§ 25-26-14-15 — Information for grant and renewal of license; surety bond; inspection; reporting change in information

Indiana § 25-26-14-15

• Jurisdiction: Indiana
• Title 25: PROFESSIONS AND OCCUPATIONS
• Art. 26: PHARMACISTS, PHARMACIES, DRUG STORES
• Ch. 14: Wholesale Legend Drug Distributors and Third Party

Text

(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.

Legislative History

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.