| (2) the regulations in 40 CFR §262.15 as adopted
under §335.53 of this title for large quantity generators and
small quantity generators, except as provided in 40 CFR Part 262,
Subpart K, as adopted under §335.59 of this title; or
(3) the conditions of 40 CFR §262.14 as adopted
under §335.53 of this title, except as provided in 40 CFR Part
262, Subpart K, as adopted by reference under §335.59 of this
title.
(j) A reverse distributor as defined in §335.751
of this title (relating to Definitions) is subject to Subchapter W
of this chapter (relating to Management Standards for Hazardous Waste
Pharmaceuticals) for the management of hazardous waste pharmaceuticals
instead of this subchapter.
(k) A healthcare facility, as defined in §335.751
of this title, must determine whether it is subject to Subchapter
W of this chapter for the management of hazardous waste pharmaceuticals,
based on the total hazardous waste it generates per calendar month
(including both hazardous waste pharmaceuticals and non-pharmaceutical
hazardous waste). A healthcare facility that generates more than 100
kilograms (kg) (220 pounds) of hazardous waste per calendar month,
or more than 1 kg (2.2 pounds) of acute hazardous waste per calendar
month, or more than 100 kg (220 pounds) per calendar month of any
residue or contaminated soil, water, or other debris, resulting from
the clean-up of a spill, into or on any land or water, of any acute
hazardous wastes listed in 40 CFR §261.31 or §261.33(e)
as adopted under §335.504 of this title (relating to Hazardous
Waste Determination), is subject to Subchapter W of this chapter for
the management of hazardous waste pharmaceuticals in lieu of this
subchapter. A healthcare facility that is a very small quantity generator
when counting all of its hazardous waste, including both its hazardous
waste pharmaceuticals and its non-pharmaceutical hazardous waste,
remains subject to 40 CFR §262.14 as adopted in §335.53
of this title, and is not subject to Subchapter W of this chapter,
except for §335.761 and §335.765 of this title (relating
to Prohibition of Sewering Hazardous Waste Pharmaceuticals; and Residues
of Hazardous Waste Pharmaceuticals in Empty Containers), and the optional
provisions of §335.759 of this title (relating to Healthcare
Facilities That are Very Small Quantity Generators for Both Hazardous
Waste Pharmaceuticals and Non-pharmaceutical Hazardous Waste).
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