Frier Levitt is pleased to announce the successful resolution of a federal investigation by the United States Attorney’s Office for the District of Maryland and the Drug Enforcement Administration (DEA) regarding alleged violations of the Controlled Substances Act on behalf of Ultra Care, a Baltimore-based community pharmacy. Our client resolved the matter through a Consent Decree involving no admission of wrongdoing and a nominal, $15,000 fine.
In addition, the Consent Decree imposes no limitations on Ultra Care’s ability to dispense controlled substances on an ongoing basis. In this regard, the settlement acknowledges the critical role pharmacists play in the delivery of medication to needy patients, including those suffering from illnesses for which pain control is essential to the maintenance of function.
Nonetheless, the federal government’s “red flag” theory of liability remains problematic. Rather than clear and established legal standards, the industry remains subject to post hoc and arbitrary claims by government regulators as to their views of purported “red flags.” For example, in this case, the federal government took the position that it was a “red flag” that individuals other than the patients to whom the prescriptions were written picked up the medication from the pharmacy. Nonetheless, the government’s argument is directly contravened by CDC guidelines for pharmacies, which specifically state that pharmacy staff should encourage individuals, especially those at an increased risk of severe illness due to COVID-19, to have another individual pick-up medications for them.
These types of meritless arguments demonstrate just how far the pendulum has swung against community pharmacy when it comes to controlled substances. In short, pharmacies and pharmacists must exercise heightened diligence to ensure that they are complying with all federal and state regulations and are properly identifying and resolving purported red flags when filling prescriptions for all controlled substances, not solely opioids.
Should you have any questions regarding controlled substance obligations, please do not hesitate to contact us for a consultation. Frier Levitt’s practice group is spearheaded by former federal and state prosecutors with decades of controlled substance experience at all levels in the distribution chain.
