Substitution of generic equivalent drug or interchangeable biological product; notice to prescriber that biological product was dispensed

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  1. A pharmacist may select a generic equivalent drug product or an interchangeable biological product only when such selection results in lower cost to the purchaser, unless product selection is expressly prohibited by the prescriber.
  2. A pharmacist shall select a generic equivalent drug product or an interchangeable biological product when:
    1. The purchaser requests the selection of a generic equivalent drug product or an interchangeable biological product; or
    2. The prescriber has not expressly prohibited product selection; and
    3. Product selection will result in lower cost to the purchaser.

      Before product selection is made, the pharmacist shall advise the purchaser of his prerogatives under this subsection.

  3. When requested by the purchaser to dispense the drug product or biological product as ordered by the prescriber, a pharmacist shall not select a generic equivalent drug product or an interchangeable biological product.
  4. Within five (5) business days following the dispensing of any biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the purchaser, including the name of the product and the manufacturer, and communicate that information to the prescriber. The communication shall be conveyed by making an entry that is electronically accessible to the prescriber through:
    1. An interoperable electronic medical records system;
    2. An electronic prescribing technology;
    3. A pharmacist benefit management system; or
    4. A pharmacy record.
  5. Entry into an electronic records system as described in subsection (4) of this section is presumed to provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication shall not be required where:
    1. There is no federal Food and Drug Administration-approved interchangeable biological product for the product prescribed; or
    2. A refill prescription is not changed from the product dispensed on the prior filling of the prescription.
  6. The board shall maintain a link on its website to the federal Food and Drug Administration's List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.


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