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
DEA Takes the First Step Towards Rescheduling Hydrocodone Combination Products
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
Hydrocodone Rescheduling: Yesterday’s Solutions for Today’s Problem
FDA recently announced that it was recommending that hydrocodone combination products be moved from Schedule III to Schedule II under the Controlled Substances Act. The placement of hydrocodone combination products in Schedule II is a great idea — for 2003. But FDA’s belated action is unlikely to have a significant impact on prescription drug abuse.
A Pharmacist’s Obligation: Corresponding Responsibility and Red Flags of Diversion
Corresponding responsibility is perhaps one of the most commonly misunderstood and/or (unfortunately) unknown concepts found in DEA’s regulations. And yet, enforcement actions against pharmacies are most frequently initiated when a pharmacist fails to exercise his/her corresponding responsibility. I have had countless conversations with practicing pharmacists who are either unfamiliar with the concept of a “corresponding responsibility” or don’t understand how to apply it in their daily practice. The DEA’s regulations (21 C.F.R. § 1306.04) addressing corresponding responsibility state A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
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