Controlled Substances

By Karla L. Palmer & Andrew J. Hull –  From time to time, we have posted on significant final orders in DEA administrative cases. We now plan to blog on these cases in a more regular fashion, partly because we have noted that a number of these …

By Karla L. Palmer – In a move unprecedented in recent memory, on October 13, 2016, DEA published a Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7- Hydroxymitragynine (i.e., kratom) in schedule I of the Controlled Substances Act. As background, a little over a …

By John A. Gilbert, Jr. & Larry K. Houck – This is third in a series of in-depth reviews of the Drug Enforcement Administration’s (“DEA’s”) and other federal agencies’ recent decisions/notices on marijuana and industrial hemp issued on August 12, 2016. Previously, we reviewed DEA’s policy …

By John A. Gilbert, Jr. & Larry K. Houck – We previously summarized (here and here) the Drug Enforcement Administration’s (“DEA’s”) recent actions related to marijuana and reviewed DEA’s notice that it will expand the number of marijuana cultivators for research. Today we analyze DEA’s denial …

By John A. Gilbert, Jr. & Larry K. Houck – Last week we summarized several new Drug Enforcement Administration (“DEA”) actions related to marijuana.  We now take a more in depth review of one of those actions related to DEA registration to cultivate marijuana for research. For …

By John A. Gilbert, Jr. & Larry K. Houck – In separate notices published today, the Drug Enforcement Administration (“DEA”) issued three major decisions on marijuana and industrial hemp. The most significant, in a move running counter to most state action, includes DEA rejecting a petition …

By John A. Gilbert Jr. & Alan M. Kirschenbaum –  On Friday, July 22, 2016, President Obama signed into law the Comprehensive Addiction and Recovery Act (“CARA” or “Act”) of 2016, which is intended to help reverse the serious prescription drug abuse trend in the United …

By Larry K. Houck – The Substance Abuse and Mental Health Services Administration (“SAMHSA”) has published a proposed rule that would increase the number of patients with opioid abuse disorder that a qualified physician can treat with buprenorphine. Medication Assisted Treatment for Opioid Use Disorders, 81 …

By Larry K. Houck – The Centers for Disease Control and Prevention (“CDC”) has released its final guidelines for prescribing opioids for chronic pain. CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016, Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Mar. …

By John A. Gilbert, Jr. & Larry K. Houck – The Government Accountability Office (“GAO”) recently released a report examining issues related to state marijuana legislation and federal monitoring of such actions. GAO, State Marijuana Legalization: DOJ Should Document Its Approach to Monitoring the Effects of …

By Larry K. Houck – Several recent developments relating to cannabidiol and marijuana occurred over the past several weeks. We summarize them below: One Step Forward for Cannabidiol Research The Drug Enforcement Administration (“DEA”) announced that it has eased some of the regulatory requirements for FDA-approved clinical trials …

By Larry K. Houck – The Centers for Disease Control and Prevention (“CDC”) have published draft guidelines for prescribing opioids for chronic pain and opened a docket seeking public comment. Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain, 80 Fed. Reg. 77,351 (Dec. 14, 2015). …

By Kurt R. Karst – Last Wednesday, November 25, 2015, after a long slog through the legislative process (see our previous post here), President Obama signed into law the Improving Regulatory Transparency for New Medical Therapies Act (H.R.639). (Unlike other bills, H.R.639 doesn’t have a sexy …

The latest issue of the Food and Drug Law Institute’s “Update” magazine features an article written by Hyman, Phelps & McNamara, P.C. attorneys John A. Gilbert, Jr. and Andrew J. Hull.  The article, titled “A Matter of Substantial Discretion: A Recent Rift Between DEA and …

By John A. Gilbert, Jr. & Larry K. Houck – Yes, with passage of the State Marihuana (sic) and Regulatory Tolerance (“SMART”) Enforcement Act.  The bill, H.R. 3746, introduced by Representative Suzan DelBene (D-WA), would authorize the Attorney General to waive the marijuana provisions of the …