Traditional Compounding Pharmacies (503A)

Frier Levitt assists traditional compounding pharmacies in a variety of representative matters including but not limited to:

Frier Levitt has gained a unique insight into representing and advising traditional compounding pharmacies operating under Section 503A to the Food and Drug Administration Modernization Act. Since the passage of the Drug Quality and Security act, traditional pharmacies have a more defined role within the healthcare delivery system. However, a more defined role is not without plenty of regulation, contractual requirements, and professional practice records.

In representing traditional compounding pharmacies, Frier Levitt attorneys rely upon the multitude of federal and state laws and regulations, including Prompt Pay Laws, Fair Audit Laws, Any Willing Provider Laws, insurance regulations, State Pharmacy Practice Acts, Section 503A of the Drug Quality and Security Act, DEA rules and regulations, State controlled substances laws and regulations, ERISA laws and regulations, Anti-Kickback Statute, Stark Law, False Claims Act, and Tricare rules and regulations.

Finally, by virtue of having represented hundreds of compounding pharmacies across the country, Frier Levitt can offer many of these services to traditional compounding pharmacies for reduced flat fee rates, which offer predictability and cost savings for our clients.

Contact Frier Levitt for additional information.