Minn. Stat. § 62J.86
This is the official text of Minn. Stat. § 62J.86, part of Minnesota’s Stat — part of the compiled statutory law of Minnesota, published by the state as "Stat." Browse the sections below, each linked to its official government source.
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§ 62J.86 DEFINITIONS.
Official statutory text
§ 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).
§ 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).
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