| (B) item 20 of the new manifest, if a new manifest
was used for the returned shipment.
(2) Transporter manifest copy. The healthcare facility
must provide the transporter a copy of the manifest used for the returned
shipment.
(3) Designated facility manifest copy. Within 30 days
of receipt of the rejected shipment, the healthcare facility must
send a copy of the manifest to the designated facility that returned
the shipment to the healthcare facility; and
(4) Maximum time to re-ship a rejected shipment. Within
90 days of receipt of the rejected shipment, the healthcare facility
must transport or offer for transport the returned shipment in accordance
with the shipping standards of §335.767(a) of this title (relating
to Shipping Non-Creditable Hazardous Waste Pharmaceuticals from a
Healthcare Facility or Evaluated Hazardous Waste Pharmaceuticals from
a Reverse Distributor).
(i) Reporting by healthcare facilities for non-creditable
hazardous waste pharmaceuticals. A healthcare facility must comply
with the following reporting requirements.
(1) Biennial and annual waste reporting by healthcare
facilities. A healthcare facility is not subject to the Annual Waste
Summary reporting requirements under §335.9 of this title (relating
to Recordkeeping and Annual Reporting Procedures Applicable to Generators)
or the biennial reporting requirements under 40 CFR §262.41 as
adopted under §335.56 of this title (relating to Recordkeeping
and Reporting Applicable to Small and Large Quantity Generators) for
non-creditable hazardous waste pharmaceuticals managed under this
subchapter.
(2) Exception reporting by healthcare facilities for
a missing copy of the manifest. A healthcare facility must submit
an exception report to the executive director in the following situations.
(A) For shipments from a healthcare facility to a designated
facility, if a healthcare facility does not receive a copy of the
manifest with the signature of the owner or operator of the designated
facility within 60 days of the date the non-creditable hazardous waste
pharmaceuticals were accepted by the initial transporter, the healthcare
facility must submit:
(i) a legible copy of the original manifest, indicating
that the healthcare facility has not received confirmation of delivery,
to the executive director; and
(ii) a handwritten or typed note on the manifest itself,
or on an attached sheet of paper, stating that the return copy was
not received and explaining the efforts taken to locate the non-creditable
hazardous waste pharmaceuticals and the results of those efforts.
(B) For shipments rejected by the designated facility
and shipped to an alternate facility, if a healthcare facility does
not receive a copy of the manifest for a rejected shipment of the
non-creditable hazardous waste pharmaceuticals that is forwarded by
the designated facility to an alternate facility (using appropriate
manifest procedures), with the signature of the owner or operator
of the alternate facility, within 60 days of the date the non-creditable
hazardous waste was accepted by the initial transporter forwarding
the shipment of non-creditable hazardous waste pharmaceuticals from
the designated facility to the alternate facility, the healthcare
facility must submit:
(i) a legible copy of the original manifest, indicating
that the healthcare facility has not received confirmation of delivery,
to the executive director; and
(ii) a handwritten or typed note on the manifest itself,
or on an attached sheet of paper, stating that the return copy was
not received and explaining the efforts taken to locate the non-creditable
hazardous waste pharmaceuticals and the results of those efforts.
(3) Additional reports. The executive director may
require a healthcare facility to furnish additional reports concerning
the quantities and disposition of non-creditable hazardous waste pharmaceuticals.
(j) Recordkeeping by healthcare facilities for non-creditable
hazardous waste pharmaceuticals. A healthcare facility is subject
to the following recordkeeping requirements.
(1) Signed manifest retention. A healthcare facility
must keep a copy of each manifest signed in accordance with 40 CFR §262.23(a)
as adopted under §335.54 of this title (relating to Hazardous
Waste Manifest) for three years or until it receives a signed copy
from the designated facility which received the non-creditable hazardous
waste pharmaceuticals. This signed copy must be retained as a record
for at least three years from the date the waste was accepted by the
initial transporter.
(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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