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:
(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.
Structure Indiana Code
Title 25. Professions and Occupations
Article 26. Pharmacists, Pharmacies, Drug Stores
Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers
25-26-14-1. Application of Chapter
25-26-14-1.8. "Authorized Distributor"
25-26-14-3.7. "Chain Drug Warehouse"
25-26-14-4.1. "Co-Licensed Products"
25-26-14-4.6. "Designated Representative"
25-26-14-6. "Health Care Entity"
25-26-14-8.5. "Normal Distribution Chain of Custody"
25-26-14-10.3. "Third Party Inspection Provider"
25-26-14-10.5. "Third Party Logistics Provider"
25-26-14-11. "Wholesale Distribution"
25-26-14-12. "Wholesale Drug Distributor"
25-26-14-14.2. Inspection and License Required for Third Party Logistics of Legend Drugs
25-26-14-14.5. Pedigree Required
25-26-14-16. Distributor Qualifications; Criminal History and Financial Background Check
25-26-14-16.5. Designated Representative; Application; Experience Requirement; Continuing Education
25-26-14-16.6. Designated Agent; Service of Process
25-26-14-17. Applicant Assurances as Condition of License
25-26-14-17.2. For Cause Authentication
25-26-14-17.9. Use of Trade or Business Name
25-26-14-18. Denial of License; Review of Board Action
25-26-14-19. Inspection of Premises; Recordkeeping
25-26-14-20. Employee Qualifications
25-26-14-21. Renewal of Licenses; Lapsed Licenses
25-26-14-21.5. Prohibitions; Sanctions
25-26-14-22. Violations of Chapter; License Revocation; Penalties
25-26-14-23. Purchase From Unlicensed Person; Offense
25-26-14-25. Refusal of Inspection; Offense
25-26-14-29. Third Party Logistics Provider License Requirements
25-26-14-30. Third Party Logistics Provider Inspection Report Standards
25-26-14-31. Third Party Logistics Provider Renewal; Expiration; Requirements