Controlled Substances, Healthcare, Food and Drug Administration (FDA)

New Mexico Becomes Third State in the U.S. to Legalize Access to Psilocybin

Foley & Lardner LLP on 4/10/2025

On April 7, 2025, New Mexico Governor Michelle Lujan Grisham signed into law SB-219, the Medical Psilocybin Act (the Act), making New Mexico the third state in the country to create a legal pathway for patients to access...more

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

Quarles & Brady LLP on 1/18/2024

On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

A Potential Breakthrough for Psychedelic Treatments: Ninth Circuit Court Ruling on Psilocybin Rescheduling

Vicente LLP on 12/12/2023

On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic...more

Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy

Husch Blackwell LLP on 12/6/2023

Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the...more

Psilocybin: Updates in Oregon and Around the Country

Perkins Coie on 7/14/2023

Oregon is the first state in the country to offer controlled use of psilocybin to the public. As we detailed in a prior Update, the state had finalized regulations. Now, the state has licensed its first psilocybin service...more

A Wake-up Call from Down Under: Australia's Therapeutic Goods Administration Reschedules Psilocybin and MDMA

Vicente LLP on 3/2/2023

As Matt Zorn discussed here and in this opinion piece with Chris Koddermann, Australia’s Therapeutic Goods Administration (TGA) recently approved a request to reschedule psilocybin and MDMA under that country’s drug...more

Oregon Finalizes New Regulations To Implement Psilocybin Services Act

Perkins Coie on 1/27/2023

Oregon became the first state to offer controlled use of psilocybin to the public on January 1, 2023. Psilocybin is a Schedule I psychoactive substance that is illegal at the federal level. Notwithstanding this federal...more

Controlled Substances › Healthcare › Food and Drug Administration (FDA)