On February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. This is the companion bill to H.R. 471, sponsored by Representatives Marino, Blackburn, Welch, and Chu that was recently approved by the Subcommittee on Health, Energy and Commerce Committee. At a recent Congressional
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
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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…
DEA Decisions: In the Matter of Roy S. Schwartz, D.D.S
In the Matter of Roy S. Schwartz, D.D.S (June 16, 2014)
DEA suspended for one year the DEA registration of a Tacoma, Washington dentist with more than 50 years experience after he admitted “sharing” his DEA number with another dentist who performed conscious sedation, and who had previously surrendered his DEA registration for cause. DEA…
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,…
Don’t Squeeze the Balloon: An International Perspective on Preventing Prescription Drug Overdoses
Last year the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) published a paper on reducing opioid overdose mortality. The paper addressed opioid overdoses related to heroin use and concluded that reduction in supply is an effective measure governments can take to reduce heroin overdoses. The UNODC and…