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OSOBio Gets DEA Approval for Controlled Substances

Injectables CMO cleared for Schedule II through V handling

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

OSO BioPharmaceuticals Manufacturing has been granted research and analytical licenses by the U.S. Drug Enforcement Administration (DEA) to handle Schedule II through V controlled substances.

“As a highly disciplined CMO, OsoBio is comfortable with the processes, controls and documentation required when working with especially sensitive pharmaceutical materials,” said Dr. Stuart Rose, president and chief executive officer of Albuquerque, NM-based OSOBio.

The DEA places strict guidelines on the research, manufacture and distribution of controlled substances to prevent their diversion into illicit markets. The agency categorizes controlled substances according to each one’s respective use in medical treatment, as well as its potential for abuse or causing dependence. The agency approved OsoBio’s registration application to conduct research and perform analytical testing related to the potential manufacture of Schedule II through V controlled substances for clients.

“There aren’t many companies in the U.S. capable of producing injectable controlled drugs, so we’ve already fielded a number of calls from clients who have that need,” said Dr. Rose. “As we broaden OsoBio’s capabilities in handling products that demand special attention, we demonstrate our continued confidence that our company will exceed quality assurance and regulatory compliance expectations.”

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