Maine § 13800. - Access to distributed drugs
Full text of Maine Maine Revised Statutes § 13800. — Access to distributed drugs, with citation guidance and answers to common questions.
§ 13800.. Access to distributed drugs
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, Section 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).]
Frequently Asked Questions About Maine § 13800.
What does Maine Revised Statutes § 13800. cover?
Section 13800. ("Access to distributed drugs") is part of the Maine Revised Statutes, the codified statutory law of Maine. It sets out the legal rule or procedure described in the text above. Statutes are amended regularly, so always verify against the official source.
How do I cite Maine § 13800.?
A common citation format is "Maine Revised Statutes § 13800." (Maine). Legal writing may require the code abbreviation, section number, and year or edition. Match the style required by your court, professor, or publisher.
Is this the official text of Maine law?
No. This page is for research and education and may not include the most recent amendments. For official current law, check the Maine official source linked on this page or consult a licensed Maine attorney.
How does Maine § 13800. apply to my situation?
Statutes are interpreted in context, and application depends on your specific facts. Only a licensed attorney in Maine can advise on how this section applies to you. Contact your state or local bar association for a referral.
Sources & Verification
Not legal advice. Verify against the official source and consult a licensed attorney in Maine.