Utah Admin. Code R315-266-501 - Hazardous Waste Pharmaceuticals - Applicability
(a) A healthcare facility that is a very
small quantity generator when counting its hazardous waste, including both its
hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste,
remains subject to Section
R315-262-14 and is not subject
to Sections R315-266-500 through
R315-266-510, except for
Sections R315-266-505 and
R315-266-507 and the optional
requirements of Section
R315-266-504.
(b) A healthcare facility that is a very
small quantity generator when counting its hazardous waste, including both its
hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, has
the option of complying with Subsection
R315-266-501(d)
for the management of its hazardous waste pharmaceuticals as an alternative to
complying with Section
R315-262-14 and the optional
requirements of Section
R315-266-504.
(c) A healthcare facility or reverse
distributor remains subject to the applicable hazardous waste rules with
respect to the management of its non-pharmaceutical hazardous waste.
(d) With the exception of healthcare
facilities identified in Subsection
R315-266-501(a),
a healthcare facility is subject to Subsections
R315-266-501(d)(1)
and R315-266-501(d)(2)
in lieu of Rules R315-262 through R315-265:
(1) Sections
R315-266-502 and
R315-266-505 through
R315-266-508 with respect to the
management of:
(i) non-creditable hazardous
waste pharmaceuticals; and
(ii)
potentially creditable hazardous waste pharmaceuticals if they are not destined
for a reverse distributor.
(2) Subsection
R315-266-502(a),
and Sections R315-266-503,
R315-266-505 through
R315-266-507 and
R315-266-509 with respect to the
management of potentially creditable hazardous waste pharmaceuticals that are
prescription pharmaceuticals and are destined for a reverse
distributor.
(e) A
reverse distributor is subject to Sections
R315-266-505 through
R315-266-510 in lieu of Rules
R315-262 through R315-265 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, that is pharmaceutical manufacturers and
reverse logistics centers, are not subject to Sections
R315-266-500 through
R315-266-510. Other generators
are subject to Rule R315-262 for the generation and accumulation of hazardous
wastes, including hazardous waste pharmaceuticals.
(g) The following are not subject to Rules
R315-260 through R315-273, except as specified:
(1) Pharmaceuticals that are not solid waste,
as defined by Section
R315-261-2, because they are
legitimately used or reused, for example, 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 Section
R315-261-2, because they have a
reasonable expectation of being legitimately used or reused, for example,
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 21 CFR part 7 subpart C. Sections
R315-266-500 through
R315-266-510 do apply 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 part 1115 .
Sections R315-266-500 through
R315-266-510 do apply 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
or both.
(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 . Sections R315-266-500 through
R315-266-510 do apply 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 an authorized collector, as defined
by the Drug Enforcement Administration, provided the authorized collector
complies with the conditional exemption in Subsections
R315-266-506(a)(2)
and R315-266-506(b).
Notes
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