HF 4098 Summary

• Amends reporting requirements for opiate manufacturers and wholesalers to clarify they must report sales, deliveries, and distributions of opiates to practitioners, pharmacies, hospitals, and other authorized entities in automation of reports and consolidated orders system format by March 1 each year, with $500 per day penalty for late reporting.

• Adds new reporting requirement for third-party logistics providers beginning March 1, 2024, to report any opiate deliveries or distributions into Minnesota not already reported by licensed wholesalers or manufacturers.

• Changes opiate product registration fee threshold language to clarify that manufacturers whose opiate products are sold, delivered, or distributed within or into the state in quantities of 2,000,000 or more units annually must pay the $250,000 registration fee.

• Excludes opiates used for substance use disorder treatment with medications for opioid use disorder from being counted toward the 2,000,000 unit threshold for registration fee assessment.

• Establishes that opiate units are assigned to the manufacturer holding the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) as listed by the FDA, and defines a unit as one tablet, capsule, patch, syringe, milliliter, or gram.