§ 25-26-14-17 — Applicant assurances as condition of license

As a condition for receiving and retaining
a wholesale drug distributor license issued under this chapter, an
applicant must satisfy the board that the applicant has and will
continuously maintain the following:
(1) Acceptable storage and handling conditions and facilities
standards for each facility at which legend drugs are received,
stored, warehoused, handled, held, offered, marketed, or
displayed, or from which legend drugs are transported, including:
(A) suitable construction of the facility and appropriate
monitoring equipment to ensure that legend drugs in the facility
are maintained in accordance with labeling or in compliance
with official compendium standards;
(B) suitable size and construction to facilitate cleaning,
maintenance, and proper wholesale distribution operations;
(C) adequate storage areas to provide appropriate lighting,
ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions;
(D) a quarantine area for separate storage of legend drugs that
are outdated, damaged, deteriorated, misbranded, adulterated,
counterfeit, suspected counterfeit, otherwise unfit for
distribution, or contained in immediate or sealed secondary
containers that have been opened;
(E) maintenance of the facility in a clean and orderly condition;
(F) maintenance of the facility in a commercial, nonresidential
building; and
(G) freedom of the facility from infestation.
(2) Security of each facility from unauthorized entry as follows:
(A) Entry into areas where legend drugs are held is limited to
authorized personnel.
(B) Each facility is equipped with a security system that
includes:
(i) an after hours central alarm or a comparable entry
detection capability;
(ii) restricted premises access;
(iii) adequate outside perimeter lighting;
(iv) safeguards against theft and diversion, including
employee theft and theft or diversion facilitated or hidden by
tampering with computers or electronic records; and
(v) a means of protecting the integrity and confidentiality of
data and documents and of making the data and documents
readily available to the board and other state and federal law
enforcement officials.
(3) A reasonable system of record keeping as follows:
(A) The system describes all the wholesale distributor's
activities governed by this chapter for the three (3) year period
after the disposition of each product, and all records are
maintained for at least three (3) years after disposition of the
legend drug to which the record applies.
(B) The system is reasonably accessible as determined by board
rules in any inspection authorized by the board.
(C) The system provides a means to establish and maintain
inventories and records of transactions regarding the receipt
and distribution or other disposition of all legend drugs,
including the following:
(i) For legend drugs manufactured by a manufacturer for
which the wholesale drug distributor is an authorized
distributor, a pedigree for each distributed legend drug that
leaves the normal distribution chain of custody, as
determined by rules adopted by the board.
(ii) For legend drugs manufactured by a manufacturer for
which the wholesale drug distributor is not an authorized
distributor, a pedigree for each distributed legend drug that
leaves the normal chain of custody.
(iii) After January 1, 2007, and after consulting with the
federal Food and Drug Administration, at the board's
discretion, for each legend drug received and distributed by
the wholesale drug distributor, an electronic pedigree
developed in accordance with standards and requirements of
the board to authenticate, track, and trace legend drugs. The
standards and requirements of the board may indicate the
information required to be part of the electronic pedigree.
(iv) Dates of receipt and distribution or other disposition of
the legend drugs by the wholesale drug distributor.
(v) Availability for inspection and photocopying by any
authorized official of a local, state, or federal governmental
agency for three (3) years after the creation date of the
inventories and records.
(D) Onsite electronic inventories and records are immediately
available for inspection, and records kept at a central location
apart from the inspection site and not electronically retrievable
are available for inspection within two (2) working days after
a request by an authorized official of a local, state, or federal
governmental agency.
(E) The system maintains an ongoing list of persons with whom
the wholesale drug distributor does business.
(F) The system provides for reporting counterfeit or suspected
counterfeit legend drugs or counterfeiting or suspected
counterfeiting activities to the board and the federal Food and
Drug Administration.
(G) The system provides for mandatory reporting of significant
shortages or losses of legend drugs to the board and the federal
Food and Drug Administration, if applicable, if diversion is
known or suspected.
(4) Written policies and procedures to which the wholesale drug
distributor adheres for the receipt, security, storage, inventory,
transport, shipping, and distribution of legend drugs, and that
assure reasonable wholesale distributor preparation for, protection
against, and handling of any facility security or operation
problems, including the following:
(A) Facility security or operation problems caused by natural
disaster or government emergency.
(B) Correction of inventory inaccuracies.
(C) Product shipping and receiving problems.
(D) Quarantine and return to the manufacturer or destruction in
accordance with state and federal law of all outdated products
and outdated or expired legend drugs, including appropriate
documentation and witnessing.
(E) Appropriate disposition of returned goods.
(F) Product recalls.
(G) Identifying, recording, and reporting losses or thefts.
(H) Recalls and withdrawals of legend drugs due to:
(i) an action initiated by the federal Food and Drug
Administration or another federal, state, or local
governmental agency;
(ii) a volunteer action by the manufacturer to remove
defective or potentially defective legend drugs from the
market; or
(iii) an action undertaken to promote public health and safety
by replacing existing merchandise with an improved product
or a new package design.
(I) Disposition and destruction of containers, labels, and
packaging to ensure that the containers, labels, and packaging
are not used in counterfeiting activities, including necessary
documentation and witnessing in accordance with state and
federal law.
(J) Investigation of discrepancies in the inventory involving
counterfeit, suspected counterfeit, contraband, or suspected
contraband legend drugs and reporting of discrepancies within
three (3) business days to the board and any other appropriate
state or federal governmental agency.
(K) Reporting of criminal or suspected criminal activities
involving the inventory of legend drugs to the board within
three (3) business days.
(L) Conducting for cause authentication as required under
sections 17.2 and 17.8 of this chapter.
(5) Written policies and procedures and sufficient inspection
procedures for all incoming and outgoing product shipments,
including the following:
(A) Upon receipt, visual examination of each shipping
container in a manner adequate to identify the legend drugs in
the container and to determine whether the legend drugs may be
outdated, adulterated, misbranded, contaminated, contraband,
counterfeit, suspected counterfeit, damaged, or otherwise unfit
for distribution.
(B) Upon receipt, review of records by the wholesale drug
distributor for the acquisition of legend drugs for accuracy and
completeness, considering the:
(i) total facts and circumstances surrounding each transaction
involving the legend drugs; and
(ii) wholesale drug distributors involved.
(C) Quarantine of a legend drug considered to be outdated,
adulterated, misbranded, contaminated, contraband, counterfeit,
suspected counterfeit, damaged, or otherwise unfit for
distribution until:
(i) examination and a determination that the legend drug is
not outdated, adulterated, misbranded, contaminated,
contraband, counterfeit, damaged, or otherwise unfit for
distribution; or
(ii) the legend drug is destroyed or returned to the
manufacturer or wholesale drug distributor from which the
legend drug was acquired.
(D) Written policies and procedures to ensure that if the
wholesale drug distributor determines that a legend drug is
adulterated, misbranded, counterfeit, or suspected counterfeit,
the wholesale drug distributor provides notice of the
adulteration, misbranding, counterfeiting, or suspected
counterfeiting to the board, the federal Food and Drug
Administration, and the manufacturer or wholesale drug
distributor from which the legend drug was acquired within
three (3) business days.
(E) Written policies and procedures to ensure that if the
immediate or sealed outer or secondary container or labeling of
a legend drug is adulterated, misbranded, counterfeit, or
suspected counterfeit, the wholesale drug distributor:
(i) quarantines the legend drug until the legend drug is
destroyed or returned to the manufacturer or wholesale drug
distributor from which the legend drug was acquired; and
(ii) provides notice of the adulteration, misbranding,
counterfeiting, or suspected counterfeiting to the board, the
federal Food and Drug Administration, and the manufacturer
or wholesale drug distributor from which the legend drug was
acquired within three (3) business days.
(F) Written policies and procedures to ensure that a legend drug
that has been opened or used, but is not adulterated,
misbranded, counterfeit, or suspected counterfeit, is identified
as such and quarantined until the legend drug is destroyed or
returned to the manufacturer or wholesale drug distributor from
which the legend drug was acquired.
(G) Written policies and procedures to ensure that:
(i) a legend drug that will be returned to a manufacturer or
wholesale drug distributor is kept under proper conditions for
storage, handling, transport, and shipment before the return;
and
(ii) documentation showing that proper conditions were
maintained is provided to the manufacturer or wholesale drug
distributor to which the legend drug is returned.
(H) Inspection of each outgoing shipment for identity of the
legend drugs and to ensure that the legend drugs have not been
damaged in storage or held under improper conditions.
(I) Written policies and procedures to ensure that if conditions
under which a legend drug has been returned to the wholesale
drug distributor cast doubt on the legend drug's safety, identity,
strength, quality, or purity, the legend drug is destroyed or
returned to the manufacturer or wholesale drug distributor from
which the legend drug was acquired unless examination,
testing, or other investigation proves that the legend drug meets
appropriate standards of safety, identity, strength, quality, and
purity. In determining whether the conditions under which a
legend drug has been returned cast doubt on the legend drug's
safety, identity, strength, quality, or purity, the wholesale drug
distributor considers the conditions under which the legend
drug has been held, stored, or shipped before or during the
legend drug's return and the condition of the legend drug and
the legend drug's container, carton, or labeling upon receipt of
the returned legend drug.
(J) Written policies and procedures to ensure that contraband,
counterfeit, or suspected counterfeit legend drugs, other
evidence of criminal activity, and accompanying documentation
are retained until a disposition is authorized by the board and
the federal Food and Drug Administration.
(K) Written policies and procedures to ensure that any shipping,
immediate, or sealed outer or secondary container or labeling,
and accompanying documentation, suspected of or determined
to be counterfeit or fraudulent, are retained until a disposition
is authorized by the board and the federal Food and Drug
Administration.
(6) Operations in compliance with all federal legal requirements
applicable to wholesale drug distribution.
(7) Written policies and procedures to provide for the secure and
confidential storage of information with restricted access and to
protect the integrity and confidentiality of the information.
(8) A pedigree as required under this chapter, including an
electronic pedigree developed in accordance with standards and
requirements of the board under subdivision (3)(C)(iii).
(9) Appropriate inventory management and control systems to:
(A) prevent; and
(B) allow detection and documentation of;
theft, counterfeiting, or diversion of legend drugs.
(10) If the wholesale drug distributor is involved in the
distribution of controlled substances, registration with the federal
Drug Enforcement Administration and the board and compliance
with all laws related to the storage, handling, transport, shipment,
and distribution of controlled substances.
(11) Isolation of controlled substances from noncontrolled
substances and storage of the controlled substances in a secure
area in accordance with federal Drug Enforcement Administration
security requirements and standards.
(12) Technology and equipment that allow the wholesale drug
distributor to authenticate, track, and trace legend drugs. The
technology and equipment meet standards set by the board and
are used as required by the board to conduct for cause and random
tracking, tracing, and authentication of legend drugs.
(13) Employment, training, and documentation of the training
concerning the proper use of the technology and equipment
required under subdivision (12).
(14) Packaging operations in accordance with an official
compendium allowing the identification of a compromise in the
integrity of the legend drugs due to tampering or adverse storage
conditions.

Legislative History

As added by P.L.182-1991, SEC.3. Amended by P.L.212-2005, SEC.53; P.L.98-2006, SEC.20.