FR 2025-03636

A Notice of Application has been filed by Aphena Pharma Solutions MD, LLC with the Drug Enforcement Administration, indicating the company's desire to be recognized as an importer of a specific class or classes of controlled substances. These substances are intended for internal use in the company's manufacturing processes for an FDA-approved over-the-counter medication. Interested parties, such as existing registered bulk manufacturers, have until April 7, 2025, to submit electronic comments or objections or to request a formal hearing on the application.

Significant Issues or Concerns

Several notable issues arise from this document:

1. Lack of Specificity: The document does not specify which classes of controlled substances Aphena Pharma Solutions MD, LLC seeks to import. This omission could result in a lack of transparency and might leave the public and other stakeholders with questions about the nature of the substances being imported and their safety or potential impact.

2. Complex Comment Process: Although submissions of comments must be done electronically, the document does not provide explicit guidelines for submitting longer comments, which might require attaching a file. This could create confusion for stakeholders wishing to provide more detailed input.

3. Multiple Hearing Request Addresses: To request a hearing, stakeholders must send requests to several different addresses. This might be seen as cumbersome or overly complex, potentially deterring some stakeholders from fully participating in the process.

4. Limited Explanation Provided: The document does not offer detailed justification for why these specific substances need to be imported or provide comprehensive information on their intended use, potentially raising questions about the necessity and oversight of this application.

Impact on the Public

Broadly speaking, the general public might not be directly affected by this notice unless there is an identified risk associated with the importation and use of these controlled substances. However, public interest could be piqued by concerns about transparency, oversight, and the potential misuse of controlled substances, even within the confines of lawful manufacturing.

Impact on Specific Stakeholders

• Registered Bulk Manufacturers: These stakeholders could be directly impacted as they might view the application as competition if it involves substances they currently produce or distribute. Their ability to comment or request a hearing is facilitated here, though some may find the process burdensome.

• Aphena Pharma Solutions MD, LLC: For Aphena Pharma Solutions, successful registration would mean they can import the necessary controlled substances to produce their FDA-approved drug, potentially saving costs and streamlining their production process.

• Regulatory Agencies: The DEA and FDA would need to ensure rigorous oversight and compliance with legal standards, which could prove resource-intensive.

Overall, while the document outlines a legal and procedural requirement, the lack of detailed information could lead to hesitations and objections, particularly from those directly involved or affected by the processes described. The extent of the impact will largely hinge on the disclosure level and effectiveness of communication as the process unfolds.