Compounding Pharmacy Compliance

Georgia’s 150 compounding pharmacies and thousands across the nation are experiencing closer scrutiny and heightened oversight by state pharmacy regulators and the Food and Drug Administration.

Hasson Law Group LLP advises and represents compounding pharmacies to help them with preventative compliance as well as preparing for and navigating through regulatory inspections and investigations. We are thoroughly familiar with federal and state laws and regulations that govern the practice of compounding pharmacy and can help you find the best path amid a labyrinth of vague, complex and obscure rules.

Our team of lawyers and experts can assist pharmacies in meeting requirements of changing state and federal laws.

We have experience successfully representing compounding pharmacies in:

  • regulatory compliance,
  • licensing,
  • government investigations,
  • criminal proceedings, and
  • litigation.

 

Among the specific services and products we offer:

  • standard operating procedures,
  • training,
  • compliance audits,
  • licensing and registration,
  • mock inspections,
  • gap/risk assessment reports,
  • government investigations,
  • criminal liability negotiation, and
  • crisis management.

Contact us for questions regarding:

  • Georgia Drug and Narcotics Inspections
  • Food and Drug Administration (FDA) Inspections
  • Federal Food, Drug and Cosmetic Act (FD&C Act), including:
    – Section 503A (traditional compounding pharmacies) and
    – Section 503B (outsourcing facilities)
  • Federal Drug Quality and Security Act of 2013
  • Georgia Pharmacy Practice Act
  • Rules of the Georgia Board of Pharmacy
  • Georgia Medical Practice Act
  • Georgia Controlled Substance Act
  • Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
  • Georgia Veterinary Practice Act
  • DEA rules and regulations
  • Stark Law and Anti-Kickback Statute
  • False Claims Act