(1) 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 s.
NR 662.014 and is not subject to this subchapter, except
for ss.
NR 666.505 and
NR 666.507 and the optional provisions under s.
NR 666.504.
(2) 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 compl ying with sub. (4) for the management of its
hazardous waste pharmaceuticals as an alternative to compl ying with s.
NR 662.014 and the optional provisions under s.
NR 666.504.
(3) 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.
(4) With the exception of healthcare
facilities identified in sub. (1), a healthcare facility is subject to the all
of the following in lieu of chs.
NR
662 to 665:
(a)
Sections
NR 666.502 and 666.505 to 666.508 of this subchapter with
respect to the management of all of the following:
1. Non-creditable hazardous waste
pharmaceuticals.
2. Potentially
creditable hazardous waste pharmaceuticals if they are not destined for a
reverse distributor.
(b)
Sections
NR 666.502(1), 666.503, 666.505 to 666.507, and 666.509 with respect to the management of potentially creditable
hazardous waste pharmaceuticals that are prescription pharmaceuticals and are
destined for a reverse distributor.
(5) A reverse distributor is subject to ss.
NR 666.505 to 666.510 of this subchapter in lieu of chs.
NR
662 to 665 with respect to the management of hazardous
waste pharmaceuticals.
(6)
Hazardous waste pharmaceuticals generated or managed by entities other than
healthcare facilities and reverse distributors, for example pharmaceutical
manufacturers and reverse logistics centers, are not subject to this
subchapter. Other generators are subject to ch. NR 662 for the generation and
accumulation of hazardous wastes, including hazardous waste
pharmaceuticals.
(7) All of the
following are not subject to chs.
NR
660 to 673, except as specified:
(a) Pharmaceuticals that are not solid waste,
as defined in s.
NR 661.0002, because they are legitimate ly used or
reused (e.g., lawful ly donated for their intended purpose) or
reclaimed.
(b) Over -the-counter
pharmaceuticals, dietary supplements, or homeopathic drugs that are not solid
wastes, as defined in s.
NR 661.0002, because they have a reasonable expectation
of being legitimate ly used or reused (e.g., lawful ly redistributed for their
intended purpose) or reclaimed.
(c)
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 subchapter does app ly to the management of the recalled
hazardous waste pharmaceuticals after the food and drug administration approves
the destruction of the recalled items.
(d) 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
subchapter does apply to the management of the recalled hazardous waste
pharmaceuticals after the consumer product safety commission approves the
destruction of the recalled items.
(e) 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.
(f) 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 subchapter does
app ly 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.
(g) 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 under s.
NR 666.506(1) (b) and (2).
