An Act To Increase Access to Safe and Affordable Prescription Drugs
Maine Legislature, Session 129, LD 1387
Committee: Health Coverage, Insurance and Financial Services
Sponsors: JACKSON, DILLINGHAM, CLAXTON, VITELLI, FECTEAU, GIDEON, MOONEN, STEWART, TEPLER

Legislative Document
No. 1387
S.P. 431
In Senate, March 26, 2019
An Act To Increase Access to Safe and Affordable Prescription 
Drugs
Reference to the Committee on Health Coverage, Insurance and Financial Services 
suggested and ordered printed.
DAREK M. GRANT
Secretary of the Senate
Presented by President JACKSON of Aroostook.
Cosponsored by Representative DILLINGHAM of Oxford and
Senators: CLAXTON of Androscoggin, SANBORN, H. of Cumberland, VITELLI of 
Sagadahoc, Representatives: FECTEAU of Biddeford, Speaker GIDEON of Freeport, 
MOONEN of Portland, STEWART of Presque Isle, TEPLER of Topsham.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  22 MRSA c. 603-A is enacted to read:
CHAPTER 603-A
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.  Definitions.  As used in this chapter, unless the context otherwise indicates, the 
following terms have the following meanings.
A.  "Pharmacy" means a business licensed by Canada to engage in the selling of 
prescription drugs at retail.
B.  "Prescription drug" means a drug required to be reported to a state prescription 
monitoring program and includes but is not limited to substances listed in the federal 
Controlled Substances Act and unapproved new drugs.
C.  "Unapproved new drug" means a drug, including a foreign-made version of a 
prescription drug, that has not been manufactured in accordance with and pursuant to 
United States Department of Health and Human Services, Food and Drug 
Administration approval.
2.  Importation of prescription drugs.  An individual may import only for the use 
of that individual or a member of that individual's immediate family a prescription drug 
from a pharmacy in Canada that is allowed to export prescription drugs under Canada's 
regulations as long as:
A.  The drug is clearly for personal use;
B.  The drug does not present an unreasonable risk to the user;
C.  No more than a 90-day supply is imported during any 90-day period; and
D.  The individual or member of the individual's immediate family for whom the drug 
is intended possesses a valid prescription for the imported drug.
3.  Prohibitions on importation of prescription drugs.  The following prohibitions 
on the importation of prescription drugs pursuant to this section apply.
A.  An individual may not import a prescription drug about which the United States 
Department of Health and Human Services, Food and Drug Administration has 
issued a public notice stating that the prescription drug:
(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.
B.  An individual may not reimport a drug approved by the United States Department 
of Health and Human Services, Food and Drug Administration under the Federal 
Food, Drug, and Cosmetic Act that was originally manufactured in the United States.
C.  An individual may not import a controlled substance.  As used in this paragraph, 
"controlled substance" has the same meaning as in the federal Controlled Substances 
Act, 21 United States Code, Section 802.
D.  An individual may not import a prescription drug for sale or resale.
An individual who violates this subsection commits a Class D crime.
4.  Rules.  The department shall adopt routine technical rules under Title 5, chapter 
375, subchapter 2-A to implement the provisions of this chapter.
SUMMARY
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.