Obtaining and maintaining state distribution licenses is a cumbersome, time-consuming process. Life sciences companies must have the appropriate licenses in all necessary jurisdictions before selling or shipping product. States have varying licensing requirements and often require licenses for companies that never touch their product, but outsource the actual manufacture and distribution. Another regulatory trap is the maintenance of distribution licenses. Submission of timely renewals, and knowing what events trigger notification requirements and when those notifications are due is essential to avoiding disciplinary action, fines and penalties.
Porzio counsels clients on the particular laws related to the wholesale distribution of prescription drugs, devices, and over-the-counter (OTC) products in all 50 states and the District of Columbia. Our attorneys have extensive experience analyzing the individual state wholesale distribution statutes and regulations and advising clients on all applicable requirements and how best to obtain any necessary licenses. Our relationships with the various state boards of pharmacy allow Porzio to provide clients with the most relevant and up-to-date information. Porzio also counsels clients on the implications of federal initiatives in the wholesale distribution arena.
The licensing process is further streamlined through the expertise of our wholly-owned subsidiary, Porzio Life Sciences. PorzioLS tracks state requirements and offers fully outsourced initial and renewal licensing services, enabling you to get your product to market faster and dramatically reducing the risk of filing delays that cause exposure to revenue loss and penalties.
In addition to its tailored licensing services, PorzioLS offers three distribution databases that contain all statutes, regulations, and pending legislation, nationwide, governing the distribution of trade product and samples by companies and their representatives, relating to either legend drugs, controlled substances or prescription devices. PorzioLS also offers Porzio Compliance Modules (“PCMs”) that address whole sale distribution requirements. PCMs provide "at-a-glance" information obtained through review of voluminous statutes, regulations and agency rules.