Collegium Pharmaceutical Inc's Comment on Supply Chain
Contract manufacturers must obtain quarterly quotas from the DEA to produce or procure Schedule I or II substances, including methylphenidate for Jornay PM, oxycodone base for Xtampza ER, and tapentadol for Nucynta products. The DEA regulates production quotas, requires special order forms for distribution, mandates suspicious order monitoring systems, and conducts inspections to ensure compliance. Non-compliance may result in penalties, registration refusals, or criminal proceedings. Additionally, individual states regulate the distribution of controlled substances. Federal laws such as the Comprehensive Addiction and Recovery Act (CARA) and the SUPPORT Act address opioid abuse and treatment, influencing the regulation and coverage of opioid medications. The company and its contract manufacturers are subject to these federal and state regulations, as well as healthcare fraud and abuse laws.
Collegium Pharmaceutical Inc's Comment on Supply Chain
Contract manufacturers must obtain quarterly quotas from the DEA to produce or procure Schedule I or II substances, including methylphenidate for Jornay PM, oxycodone base for Xtampza ER, and tapentadol for Nucynta products. The DEA regulates production quotas, requires special order forms for distribution, mandates suspicious order monitoring systems, and conducts inspections to ensure compliance. Non-compliance may result in penalties, registration refusals, or criminal proceedings. Additionally, individual states regulate the distribution of controlled substances. Federal laws such as the Comprehensive Addiction and Recovery Act (CARA) and the SUPPORT Act address opioid abuse and treatment, influencing the regulation and coverage of opioid medications. The company and its contract manufacturers are subject to these federal and state regulations, as well as healthcare fraud and abuse laws.
Sources:
Collegium Pharmaceutical Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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