Pharmacies, Drugs & Medical Devices
Helping Clients to Minimize Risk in a Heavily Regulated Industry
Parsons Behle & Latimer has partnered with clients in virtually every area of the drug and medical device industry.
Few industries are more highly regulated by multiple state and federal laws than the pharmacy and pharmaceutical industry. State pharmacy practice acts and rules, the federal Food, Drug, and Cosmetic Act, and federal and state controlled substances acts are but a few of the complex and often contradictory laws that impact pharmacies, drug wholesalers, and drug and device manufacturers. Federal and state laws governing reimbursement such as anti-kickback and other illegal remuneration laws, privacy laws such as HIPAA and the HITECH Act, and insurance laws add additional regulatory layers.
The attorneys at Parsons Behle & Latimer counsel clients in the face of increasing DEA regulations and enforcement; FDA and state pharmacy boards regulations of compounded pharmacy products; and claims for product liability, misdispensing, and negligence based on alleged failures to provide patient counseling. With clients ranging from individual pharmacists to Fortune 500 pharmacy retailers, from small start-ups and independent pharmacies to multinational biotech and pharmaceutical companies, the firm's attorneys have strong experience in assisting with drug regulatory issues and related intellectual property concerns.