"The Orange Book": DEA Booklet or FDA Book?

If someone says “the orange book” in a conversation about drug scheduling, that phrase alone does not tell you which federal document they mean. Two different federal agencies each publish a document reachable under that nickname: the Drug Enforcement Administration (DEA) publishes a scheduling-actions booklet at a URL literally path-named “orangebook,” and the Food and Drug Administration (FDA) separately publishes a therapeutic-equivalence book that is also nicknamed the Orange Book. They are not the same publication, they come from different agencies, and they version themselves differently. Saying “the orange book” without naming the agency is ambiguous.

This original record-reading guide is a general reading aid, not cited evidence. It does not depict a source record; the article text and source links provide the facts.

Key points

• Two separate federal “orange book” documents exist: one from the DEA, one from the FDA.
• The DEA’s document is dated by month and year on its cover and foreword — currently “August 2026” — with no numbered edition.
• The FDA’s document uses a numbered edition scheme — its preface page currently reads “PREFACE TO FORTY SIXTH EDITION.”
• The two documents cover different subject matter and are issued by different federal agencies, so “the orange book” by itself does not specify which one is meant.
• This article confirms only that both documents exist and how each is dated; it does not describe what either document contains.

The DEA’s “orange book”

The DEA publishes a booklet titled “Lists of Scheduling Actions, Controlled Substances, Regulated Chemicals,” served at a URL whose path literally reads “orangebook.” Its title page and attribution read:

“U.S. Department of Justice / Drug Enforcement Administration / Diversion Control Division / Drug & Chemical Evaluation Section … Lists of: Scheduling Actions / Controlled Substances / Regulated Chemicals … August 2026” (DEA Diversion Control Division)

The same document repeats its issuing office and date elsewhere in the file:

“Drug and Chemical Evaluation Section / Diversion Control Division / Drug Enforcement Administration … August 2026” (DEA Diversion Control Division)

Note what versioning scheme this is: a bare month and year (“August 2026”), with no edition number printed anywhere in these lines.

The FDA’s “Orange Book”

Separately, the FDA publishes “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is also commonly nicknamed the Orange Book. Its preface page currently identifies itself by edition number rather than by date:

“PREFACE TO FORTY SIXTH EDITION” (FDA, Orange Book Preface)

This is a different versioning scheme from the DEA booklet: a numbered edition (“Forty Sixth Edition”) rather than a month-and-year stamp.

Why the name alone is ambiguous

Put side by side, the two publications differ in three confirmed ways: the issuing agency (DEA versus FDA), the document title, and the versioning convention used on the document itself (month/year versus numbered edition). Because both are genuinely nicknamed “the orange book” in common usage, a reference to “the orange book” without naming DEA or FDA does not tell a reader which document — or which version of that document — is being cited. Naming the agency (or linking the specific document) resolves the ambiguity; the nickname by itself does not.

This article does not describe what is inside either publication. It does not identify, list, or characterize any substance, drug, schedule placement, or product name from either record — that is outside what this narrowed check confirms. It also does not state a specific FDA cumulative-supplement number: the FDA preface page confirmed here shows the edition heading (“PREFACE TO FORTY SIXTH EDITION”) and generic references to “Cumulative Supplements,” but no specific supplement number appears on that page in this check, so none is asserted here.

Source records

https://www.deadiversion.usdoj.gov/schedules/orangebook/orangebook.pdf https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface