Regulatory & Compliance

Schedule I Controlled Substance

At-a-glance comparison

SpecValue
Statutory frameworkU.S. Controlled Substances Act (CSA), 21 U.S.C. § 812
Two-part definition(1) No currently accepted medical use in the United States; (2) High potential for abuse
Examples (currently scheduled)Heroin, LSD, MDMA, marijuana (federal), peyote, psilocybin, methaqualone
Research accessSchedule I research requires DEA Schedule I researcher registration
Effect on commerceManufacture, distribution, dispensing, possession outside research is prohibited under federal law
7-OH status (May 2026)FDA recommended Schedule I in July 2025; final DEA action pending

What is a Schedule I controlled substance?

Schedule I is the most restrictive of the five schedules established by the U.S. Controlled Substances Act (CSA). The two statutory criteria for Schedule I placement are codified at 21 U.S.C. § 812(b)(1): the substance must have no currently accepted medical use in treatment in the United States, and it must have a high potential for abuse. A substance must satisfy both criteria for Schedule I placement.

Schedule I substances are subject to the strictest controls under federal law. Their manufacture, distribution, dispensing, and possession outside of authorized research is prohibited. Research with Schedule I substances requires the DEA's Schedule I researcher registration, which is more restrictive than registrations for other schedules.

How a substance is placed in Schedule I

Schedule I placement, like other CSA scheduling decisions, follows the standard DEA scheduling process: the FDA conducts an eight-factor scientific and medical evaluation, the FDA submits a recommendation to the DEA, the DEA issues a proposed rule, a public-comment period follows, and the DEA issues a final rule. Substances posing an imminent hazard can be emergency-scheduled under 21 U.S.C. § 811(h), bypassing the standard process; emergency scheduling is initially time-limited and can be made permanent through the standard process.

Schedule I placement can be challenged. Petitioners can request rescheduling, and the DEA periodically reconsiders specific substances. The 2016 DEA notice of intent to emergency-schedule mitragynine and 7-OH was withdrawn following a substantial public response, illustrating that the process incorporates feedback even on substances initially proposed for the most restrictive schedule.

Schedule I and 7-hydroxymitragynine

In July 2025 the U.S. Food and Drug Administration formally recommended that the DEA place 7-hydroxymitragynine in Schedule I. The recommendation specifically targeted 7-OH as an isolated and concentrated form, distinct from kratom or mitragynine broadly. The FDA's eight-factor analysis concluded that 7-OH meets both Schedule I statutory criteria, no currently accepted medical use and high potential for abuse, in the agency's determination.

As of May 2026, the DEA had not published a final rule scheduling 7-OH. The dedicated DEA Scheduling and FDA Position glossary entries cover the procedural status in more detail. Verify current status before relying on this summary; this page is reviewed monthly.

Common questions about schedule i controlled substance

What is a Schedule I controlled substance?
A substance placed in the most restrictive of the five schedules under the U.S. Controlled Substances Act. Schedule I requires that the substance have no currently accepted medical use in treatment in the United States and a high potential for abuse.
What are some examples of Schedule I substances?
Heroin, LSD, MDMA, marijuana (under federal law, despite state-level variation), peyote, psilocybin, and methaqualone are among the substances currently in Schedule I.
Is 7-OH a Schedule I substance?
As of May 2026, no. The FDA recommended Schedule I status for 7-hydroxymitragynine in July 2025; the DEA had not published a final scheduling rule by that date. Verify current status before relying on this summary.
Can research be conducted with Schedule I substances?
Yes, but it requires DEA Schedule I researcher registration, which is more restrictive than registrations for other schedules. The registration process verifies the researcher's credentials, security measures, and research plan.
What is the difference between Schedule I and Schedule II?
Both schedules are reserved for substances with high potential for abuse. The principal difference is medical use: Schedule II substances have currently accepted medical use in the United States (e.g., morphine, oxycodone, fentanyl), while Schedule I substances are determined to have no such accepted medical use.
Can a Schedule I substance be moved to a less restrictive schedule?
Yes, through a rescheduling petition or DEA-initiated reconsideration. Rescheduling typically requires evidence of accepted medical use, lower abuse potential, or both, evaluated through the standard FDA/DEA process.

References

  1. U.S. Controlled Substances Act. 21 U.S.C. § 812 - Schedules of Controlled Substances.
  2. U.S. Drug Enforcement Administration. 21 CFR Part 1308 - Schedules of Controlled Substances.
  3. U.S. Food and Drug Administration. (2025, July). Recommendation to schedule 7-hydroxymitragynine.
  4. U.S. Drug Enforcement Administration. (2016). Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7-Hydroxymitragynine into Schedule I. Federal Register.

Important safety information:

Products containing 7-hydroxymitragynine (7-OH) are sold for adult use only (21+). These statements have not been evaluated by the U.S. Food and Drug Administration. Products are not intended to diagnose, treat, cure, or prevent any disease. The FDA has raised safety concerns regarding concentrated 7-OH products; consult a qualified healthcare professional before use. Do not operate vehicles or machinery after use. Keep out of reach of children and pets. Laws vary by state, buyers are responsible for knowing applicable law.

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