Current through Register Vol. 48, No. 38, September 20, 2024
a) A healthcare
facility that is a VSQG when counting all of its hazardous waste, including
both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous
waste, remains subject to 35 Ill. Adm. Code
722.114
and is not subject to this Subpart P, except for Sections 726.605 and 726.607
and the optional provisions of Section 726.604.
b) A healthcare facility that is a VSQG 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 Section 726.601(d) for the management of its hazardous waste
pharmaceuticals as an alternative to complying with 35 Ill. Adm. Code
722.114
and the optional provisions of Section 726.604.
c) A healthcare facility or reverse
distributor remains subject to all applicable requirements in 35 Ill. Adm. Code
722 through 725 with respect to the management of its non-pharmaceutical
hazardous waste.
d) With the
exception of healthcare facilities identified in subsection (a), a healthcare
facility is subject to the following in lieu of 35 Ill. Adm. Code 722 through
725:
1) Sections 726.602 and 726.605 through
726.608 with respect to the management of the following:
A) Non-creditable hazardous waste
pharmaceuticals; and
B) Potentially
creditable hazardous waste pharmaceuticals if they are not destined for a
reverse distributor.
2)
Sections 726.602(a), 726.603, 726.605 through 726.607, and 726.609 with respect
to the management of potentially creditable hazardous waste pharmaceuticals
that are prescription pharmaceuticals and that are destined for a reverse
distributor.
e) A
reverse distributor is subject to Sections 726.605 through 726.610, in lieu of
35 Ill. Adm. Code 722 through 725, with respect to 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 Subpart P. Other generators
are subject to 35 Ill. Adm. Code 722 for the generation and accumulation of
hazardous wastes, including hazardous waste pharmaceuticals.
g) The following are not subject to 35 Ill.
Adm. Code 720 through 733, except as otherwise specified:
1) Pharmaceuticals that are not solid waste,
as defined by 35 Ill. Adm. Code
721.102,
because they are legitimately used or 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 by 35 Ill. Adm. Code 721.102, because
there is a reasonable expectation of their being legitimately used or 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 in accordance with subpart C of 21 CFR 7. This Subpart
P applies to the management of the recalled hazardous waste pharmaceuticals
after the Food and Drug Administration approves the destruction of the recalled
items.
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
1115. This Subpart P applies to the management of the recalled hazardous waste
pharmaceuticals after the Consumer Product Safety Commission approves the
destruction of the recalled items.
5) Pharmaceuticals stored according to a
preservation order or during an investigation or judicial proceeding, until
after the preservation order, investigation, or judicial proceeding has
concluded or a decision is made to discard the pharmaceuticals.
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 312. This Subpart P applies to
the management of the investigational new drug after 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.
7) Household waste pharmaceuticals, including
those that have been collected by a "collector", as defined in
21 CFR
1300.01, incorporated by reference in 35 Ill.
Adm. Code
720.111, provided the
authorized collector complies with the conditional exemption in Section
726.606(a)(2) and (b).
BOARD NOTE: The Drug Enforcement Administration regulations
define "collector" in the second segment of the definition of "collection" in
21 CFR
1300.01. The authorized status of the
collector is part of the definition.
