Sec. 17.2. (a) A wholesale drug distributor that purchases legend drugs from another wholesale drug distributor and has reason to believe that a legend drug purchased from the other wholesale drug distributor is counterfeit, suspected counterfeit, misbranded, or adulterated shall conduct a for cause authentication of each distribution of the legend drug back to the manufacturer.

     (b) A wholesale drug distributor that has engaged in the distribution of a legend drug for which a purchasing wholesale drug distributor conducts a for cause authentication under subsection (a) shall provide, upon request, detailed information regarding the distribution of the legend drug, including the:

Terms Used In Indiana Code 25-26-14-17.2

  • adulterated: refers to a legend drug that:

    Indiana Code 25-26-14-1.5

  • authenticate: means to affirmatively verify before distribution occurs that each transaction that is listed on:

    Indiana Code 25-26-14-1.7

  • board: refers to the Indiana board of pharmacy established under IC 25-26-13-3. See Indiana Code 25-26-14-4
  • counterfeit: refers to a legend drug, or the container, seal, or labeling of a legend drug, that, without authorization, bears the trademark, trade name, or other identifying mark or imprint of a manufacturer, processor, packer, or distributor other than the person that manufactured, processed, packed, or distributed the legend drug. See Indiana Code 25-26-14-4.4
  • legend drug: has the meaning set forth in IC 16-18-2-199. See Indiana Code 25-26-14-7
  • manufacturer: means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a legend drug. See Indiana Code 25-26-14-8
  • misbranded: means that a legend drug's label:

    Indiana Code 25-26-14-8.3

  • wholesale drug distributor: means a person engaged in wholesale distribution of legend drugs, including:

    Indiana Code 25-26-14-12

(1) date of purchase of the legend drug;

(2) lot number of the legend drug;

(3) sales invoice number of the legend drug; and

(4) contact information, including name, address, telephone number, and electronic mail address of the wholesale drug distributor that sold the legend drug.

     (c) If a wholesale drug distributor conducts a for cause authentication under subsection (a) and is unable to authenticate each distribution of the legend drug, the wholesale drug distributor shall quarantine the legend drug and report the circumstances to the board and the federal Food and Drug Administration, if applicable, not more than ten (10) business days after completing the attempted authentication.

     (d) If a wholesale drug distributor authenticates the distribution of a legend drug back to the manufacturer under subsection (a), the wholesale drug distributor shall maintain records of the authentication for three (3) years and shall produce the records for the board and the federal Food and Drug Administration upon request.

As added by P.L.212-2005, SEC.54. Amended by P.L.98-2006, SEC.21.

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