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ME LD2019

ME LD2019
An Act to Amend the Laws Governing Licensure of Wholesalers and Manufacturers Under the Maine Pharmacy Act


summary

Introduced
12/03/2025
In Committee
12/03/2025
Crossed Over
02/10/2026
Passed
02/26/2026
Dead

Introduced Session

132nd Legislature

Bill Summary

This bill modifies the initial licensure qualifications for prescription drug manufacturers and wholesalers by allowing an applicant to apply for licensure before the applicant has obtained a registration number from the appropriate federal agencies but requires that a manufacturer or wholesaler licensed in this State file the applicable registration numbers with the Maine Board of Pharmacy once the registration numbers are obtained by the manufacturer or wholesaler. The bill also provides that the board may deny a license, refuse to renew a license or impose disciplinary sanctions if the manufacturer or wholesaler fails to file the applicable registration numbers with the board once the registration numbers are obtained.

AI Summary

This bill modifies the licensure process for prescription drug manufacturers and wholesalers in Maine by allowing applicants to apply for a license before obtaining their federal registration numbers from the Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA). Under the new provisions, applicants must still submit their license forms with as much information as possible, including their name, address, contact details, and ownership status. If the applicant has not yet received their federal registration numbers at the time of application, they will be required to file those numbers with the Maine Board of Pharmacy once they are obtained. The bill also establishes that the Board of Pharmacy may deny, refuse to renew, or impose disciplinary sanctions on a manufacturer or wholesaler's license if they fail to submit their federal registration numbers after obtaining them. This change is designed to streamline the licensure process while ensuring that all necessary regulatory information is ultimately provided to the state pharmacy board. The bill is being enacted as emergency legislation to address potential barriers to business operations for pharmaceutical companies in Maine.

Committee Categories

Health and Social Services

Sponsors (1)

Last Action

PASSED TO BE ENACTED - Emergency - 2/3 Elected Required, in concurrence. (on 02/26/2026)

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