Definitions.

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As used in this part 3, unless the context otherwise requires:

  1. "Authentication" means the process of affirmatively verifying that each transactionlisted on a pedigree has occurred before any wholesale distribution of a prescription drug occurs.

  2. "Board-registered outlet" means a prescription drug outlet, an other outlet, a nonresident prescription drug outlet, a wholesaler, or a manufacturer.

  3. "Designated representative" means a person authorized by a licensed wholesaler toact as a representative for the wholesaler.

  4. "Drop shipment" means the sale by a manufacturer of the manufacturer's prescriptiondrug, that manufacturer's third-party logistics provider, or that manufacturer's exclusive distributor to a wholesaler whereby the wholesaler takes title to, but not possession of, the prescription drug and the wholesaler invoices the board-registered outlet or practitioner authorized by law to prescribe the prescription drug and the board-registered outlet or the practitioner authorized by law to prescribe the prescription drug receives delivery of the prescription drug directly from the manufacturer of the drug, that manufacturer's third-party logistics provider, or that manufacturer's exclusive distributor.

  5. "Facility" means a facility of a wholesaler where prescription drugs are stored, handled, repackaged, or offered for sale.

  6. "Normal distribution channel" means a chain of custody for a prescription drug thatgoes directly or by drop shipment from a manufacturer of the prescription drug to:

(a) (I) A wholesaler to a pharmacy to a patient or other designated persons authorized by law to dispense or administer a prescription drug to a patient;

  1. A wholesaler to a chain pharmacy warehouse to their intracompany pharmacies to apatient;

  2. A chain pharmacy warehouse to its intracompany pharmacies to a patient; or

  3. A pharmacy to a patient; or

  1. A manufacturer's colicensed partner, third-party logistics provider, or exclusive distributor to a wholesaler to a pharmacy to a patient or other designated persons authorized by law to dispense or administer the prescription drug to a patient; or

  2. A manufacturer's colicensed partner, or that manufacturer's third-party logistics provider, or exclusive distributor to a wholesaler to a chain pharmacy warehouse to that chain pharmacy warehouse's intracompany pharmacy to a patient or other designated persons authorized by law to dispense or administer the prescription drug to a patient; or

  3. A wholesaler to a pharmacy buying cooperative warehouse to a pharmacy that is amember or member owner of the cooperative to a patient or other designated person authorized by law to dispense or administer the prescription drug to a patient.

  1. "Pedigree" means a document or electronic file containing information that recordseach distribution of any given prescription drug that leaves the normal distribution channel.

  2. "Third-party logistics provider" means anyone who contracts with a manufacturer toprovide or coordinate warehousing, distribution, or other services on behalf of a manufacturer but does not take title to a prescription drug or have general responsibility to direct the prescription drug's sale or disposition.

Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1488, § 1, effective October 1.

Editor's note: This section is similar to former § 12-42.5-301 as it existed prior to 2019.


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