine (AAPM) in connection with the Committee’s July 2026 review of seven peptides. Presented arguments supporting the inclusion of the peptides on the 503A Bulks List to restore regulated access through licensed compounding pharmacies. The Committee recommended that six of the seven peptides be added to the list.
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.