FR 2021-03837

This document is an official notice from the Drug Enforcement Administration (DEA) of the Justice Department, announcing that S&B Pharma, Inc., based in Azusa, California, has applied to register as a bulk manufacturer of controlled substances. Published in the Federal Register, the notice provides critical details on S&B Pharma's intentions to manufacture synthetic versions of drugs classified under the codes 7360 and 7370, namely Marihuana and Tetrahydrocannabinols, for product development and commercial sales.

General Summary

S&B Pharma, Inc. has taken a formal step to become a bulk producer of specific controlled substances. The company seeks permission from the DEA to manufacture these substances in significant quantities for developmental and commercial purposes. The notice emphasizes the deadline of April 26, 2021, for any registered bulk manufacturers or interested parties to submit comments or objections regarding this application. A request for a hearing can also be made by this date. The notice serves as an essential update to stakeholders and potentially impacted parties, outlining the procedural requirements for public comment.

Significant Issues and Concerns

Several critical issues emerge from this announcement:

1. Criteria for Approval: The document does not provide clarity on the rationale for S&B Pharma's application nor the criteria used by the DEA to consider such applications. This lack of transparency might lead to concerns about the decision-making process.

2. Access to Information: The document references "Supplemental Information" pertinent to the application, but does not indicate how the public can access this information. This omission could raise transparency issues and hinder public engagement.

3. Clarity on Controlled Substances: The notice references drug codes instead of explicitly naming the substances, except for a brief mention. For those unfamiliar with these codes, this could lead to confusion regarding which substances are at issue.

4. Terminology: The language used, such as "bulk manufacturer of basic class(es) of controlled substance(s)," may not be readily understandable to the general public, potentially limiting comprehension of the document's significance.

Broad Impact on the Public

For the general public, this application could indicate upcoming changes in the market for synthetic controlled substances, which could have implications for healthcare, pharmaceutical developments, and regulatory landscapes. Understanding that this application relates to controlled substance manufacture unveils the complex interplay between regulatory oversight and pharmaceutical production.

Impact on Specific Stakeholders

• Current Manufacturers: Existing manufacturers of similar substances might face increased competition or, alternatively, potential collaboration opportunities. They might also need to reassess their current practices in light of possible new market entrants.

• Patients and Healthcare Providers: For patients depending on treatments involving these substances, this development may eventually lead to increased availability of products or possibly innovative pharmaceutical options.

• Regulatory Bodies: Regulatory institutions, including the DEA, bear the responsibility of ensuring the safe production, distribution, and use of these substances, potentially adjusting their oversight mechanisms in response to new entrants.

The document encapsulates a pivotal move in the pharmaceutical manufacturing sector, spotlighting the regulatory process vital to public safety and the industrial evolution of drug development.