This article, co-authored by partner Heather L. Stutz and associate Sarah H. Stec, was recently published by the Hospitals and Health Systems Practice Group of the American Health Lawyers Association.
The article discusses the importance of health system pharmacies' compliance with existing regulations to avoid costly penalties from the Drug Enforcement Agency (DEA), focusing on often overlooked requirements triggered by practices stemming from new operations and affiliations. It also points out practical considerations related to DEA regulations and how to avoid common pitfalls expanding hospital systems are experiencing with respect to their growing pharmacy practices.
Four common pitfalls are covered in more detail:
- Not performing a comprehensive compliance audit on both old and new pharmacies
- Not following proper discontinuation procedures
- Too many transfers among registrants in the same health system without a distribution registration
- Locum tenens and practicing "under another's registration"
Copyright 2017, American Health Lawyers Association, Washington DC. Reprint permission granted.