An Act To Increase Access to Safe and Affordable Prescription Drugs
Sec. 1. 22 MRSA c. 603-A is enacted to read:
MAINE PHARMACEUTICAL DRUG SAFETY ACT
§ 2699-A. Short title
This chapter may be known and cited as "the Maine Pharmaceutical Drug Safety Act."
§ 2699-B. Findings
The Legislature finds that allowing the citizens of the State to import certain prescription drugs that are branded and registered in Canada, but unapproved by the United States Department of Health and Human Services, Food and Drug Administration in the Canadian branded or generic formula, will not present an unreasonable risk to individuals or public health and will result in a significant reduction in the cost of necessary drugs for consumers in the State.
§ 2699-C. Personal importation policy
(1) Lacks evidence of effectiveness;
(2) Is a health fraud drug product;
(3) Presents a direct challenge to the United States Department of Health and Human Services, Food and Drug Administration's new drug application and over-the-counter monograph processes; or
(4) Has been reformulated by the manufacturer or exporter to evade an existing United States Department of Health and Human Services, Food and Drug Administration enforcement action.
An individual who violates this subsection commits a Class D crime.
Under the Federal Food, Drug, and Cosmetic Act, the importation of unapproved new prescription drugs, including foreign-made versions of prescription drugs that have been approved by the federal Department of Health and Human Services, Food and Drug Administration, is prohibited. However, the Food and Drug Administration has developed guidance that allows the personal importation of certain drugs.
This bill, using the guidance developed by the federal Department of Health and Human Services, Food and Drug Administration, enacts the Maine Pharmaceutical Drug Safety Act to allow an individual in Maine to import prescription drugs from Canada as long as specific criteria are met, including that the drug is imported for personal use, that the individual importing the drug has a valid prescription, that the drug does not present an unreasonable risk to the individual and that no more than a 90-day supply of the drug is imported. The prescription drug to be imported must also meet specific requirements. The importation of controlled substances and prescription drugs for sale or resale is specifically prohibited.