As we previously reported, on February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. Also on that date, the Senators introduced legislation that would also amend the Controlled Substances Act, as well as the Food, Drug, and Cosmetic Act. This legislation addresses, among other things,
DEA Decisions: In the Matter of The Medicine Shoppe
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:
- dispensed controlled substances without a prescription;
- dispensed controlled substances when the prescription was
DEA Announces New Ways for the Public to Dispose of Unused Controlled Substances
Beginning next month, consumers will have an easier time getting rid of unused painkillers and other addictive drugs, which DEA hopes will discourage people from flushing the drugs down the toilet, throwing them in the garage, or leaving them, forgotten, in their medicine cabinets. The new disposal methods include allowing people to drop off
DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products
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.
DEA Decisions: In the Matter of Moore Clinical Trials, L.L.C.
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
FedEx Pleads Not Guilty
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
DEA Finalizes Rule to Schedule Tramadol
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
NABP Releases “Red Flags”
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,
Non-Suspicious is Suspicious: DEA Moved the Goal Post Again!
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
Eisai Inc. Sues DEA
On Monday, Japanese drug maker Eisai Inc. filed a lawsuit against the DEA in the District of Columbia Court of Appeals. Their complaint? Eisai created a drug, called Fycompa, that the FDA approved last October to treat epileptic seizures. Due to FDA’s scheduling recommendation and the drug’s effect on the central nervous system, the DEA