Maine Legislative Document 793 ("L.D. 793") became law without the Governor's signature on January 12, 2020. Among other things, L.D. 793 establishes the Opioid Use Disorder Prevention and Treatment Fund, administered by the Department of Administrative and Financial Services.
Manufacturers of opioid medications made available in Maine, and wholesalers that sell or distribute opioid medications in the state are required to submit to the Maine Department of Health and Human Services the same information that is submitted to the U.S. Drug Enforcement Administration's ("DEA") ARCOS reporting system. Information must be submitted to the state at the time it is submitted to the DEA. Manufacturers that sell, deliver, or distribute 2 million or more opioid medication units must pay an annual opioid medication product registration fee of $250,000 to the Board of Pharmacy ("Board"). Opioid manufacturers that do not sell, deliver, or distribute 2 million or more opioid medication units are not required to pay the $250,000 fee.
Additionally, opioid manufacturers must pay an annual $55,000 fee to the Board.
Please note that implementing regulations have not yet been issued.
For more information, and to view a copy of L.D. 793, please visit Maine's Reporting Requirements section of the Distribution: Trade and Sample Controlled Substances Database.
If you are interested in receiving updates relevant to Life Sciences compliance, please contact us for two weeks of complimentary access to all Porzio Compliance Digest InfoCenters. Topics include US and International transparency, US Enforcement Action, HCP Authorities/Restrictions and Licensing Distribution: Trade and Sample.