Current through Register Vol. 48, No. 9, September 27, 2024
(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 section 262.14 and is
not subject to this subpart, except for section s 266.505 and 266.507 and the
optional provisions of section 266.504.
(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 section 266.501(d) for the management
of its hazardous waste pharmaceuticals as an alternative to complying with
section 262.14 and the optional provisions of section 266.504.
(c) A healthcare facility or reverse
distributor remains subject to all applicable hazardous waste regulations 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 parts 262-265:
(1)
section s 266.502 and 266.505 through 266.508 of this subpart 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) section s 262.502(a), 266.503,
266.505 through 266.507, and 266.509 of this subpart 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 section s 266.505 through 266.510 of this
subpart in lieu of parts 262 through 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 (e.g., pharmaceutical manufacturers and reverse logistics centers)
are not subject to this subpart. Other generators are subject to 40 CFR part
262 for the generation and accumulation of hazardous wastes, including
hazardous waste pharmaceuticals.
(g) The following are not subject to parts
260 through 273, except as specified:
(1)
Pharmaceuticals that are not solid waste, as defined by section 261.2, because
they are legitimately used/re-used (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 section 261.2, because they have a
reasonable expectation of being legitimately used/re-used (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 21 CFR part 7, subpart C. This subpart does
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. This subpart does 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 and/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 part 312. This subpart does
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 section s 266.506(a)(2) and
266.506(b).
