Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC; John Patrick Oroho, Esq., Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC; Teresita Weiss, Ph.D., J.D., Sr. Vice President, Regulatory Affairs and Compliance, for J. Knipper and Company, Inc.; Bryan Andrews, Director of Sales Operations, MedPro Systems LLC.
The pharmaceutical industry faces monumental challenges in the age of globalization within the United States: state laws and regulations that are more stringent than their federal counterparts. This article provides the historical context and current overview of Ohio’s laws, regulations, and sub-regulatory guidance concerning the distribution of prescription drugs, including drug samples, into and within the state, the verification requirements when distributing product to terminal distributors of dangerous drugs and prescribers, record retention responsibilities, and penalties for noncompliance. The article then examines the industry’s response from a major manufacturer, a distributor/third-party logistics provider, verification vendor, and compliance advisory vendors. It concludes with a call to action to the industry to form a new coalition to address state legislative and regulatory actions that have the potential to disrupt the entire supply chain.