The Drug Distributor's Guide to DEA Compliance - Volume I "The History"

By Benjamin F. Mink

On October 26, 2017, the Acting Secretary of Health & Human Services (HHS) for the United States of America declared the opioid crisis a public health emergency under section 319 of the Public Health Service Act leading to unprecedented nationwide lawsuits alleging compliance failures by the pharmaceutical industry resulted in drug diversion. According to HHS's Centers for Disease Control and Prevention (CDC), over 42,000 people died from opioid-involved overdoses in 2016. In the wake of this national crisis declaration many states, counties, and tribal entities, and local governments have sought remedy from the opioid manufacturers, distributors, pharmacies, and even the pharmacy benefit managers alleging their lack of compliance with the controlled substances act (CSA) of 1970, paired with deceptive marketing practices, resulted in wide-spread drug diversion. With the pharmaceutical industry, firmly in the cross-hairs of an ever growing group of multi-district plaintiffs, some have agreed to settle for millions and in some cases billons of dollars, while many cases drag on with no clear end in sight. Although, we can't change the past, we can change the future. This series is intended to help the Drug Enforcement Agency (DEA) Registered community, also known as the pharmaceutical supply chain, mitigate costly non-compliance risks and better operate in a manner that is consistent with the publics interest. This book is a must read for DEA compliance professionals, pharmaceutical executives, healthcare executives, state/federal regulators, healthcare attorneys, state board of pharmacy agents/inspectors, law makers, public health officials, and students.

• Format: Paperback
• Language: English
• ISBN: B0CW2ZP5F7
• ISBN13: 9798878892827
• Release Date: February 2024
• Publisher: Independently published
• Length: 50 Pages
• Dimensions: 8.0" x 0.1" x 5.0"