On Monday, September 14, the United States Court of Appeals for the Second Circuit reversed the December 2018 opinion from the United States District Court for the Southern District of New York that invalidated the New York Opioid Stewardship Act (OSA). In Association for Accessible …
During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and …
On July 29, 2020, DEA published a Notice of Proposed Rulemaking titled, “Reporting of Thefts or Significant Loss of Controlled Substances.” (85 Fed. Reg. 45547 (Jul. 29, 2020)). See Federal Register notice here. As registrants are well aware, the current DEA regulation addressing reporting to …
An interesting aspect of a federal or state administrative agency seeking appropriations or raising fees is its justification for doing so and the light it sheds on the priorities for fulfilling its mission. The Drug Enforcement Administration’s (“DEA’s”) recent increase of initial registration and renewal …
The U.S. Department of Agriculture (“USDA”) continues to consider and approve state and tribal hemp production plans, announcing the approval of plans for the U.S. Virgin Islands, Cheyenne River Sioux Tribe, Chippewa Cree Tribe, Lac Courte Oreilles Band of Superior Chippewa Indians, and Red Lake …
A little more than ten years ago, on March 31, 2010, the Drug Enforcement Administration published its Interim Final Rule (IFR) with request for comments, titled “Electronic Prescriptions for Controlled Substances” (Docket No. DEA-218, RIN 1117-AA61). The rule became effective June 1, 2010, and is …
In 2009, Levon Helm, formerly of The Band, wrote and recorded “Growin’ Trade,” a song about a weary, disillusioned American farmer reluctantly staves off bankruptcy by growing illegal cannabis. Helm nor anyone else could have known that in the ensuing years, a majority of states …
On February 27, the U.S. Department of Agriculture (USDA) announced the delay of enforcement of certain requirements under the interim final rule (IFR) for the U.S. Domestic Hemp Production Program. As we previously reported, on Nov. 7, 2019, USDA published its much-anticipated rule establishing the requirements …
Under current law, a Narcotic Treatment Program (“NTP”) registered with the Drug Enforcement Administration (“DEA”) can only provide treatment at its registered location. With the current opioid epidemic, the need to ensure access to medication-assisted treatment is more acute than ever. To help address this …
Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …
In a September 2018 post, we observed that the Drug Enforcement Administration (“DEA”) had come to a fork in the road with respect to DEA’s August 12, 2016 policy statement that it would be accepting applications and would in fact issue additional marijuana manufacturer registrations …
Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …
We sometimes use the term “act of Congress” when referring to something that is difficult or requires large effort to achieve. But, as nothing else has worked, a real act of Congress may be required to compel the Drug Enforcement Administration (“DEA”) to issue marijuana …
After years of talk about replacing the antiquated, carbon-leaved triplicate Official Order Form (“DEA Form 222” or “DEA-222s”) required for schedule I and II controlled substance transfers, the Drug Enforcement Administration (“DEA”) is proposing to implement a single-sheet order form. New Single-Sheet Format for U.S. …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …
