On March 4, 2015, the Government Accountability Office (GAO) released a report titled, Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved. GAO’s report examined, (1) the trends in such shortages, (2) the effect on patients and providers, (3) DEA’s administration of the quota
Second Bill Introduced in the Senate to Amend the Controlled Substances Act
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,
Legislation Introduced in Senate Seeking to Amend CSA
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
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
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,
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
Veterans’ Affairs Hearing on VA Prescribing Practices
Around this time last year I wrote an article for Q&B’s Diversity Blog discussing two disturbing trends regarding members of the Armed Forces and specifically veterans. The increasing suicide rate and abuse of prescription drugs are unfortunate outcomes of the stress that more than 12 years of persistent war has placed on the
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
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
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.