Indiana Code
Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers
25-26-14-30. Third Party Logistics Provider Inspection Report Standards

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

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

25-26-14-1.5. "Adulterated"

25-26-14-1.7. "Authenticate"

25-26-14-1.8. "Authorized Distributor"

25-26-14-2. "Blood"

25-26-14-3. "Blood Component"

25-26-14-3.7. "Chain Drug Warehouse"

25-26-14-4. "Board"

25-26-14-4.1. "Co-Licensed Products"

25-26-14-4.2. "Compendium"

25-26-14-4.3. "Contraband"

25-26-14-4.4. "Counterfeit"

25-26-14-4.5. "Deliver"

25-26-14-4.6. "Designated Representative"

25-26-14-4.7. "Distribute"

25-26-14-5. "Drug Sample"

25-26-14-6. "Health Care Entity"

25-26-14-6.5. "Label"

25-26-14-6.6. "Labeling"

25-26-14-7. "Legend Drug"

25-26-14-8. "Manufacturer"

25-26-14-8.3. "Misbranded"

25-26-14-8.5. "Normal Distribution Chain of Custody"

25-26-14-8.7. "Pedigree"

25-26-14-9. "Person"

25-26-14-9.2. "Practitioner"

25-26-14-9.3. "Repackage"

25-26-14-10. "Sale"

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"

25-26-14-13. Rules

25-26-14-14. Accreditation and License for Wholesale Distribution of Legend Drugs; Provisional License

25-26-14-14.2. Inspection and License Required for Third Party Logistics of Legend Drugs

25-26-14-14.5. Pedigree Required

25-26-14-15. Information for Grant and Renewal of License; Surety Bond; Inspection; Reporting Change in Information

25-26-14-15.5. Repealed

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

25-26-14-17.3. Repealed

25-26-14-17.8. Purchase From Unlicensed Wholesale Drug Distributor; Requirements; for Cause Authentication; Random Authentication; Quarantine

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

25-26-14-24. Injunction

25-26-14-25. Refusal of Inspection; Offense

25-26-14-26. Offenses

25-26-14-27. Offenses

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

25-26-14-32. Third Party Logistics Provider Rules