| (a) 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 Code of Federal Regulations (CFR) §262.14
as adopted under §335.53 of this title (relating to General Standards
Applicable to Generators of Hazardous Waste) and is not subject to
this subchapter, 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).
(b) 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, has the option of complying with subsection (d) of this section
for the management of its hazardous waste pharmaceuticals as an alternative
to complying with 40 CFR §262.14 as adopted in §335.53 of
this title and the optional provisions of §335.759 of this title.
(c) A healthcare facility or reverse distributor remains
subject to all applicable hazardous waste regulations for the management
of its non-pharmaceutical hazardous waste.
(d) Unless a healthcare facility is managing waste
in compliance with subsection (a) of this section, a healthcare facility
is subject to this subsection instead of Subchapters C, D, E, and
F of this chapter (relating to Standards Applicable to Generators
of Hazardous Waste; Standards Applicable to Transporters of Hazardous
Waste; Interim Standards for Owners and Operators of Hazardous Waste
Treatment, Storage, or Disposal Facilities; and Permitting Standards
for Owners and Operators of Hazardous Waste Treatment, Storage, or
Disposal Facilities) except as provided in this subchapter.
(1) A healthcare facility managing potentially creditable
hazardous waste pharmaceuticals that are not destined for a reverse
distributor or non-creditable hazardous waste pharmaceuticals must
comply with §335.755 of this title (relating to Standards for
Healthcare Facilities Managing Non-Creditable Hazardous Waste Pharmaceuticals)
and §§335.761, 335.763, 335.765, and 335.767 of this title
(relating to Prohibition of Sewering Hazardous Waste Pharmaceuticals;
Conditional Exemptions for Hazardous Waste Pharmaceuticals that are
Controlled Substances and Household Waste Pharmaceuticals Collected
in a Take-back Event or Program; Residues of Hazardous Waste Pharmaceuticals
in Empty Containers; and Shipping Non-Creditable Hazardous Waste Pharmaceuticals
from a Healthcare Facility or Evaluated Hazardous Waste Pharmaceuticals
from a Reverse Distributor).
(2) A healthcare facility managing potentially creditable
hazardous waste pharmaceuticals that are prescription pharmaceuticals
and are destined for a reverse distributor must comply with §335.755(a)
and §335.757 (relating to Standards for Healthcare Facilities
Managing Potentially Creditable Hazardous Waste Pharmaceuticals), §§335.761,
335.763, 335.765, and 335.769 of this title (relating to Shipping
Potentially Creditable Hazardous Waste Pharmaceuticals from a Healthcare
Facility or a Reverse Distributor to a Reverse Distributor).
(e) A reverse distributor is subject to §§335.761,
335.763, 335.765, 335.767, 335.769, and 335.771 of this title (relating
to Standards for the Management of Potentially Creditable Hazardous
Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals
by Reverse Distributors) of this title in lieu of Subchapters C, D,
E or F of this chapter for the management of hazardous waste pharmaceuticals.
(f) Hazardous waste pharmaceuticals generated or managed
by entities other than healthcare facilities and reverse distributors
(e.g., pharmaceutical manufacturers and reverse logistics centers)
are not subject to this subchapter. Other generators are subject to
Subchapter C of this chapter for the generation and accumulation of
hazardous wastes, including hazardous waste pharmaceuticals.
(g) Except as specified in this subsection and §335.4
of this title (relating to General Prohibitions), and unless the Commission
finds or the executive director determines that industrial solid waste
or recycling requirements are necessary to protect human health, the
environment, or property, the following are not subject to this chapter:
(1) pharmaceuticals that are not solid waste, as defined
by §335.1 of this title (relating to Definitions), because they
are legitimately used/reused (e.g., lawfully donated for their intended
purpose) or reclaimed;
(2) over-the-counter pharmaceuticals, dietary supplements,
or homeopathic drugs that are not solid wastes, as defined in §335.1
of this title, because they have a reasonable expectation of being
legitimately used/reused (e.g., lawfully redistributed for their intended
purpose) or reclaimed;
(3) pharmaceuticals being managed in accordance with
a recall strategy that has been approved by the Food and Drug Administration
(FDA) in accordance with 21 CFR Part 7, Subpart C, until the FDA approves
the destruction of the pharmaceuticals or the pharmaceuticals are
discarded;
(4) pharmaceuticals being managed in accordance with
a recall corrective action plan that has been accepted by the Consumer
Product Safety Commission in accordance with 16 CFR Part 1115, until
the Consumer Product Safety Commission approves the destruction of
the recalled pharmaceuticals;
(5) pharmaceuticals stored according to a preservation
order, or stored in accordance with a litigation hold pursuant to
an investigation or judicial proceeding until after the preservation
order, investigation, or judicial proceeding has concluded or the
pharmaceuticals are discarded;
(6) investigational new drugs for which an investigational
new drug application is in effect in accordance with the Food and
Drug Administration's regulations in 21 CFR Part 312, until the decision
is made to discard the investigational new drug or the Food and Drug
Administration approves the destruction of the investigational new
drug, if the investigational new drug is a hazardous waste; and
(7) household waste pharmaceuticals, including those
that have been collected by an authorized collector (as defined by
the Drug Enforcement Administration), provided the authorized collector
complies with the conditional exemption in §335.763(a)(2) and §335.763(b)
of this title.
(h) Healthcare facilities and reverse distributors
regulated under this subchapter remain subject to Subchapter A of
this chapter (relating to Industrial Solid Waste and Municipal Hazardous
Waste in General), Subchapter B of this chapter (relating to Hazardous
Waste Management General Provisions), Subchapter O of this chapter
(relating to Land Disposal Restrictions), and Subchapter R of this
chapter (relating to Waste Classification), except as provided under
this subchapter.
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