FR 2021-03758

Synthcon LLC, a company based in Colorado Springs, has submitted an application to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of controlled substances. As specified in the notice from the DEA, Synthcon intends to manufacture these substances primarily for producing analytical reference materials, proficiency test materials, and academic research materials.

General Summary

The document outlines Synthcon LLC's proposal to enter the field of manufacturing controlled substances in bulk. While the notice does not provide detailed information about the types of substances for which registration is sought, it states the company's aim to use these substances mainly in scientific and academic contexts. The opportunity for stakeholders to comment or request a hearing on this application underscores the importance of transparency and regulatory compliance in the process.

Significant Issues and Concerns

1. Lack of Specific Information on Substances: The document does not delineate which controlled substances Synthcon LLC seeks to manufacture. This omission can lead to questions about the scope and potential implications of the application.

2. Environmental and Health Impact: There is no information provided about the environmental or health impacts related to the manufacturing of these controlled substances. Understanding these impacts is vital for community safety and welfare.

3. Regulatory Compliance: With the handling of controlled substances comes the significant responsibility of adhering to stringent legal and safety regulations. The document does not address how Synthcon plans to maintain compliance with these requirements.

4. Security Measures: The absence of any discussion on security protocols for managing controlled substances poses concerns. Proper security measures are paramount in preventing misuse or diversion of these materials.

5. Filing Procedures: The procedures for stakeholders to submit comments or objections, or request hearings, could be perceived as complex, particularly by individuals not familiar with DEA processes.

Public Impact

For the general public, the approval of this application could mean enhanced availability of reference materials that support research and development in various scientific fields. However, the extent of public impact cannot be fully assessed without further details on the specific substances involved and measures to mitigate risks associated with their production and distribution.

Impact on Stakeholders

Stakeholders such as existing bulk manufacturers, researchers, and academic institutions could be significantly affected by this application. The entry of Synthcon LLC into the market might increase competition for current manufacturers, potentially leading to innovations or pricing changes. In contrast, academic and research institutions may benefit from increased access to reference materials, aiding in the advancement of scientific studies.

In conclusion, while Synthcon LLC's initiative poses potential benefits, transparency, regulatory adherence, and public engagement are essential in ensuring safe and positive outcomes for all parties involved.