# 2025-04284: Pharma Firm Seeks DEA OK to Bulk-Manufacture Magic Mushroom Psilocybin

2025-04284, Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC, is a Federal Register notice from Justice Department, Drug Enforcement Administration published 2025-03-17, effective Registered bulk manufacturers of the affected basic class(es), and applicants, may submit comments or file a written request for a hearing on or before May 16, 2025.; PRIA reads it as touching household money (as of 2026-09-30).

- Canonical: https://policyrisk.com/federal-register/2025-04284
- As of: 2026-09-30
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-04284
- Title: Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC
- Type: Notice
- Agencies: Justice Department; Drug Enforcement Administration
- Citation: 90 FR 12367
- Published: 2025-03-17
- Effective: Registered bulk manufacturers of the affected basic class(es), and applicants, may submit comments or file a written request for a hearing on or before May 16, 2025.
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-09-30

## In one line

Pharma Firm Seeks DEA OK to Bulk-Manufacture Magic Mushroom Psilocybin

## Summary

Sterling Pharma USA LLC wants to become a big-time maker of some powerful controlled substances like psilocybin and DMT for research and early drug testing. If you’re a current manufacturer or interested party, you can share your thoughts or ask for a hearing by May 16, 2025. This move could speed up new medicine research, but it’s all tightly watched and regulated.

## Abstract

Sterling Pharma USA LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

## Effects PRIA read

- Sterling Pharma applied to bulk-manufacture Schedule I drugs: benefit, low. On February 11, 2025, Sterling Pharma USA LLC applied to register as a bulk manufacturer of Schedule I substances including tetrahydrocannabinols (code 7370), 5-methoxy-N,N-dimethyltryptamine (code 7431), dimethyltryptamine (code 7435), psilocybin (code 7437), and psilocyn (code 7438). The company…
- Stakeholders can object or request a hearing by May 16, 2025: benefit, low. Registered bulk manufacturers of the affected drug classes and other applicants may submit electronic comments or objections, or file a written request for a hearing, on or before May 16, 2025 using regulations.gov.
- Registration limited to bulk manufacture for research: cost, low. The application states that no other activities for the listed drug codes are authorized for this registration; the planned authorization would be limited to bulk manufacture to support internal research and sale for pre-clinical studies.

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## Sources
- [2025-04284 on federalregister.gov](https://www.federalregister.gov/documents/2025/03/17/2025-04284/bulk-manufacturer-of-controlled-substances-application-sterling-pharma-usa-llc)
- [2025-04284 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-03-17/pdf/2025-04284.pdf)

## Related
- [Previous: 2025-04283, North Pacific Fishery Management Council; Public Meeting](https://policyrisk.com/federal-register/2025-04283)
- [Next: 2025-04285, Importer of Controlled Substance Application: Fisher Clinical Services, Inc.](https://policyrisk.com/federal-register/2025-04285)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-04284 (as of 2026-09-30).