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
DEA Must Obtain a Warrant to Access PDMP Data in Oregon
Federal Court Rules Patients Have Reasonable Expectation to Privacy of Prescription Drug Information
A Federal District Court in Oregon has ruled that patients have a Fourth Amendment privacy right in their prescription drug information–even if such information is forwarded to and maintained by a state-run database. Consequently, government agencies will be required to obtain a
DEA Decisions: In the Matter of Hoi Y. Kam, M.D.
In the Matter of Hoi Y. Kam, M.D. (October 22, 2013)
In July 2011, the New York Department of Health revoked Dr. Hoi Kam’s medical license on the ground that he previously committed Medicaid fraud and had been excluded from the Medicaid program in 2006. Three months later, however, the State’s Administrative Review Board (ARB)
DEA Decisions: In the Matter of Kenneth Harold Bull, M.D.
In the Matter of Kenneth Harold Bull, M.D. (October 22, 2013)
Dr. Kenneth Bull is a New Mexico psychiatrist known for treating difficult or complex psychiatric conditions. During his long career, Dr. Bull worked as the chief of psychiatry or medical director of psychiatric services at nearly every hospital in the Albuquerque area, and he
DEA Decisions: In the Matter of Anthony E. Wicks, M.D.
In the Matter of Anthony E. Wicks, M.D. (October 22, 2013)
DEA refused to issue a new DEA registration to a doctor who moved from California to central Florida in December 2010 and, in the seven months after his move, wrote more than 2,000 controlled substance prescriptions from his new location without notifying DEA of
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.
DEA Finalizes 2014 Quota
Sometimes consistency is a bad thing…
On September 9, 2013, the DEA published the 2014 Aggregate Production Quota (APQ) and Annual Assessment of Needs (AAN). This is noteworthy because it continues the DEA’s streak of failing to meet the deadline for establishing the APQ going back at least to 1998 and the AAN since
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.
DEA and Walgreens Settlement
On June 11, 2013, the DEA announced that Walgreens Corporation agreed to pay $80 million in civil penalties, the largest settlement in DEA history. This settlement resolves both the DEA’s administrative actions against Walgreens and the U.S. Attorney’s Office’s civil penalty investigation. In addition to the civil penalty, Walgreens agreed to a two year
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