| (2) Exception report retention. A healthcare facility
must keep a copy of each exception report for a period of at least
three years from the date of the report.
(3) Waste determination documentation retention. A
healthcare facility must keep records of any test results, waste analyses,
or other determinations made to support its hazardous waste determination(s)
consistent with 40 CFR §262.11(f) as adopted under §335.53
of this title, for at least three years from the date the waste was
last sent to on-site or off-site treatment, storage or disposal. A
healthcare facility that manages all its non-creditable nonhazardous
waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals
is not required to keep documentation of hazardous waste determinations.
(4) Documentation retention extension. The periods
of retention referred to in this section are extended automatically
during the course of any unresolved enforcement action regarding the
regulated activity, or as requested by the executive director.
(5) Record inspections. All records must be readily
available upon request by an inspector.
(k) Response to spills of non-creditable hazardous
waste pharmaceuticals at healthcare facilities. A healthcare facility
must immediately contain all spills of non-creditable hazardous waste
pharmaceuticals and manage the spill clean-up materials as non-creditable
hazardous waste pharmaceuticals in accordance with the requirements
of this subchapter.
(l) Accepting non-creditable hazardous waste pharmaceuticals
from an off-site healthcare facility that is a very small quantity
generator. A healthcare facility may accept non-creditable hazardous
waste pharmaceuticals from an off-site healthcare facility that is
a very small quantity generator under 40 CFR §262.14 as adopted
under §335.53 of this title, without a permit or without having
interim status, if the receiving healthcare facility complies with
the following.
(1) Consolidating waste pharmaceuticals at another
healthcare facility under the control of the same person. The healthcare
facility must be under the control of the same person as the very
small quantity generator healthcare facility that is sending the non-creditable
hazardous waste pharmaceuticals off-site or has a contractual or other
documented business relationship whereby the receiving healthcare
facility supplies pharmaceuticals to the very small quantity generator
healthcare facility. "Control," for the purposes of this section,
means the power to direct the policies of the healthcare facility,
whether by the ownership of stock, voting rights, or otherwise, except
that contractors who operate healthcare facilities on behalf of a
different person shall not be deemed to "control" such healthcare
facilities.
(2) Operating under this subchapter. The healthcare
facility must be operating under this subchapter for the management
of its non-creditable hazardous waste pharmaceuticals.
(3) Compliance with this subchapter. The healthcare
facility must manage the non-creditable hazardous waste pharmaceuticals
that it receives from off-site in compliance with this subchapter.
(4) Recordkeeping requirements. The healthcare facility
must keep records of the non-creditable hazardous waste pharmaceuticals
shipments it receives from off-site for three years from the date
that the shipment is received.
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