FR 2021-00351

Summary

The document is a formal notice published by the Drug Enforcement Administration (DEA), part of the Justice Department, announcing that Cedarburg Pharmaceuticals has applied for registration as a bulk manufacturer of controlled substances. Specifically, the company seeks to produce synthetic Tetrahydrocannabinols (THC), a form of the chemical found in cannabis, as an active pharmaceutical ingredient (API) for distribution to its clients. Interested parties, such as existing manufacturers and other applicants, have the opportunity to submit comments or objections, or request a hearing about this application, up until March 15, 2021.

Significant Issues and Concerns

A few concerns arise from the document as presented:

1. Lack of Detailed Substance Information: The notice specifies only Tetrahydrocannabinols by its drug code, 7370, as the controlled substance Cedarburg Pharmaceuticals intends to produce. Additional details on other possible substances were not provided, which could limit stakeholders' ability to fully assess the implications of the application.

2. Purpose and Use of Manufactured Products: While the document states that Cedarburg Pharmaceuticals plans to manufacture these substances for distribution to customers, it fails to clarify the precise intended uses or the nature of the customer base, leaving room for uncertainty regarding the end application of these substances.

3. Regulatory Compliance: The notice does not discuss the specific measures in place to ensure Cedarburg Pharmaceuticals’ compliance with existing regulatory standards. This omission raises questions about how regulatory bodies will monitor the manufacture and distribution of these controlled substances.

4. History of Manufacturing: No mention is made of Cedarburg Pharmaceuticals' experience or past conduct in handling controlled substances. Such historical information could be pertinent when assessing the reliability and credibility of their application.

5. Economic and Community Impact: The document does not provide insight into the potential economic benefits or drawbacks for the local community in Grafton, Wisconsin, or the broader market impacts that might arise from granting this application to Cedarburg Pharmaceuticals.

Impact on the Public and Stakeholders

The registration of Cedarburg Pharmaceuticals as a bulk manufacturer of controlled substances holds potential implications for a variety of stakeholders:

• General Public: Manufacturing controlled substances, particularly those like THC, touches on broader public discussions about drug safety, regulation, and the pharmaceutical landscape. The public may be concerned with how such manufacturing practices align with existing laws and ethical standards.

• Existing Manufacturers: Current manufacturers of controlled substances might be impacted by increased competition if Cedarburg Pharmaceuticals enters the market. This could lead to shifts in market dynamics, pricing, and resource allocation within the industry.

• Regulatory Bodies: Authorities such as the DEA will have an ongoing role to ensure that Cedarburg Pharmaceuticals complies with the stringent monitoring and control measures required for manufacturing controlled substances, impacting how regulatory resources are distributed.

• Local Community: On a local level, the establishment or expansion of manufacturing operations in Grafton, Wisconsin, could have economic implications, possibly providing jobs and boosting local economy but also raising concerns about environmental and societal impacts from increased manufacturing activities.

In conclusion, while the document serves a procedural purpose in notifying relevant parties about the application, the lack of detailed information on various issues invites questions among stakeholders and the general public regarding the application’s broader implications and potential outcomes.