Sec. 15. (a) The board shall require the following minimum information from each wholesale drug distributor as part of the license described in section 14 of this chapter and as part of any renewal of such license:
(1) The name, full business address, and telephone number of the licensee.
(2) All trade or business names used by the licensee.
(3) Addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of legend drugs.
(4) The type of ownership of operation.
(5) The name of each owner and operator of the licensee, including:
(A) if an individual, the name, address, Social Security number, and date of birth of the individual;
(B) if a partnership, the name, address, Social Security number, and date of birth of each partner, and the name of the partnership and federal employer identification number;
(C) if a corporation:
(i) the name, address, Social Security number, date of birth, and title of each corporate officer and director;
(ii) the corporate names, the name of the state of incorporation, the federal employer identification number, and the name of the parent company, if any; and
(iii) the name, address, and Social Security number of each shareholder owning ten percent (10%) or more of the voting stock of the corporation, unless the stock is traded on a major stock exchange and not traded over the counter;
(D) if a limited liability company, the name of each manager and member, the name and federal employer identification number of the limited liability company, and the name of the state where organized; and
(E) if a sole proprietorship, the full name, address, Social Security number, and date of birth of the sole proprietor and the name and federal employer identification number of the business entity.
(6) The name, address, and telephone number of the designated representative of each facility.
(7) Additional information concerning record keeping required under this chapter.
(b) The board shall require a wholesale drug distributor to post a surety bond of at least one hundred thousand dollars ($100,000), or an equivalent means of security acceptable to the board, including insurance, an irrevocable letter of credit, or funds deposited in a trust account or financial institution, to secure payment of any administrative penalties that may be imposed by the board and any fees and costs that may be incurred by the board and that:
(1) are related to a license held by the wholesale drug distributor;
(2) are authorized under Indiana law; and
(3) the wholesale drug distributor fails to pay less than thirty (30) days after the penalties, fees, or costs become final.
However, a separate surety bond or an equivalent means of security is not required for a separate location or a company of the wholesale drug distributor.
(c) The board may make a claim against a bond or security posted under subsection (b) within one (1) year after the wholesale drug distributor's license is no longer valid or sixty (60) days after the conclusion of:
(1) an administrative or legal proceeding before or on behalf of the board that involves the wholesale drug distributor and results in penalties, fees, or costs described in subsection (b); or
(2) an appeal of a proceeding described in subdivision (1);
whichever occurs later.
(d) The board or the board's designee shall inspect each facility where wholesale distribution operations are conducted before initial licensure and periodically thereafter in accordance with a schedule determined by the board, but at least one (1) time in each three (3) year period.
(e) A wholesale drug distributor must publicly display or have readily available all licenses and the most recent inspection report administered by the board or the board's designee.
(f) A material change in any information in this section must be submitted to the board at the time of license renewal or within thirty (30) days from the date of the change, whichever occurs first.
As added by P.L.182-1991, SEC.3. Amended by P.L.8-1993, SEC.396; P.L.212-2005, SEC.48; P.L.98-2006, SEC.17.
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