Sec. 30. (a) The board shall develop standards for inspections of third party logistics providers to be included on an inspection report.

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Terms Used In Indiana Code 25-26-14-30

  • board: refers to the Indiana board of pharmacy established under IC 25-26-13-3. See Indiana Code 25-26-14-4
  • 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
  • third party logistics provider: means an entity that:

    Indiana Code 25-26-14-10.5

     (b) The report shall include whether the third party logistics provider‘s facility is compliant with the following storage practices:

(1) Maintaining access to warehouse space of suitable size to facilitate safe operations, including a suitable area to quarantine suspect product.

(2) Maintaining adequate security.

(3) Having written policies and procedures to:

(A) address receipt, security, storage, inventory, shipment, and distribution of a product;

(B) identify, record, and report confirmed losses or thefts;

(C) correct errors and inaccuracies in inventories;

(D) provide support for manufacturer recalls;

(E) prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the third party logistics provider’s facility, such as a strike, fire, or flood;

(F) ensure that any expired product is segregated from other products and returned to the manufacturer or repackager or destroyed;

(G) maintain the capability to trace the receipt and outbound distribution of a product and supplies and records of inventory; and

(H) quarantine or destroy a suspect product if directed to do so by the respective manufacturer, wholesale distributor, dispenser, or an authorized government agency.

As added by P.L.180-2018, SEC.29.