§ 25-26-14-17.8 — Purchase from unlicensed wholesale drug distributor; requirements; for cause authentication; random authentication; quarantine

Indiana § 25-26-14-17.8

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

Text

8. (a) A wholesale drug distributor
licensed under this chapter that purchases legend drugs from a
wholesale drug distributor that is not licensed under this chapter shall
act with due diligence as required under this section and rules adopted
by the board. However, the due diligence requirements of this section
do not apply to purchases from an unlicensed wholesale drug
distributor that has obtained accreditation through the National
Association of Boards of Pharmacy’s Verified-Accredited Wholesale
Distributors program.
(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:
(1) A list of states in which the unlicensed wholesale drug
distributor is licensed.
(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.

Legislative History

As added by P.L.212-2005, SEC.56. Amended by P.L.98-2006, SEC.22.