Legal Insights

A pending Supreme Court case could reshape how compounding pharmacies face litigation under state unfair competition laws tied to FDA approval standards.

Health Law Alliance adds powerhouse Pharmacist/Attorney Dr. Martha Rumore to their team of boutique healthcare attorneys.

PBMs are using rigid documentation standards to recoup payments and pressure pharmacies. Minor clerical errors can now threaten reimbursement and network participation.

PBMs are quietly expanding their power, terminating pharmacies based on affiliation rather than wrongdoing and putting entire businesses at risk overnight.

Facing an Optum PBM audit that threatened network participation, a New York pharmacy turned to Health Law Alliance for strategic legal guidance, resulting in a successful audit resolution and uninterrupted network status.

FDA ramps up enforcement on GLP-1s, peptides, RUO labeling, and compounding practices. See how 503A and 503B facilities are affected.

For years, New York healthcare providers have navigated the complex oversight of the Office of the Medicaid Inspector General (OMIG), primarily through its Medicaid Recovery Audit Contractor (RAC) vendors. In April 2025 the landscape shifted as the state engaged Performant Healthcare Solutions (“Performant”) as its exclusive Medicaid Recovery Audit Contractor (“RAC”).

FDA issued a Warning Letter to Darmerica citing cGMP violations and improper distribution of GLP-1 and peptide APIs. Learn what this means for 503A compounding pharmacies and supply chain compliance.

Italian national Claudio Fogale was released from federal jail after his attorney, Anthony J. Mahajan, successfully argued that the evidence was weak and legal requirements were ambiguous.