DEA Eyes Bulk Production of Psilocybin and Fentanyl—Wait, What?
Published Date: 3/26/2026
Notice
Summary
SpecGx LLC wants to become a big-time maker of some powerful and tightly controlled drugs, including things like psilocybin and fentanyl. People and companies already registered can share their thoughts or ask for a hearing by May 26, 2026. This move could shake up how these substances are made and handled, so keep an eye on the deadlines if you’re involved!
Analyzed Economic Effects
4 provisions identified: 0 benefits, 0 costs, 4 mixed.
SpecGx Applied To Bulk-Produce Many Drugs
SpecGx LLC applied on February 4, 2026 to be registered as a bulk manufacturer for many Schedule I and II controlled substances, including psilocybin (code 7437), fentanyl and related compounds (codes 9801, 9821, 9822, 9850), tetrahydrocannabinols (code 7370), and gamma hydroxybutyric acid (code 2010). The notice lists the full set of drug codes the company seeks to manufacture in bulk.
Deadline to Comment or Request Hearing
Registered bulk manufacturers of the affected drug classes and applicants may submit electronic comments or objections, or file a written request for a hearing, on or before May 26, 2026. Comments must be submitted via https://www.regulations.gov and commenters will receive a Comment Tracking Number when submitted.
Planned Sale And Internal Use Of Manufactured Drugs
SpecGx plans to bulk manufacture the listed controlled substances for sale to its customers and for internal use to produce non-controlled substances, according to the application text. The registration, if granted, would be limited to the activities listed for those drug codes.
THC Manufacture Limited To Synthetic Form
For drug code 7370 (Tetrahydrocannabinols), SpecGx states it plans to bulk manufacture this drug code as synthetic. The application notes that no other activities for these drug codes are authorized by this registration.
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