Notice 2026-17388

A notice of an application to import controlled substances — the people who may object are mostly others in the same trade

Department of Justice Published Aug 26, 2026 91 FR 55113

The Drug Enforcement Administration gave notice that a company had applied to register as an importer of controlled substances. Those who may comment, object or demand a hearing are mostly registered bulk manufacturers of the same substances, and applicants.

Document overview (primary data)

  • Document typeNotice
  • AgencyDepartment of Justice
  • Citation91 FR 55113

Key points

  • The Drug Enforcement Administration gave notice that a company applied to register as an importer of controlled substances.
  • The substances are gamma hydroxybutyric acid (Schedule I), 4-anilino-N-phenethyl-4-piperidine and poppy straw concentrate (both Schedule II).
  • Those who may comment, object or request a hearing are registered bulk manufacturers of the affected substances, and applicants.
  • The deadline for comments and objections and for requesting a hearing is September 25, 2026 in both cases.
  • Handling controlled substances requires registration for each activity — manufacturing, distributing, importing, exporting.

1Who the notice addresses

A government notice usually addresses the public at large. This one names, on its face, who may comment or object: registered bulk manufacturers of the affected substances, and applicants. What the notice actually speaks to is other businesses in the same market.

  1. 1July 10, 2026A company applies to register as an importer of controlled substances
  2. 2August 26, 2026The agency gives notice of the application in the Federal Register
  3. 3By September 25, 2026Registered bulk manufacturers and applicants may submit comments or objections
  4. 4By the same dateThose persons may file a written request for a hearing on the application

The structure gives an opportunity to object to businesses already handling the same substances. A new importer changes competitive conditions for incumbents — and those same incumbents are best placed to know whether an applicant is fit.

2What was applied for

SubstanceControlled substance codeSchedule
Gamma hydroxybutyric acid2010Schedule I
4-Anilino-N-phenethyl-4-piperidine8333Schedule II
Poppy straw concentrate9670Schedule II

Controlled substances are classified by potential for abuse and accepted medical use. Schedule I covers substances with no accepted medical use under federal law; Schedule II covers those with accepted medical use but a high potential for abuse. These serve as pharmaceutical raw materials and intermediates, so legitimate manufacturing requires importation.

3Registration as a mechanism

Handling controlled substances requires registration with the agency for each activity — manufacturing, distributing, importing, exporting. The regime lets the government know who handles which substance in what capacity, and notices place that process on the public record. Because applications themselves appear in the Federal Register, where registrations are increasing can be followed from outside.

4Both deadlines on one day

The deadline for comments and objections and the deadline for requesting a hearing are both September 25, 2026. Funnelling the entry points to a single date fixes when review of the application begins. After that day, review proceeds on what has been submitted.

Why it matters

Because applications appear in the Federal Register, growth in who handles controlled substances can be tracked from outside. Opening objections to the trade is one way an agency draws industry knowledge into its review.

FAQ

Why is the right to object limited?
The notice on its face addresses registered bulk manufacturers of the affected substances and applicants — businesses in the same market, who hold the information bearing on fitness.
How do Schedule I and II differ?
Schedule I covers substances with no accepted medical use under federal law; Schedule II covers those with accepted medical use but a high potential for abuse.

Sources (primary)

Source: Federal Register (federal documents, public domain). Links go to the official site.

#DEA#Controlled substances#Importer registration#Justice#Administrative process
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