The Governor of Minnesota signed legislation in May 2019 that establishes an opiate product registration fee and opiate distribution reporting requirements. In order to determine whether a company is required to pay the registration fee or report opiate distributions, manufacturers and wholesalers must complete and submit the Opiate Product Registration Qualification Survey. The form is available on the Board of Pharmacy ("Board") website, and must be submitted by December 18, 2019.
The Board recently posted on its website a Notice to Manufacturers and Wholesalers ("Notice"). Beginning March 1, 2020, and by March 1 annually thereafter, each manufacturer and each wholesaler of opiate products must report to the Board "every sale, delivery, or other distribution within or into [Minnesota] made to any practitioner, pharmacy, hospital, veterinary hospital, or other person who is allowed by [law] to possess controlled substances for dispensing or administration to patients" for the previous calendar year. The Board will assess an annual fee of $250,000 upon any opiate manufacturer that sells, delivers, or distributes 2 million or more opiate product units within or into Minnesota in a reported year.
Information must be reported in the Automation of Reports and Consolidated Orders System (ARCOS) format, and must contain only opiate product data. The Board is developing a data repository tool to enable reporting, with the goal of having the tool available in early February 2020.
Manufacturers or wholesalers that fail to provide the information required on a timely basis may be assessed an administrative penalty of $500 per day.
For more information, please visit Minnesota's Reporting Requirements section of the Distribution: Trade and Sample Controlled Substances database.
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