I. Returned, outdated, damaged, deteriorated,
adulterated, misbranded, counterfeited, and contraband drugs.
1. Except as specified in subsection (H)(1)
for a prescription-only drug, a full-service drug wholesale permittee shall
ensure that the return of any narcotic or other controlled substance,
prescription-only drug or device, nonprescription drug, precursor chemical, or
regulated chemical meets the following criteria.
a. Any narcotic or other controlled
substance, prescription-only drug or device, nonprescription drug, precursor
chemical, or regulated chemical that is outdated, damaged, deteriorated,
adulterated, misbranded, counterfeited, or contraband or suspected of being
adulterated, misbranded, counterfeited, or contraband, or otherwise deemed
unfit for human or animal consumption shall be quarantined and physically
separated from other narcotics or other controlled substances,
prescription-only drugs or devices, nonprescription drugs, precursor chemicals,
or regulated chemicals until the narcotic or other controlled substance,
prescription-only drug or device, nonprescription drug, precursor chemical, or
regulated chemical is destroyed or returned to the manufacturer or wholesale
distributor from which it was acquired as authorized by the Board and the
FDA.
b. Any narcotic or other
controlled substance, prescription-only drug or device, nonprescription drug,
precursor chemical, or regulated chemical whose immediate or sealed outer or
secondary containers or product labeling are misbranded, counterfeited, or
contraband or suspected of being misbranded, counterfeited, or contraband shall
be quarantined and physically separated from other narcotics or other
controlled substances, prescription-only drugs or devices, nonprescription
drugs, precursor chemicals, or regulated chemicals until the narcotic or other
controlled substance, prescription-only drug or device, nonprescription drug,
precursor chemical, or regulated chemical is destroyed or returned to the
manufacturer or wholesale distributor from which it was acquired as authorized
by the Board and the FDA. When the immediate or sealed outer or secondary
containers or product labeling are determined to be misbranded, counterfeited,
or contraband or suspected of being misbranded, counterfeited, or contraband,
the full-service drug wholesale permittee shall provide notice of the
misbranding, counterfeiting, or contrabanding or suspected misbranding,
counterfeiting, or contrabanding within three business days of the
determination to the Board, FDA, and manufacturer or wholesale distributor from
which the narcotic or other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or regulated chemical was
acquired.
c. Any narcotic or other
controlled substance, prescription-only drug or device, nonprescription drug,
precursor chemical, or regulated chemical that has been opened or used, but is
not adulterated, misbranded, counterfeited, or contraband or suspected of being
misbranded, counterfeited, or contraband shall be identified as opened or used,
or both, and quarantined and physically separated from other narcotics or other
controlled substances, prescription-only drugs or devices, nonprescription
drugs, precursor chemicals, or regulated chemicals until the narcotic or other
controlled substance, prescription-only drug or device, nonprescription drug,
precursor chemical, or regulated chemical is destroyed or returned to the
manufacturer or wholesale distributor from which it was acquired as authorized
by the Board and the FDA.
d. If the
conditions under which a narcotic or other controlled substance,
prescription-only drug or device, nonprescription drug, precursor chemical, or
regulated chemical has been returned cast doubt on the safety, identity,
strength, quality, or purity of the narcotic or other controlled substance,
prescription-only drug or device, nonprescription drug, precursor chemical, or
regulated chemical, the narcotic or other controlled substance,
prescription-only drug or device, nonprescription drug, precursor chemical, or
regulated chemical shall be quarantined and physically separated from other
narcotics or other controlled substances, prescription-only drugs or devices,
nonprescription drugs, precursor chemicals, or regulated chemicals until the
narcotic or other controlled substance, prescription-only drug or device,
nonprescription drug, precursor chemical, or regulated chemical is destroyed or
returned to the manufacturer or wholesale distributor from which it was
acquired as authorized by the Board and the FDA, except as provided in
subsection (I)(1)(d)(i).
i. If examination,
testing, or other investigation proves that the narcotic or other controlled
substance, prescription-only drug or device, nonprescription drug, precursor
chemical, or regulated chemical meets appropriate standards of safety,
identity, strength, quality, and purity, it does not have to be destroyed or
returned to the manufacturer or wholesale distributor.
ii. In determining whether the conditions
under which a narcotic or other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or regulated chemical has
been returned cast doubt on the safety, identity, strength, quality, or purity
of the narcotic or other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or regulated chemical, the
full-service drug wholesale permittee shall consider, among other things, the
conditions under which the narcotic or other controlled substance,
prescription-only drug or device, nonprescription drug, precursor chemical, or
regulated chemical has been held, stored, or shipped before or during its
return and the condition of the narcotic or other controlled substance,
prescription-only drug or device, nonprescription drug, precursor chemical, or
regulated chemical and the condition of its container, carton, or product
labeling as a result of storage or shipping.
e. For any narcotic or other controlled
substance, prescription-only drug or device, nonprescription drug, precursor
chemical, or regulated chemical identified under subsections (I)(1)(a) or (b),
the full-service drug wholesale permittee shall ensure that the identified item
or items and other evidence of criminal activity, and accompanying
documentation is retained and not destroyed until its disposition is authorized
by the Board and the FDA.
2. A nonprescription drug wholesale permittee
shall ensure that the return of any nonprescription drug, precursor chemical,
or regulated chemical meets the following criteria.
a. Any nonprescription drug, precursor
chemical, or regulated chemical that is outdated, damaged, deteriorated,
adulterated, misbranded, counterfeited, or contraband or suspected of being
adulterated, misbranded, counterfeited, or contraband, or otherwise deemed
unfit for human or animal consumption shall be quarantined and physically
separated from other nonprescription drugs, precursor chemicals, or regulated
chemicals until the nonprescription drug, precursor chemical, or regulated
chemical is destroyed or returned to the manufacturer or wholesale distributor
from which it was acquired as authorized by the Board and the FDA.
b. Any nonprescription drug, precursor
chemical, or regulated chemical whose immediate or sealed outer or secondary
containers or product labeling are misbranded, counterfeited, or contraband or
suspected of being misbranded, counterfeited, or contraband shall be
quarantined and physically separated from other nonprescription drugs,
precursor chemicals, or regulated chemicals until the nonprescription drug,
precursor chemical, or regulated chemical is destroyed or returned to the
manufacturer or wholesale distributor from which it was acquired as authorized
by the Board and the FDA. When the immediate or sealed outer or secondary
containers or product labeling are determined to be misbranded, counterfeited,
or contraband or suspected of being misbranded, counterfeited, or contraband,
the nonprescription drug wholesale permittee shall provide notice of the
misbranding, counterfeiting, or contrabanding or suspected misbranding,
counterfeiting, or contrabanding within three business days of the
determination to the Board, FDA, and manufacturer or wholesale distributor from
which the nonprescription drug, precursor chemical, or regulated chemical was
acquired.
c. Any nonprescription
drug, precursor chemical, or regulated chemical that has been opened or used,
but is not adulterated, misbranded, counterfeited, or contraband or suspected
of being misbranded, counterfeited, or contraband, shall be identified as
opened or used, or both, and quarantined and physically separated from other
nonprescription drugs, precursor chemicals, or regulated chemicals until the
nonprescription drug, precursor chemical, or regulated chemical is destroyed or
returned to the manufacturer or wholesale distributor from which it was
acquired as authorized by the Board and the FDA.
d. If the conditions under which a
nonprescription drug, precursor chemical, or regulated chemical has been
returned cast doubt on the safety, identity, strength, quality, or purity of
the nonprescription drug, precursor chemical, or regulated chemical, the
nonprescription drug, precursor chemical, or regulated chemical shall be
quarantined and physically separated from other nonprescription drugs,
precursor chemicals, or regulated chemicals until the nonprescription drug,
precursor chemical, or regulated chemical is destroyed or returned to the
manufacturer or wholesale distributor from which it was acquired as authorized
by the Board and the FDA, except as provided in subsection (I)(2)(d)(i).
i. If examination, testing, or other
investigation proves that the nonprescription drug, precursor chemical, or
regulated chemical meets appropriate standards of safety, identity, strength,
quality, and purity, the nonprescription drug, precursor chemical, or regulated
chemical does not need to be destroyed or returned to the manufacturer or
wholesale distributor.
ii. In
determining whether the conditions under which a nonprescription drug,
precursor chemical, or regulated chemical has been returned cast doubt on the
safety, identity, strength, quality, or purity of the nonprescription drug,
precursor chemical, or regulated chemical, the nonprescription drug wholesale
permittee shall consider, among other things, the conditions under which the
nonprescription drug, precursor chemical, or regulated chemical has been held,
stored, or shipped before or during its return and the condition of the
nonprescription drug, precursor chemical, or regulated chemical and the
condition of its container, carton, or product labeling as a result of storage
or shipping.
e. For any
nonprescription drug, precursor chemical, or regulated chemical identified
under subsections (I)(2)(a) or (b), the nonprescription drug wholesale
permittee shall ensure that the identified item or items and other evidence of
criminal activity, and accompanying documentation is retained and not destroyed
until its disposition is authorized by the Board and the FDA.
3. A full-service drug wholesale
permittee and nonprescription drug wholesale permittee shall comply with the
recordkeeping requirements of subsection (G) for all outdated, damaged,
deteriorated, adulterated, misbranded, counterfeited and contraband narcotics
or other controlled substances, prescription-only drugs or devices,
nonprescription drugs, precursor chemicals, or regulated chemicals.