NR 666.360(1)(b)
(b) You send a notice, by certified delivery, to us that you are reclaiming the exemption for the waste. Your notice shall be signed by your authorized representative certifying that the information provided is true, accurate and complete. The notice shall do all of the following:
NR 666.360(1)(b)2.
2. Certify that each failure that caused you to lose the exemption for the waste has been corrected and that you again meet all conditions for the waste as of the date you specify.
NR 666.360(1)(b)3.
3. Describe plans you have implemented, listing the specific steps that you have taken, to ensure that conditions will be met in the future.
NR 666.360(1)(b)4.
4. Include any other information you want us to consider when we review your notice reclaiming the exemption.
NR 666.360(2)
(2) We may terminate a reclaimed conditional exemption if we find that your claim is inappropriate based on factors including, but not limited to, your failure to correct the problem, to provide a satisfactory explanation of the circumstances of the failure or to implement a plan with steps to prevent another failure to meet the conditions of s.
NR 666.315. In reviewing a reclaimed conditional exemption under this section, we may add conditions to the exemption to ensure that transportation and disposal activities will protect human health and the environment.
NR 666.360 History
History: CR 05-032: cr.
Register July 2006 No. 607, eff. 8-1-06.
NR 666.500
NR 666.500 Definitions. The following definitions apply to this subchapter:
NR 666.500(1)
(1) “
Evaluated hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that has been evaluated
by
a reverse distributor in accordance with s.
NR 666.510 (1) (c) and will not be sent to another reverse distributor for further evaluation or verification of manufacture credit.
NR 666.500(2)
(2) “
Hazardous waste pharmaceutical” means a pharmaceutical that is a solid waste, as defined in s.
NR 661.0002, and exhibits one or more characteristics identified in subch.
C of ch. NR 661 or is listed in subch.
D of ch. NR 661. A pharmaceutical is not a solid waste, as defined in s.
NR 661.0002, and therefore not a hazardous waste pharmaceutical, if it is legitimately
used, reused, for example lawfully
donated for its intended purpose, or reclaimed. An over-the-counter pharmaceutical, dietary
supplement, or homeopathic drug is not a solid waste, as defined in s.
NR 661.0002, and therefore not a hazardous waste pharmaceutical, if it has a reasonable expectation of being legitimately
used, reused, for example lawfully redistributed for its intended purpose, or reclaimed.
NR 666.500(3)
(3) “
Healthcare facility” means any
person that is lawfully
authorized to do any of the following:
NR 666.500(3)(a)
(a) Provide preventative, diagnostic
, therapeutic
, rehabilitative, maintenance or palliative care, and counseling, service
, assessment or procedure with respect to the p
h
ysical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal bod
y
.
NR 666.500(3)(b)
(b) Distribute, sell, or dispense pharmaceuticals, including over-the
-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. Including wholesale distribution, third
-party
logistics that serve as forward distributors, military
medical logistics facilities, hospitals, ps
ychiatric hospitals, ambulatory
surgical centers, health clinics, ph
ysicians' offices, optical and dental providers, chiropractors, long
-term care facilities, ambulance services, pharmacies, long
-term care pharmacies, mail
-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary
hospitals. This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers.
NR 666.500(5)
(5) “
Long
-term care facility” means a licensed entity
that provides assistance with activities of daily
living, including managing and administering pharmaceuticals to one or more individuals at the facili
ty. This definition includes hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. Not included within the scope of this definition are group homes, independent living communities, assisted living facilities, and the independent and assisted living portions of continuing care retirement communities.
NR 666.500(6)
(6) “
Non-creditable hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a nonprescription hazardous waste pharmaceutical that does not have a reasonable expectation to be legitimate
ly
used, reused, or reclaimed. This includes investigational drugs, free samples of pharmaceuticals received by healthcare facilities, residues of pharmaceuticals remaining in emp
ty
containers, contaminated personal protective equipment, floor sweepings, and clean
-up material from the spills of pharmaceuticals.
NR 666.500(8)
(8) “
Non
-pharmaceutical hazardous waste” means a solid waste, as defined in s.
NR 661.0002, that is listed in subch.
D of ch. NR 661, or exhibits one or more characteristics identified in subch.
C of ch. NR 661, but is not a pharmaceutical, as defined in this section.
NR 666.500(9)
(9) “
Pharmaceutical” means any
drug or dietary
supplement for use
by
humans or other animals; any electronic nicotine delivery
system, for example electronic cigarette or vaping pen; or a
ny liquid nicotine, or e-liquid, packaged for retail sale for use in electronic nicotine delivery
s
ystems, such pre-filled cartridges or vials. This definition includes dietary supplements, as defined by
the federal food, drug and cosmetic act; prescription drugs, as defined
by
21 CFR 203.3 (
y); over-the-counter drugs; homeopathic drugs; compounded drugs; investigational new drugs; pharmaceuticals remaining in non-emp
ty
containers; personal protective equipment contaminated with pharmaceuticals; and clean
-up material from spills of pharmaceuticals. This definition does not include dental amalgam or sharps.
NR 666.500(10)
(10) “Potentially creditable hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that is all of the following:
NR 666.500(10)(b)
(b) Is in original manufacturer packaging, except pharmaceuticals that were subject to a recall.
NR 666.500(10)(e)
(e) The term does not include evaluated hazardous waste pharmaceuticals or nonprescription pharmaceuticals including over-the
-counter drugs, homeopathic drugs, and dietary supplements.
NR 666.500(11)
(11) “Reverse distributor” means any
person that receives and accumulates prescription pharmaceuticals that are potentially
creditable hazardous waste pharmaceuticals for the purpose of facilitating or verif
ying manufacturer credit. Any
person, including forward distributors, third-party
logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor
.
NR 666.500 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20.
NR 666.501(1)(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.
NR 666.501(2)
(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.
NR 666.501(3)
(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.
NR 666.501(4)
(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:
NR 666.501(4)(a)2.
2. Potentially
creditable hazardous waste pharmaceuticals if they
are not destined for a reverse distributor
.
NR 666.501(5)
(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.
NR 666.501(6)
(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.
NR 666.501(7)(a)
(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.
NR 666.501(7)(b)
(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.
NR 666.501(7)(c)
(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.
NR 666.501(7)(d)
(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.
NR 666.501(7)(e)
(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.
NR 666.501(7)(f)
(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
.
NR 666.501(7)(g)
(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).
NR 666.501 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20; correction in (4) (b) made under s.
13.92 (4) (b) 7., Stats.,
Register April 2021 No. 784.
NR 666.502
NR 666.502 Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals. NR 666.502(1)(1)
Notification and withdrawal from this subchapter for healthcare facilities managing hazardous waste pharmaceuticals. NR 666.502(1)(a)
(a)
Notification. A healthcare facility
shall notify
the department, using the site identification form
, EPA form 8700
-12
, that it is a healthcare facility
operating under this subchapter. A healthcare facility
is not required to fill out box 10.B., waste codes for federal
ly regulated hazardous waste, of the site identification form with respect to its hazardous waste pharmaceuticals. A healthcare facility
shall submit a separate notification, using a site identification form, for each site or EPA identification number
.
NR 666.502(1)(a)1.
1. A healthcare facility
that alrea
dy
has an EPA identification number shall notify
the department, using the site identification form EPA form 8700
-12, that it is a healthcare facility
as part of its next annual report, if it is required to submit one; or if not required to submit an annual report, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter.
NR 666.502(1)(a)2.
2. A healthcare facility
that does not have an EPA identification number shall obtain one by
notif
ying the department, using the site identification form EPA form 8700
-12, that it is a healthcare facility as part of its next annual report, if it is required to submit one; or if not required to submit an annual report, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter.
NR 666.502(1)(a)3.
3. A healthcare facility shall keep a co
py
of its notification on file for as long as the healthcare facility
is subject to this subchapter.
NR 666.502(1)(b)
(b)
Withdrawal. A healthcare facility
that operated under this subchapter but is no longer subject to this subchapter, because it is a very
small quantity generator under s.
NR 662.014, and elects to withdraw from this subchapter, shall notify
the department using the site identification form EPA form 8700
-12 that it is no longer operating under this subchapter. A healthcare facility
is not required to fill out box 10.B., waste codes for federal
ly
regulated hazardous waste, of the site identification form with respect to its hazardous waste pharmaceuticals. A healthcare facility
shall submit a separate notification, using a site identification form, for each EPA identification number
.
NR 666.502(1)(b)1.
1. A healthcare facility shall submit the site identification form notif
ying that it is withdrawing from this subchapter before it begins operating under the conditional exemption under s.
NR 662.014.
NR 666.502(1)(b)2.
2. A healthcare facility shall keep a co
py
of its withdrawal on file for 3
years from the date of signature on the notification of its withdrawal.
NR 666.502(2)
(2)
Training of personnel managing non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility
shall ensure that all personnel that manage non-creditable hazardous waste pharmaceuticals are thorough
ly
familiar with proper waste handling and emergency
procedures relevant to their responsibilities during normal facility
operations and emergencies.
NR 666.502(3)
(3)
Hazardous waste determination for non-creditable pharmaceuticals. A healthcare facility
that generates a solid waste that is a non
-creditable pharmaceutical shall determine whether that pharmaceutical is a hazardous waste pharmaceutical, because it exhibits a characteristic identified in ch.
NR 661 subchapter C or is listed in ch.
NR 661 subchapter D, in order to determine whether the waste is subject to this subchapter. A healthcare facility may choose to manage its non
-hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals under this subchapter.
NR 666.502(4)
(4)
Standards for containers used to accumulate non-creditable hazardous waste pharmaceuticals at healthcare facilities. NR 666.502(4)(a)
(a) A healthcare facility shall place non-creditable hazardous waste pharmaceuticals in a container that is structurally
sound, compatible with its contents, and that lacks evidence of leakage, spillage, or damage that could cause leakage under reasonab
ly
foreseeable conditions.
NR 666.502(4)(b)
(b) A healthcare facility
that manages ignitable or reactive non-creditable hazardous waste pharmaceuticals, or that mixes or commingles incompatible non-creditable hazardous waste pharmaceuticals shall manage the container so that it does not have the potential to do any of the following:
NR 666.502(4)(b)1.
1. Generate extreme heat or pressure, fire or explosion, or violent reaction.
NR 666.502(4)(b)2.
2. Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health.
NR 666.502(4)(b)3.
3. Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions.
NR 666.502(4)(b)4.
4. Damage the structural integri
ty
of the container of non
-creditable hazardous waste pharmaceuticals.
NR 666.502(4)(c)
(c) A healthcare facility shall keep containers of non-creditable hazardous waste pharmaceuticals closed and secured in a manner that prevents unauthorized access to its contents.
NR 666.502(4)(d)
(d) A healthcare facility may accumulate non
-creditable hazardous waste pharmaceuticals and non
-hazardous non
-creditable waste pharmaceuticals in the same container, except that non-creditable hazardous waste pharmaceuticals prohibited from being combusted because of the dilution prohibition under s.
NR 668.03 (3) shall be accumulated in separate containers and labeled with all applicable hazardous waste numbers, or hazardous waste codes
.
NR 666.502(5)
(5)
Labeling containers used to accumulate non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility
shall label or clear
ly
mark each container of non-creditable hazardous waste pharmaceuticals with the phrase “Hazardous Waste Pharmaceuticals.”
NR 666.502(6)
(6)
Maximum accumulation time for non-creditable hazardous waste pharmaceuticals at healthcare facilities. NR 666.502(6)(a)(a) A healthcare facility may accumulate non
-creditable hazardous waste pharmaceuticals on-site for one
year or less without a license or having interim status.
NR 666.502(6)(b)
(b) A healthcare facility
that accumulates non-creditable hazardous waste pharmaceuticals on
-site shall demonstrate the length of time that the non
-creditable hazardous waste pharmaceuticals have been accumulating, starting from the date the pharmaceuticals first become a waste. A healthcare facility
may
make this demonstration by a
ny
of the following methods:
NR 666.502(6)(b)1.
1. Marking or labeling the container of non
-creditable hazardous waste pharmaceuticals with the date that the non-creditable hazardous waste pharmaceuticals became a waste.
NR 666.502(6)(b)2.
2. Maintaining an inventory
system that identifies the date the non
-creditable hazardous waste pharmaceuticals being accumulated first became a waste.
NR 666.502(6)(b)3.
3. Placing the non
-creditable hazardous waste pharmaceuticals in a specific area and identif
ying the earliest date that a
ny
of the non
-creditable hazardous waste pharmaceuticals in the area became a waste.
NR 666.502(7)
(7)
Land disposal restrictions for non-creditable hazardous waste pharmaceuticals. The non-creditable hazardous waste pharmaceuticals generated
by
a healthcare facility are subject to the land disposal restrictions under ch.
NR 668. A healthcare facility
that generates non-creditable hazardous waste pharmaceuticals shall comply
with the land disposal restrictions in accordance with s.
NR 668.07 (1) requirements, except that it is not required to identify
the hazardous waste numbers or hazardous waste codes on the land disposal restrictions notification.
NR 666.502(8)
(8)
Procedures for healthcare facilities for managing rejected shipments of non-creditable hazardous waste pharmaceuticals. A healthcare facility
that sends a shipment of non-creditable hazardous waste pharmaceuticals to a designated facility
with the understanding that the designated facility
can accept and manage the waste, and later receives that shipment back as a rejected load in accordance with the manifest discrepancy
provisions under s.
NR 664.0072 or
665.0072 may
accumulate the returned non
-creditable hazardous waste pharmaceuticals on-site for up to an additional 90 calendar days provided the rejected or returned shipment is managed in accordance with subs.
(4) and
(5). Upon receipt of the returned shipment, the healthcare facility
shall do all of the following:
NR 666.502(8)(a)1.
1. Item 18c of the original manifest, if the original manifest was used for the returned shipment.
NR 666.502(8)(a)2.
2. Item 20 of the new manifest, if a new manifest was used for the returned shipment.
NR 666.502(8)(c)
(c) Within 30 calendar days of receipt of the rejected shipment, send a co
py
of the manifest to the designated facility
that returned the shipment to the healthcare facilit
y.
NR 666.502(8)(d)
(d) Within 90 calendar days of receipt of the rejected shipment, transport or offer for transport the returned shipment in accordance with the shipping standards under s.
NR 666.508 (1).
NR 666.502(9)
(9)
Reporting by healthcare facilities for non-creditable hazardous waste pharmaceuticals. NR 666.502(9)(a)
(a)
Annual reporting by healthcare facilities. A healthcare facility is not subject to annual reporting requirements under s.
NR 662.041 with respect to non
-creditable hazardous waste pharmaceuticals managed under this subchapter.
NR 666.502(9)(b)
(b)
Exception reporting by healthcare facilities for a missing copy of the manifest. NR 666.502(9)(b)1.
1. `Shipments from a healthcare facility to a designated facility.' For shipments from a healthcare facility to a designated facility, all of the following exception reporting requirements apply:
