450.135 Using interchangeable biological product in dispensing prescriptions.
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450.135 Using interchangeable biological product in dispensing prescriptions.
(1)Definition. In this section, “interchangeable biological product” means a biological product that the federal food and drug administration has licensed and has determined meets the standards for interchangeability pursuant to 42 USC 262
(4)or has determined is therapeutically equivalent as set forth in the latest edition of or supplement to the federal food and drug administration’s Approved Drug Products with Therapeutic Equivalence Evaluations.
(2)Biological product or interchangeable biological product to be used. Except as provided in sub.
(3), a pharmacist shall dispense every prescription using either the biological product prescribed or an interchangeable biological product, if the interchangeable biological product is lower in price to the consumer than the biological product prescribed, and shall inform the consumer of the options available in dispensing the prescription.
(3)Exception. A prescribing practitioner may indicate, by writing on the face of the prescription order or, with respect to a prescription order transmitted electronically, by designating in electronic format the phrase “No substitutions” or words of similar meaning or the initials “N.S.,” that no substitution of the biological product prescribed may be made under sub.
(2). If such indication is made, the pharmacist shall dispense the prescription with the specific biological product prescribed. No preprinted statement regarding biological product substitution may appear on the face of the prescription order.