DEA Notice: Pisgah Laboratories Inc Importer Application

FR: Drug Enforcement Administration

Published March 19th, 2026

Detected March 19th, 2026

Summary

The Drug Enforcement Administration (DEA) has issued a notice regarding an application from Pisgah Laboratories Inc. to be registered as an importer of controlled substances, specifically Phenylacetone, Ecgonine, Thebaine, and Tapentadol. The public comment period for this application closes on April 20, 2026.

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What changed

The Drug Enforcement Administration (DEA) has published a notice concerning an application submitted by Pisgah Laboratories Inc. for registration as an importer of controlled substances, including Phenylacetone (Schedule II), Ecgonine (Schedule II), Thebaine (Schedule II), and Tapentadol (Schedule II). The company intends to manufacture these substances in bulk for distribution. This notice is in accordance with 21 CFR 1301.34(a) and does not authorize the import of finished dosage forms for commercial sale.

Registered bulk manufacturers and other interested parties have until April 20, 2026, to submit electronic comments or objections to the proposed registration, or to file a written request for a hearing. Failure to act by this deadline may result in the approval of the application. Compliance officers should review the specific controlled substances listed and determine if any objections or requests for hearing are warranted based on business interests or regulatory concerns.

What to do next

Review DEA application for Pisgah Laboratories Inc. for controlled substance importation.
Submit electronic comments or objections by April 20, 2026, if applicable.
File a written request for a hearing by April 20, 2026, if applicable.

Source document (simplified)

Notice

Importer of Controlled Substances Application: Pisgah Laboratories Inc

A Notice by the Drug Enforcement Administration on 03/19/2026

This document has a comment period that ends in 32 days.
(04/20/2026) View Comment Instructions
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Public Inspection Published Document: 2026-05360 (91 FR 13339) Document Headings ###### Department of Justice

Drug Enforcement Administration

[Docket No. DEA-1686]

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Pisgah Laboratories Inc has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

DATES:

Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before April 20, 2026. Such persons may also file a written request for a hearing on the application on or before April 20, 2026.

ADDRESSES:

The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.34(a), this is notice that on January 23, 2026, Pisgah Laboratories Inc, 3222 Old Hendersonville Highway, Pisgah Laboratories Inc, Pisgah Forest, North Carolina 28768, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

| Controlled substance | Drug
code | Schedule |
| --- | --- | --- |
| Phenylacetone | 8501 | II |
| Ecgonine | 9180 | II |
| Thebaine | 9333 | II |
| Tapentadol | 9780 | II |
The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. No other activities for these drug codes are authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

Thomas Prevoznik,

Deputy Assistant Administrator.

[FR Doc. 2026-05360 Filed 3-18-26; 8:45 am]

BILLING CODE 4410-09-P

Published Document: 2026-05360 (91 FR 13339)