Subdivision 1.Definitions.

For the purposes of sections 62J.85 to 62J.95, the following terms have the meanings given.

Subd. 2.Advisory council.

"Advisory council" means the Prescription Drug Affordability Advisory Council established under section 62J.88.

Subd. 3.Biologic.

"Biologic" means a drug that is produced or distributed in accordance with a biologics license application approved under Code of Federal Regulations, title 42, section 447.502.

Subd. 4.Biosimilar.

"Biosimilar" has the meaning provided in section 62J.84, subdivision 2, paragraph (b).

Subd. 5.Board.

"Board" means the Prescription Drug Affordability Board established under section 62J.87.

Subd. 6.Brand name drug.

"Brand name drug" means a drug that is produced or distributed pursuant to:

(1) a new drug application approved under United States Code, title 21, section 355(c), except for a generic drug as defined under Code of Federal Regulations, title 42, section 447.502; or

(2) a biologics license application approved under United States Code, title 45, section 262(a)(c).

Subd. 7.Generic drug.

"Generic drug" has the meaning provided in section 62J.84, subdivision 2, paragraph (e).

Subd. 8.Group purchaser.

"Group purchaser" has the meaning given in section 62J.03, subdivision 6, and includes pharmacy benefit managers, as defined in section 62W.02, subdivision 15.

Subd. 9.Manufacturer.

"Manufacturer" means an entity that:

(1) engages in the manufacture of a prescription drug product or enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity's own name; and

(2) sets or changes the wholesale acquisition cost of the prescription drug product it manufacturers or markets.

Subd. 10.Prescription drug product.

"Prescription drug product" means a brand name drug, a generic drug, a biologic, or a biosimilar.

Subd. 11.Wholesale acquisition cost or WAC.

"Wholesale acquisition cost" or "WAC" has the meaning given in United States Code, title 42, section 1395W-3a(c)(6)(B).