Pisgah Labs Seeks DEA Nod to Import Drug Precursors
Published Date: 3/19/2026
Notice
Summary
Pisgah Laboratories Inc wants to become an official importer of certain controlled substances like Phenylacetone and Ecgonine. People and companies involved can share their thoughts or ask for a hearing by April 20, 2026. This move could impact drug manufacturing and import rules, but no direct costs are mentioned yet.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Application to Import Schedule II Substances
Pisgah Laboratories Inc applied on January 23, 2026 to be registered as an importer for four Schedule II controlled substances: Phenylacetone (drug code 8501), Ecgonine (9180), Thebaine (9333), and Tapentadol (9780). The company plans to manufacture these substances in bulk for distribution to its customers, and no other activities for these drug codes are authorized under the application.
Import Authorization Excludes Finished Dosage Forms
The DEA notice states that any approval will not authorize the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale; authorization is limited to the listed bulk controlled substance activities consistent with 21 U.S.C. 952(a)(2).
Comment and Hearing Deadline for Stakeholders
Registered bulk manufacturers of the affected drug classes and other applicants may submit electronic comments or objections, or request a hearing, on or before April 20, 2026 via https://www.regulations.gov or by filing written hearing requests to DEA addresses provided in the notice.
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