Indiana Code 25-26-14-17.8. Purchase from unlicensed wholesale drug distributor; requirements; for cause authentication; random authentication; quarantine
(b) Before the initial purchase of legend drugs from the unlicensed wholesale drug distributor, the licensed wholesale drug distributor shall obtain the following information from the unlicensed wholesale drug distributor:
Terms Used In Indiana Code 25-26-14-17.8
- adulterated: refers to a legend drug that:
Indiana Code 25-26-14-1.5
- authenticate: means to affirmatively verify before distribution occurs that each transaction that is listed on:
Indiana Code 25-26-14-1.7
- authorized distributor: means a wholesale drug distributor with which a manufacturer has established an ongoing relationship to distribute the manufacturer's products. See Indiana Code 25-26-14-1.8
- board: refers to the Indiana board of pharmacy established under IC 25-26-13-3. See Indiana Code 25-26-14-4
- counterfeit: refers to a legend drug, or the container, seal, or labeling of a legend drug, that, without authorization, bears the trademark, trade name, or other identifying mark or imprint of a manufacturer, processor, packer, or distributor other than the person that manufactured, processed, packed, or distributed the legend drug. See Indiana Code 25-26-14-4.4
- legend drug: has the meaning set forth in IC 16-18-2-199. See Indiana Code 25-26-14-7
- 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
- misbranded: means that a legend drug's label:
Indiana Code 25-26-14-8.3
- wholesale drug distributor: means a person engaged in wholesale distribution of legend drugs, including:
Indiana Code 25-26-14-12
(2) A list of states into which the unlicensed wholesale drug distributor ships legend drugs.
(3) Copies of all state and federal regulatory licenses and registrations held by the unlicensed wholesale drug distributor.
(4) The unlicensed wholesale drug distributor’s most recent facility inspection reports.
(5) Information regarding general and product liability insurance maintained by the unlicensed wholesale drug distributor, including copies of relevant policies.
(6) A list of other names under which the unlicensed wholesale drug distributor does business or has been previously known.
(7) A list of corporate officers and managerial employees of the unlicensed wholesale drug distributor.
(8) A list of all owners of the unlicensed wholesale drug distributor that own more than ten percent (10%) of the unlicensed wholesale drug distributor, unless the unlicensed wholesale drug distributor is publicly traded.
(9) A list of all disciplinary actions taken against the unlicensed wholesale drug distributor by state and federal agencies.
(10) A description, including the address, dimensions, and other relevant information, of each facility used by the unlicensed wholesale drug distributor for legend drug storage and distribution.
(11) A description of legend drug import and export activities of the unlicensed wholesale drug distributor.
(12) A description of the unlicensed wholesale drug distributor’s procedures to ensure compliance with this chapter.
(13) A statement:
(A) as to whether; and
(B) of the identity of each manufacturer for which;
the unlicensed wholesale drug distributor is an authorized distributor.
(c) Before the initial purchase of legend drugs from an unlicensed wholesale drug distributor, the licensed wholesale drug distributor shall:
(1) request that the board obtain and consider the results of a national criminal history background check (as defined in IC 10-13-3-12) through the state police department of all individuals associated with the unlicensed wholesale drug distributor as specified for licensure of a wholesale drug distributor under section 16(b) of this chapter; and
(2) verify the unlicensed wholesale drug distributor’s status as an authorized distributor, if applicable.
(d) If an unlicensed wholesale drug distributor’s facility has not been inspected by the board or the board’s agent within three (3) years after a contemplated purchase described in subsection (a), the licensed wholesale drug distributor shall conduct an inspection of the unlicensed wholesale drug distributor’s facility:
(1) before the initial purchase of legend drugs from the unlicensed wholesale drug distributor; and
(2) at least once every three (3) years unless the unlicensed wholesale drug distributor’s facility has been inspected by the board, or the board’s agent, during the same period;
to ensure compliance with applicable laws and regulations relating to the storage and handling of legend drugs. A third party may be engaged to conduct the site inspection on behalf of the licensed wholesale drug distributor.
(e) At least annually, a licensed wholesale drug distributor that purchases legend drugs from an unlicensed wholesale drug distributor shall ensure that the unlicensed wholesale drug distributor maintains a record keeping system that meets the requirements of section 17(3) of this chapter.
(f) If a licensed wholesale drug distributor that purchases legend drugs from an unlicensed wholesale drug distributor has reason to believe that a legend drug purchased from the unlicensed wholesale drug distributor is misbranded, adulterated, counterfeit, or suspected counterfeit, the licensed wholesale drug distributor shall conduct a for cause authentication of each distribution of the legend drug back to the manufacturer.
(g) An unlicensed wholesale drug distributor that has engaged in the distribution of a legend drug for which a licensed wholesale drug distributor conducts a for cause authentication under subsection (f) shall provide, upon request, detailed information regarding the distribution of the legend drug, including the:
(1) date of purchase of the legend drug;
(2) lot number of the legend drug;
(3) sales invoice number of the legend drug; and
(4) contact information, including name, address, telephone number, and any electronic mail address of the unlicensed wholesale drug distributor that sold the legend drug.
(h) If a licensed wholesale drug distributor conducts a for cause authentication under subsection (f) and is unable to authenticate each distribution of the legend drug, the licensed wholesale drug distributor shall quarantine the legend drug and report the circumstances to the board and the federal Food and Drug Administration within ten (10) business days after completing the attempted authentication.
(i) If a licensed wholesale drug distributor authenticates the distribution of a legend drug back to the manufacturer under subsection (f), the licensed wholesale drug distributor shall maintain records of the authentication for three (3) years and shall provide the records to the board upon request.
(j) A licensed wholesale drug distributor that purchases legend drugs from an unlicensed wholesale drug distributor shall, at least annually, conduct random authentications of required pedigrees on at least ten percent (10%) of sales units of distributions of legend drugs that were purchased from unlicensed wholesale drug distributors.
(k) An unlicensed wholesale drug distributor from which a licensed wholesale drug distributor has purchased legend drugs shall cooperate with the random authentications of pedigrees under this section and provide requested information in a timely manner.
(l) If a wholesale drug distributor conducts a random authentication under subsection (j) and is unable to authenticate each distribution of the legend drug, the wholesale drug distributor shall quarantine the legend drug and report the circumstances to the board and the federal Food and Drug Administration not more than ten (10) business days after completing the attempted authentication.
As added by P.L.212-2005, SEC.56. Amended by P.L.98-2006, SEC.22.