62J.86 DEFINITIONS.
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62J.86 DEFINITIONS.
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Subdivision 1. Definitions.
For the purposes of sections 62J.85 to 62J.95 , the following terms have the meanings given.
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Subd. 2. Advisory council.
"Advisory council" means the Prescription Drug Affordability Advisory Council established under section 62J.88 .
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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.
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Subd. 4. Biosimilar.
"Biosimilar" has the meaning provided in section 62J.84, subdivision 2, paragraph (b).
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Subd. 5. Board.
"Board" means the Prescription Drug Affordability Board established under section 62J.87 .
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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).
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Subd. 7. Generic drug.
"Generic drug" has the meaning provided in section 62J.84 , subdivision 2, paragraph (e).
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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.
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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.
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Subd. 10. Prescription drug product.
"Prescription drug product" means a brand name drug, a generic drug, a biologic, or a biosimilar.
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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).