C.M.R. 10, 144, ch. 104, § 144-104-8, subsec. 144-104-8.01
This rule implements 5 MRSA c. 167, which directs the Department of Health and Human Services ("the Department") to develop a program to allow for the wholesale importation of prescription drugs from Canada (the "program"), and to submit a proposal to the federal Secretary of Health and Human Services to approve the program. At the time that the law was enacted, there was no defined pathway for application to the federal government for approval of such a program. On July 31st 2019, the federal government released its Safe Importation Action Plan, which newly described its intent to promulgate rules governing prescription drug importation demonstration projects by states, wholesalers, and pharmacists. These federal rules will be based on 21 U.S.C. § 384, the same federal law that c. 167 requires the program to comply with. As of April 28th, 2020, a final rule has not been promulgated by the federal government.
This rule creates a process to inform the design of the program and provides that the Department will submit an application to the federal government no later than May 1, 2020, and, if the federal rule is not finalized prior to May 1st, 2020, that the Department shall submit a subsequent or revised application as soon as practicable after finalization of the federal rule.
C.M.R. 10, 144, ch. 104, § 144-104-8, subsec. 144-104-8.01