On September 23, 2014, DEA announced that its ninth Take Back Day would be the agency’s last. The announcement was made shortly after DEA published the Final Rule implementing the Secure and Responsible Drug Disposal Act of 2010. The regulations promulgated by DEA allow “authorized collectors” the opportunity to receive and securely dispose of prescription
On May 20, 2015, DEA issued a press release regarding a recent major enforcement action in Arkansas, Alabama, Louisiana, and Mississippi. Operation Pilluted targeted alleged pill mills that were engaged in the illegal distribution of oxycodone, hydrocodone and Xanax. The operation resulted in the arrest of 280 individuals, including 22 doctors and pharmacists. Executing 21
In the Matter of the Medicine Shoppe (October 2, 2014)
DEA recently revoked the registration of the Medicine Shoppe, a San Antonio, Texas, pharmacy, based on a finding that the pharmacy violated the Controlled Substances Act in all of the following ways:
In 45 days, hydrocodone combination products (“HCPs”) will be Schedule II controlled substances. This means that by early October, manufacturers, wholesalers, pharmacies, prescribers, and everyone in the drugs’ supply chains will have to be in compliance with the more restrictive regulatory requirements applicable to Schedule II drugs.
In the Matter of Moore Clinical Trials, L.L.C (July 11, 2014)
DEA last month denied the DEA research registration application of an Arkansas clinical research company, finding that the person who would be primarily responsible for ordering and storing controlled substances had a “shocking” lack of knowledge of the fundamental requirements imposed by the Controlled
As expected, FedEx appeared in federal district court and entered a plea of not guilty to the charges brought against the company by the Drug Enforcement Administration (“DEA”) and the United States Attorney’s Office for the Northern District of California. As we have recently discussed, this is an unprecedented action by the government seeking
Possibly in the hopes of catching everyone before they leave for their 4th of July holiday, the DEA published its Final Rule in the Federal Register on July 2nd placing tramadol into Schedule IV effective August 18, 2014. (Tramadol is a centrally acting opioid analgesic first approved for use in the U.S. in 1995 under
At the 110th Annual Meeting of the National Association of Boards of Pharmacy (“NABP”) a new educational video entitled “Red Flags” was released by NABP to assist pharmacists in properly exercising their corresponding responsibility and identifying the warning signs of prescription drug abuse and diversion. The educational video was sponsored by Mallinckrodt Pharmaceuticals, Cardinal Health,
Just when you thought it was safe to have a robust order monitoring program to detect and report suspicious orders, DEA has moved the goal post. In previous posts (here and here), we’ve talked about DEA’s “extra-regulatory” guidance on both suspicious orders and “due diligence”. In late February-early March, the DEA held a
On Thursday, February 27, 2014, the DEA issued a long-awaited Notice of Proposed Rulemaking (NPRM) seeking to reschedule hydrocodone combination products as Schedule II controlled substances. In a previous post we questioned whether such a step would actually have an impact on the abuse and diversion of these drugs. DEA relied on the scientific analysis