DEA Notice: Pisgah Labs Importer Application for Controlled Substances

Detected March 19th, 2026

Summary

The DEA has published a notice regarding an application from Pisgah Laboratories Inc. to be registered as an importer of Schedule II controlled substances, including Phenylacetone and Thebaine. Comments and requests for a hearing are due by April 20, 2026.

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What changed

The Drug Enforcement Administration (DEA) has issued a notice concerning an application from Pisgah Laboratories Inc. for registration as an importer of specific Schedule II controlled substances: Phenylacetone (8501), Ecgonine (9180), Thebaine (9333), and Tapentadol (9780). The company intends to manufacture these substances in bulk for distribution. The notice specifies that approval will only be granted if the business activity aligns with 21 U.S.C. 952(a)(2) and will not extend to finished dosage forms.

Registered bulk manufacturers and other applicants have until April 20, 2026, to submit electronic comments or objections to the proposed registration, or to file a written request for a hearing. All comments must be submitted electronically via the Federal eRulemaking Portal. Requests for a hearing must be sent to specific DEA addresses as outlined in the notice. Failure to act by the deadline may result in the approval of the application without further opportunity for input.

What to do next

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

Source document (simplified)

Content

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