# DEA Schedule I Registration Packet — DRAFT

**Applicant:** Crowe Logic, Inc.
**Principal Investigator:** Michael B. Crowe, 
**Facility:** Crowe Logic Psychedelic Research Laboratory
**Generated:** 2026-04-21
**Tool:** Crowe Psychedelics lfpsy reg-pack

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## ⚠️ LEGAL REVIEW REQUIRED

> This packet is a **drafting aid**, not a submission artifact. Every
> document in this directory **MUST** be reviewed by DEA-registered
> counsel before it is filed with the Drug Enforcement Administration.
>
> This tool does not provide legal advice. It assembles regulatory
> boilerplate and applicant-specific fields into draft documents that
> reflect common DEA Schedule I application structure. Ambiguities in
> the regulations are flagged inline with `[LEGAL REVIEW]` markers.
> A registered attorney must resolve each before submission.

---

## Packet contents

1. **01_cover_letter.md** — Cover letter to DEA Registration Section
   *Maps to:* 21 CFR 1301.13, 21 CFR 1301.18
2. **02_research_protocol.md** — Research protocol summary
   *Maps to:* 21 CFR 1301.18(a)(2)
3. **03_security_plan.md** — Physical security plan
   *Maps to:* 21 CFR 1301.71 through 1301.76
4. **04_sop_inventory.md** — SOP: inventory and record-keeping
   *Maps to:* 21 CFR 1304.11, 21 CFR 1304.21
5. **05_sop_destruction.md** — SOP: substance destruction
   *Maps to:* 21 CFR 1317, DEA Form 41
6. **06_sop_emergency.md** — SOP: theft, loss, breach response
   *Maps to:* 21 CFR 1301.74(c), DEA Form 106
7. **07_facility_diagram_template.md** — Facility diagram template (narrative prompt)
8. **08_dea_form_225_fields.md** — DEA Form 225 field map (transcription aid)
   *Maps to:* 21 CFR 1301.13 (Form 225 requirement)


## Compounds covered

| # | Compound | Schedule | Est. annual qty (mg) | Source |
|---|---|---|---|---|
| 1 | Psilocybin | I | 500.0 | Cayman Chemical (DEA-registered supplier) — analytical standard |
| 2 | Psilocin | I | 250.0 | Cayman Chemical — analytical standard |
| 3 | DMT | I | 100.0 | Cayman Chemical — analytical standard |


## Next steps checklist

- [ ] Counsel reviews every document in this packet
- [ ] PI CV + publications compiled as separate attachments
- [ ] Signed facility lease / ownership proof obtained
- [ ] Security system installation confirmed (see `03_security_plan.md`)
- [ ] IRB approval letter attached (if human subjects)
- [ ] Animal protocol / IACUC approval attached (if animal subjects)
- [ ] Institutional sign-off letter obtained
- [ ] DEA Form 225 completed using `08_dea_form_225_fields.md` as source
- [ ] Application fee paid ($244 per registration, 2025 schedule —
      *verify current fee before submission*)
- [ ] Packet submitted via DEA Diversion online system or paper
      (paper submission to DEA Registration Section, Washington, DC)

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*Grounded in 21 CFR 1301 (registration + security), 21 CFR 1304
(records), 21 CFR 1308.11 (Schedule I substance list), and FDA Guidance
FDA-2023-D-1987 (psychedelic drug development, June 2023).*
