§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).]
SECTION HISTORY
PL 2017, c. 434, §5 (NEW).
Structure Maine Revised Statutes
TITLE 32: PROFESSIONS AND OCCUPATIONS
Chapter 117: MAINE PHARMACY ACT
Subchapter 9: MISCELLANEOUS PROVISIONS
32 §13781. Generic and therapeutically equivalent substitution
32 §13783. Posting prices (REPEALED)
32 §13784. Patient information regulation
32 §13785. Patient profile record system regulation
32 §13786. Identification of persons prescribing medicines on hospital prescription blanks
32 §13786-A. Security requirements; rules
32 §13786-B. Partial dispensing of prescription for opioid medication
32 §13786-C. Dispensing of prescription of opioid medication; immunity
32 §13786-D. Prescribing and dispensing insulin
32 §13786-E. Prescribing, dispensing and administering HIV prevention drugs
32 §13786-F. Dispensing of emergency supplies of chronic maintenance drug
32 §13787. Hypodermic syringes; prescriptions (REPEALED)
32 §13787-A. Sale of hypodermic apparatus
32 §13788. Sale of poisonous drugs
32 §13789. Possession of drug samples
32 §13790. Using drugs not in prescription
32 §13792. Sale by certain methods prohibited
32 §13793. Adulterating and selling drugs
32 §13794. Labeling of prescriptions
32 §13795. Photographic proof of identification; discretion to sell or dispense; immunity
32 §13796. Retail sale of targeted methamphetamine precursors
32 §13797. Prescription drug price information
32 §13798. Expedited partner therapy
32 §13799. Consumer choice preserved
32 §13800. Access to distributed drugs
32 §13800-A. Liability for product of another; exemption
32 §13800-B. Prohibition on providing conversion therapy to minors