(a) Hazardous waste determination for potentially creditable
pharmaceuticals. A healthcare facility that generates a solid waste
that is a potentially creditable pharmaceutical must determine whether
the potentially creditable pharmaceutical is a potentially creditable
hazardous waste pharmaceutical by determining if it is listed in 40
Code of Federal Regulations (CFR) Part 261, Subpart D or exhibits
a characteristic identified in 40 CFR Part 261, Subpart C as adopted
under §335.504 of this title (relating to Hazardous Waste Determination).
A healthcare facility may choose to manage its potentially creditable
nonhazardous waste pharmaceuticals as potentially creditable hazardous
waste pharmaceuticals under this subchapter.
(b) Accepting potentially creditable hazardous waste
pharmaceuticals from an off-site healthcare facility that is a very
small quantity generator. A healthcare facility may accept potentially
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 (relating to General Standards
Applicable to Generators of Hazardous Waste) without a permit or without
having interim status, provided the receiving healthcare facility:
(1) is under the control of the same person as the
very small quantity generator healthcare facility that is sending
the potentially 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;
(2) is operating under this subchapter for the management
of its potentially creditable hazardous waste pharmaceuticals;
(3) manages the potentially creditable hazardous waste
pharmaceuticals that it receives from off-site in compliance with
this subchapter; and
(4) keeps records of the potentially creditable hazardous
waste pharmaceuticals shipments it receives from off-site for three
years from the date that the shipment is received.
(c) Prohibition. Healthcare facilities are prohibited
from sending hazardous wastes other than potentially creditable hazardous
waste pharmaceuticals to a reverse distributor.
(d) Biennial and Annual Waste Summary 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 in 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
potentially creditable hazardous waste pharmaceuticals managed under
this subchapter.
(e) Recordkeeping by healthcare facilities. Healthcare
facilities are subject to the following recordkeeping requirements
for managing potentially creditable hazardous waste pharmaceuticals.
(1) A healthcare facility that initiates a shipment
of potentially creditable hazardous waste pharmaceuticals to a reverse
distributor must keep the following records (paper or electronic)
for each shipment of potentially creditable hazardous waste pharmaceuticals
for three years from the date of shipment:
(A) the confirmation of delivery; and
(B) the shipping papers prepared in accordance with
49 CFR Part 172, Subpart C, if applicable.
(2) 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.
(3) All records must be readily available upon request
by an inspector.
(f) Response to spills of potentially creditable hazardous
waste pharmaceuticals at healthcare facilities. A healthcare facility
must immediately contain all spills of potentially creditable hazardous
waste pharmaceuticals and manage the spill clean-up materials as non-creditable
hazardous waste pharmaceuticals in accordance with this subchapter.
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