How a substance gets onto a controlled schedule

Five schedules, and the findings each one needs

Five schedules exist by statute. A drug or other substance may not be placed in any of them unless the findings required for that schedule are made. Two exceptions sit beside that rule: control required by an international treaty in effect at the time of the original Act, and immediate precursors.

Each schedule has three findings. The first schedule requires a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.

The second requires a high potential for abuse, a currently accepted medical use or one with severe restrictions, and abuse that may lead to severe psychological or physical dependence.

The third, fourth and fifth descend in steps. Each requires a potential for abuse lower than the schedule above it, a currently accepted medical use, and a dependence profile stated relative to the schedule above.

The list is meant to move. The statute directs that the schedules be updated and republished on an annual basis.

Three of the five schedules share two of their three findings in structure. Each of the lower schedules asks for a currently accepted medical use in treatment in the United States, and describes dependence relative to the schedule above it. Only the first schedule requires a finding that there is no such accepted use.

The eight factors

Before a finding is made, eight factors have to be considered with respect to each drug or substance proposed to be controlled or removed.

They are its actual or relative potential for abuse. Scientific evidence of its pharmacological effect, if known. The state of current scientific knowledge regarding it. Its history and current pattern of abuse. The scope, duration and significance of abuse. What risk there is to public health. Its psychic or physiological dependence liability. And whether it is an immediate precursor of a substance already controlled.

Reading them in order shows what the scheme is measuring. Five of the eight are about abuse, dependence or public health risk, a sixth is about a substance's relationship to something already controlled, and two are scientific. None of them asks whether a substance works, and none asks whether it is a good medicine.

That is worth holding onto in a market where the two questions get merged. A substance can be unapproved as a drug and still be nowhere near a schedule, because the schedules answer a different question.

The list of factors is also the list a petitioner has to speak to. A petition asking for control or removal is judged on the same eight, which makes them the shape of the argument rather than only the shape of the decision.

Who is bound by whom

Two agencies share the process, and one has a veto that is stated in a single sentence.

Before initiating proceedings to control a substance or to remove one entirely, the Attorney General requests a scientific and medical evaluation and recommendations from the Secretary of Health and Human Services.

The recommendations of the Secretary are binding on the Attorney General as to those scientific and medical matters. And if the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control it.

The Secretary considers a subset of the factors directly. The statute names factors two, three, six, seven and eight, along with any scientific or medical considerations involved in factors one, four and five.

The evaluation and recommendations are made in writing and submitted within a reasonable time. Proceedings are initiated where the Attorney General determines that the facts and all other relevant data constitute substantial evidence of potential for abuse warranting control, or substantial evidence that a substance should be removed.

The same threshold governs a move in the other direction. Substantial evidence that a substance should be subjected to lesser control, or removed entirely, is what starts a proceeding to do that.

Anyone may ask, and there is a form

Proceedings can start in three ways. On the Attorney General's own motion, at the request of the Secretary, or on the petition of any interested party.

The regulation prints the petition. Any interested person may submit one to initiate proceedings for the issuance, amendment or repeal of a rule under the scheduling section, and it is submitted in quintuplicate.

Two attachments are required. The first is the proposed rule, in the form the petitioner proposes. The second is a statement of the grounds relied on. That statement has to include a reasonably concise statement of the facts, and a summary of any relevant medical or scientific evidence known to the petitioner.

Acceptance is not automatic. The Administrator notifies the petitioner of acceptance or non-acceptance within a reasonable time. A petition missing a required element, or not set out so as to be readily understood, need not be accepted at all. An accepted petition may still be denied where the grounds are not sufficient to justify initiating proceedings.

Where proceedings do begin, general notice of the proposed rulemaking is published in the Federal Register, and any hearing may not start until at least thirty days after that notice.

That notice has prescribed contents. It states the time, place and nature of any hearing, references the legal authority under which the rule is proposed, and states the proposed rule itself. Interested persons may be permitted to file written comments or objections during a period the notice designates.

The fast route, and the one built for steroids

A separate authority exists for speed, and it carries its own limits.

Where the Attorney General finds that scheduling a substance in the first schedule on a temporary basis is necessary to avoid an imminent hazard to the public safety, an order may issue. That order does not require the health department evaluation. The order may not issue before thirty days from publication of a notice of intention in the Federal Register and from transmitting notice to the Secretary.

Temporary scheduling expires at the end of two years, extendable by up to one year while permanent proceedings are pending. Only three of the eight factors are considered for the imminent hazard finding, and the statute states that such an order is not subject to judicial review.

A parallel mechanism exists for anabolic steroids. The Attorney General may temporarily add a substance to the statutory definition of anabolic steroids where it satisfies the criteria but is not listed, and where adding it will assist in preventing abuse or misuse. That order expires no later than twenty-four months after taking effect, extendable by six months.

There are also exits. The Attorney General is directed to exclude by regulation any non-narcotic drug containing a controlled substance where it may lawfully be sold over the counter without a prescription. And a compound containing an anabolic steroid may be exempted, on the Secretary's recommendation, where its concentration, preparation, formulation or delivery system means it does not present any significant potential for abuse.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. 21 U.S.C. 811 — Authority and criteria for classification of substances, read in full for the rulemaking routes, the eight factors, the binding effect of the health department recommendation, the over-the-counter and anabolic steroid exclusions, temporary scheduling to avoid an imminent hazard, and temporary scheduling of recently emerged anabolic steroids — Office of the Law Revision Counsel, United States Code, September 2026
2. 21 U.S.C. 812 — Schedules of controlled substances, subsections (a) and (b), read for the establishment of five schedules, the annual update duty, and the three findings required for each schedule — Office of the Law Revision Counsel, United States Code, September 2026
3. 21 CFR 1308.43 — Initiation of proceedings for rulemaking, read in full for the petition form, its two required attachments, the acceptance and denial procedure, and the thirty-day interval before a hearing may begin — Office of the Federal Register, Electronic Code of Federal Regulations, September 2026