Articles and Blogs

This past week, the Drug Enforcement Administration (“DEA”) and the U.S. Department of Health and Human Services (“HHS,” and together with the DEA, the “Agencies”) announced the release of three highly anticipated rules related to the prescription of controlled substances through telemedicine. These new rules include: A final rule on the “Expansion of Buprenorphine Treatment... READ MORE

On Friday, November 15, 2024, the Drug Enforcement Administration (“DEA”) and the Department of Health and Human Services (“HHS,” and together with the DEA, the “Agencies”) issued a third temporary rule (the “Third Temporary Rule”) extending the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“telemedicine flexibilities”). As a result of both Congressional and... READ MORE

On Tuesday, October 10, 2023, the Drug Enforcement Administration (“DEA”) and the Department of Health and Human Services (“HHS”) issued a second temporary rule (the “Second Temporary Rule”) extending the effective period for the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“telemedicine flexibilities”). These telemedicine flexibilities were previously extended by an earlier temporary... READ MORE

This Week (September 15, 2023): Drug Enforcement Administration (“DEA”) officials have been holding pre-regulatory listening sessions with stakeholders to discuss a new special provider registration requirement for practitioners who are prescribing controlled substances through telehealth without first establishing a provider-patient relationship. Why it Matters: The special registration is mandated by the Ryan Haight Act,... READ MORE

On November 17, 2021, the Drug Enforcement Administration (“DEA”) issued an advanced notice of proposed rulemaking (“ANPR”) with the goal of obtaining further information regarding the practice of telepharmacy. The DEA is seeking input as it considers promulgating new telepharmacy regulatory requirements. Interested stakeholders have until January 18, 2022 at 11:59 PM EST to... READ MORE

The Drug Enforcement Administration (“DEA”) recently released the 2020 edition of the Pharmacist’s Manual, replacing all previous versions. Since 2010, the Pharmacist’s Manual (“Manual”) has aided pharmacies and pharmacists in understanding how to apply requirements under the Federal Controlled Substances Act (“CSA”) and related DEA regulations. As an agency guidance document, the Manual offers... READ MORE

On Wednesday, July 29, 2020, the U.S. Department of Justice Drug Enforcement Administration (“DEA”) proposed a new rule that would require DEA registrants to electronically report “theft or significant loss” of controlled substances within 15 days of discovery of the circumstances requiring the report (“Proposed Rule”). This proposal is notable as currently there is... READ MORE

On October 30, a bipartisan, bicameral group of lawmakers reintroduced the Creating Opportunities Now for Necessary and Effective Care Technologies (“CONNECT”) for Health Act (S. 2741/ H.R. 4932). This legislation is intended to remove roadblocks to telehealth expansion in Medicare by giving providers the freedom to use alternative payment models and incentive programs, reducing... READ MORE