Particle Sciences Gains DEA Schedule I Registration

May 28, 2019

Expanded controlled substance capabilities enables Particle Sciences to develop and manufacture Schedule I–V drugs.

Particle Sciences, a Lubrizol LifeSciences company and pharmaceutical contract development and manufacturing organization, announced on May 23, 2019 that it received Drug Enforcement Administration (DEA) registration to be an authorized manufacturer of Schedule I substances.

The expanded registration will allow the company to conduct analytical testing, development, and manufacturing of cannabis-derived materials to be used in pharmaceutical applications for medically justified, legal uses in the United States.

The company reports existing capabilities to develop and manufacture Schedule II–V controlled drug products at its facility in Bethlehem, PA. Previously, the company worked on projects ranging from a novel nasal delivery system for diazepam to long-acting buprenorphine dosage forms. 

“Particle Sciences has built a solid reputation and specialized expertise in controlled substances as a result of our team’s work in complex formulations with substances in Schedules II–V,” said Robert Lee, president of Particle Sciences in a press statement announcing the approval. “A high level of ethical standards and water-tight controls/processes including accurate documentation are essential to carry out controlled substances work and these are already firmly ingrained in our day-to-day operations.”

Source: Particle Sciences