Karr Tuttle Campbell provides skilled advice, guidance, and defense in all aspects of pharmacy law, DEA regulatory law, and FDA compliance.
Our pharmacy team is headed by Ronald Friedman, a graduate of Harvard Law School, a former federal prosecutor and member of the American Society of Pharmacy Law.
Our clients include pharmacies, clinics, hospitals, practitioners, and pharmaceutical and medical device suppliers and distributors throughout the United States. Our team has extensive legal experience in all aspects of pharmaceutical compliance.
We help individuals and businesses navigate complex problems, obtain proper licensing and regulatory approval, and avoid adverse regulatory action. We are skilled at responding to an investigation, developing due diligence protocols, and providing a defense in regulatory proceedings by the United States Department of Justice, the Drug Enforcement Administration, the Food and Drug Administration, the Office of Inspector General, and Departments of Health and Boards of Pharmacy throughout the United States. We are skilled at responding to administrative, civil, and criminal investigations.
We believe in working collaboratively to find common solutions to practical problems and avoiding unwarranted discipline.
In addition to medical products, our lawyers have extensive experience representing food and consumable manufacturers and distributors in FDA and Department of Agriculture compliance proceedings, including addressing potential warning letters, recalls, and helping develop due diligence protocols.
Pharmaceutical and Medical Device
- Represented national retail drug chain in DEA compliance investigation
- Represented national drug wholesaler in board of pharmacy compliance investigation
- Represented major league sports franchise in DEA regulatory investigation
- Represented national relief organization in board of pharmacy investigation related to donated pharmaceuticals
- Represented regional drug chain and pharmacists in multiple board of pharmacy investigations related to pharmacy law compliance
- Represented national drug distributor in DEA criminal investigation related to 21 CFR compliance. No charges brought.
- Represented closed door hospice and specialty pharmacies with variety of business, regulatory, and licensing issues
- Assisted out of state pharmacy with DEA diversion and regulatory compliance investigation
- Represented several out of state pharmacies, including compounding and specialty pharmacies in regulatory board of pharmacy proceedings in their states
- Represented pharmacy and owner in FDA criminal investigation relating to resale of returned drug product. No charges brought.
- Represented chain of health care clinics and a corporate officer in FDA criminal investigation alleging unlawful importation of a misbranded drug and sale of an unapproved new drug. No charges brought.
- Represented a national diabetic drug wholesaler and distributor in FDA criminal investigation alleging the sale of stolen merchandise. No charges brought.
- Represented drug device distributors in regulatory investigation by board of pharmacy and Attorney General
- Assisted multiple LTC closed door pharmacies in responding to compliance investigations and drafting due diligence protocols
- Assisted multiple pharmacies in successfully responding to third party audits and supplier issues
- Assisted multiple compounding pharmacies in responding to FDA inspections, local compliance issues, and out of state regulatory proceedings
- Assisted numerous pharmacies in state and federal licensing matters
Physicians, Hospitals and Clinics
- Represented numerous physicians in responding to Medical Quality Assurance Commission investigations and developing due diligence protocols
- Represented medical trauma training center in DEA regulatory compliance investigation
- Provided guidance to hospitals regarding handling and record-keeping relating to controlled substances
- Represented physician in criminal investigation alleging unlawful inducement/kickbacks. No charges brought.
- Represented physician in criminal investigation alleging unlawful distribution of a controlled substance. No charges brought.
- Represented multiple pain clinics and physicians in DEA and state board compliance investigations across the United States
- Represented physicians and facilities in responding to third-party audits
- Represented drug addiction/buprenorphine clinics in regulatory investigations by DEA and Attorney General
Food and Consumables
- Represented national tea manufacturer in FDA and Department of Agriculture adulterated product investigation. Recall and fines avoided.
- Represented U.S. birthing product importer in FDA investigation where shipments seized. Recall and fines avoided.
- Represented British Columbia-based cosmetic manufacturer in FDA investigation relating to use of unapproved ingredients. Fines and recall avoided.
- Represented Washington farming consortium in federal investigation relating to potential violations of federal law. No charges brought.
- Representing a Canadian food importer (mushrooms) in FDA adulterated product investigation. Recall and fines avoided.
- Represented domestic cheese manufacturer/distributor in licensing and regulatory matters