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

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

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

(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.