On June 11, 2013, the DEA announced that Walgreens Corporation agreed to pay $80 million in civil penalties, the largest settlement in DEA history. This settlement resolves both the DEA’s administrative actions against Walgreens and the U.S. Attorney’s Office’s civil penalty investigation. In addition to the civil penalty, Walgreens agreed to a two year
Larry P. Cote
Upcoming DEA Conferences
The DEA has announced an upcoming Manufacturer/Importer/Exporter Conference to be held in June 2013 at the National Harbor, Gaylord National Resort & Convention Center. “The purpose of this conference is to provide a forum to present federal laws and regulations that affect the pharmaceutical and chemical manufacturing, importing, and exporting industry and to discuss practices…
Obtaining DEA Quota to Manufacture Controlled Substances
DEA Quota Season is Upon Us This is the first of several discussions we will have regarding the DEA quota process and the adverse impact DEA’s handling of the quota process can have on the availability of controlled substances for the legitimate medical needs of the United States. Some context and background is required to…
Oral Argument: Walgreen Co. v. DEA
Today the Court of Appeals for the District of Columbia Circuit heard oral arguments in the matter of Walgreen Co. v. Drug Enforcement Administration, et al., (Docket No. 12-1397). I will leave the prognosticating to trained professionals; however, it was clear to me that Walgreens was before a sympathetic panel. The three-judge panel asked…
Significant Shift in Drug Diversion
Go West, young man!
The Wall Street Journal published a very interesting article on the shift in drug diversion trends within the United States. DEA has very publicly focused its enforcement efforts on South Florida pill mills as well as other problematic locations in the Eastern United States. According to information obtained by the Wall…
Suspicious Order Monitoring
…to infinity and beyond!
For years manufacturers and distributors have searched for the holy grail of DEA compliance – specific guidance from DEA on what actually constitutes a suspicious order. The obvious source of assistance and the sole legal basis establishing the requirement to detect and report suspicious orders is found in DEA’s own regulations. …
DEA Compliance Programs
Do you see what DEA sees? The Controlled Substances Act and the DEA’s regulations are unambiguous and DEA’s interactions with registrants are predictable, right? Well, not always. However, the maze of DEA compliance issues can be made a little less complex by understanding the Agency’s perspective on issues. In the DEA Chronicles you will find…
2012 DEA Enforcement Actions: A Year in Review
While the Drug Enforcement Administration (“DEA”) prosecuted far fewer administrative actions in FY2012 than FY2011, the Agency nonetheless continued to be very active in investigating pharmaceutical diversion cases. The highly publicized and unprecedented actions taken by DEA in FY2012 provide valuable insight to where the DEA may focus its enforcement efforts in 2013. The “DEA…