Pharmacists, in general, can partially fill any prescription for non-controlled and most Schedule III-V controlled substances. Partial filling has several benefits, including reducing waste and potentially lowering the cost of a prescription. However, Schedule II (C-II) controlled drugs are an exception to general rule allowing …
To close out 2020, Hyman, Phelps & McNamara, P.C. is pleased to present the latest issue 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 enforcement …
Cannabidiol (“CBD”) products are everywhere. They are sold in pharmacies, as well as grocery, health food and convenience stores, and over the Internet. To protect its citizens in the absence of federal requirements governing CBD and hemp-derived products for human consumption, the New York Department …
Recently, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking (“NPRM”) that provides much needed clarity on the requirements for how emergency medical services handle controlled substances. The NPRM would codify its regulations consistent with the Protecting Patient Access to Emergency Medications Act …
As we blogged about last week, DEA published its long-anticipated Notice of Proposed Rulemaking (“NPRM”) addressing suspicious orders of controlled substances. The Proposed Rule is intended to (finally) “clarify” the procedures that DEA registrants must follow for what DEA now deems “orders received under suspicious …
Today, more than two years after Congress passed the Preventing Drug Diversion Act of 2018 (PDDA) and after more than a decade of industry requests for regulations addressing the Drug Enforcement Administration’s (DEA) interpretation of suspicious order requirements under 21 C.F.R. § 1301.74(b), DEA has …
Back on August 20, 2020, the Drug Enforcement Administration (“DEA”) issued an Interim Final Rule (“IFR”) purporting to “clarify” certain provisions of the Agriculture Improvement Act of 2018 (“AIA”). As we explained back when Congress passed the AIA in December 2018, the AIA upended the …
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 …
