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 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
Defining, but Protecting, DEA’s Suspension Powers: the Impact of HR 4069
The “Ensuring Patient Access and Effective Drug Enforcement Act” introduced by Representatives Blackburn and Marino defines the term “imminent danger.” The Controlled Substances Act requires DEA to find that a registrant poses an imminent danger to public health or safety before the Agency can issue an immediate suspension order, but the current law
Congressional Hearing on CSA Amendment
Today at 3 p.m., I will be joining DEA’s Mr. Joseph Rannazzisi, HDMA CEO John Gray and others to testify before the House Energy and Commerce Subcommittee on Health regarding a proposed amendment to the Controlled Substances Act. H.R.
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
Sometimes Numbers Lie: Decline in Opioid Prescriptions is Hollow
According to the Milwaukee Journal Sentinel, IMS has reported that the number of prescriptions for opioids declined 5% in 2013 compared to 2012. Although this could signal a positive step in combating opioid abuse, data suggest otherwise. The decline in the number of prescriptions for opioids