Wholesale Drug and Device Distribution
Quarles & Brady serves as national regulatory counsel for a number of wholesalers and third-party logistics providers (3PLs) of human and animal prescription and over-the-counter drugs and devices. We advise on regulations and requirements regarding operations and state licensing and reporting requirements, and guide clients through regulatory inquiries and investigations.
We provide efficient business solutions to legal issues while being protective of our clients' resources and promoting their business goals and expectations.
Following are some of the major aspects of our practice:
- Regulatory Compliance: Our attorneys provide counsel to wholesale distributors and 3PLs in disciplinary and regulatory matters pending before Boards of Pharmacy, the US Drug Enforcement Administration (DEA), and other governmental agencies across the country. We have worked to set up complex arrangements between pharmacy clients and veterinary practices that require clients to be both wholesalers and pharmacies. And our team routinely provides advice to 3PL providers, distributors, and reverse distributors related to compliance with the Drug Supply Chain Security Act of 2013.
- Licensing: We assist clients with the licensing of their facilities at initial start-up or as a result of changes of ownership that result from re-organizations or mergers & acquisitions. We also assist clients with licensure filings necessary to report changes to their officers, business name, or location. We also advise on licensure necessary for novel business models.
- DEA Regulatory: We assist clients with DEA matters, including licensing, investigations, compliance with reporting requirements, and development of policies and processes regarding the handling of controlled substances and listed chemicals. We advise on all aspects of compliance with the Controlled Substances Act (CSA) and DEA regulations, including registration and recordkeeping.
- FDA Regulatory Compliance: Our Food and Drug Administration (FDA) regulatory attorneys provide a wide variety of legal advice concerning wholesale distribution of drug and device products, including controlled substances and biologics; importation and re-importation; state requirements; the secondary market; repackaging; and combating counterfeiting, diversion, and other avenues by which products become unsaleable.
- Administrative Proceedings and Litigation: We provide counsel to wholesale distributors and third-party logistics providers in disciplinary and regulatory matters pending before Boards of Pharmacy, the DEA, and other governmental agencies across the country.
- Mergers & Acquisitions: We have helped multiple clients acquire or sell 3PLs and wholesale facilities and complete internal corporate restructuring. We have also assisted with the resultant licensure changes allowing seamless transitions.