Maine Revised Statutes Title 32 Sec. 13800 – Access to distributed drugs
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Terms Used In Maine Revised Statutes Title 32 Sec. 13800
- Drug: means :
A. See Maine Revised Statutes Title 32 Sec. 13702-AEligible product developer: means a person that seeks to develop an application for the approval of a drug under the Federal Food, Drug, and Cosmetic Act, Section 505(b) or 505(j) or the licensing of a biological product under the federal Public Health Service Act, Section 351. See Maine Revised Statutes Title 32 Sec. 13702-A Manufacturer: means a person engaged in the manufacture of prescription drugs. See Maine Revised Statutes Title 32 Sec. 13702-A Month: means a calendar month. See Maine Revised Statutes Title 1 Sec. 72 Person: means an individual, corporation, partnership, association or any other legal entity. See Maine Revised Statutes Title 32 Sec. 13702-A United States: includes territories and the District of Columbia. See Maine Revised Statutes Title 1 Sec. 72 Wholesaler: means a person who buys prescription drugs for resale and distribution to persons other than consumers. See Maine Revised Statutes Title 32 Sec. 13702-A Year: means a calendar year, unless otherwise expressed. See Maine Revised Statutes Title 1 Sec. 72
A manufacturer or wholesaler licensed under section 13758 shall make a drug distributed in this State available for sale in this State to an eligible product developer for purposes of conducting testing required to support an application for approval of a drug under the Federal Food, Drug, and Cosmetic Act, Section 505(b) or 505(j) or the licensing of a biological product under the federal Public Health Service Act, Section 351. [PL 2017, c. 434, §5 (NEW).]
The manufacturer or wholesaler licensed under section 13758 shall make the drug available for sale at a price no greater than the wholesale acquisition cost and without any restriction that would block or delay the eligible product developer’s application in a manner inconsistent with Section 505?1(f)(8) of the Federal Food, Drug, and Cosmetic Act, 21 United States Code § 355?1(f)(8) (2016). [PL 2017, c. 434, §5 (NEW).]
An eligible product developer that receives a drug at a price no greater than the wholesale acquisition cost for that drug pursuant to this section shall charge consumers in this State the same price or less for the drug manufactured by that eligible product developer. [PL 2017, c. 434, §5 (NEW).]
As used in this section, “wholesale acquisition cost” means the manufacturer’s list price for a brand-name drug or a generic drug per person per year or course of treatment when sold to wholesalers or direct purchasers in the United States, not including discounts or rebates, for the most recent month for which information is available. [PL 2017, c. 434, §5 (NEW).]
SECTION HISTORY
PL 2017, c. 434, §5 (NEW).