An Act To Allow Maine Residents To Personally Import Medications as Permitted under the Federal Food, Drug, and Cosmetic Act
Maine Legislature, Session 127, LD 1422
Committee: Health and Human Services
Sponsors: MARTIN

Legislative Document 
No. 1422 
H.P. 968 
House of Representatives, May 19, 2015 
An Act To Allow Maine Residents To Personally Import 
Medications as Permitted under the Federal Food, Drug, and 
Cosmetic Act 
(AFTER DEADLINE) 
(EMERGENCY) 
Approved for introduction by a majority of the Legislative Council pursuant to Joint Rule 
205. 
Reference to the Committee on Health and Human Services suggested and ordered printed. 
ROBERT B. HUNT 
Clerk 
Presented by Representative MARTIN of Eagle Lake. 
Emergency preamble. Whereas, acts and resolves of the Legislature do not 
become effective until 90 days after adjournment unless enacted as emergencies; and 
Whereas, Maine residents benefitted until recently from a Maine law that allowed 
importation of prescription drugs from pharmacies in other countries; and 
Whereas, a federal court ruled that the Maine law was in violation of federal law, a 
ruling that could cause many residents, including senior citizens and low-income 
residents, to forgo their medication because it is too costly; and 
Whereas, this legislation, based on federal guidance regarding the personal 
importation of prescription drugs, allows the importation of certain prescription drugs 
from certain countries; and 
Whereas, this legislation needs to take effect as soon as possible to provide some 
relief to those Maine residents who can no longer afford their prescription drugs; and 
Whereas, in the judgment of the Legislature, these facts create an emergency within 
the meaning of the Constitution of Maine and require the following legislation as 
immediately necessary for the preservation of the public peace, health and safety; now, 
therefore, 
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 Maine to import certain 
prescription drugs that are branded and registered in Canada and member countries of the 
European Union, but unapproved by the United States Food and Drug Administration in 
the Canadian or European branded or generic formula, will provide a level of safety to 
Maine consumers that they do not currently enjoy from unapproved foreign imports and 
the Food and Drug Administration personal importation policy. 
§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.  "Member country" means Canada or a member country of the European Union.  
"Member country" does not include a country: 
(1)  In the European Union that was admitted into the European Union pursuant 
to the Treaty of Accession 2003 to which a transitional measure for the regulation 
of human pharmaceutical products applies and has expired; 
(2)  That the United States Secretary of State determines will not meet the 
requirements for the regulation of human pharmaceutical products by the date on 
which a transitional measure for the regulation of human pharmaceutical products 
expires; 
(3)  That the United States Secretary of State confirms to the Attorney General 
has failed to: 
(a)  Authorize the approval of those drugs that have been determined to be 
safe and effective by experts qualified by scientific training and experience to 
evaluate the safety and effectiveness of drugs on the basis of adequate and 
well-controlled investigations, including clinical investigations; 
(b)  Require the methods used in and the facilities and controls used for the 
manufacture, processing and packaging of drugs in that country to be 
adequate to preserve the drugs' identity, quality, purity and strength; 
(c)  Undertake the reporting of adverse reactions to drugs and procedures to 
withdraw approval and remove drugs found not to be safe or effective; 
(d)  Require the labeling and promotion of a drug to be in accordance with 
the approval of the drug; 
(e)  Adequately train pharmacists; 
(f)  Adequately regulate the practice of pharmacy; or 
(g)  Adequately protect the privacy of personal medical information; or 
(4)  From which the importation of drugs to the United States will adversely 
affect public health as determined by the United States Secretary of State. 
B.  "Pharmacist" means a person licensed by a member country to practice in a 
pharmacy, including the dispensing and selling of prescription drugs. 
C.  "Pharmacy" means a business licensed by a member country to engage in the 
selling of prescription drugs at retail that employs 50 or more licensed pharmacists. 
D.  "Prescription drug" means any 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. 
E.  "Unapproved new drug" means any drug, including a foreign-made version of a 
prescription drug, that has not been manufactured in accordance with and pursuant to 
the United States 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 a member country that is allowed to export prescription drugs under 
that member country's regulations.  
3.  Prohibitions on importation of prescription drugs.  The following actions are 
prohibited. 
A.  An individual may not import a prescription drug about which the United States 
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 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 Food and Drug Administration enforcement action. 
B.  An individual may not reimport a drug approved by the United States 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 Section 802 of the federal 
Controlled Substances Act. 
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. 
Emergency clause.  In view of the emergency cited in the preamble, this 
legislation takes effect when approved. 
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 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 Food and Drug Administration, enacts 
the Maine Pharmaceutical Drug Safety Act to allow an individual in Maine to import 
prescription drugs from Canada or certain member countries of the European Union for 
use by that individual or a member of that individual's immediate family.  The country 
from which the prescription drug is to be imported must meet specific criteria regarding 
regulation of its pharmacies and pharmacists, as determined by the United States 
Secretary of State.  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.