News & Analysis as of

Life Sciences DEA Controlled Substances

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

Morgan Lewis - As Prescribed

Taking a Trip into the Future of Psychedelics

The development of psychedelic drugs for medicinal uses has substantially expanded since 2020, as evidenced by an exponential growth in Drug Enforcement Administration (DEA) production quotas for both psilocybin and psilocin....more

Mandelbaum Barrett PC

Life on the Line: Battling Bureaucracy for Timely Medical Innovations

Mandelbaum Barrett PC on

In the ever-evolving landscape of medical innovation, the journey to bring breakthrough therapies to those in need is often fraught with obstacles and red tape. For many patients grappling with life-threatening conditions,...more

Burr & Forman

Telehealth Prescribing Flexibilities for Controlled Substances Extended Through End of 2024

Burr & Forman on

The rule allowing for providers to prescribe controlled substances via telehealth, set to expire for new patient-provider relationships on November 11, has been extended through the end of 2024....more

Arnall Golden Gregory LLP

DEA Issues Second Extension of COVID-19 Telemedicine Flexibilities for Controlled Substance Prescriptions

Earlier this month, the United States Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) issued a temporary rule extending certain flexibilities for the prescription of controlled...more

Sheppard Mullin Richter & Hampton LLP

Tele-Prescribing Flexibilities Extended Again in Second Temporary Rule

This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...more

Quarles & Brady LLP

Brace Yourself: DEA’s Final Rule on Quotas Squeezes Inventory Levels and Signals Further Supply Restrictions

Quarles & Brady LLP on

On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more

Quarles & Brady LLP

Protect Your CSOS Credentials…Or Else.

Quarles & Brady LLP on

Over the last decade, the increased use of Controlled Substance Ordering System (“CSOS”) applications (i.e., platforms used to electronically transmit controlled substance orders) and Electronic Prescriptions for Controlled...more

Dickinson Wright

DEA Reverses Course and Extends Telehealth Prescriptions of Controlled Substances

Dickinson Wright on

Reversing previously proposed rules, the DEA recently issued new guidance allowing the continued use of telehealth when prescribing controlled substances following the end of the Covid-19 public health emergency (“PHE”)....more

Robinson & Cole LLP

Health Law Diagnosis - DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

Robinson & Cole LLP on

On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in...more

Polsinelli

DEA Temporary Rule Extends Telemedicine Flexibilities Through November 2023 and Grants Additional One-Year Grace Period

Polsinelli on

Two days ahead of the expiration of the COVID-19 Public Health Emergency (PHE), the  Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule extending...more

Robinson+Cole Health Law Diagnosis

DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in...more

Vicente LLP

What is the Process for Federal Psilocybin Registration?

Vicente LLP on

We’re fielding an increasing number of questions these days from companies and organizations about registering with the U.S. Drug Enforcement Administration (DEA) to handle psilocybin and psilocin in various ways. In light of...more

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