NR 666.506 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20.
NR 666.507
NR 666.507 Residues of hazardous waste pharmaceuticals in empty containers. NR 666.507(1)(1)
Stock, dispensing and unit-dose containers. A stock bottle, dispensing bottle, vial, or ampule (not to exceed 1 liter or 10,000 pills); or a unit-dose container (e.g., a unit-dose packet, cup, wrapper, blister pack, or delivery device) is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals have been removed from the stock bottle, dispensing bottle, vial, ampule, or the unit-dose container using the practices commonly employed to remove materials from that type of container.
NR 666.507(2)
(2)
Syringes. A
syringe is considered empty and the residues are not regulated as hazardous waste under this subchapter provided the contents have been removed by fully
depressing the plunger of the
syringe
. If a
syringe is not empt
y, the
s
yringe shall be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subchapter and a
ny applicable federal, state, and local requirements for sharps containers and medical waste.
NR 666.507(3)
(3)
Intravenous (IV) bags. An IV bag is considered emp
ty
and the residues are not regulated as hazardous waste provided the pharmaceuticals in the IV bag have been fully administered to a patient. If an IV bag is not empt
y, the IV bag shall be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subchapter, unless the IV bag held non-acute hazardous waste pharmaceuticals and is empty
as defined in s.
NR 661.0007 (2) (a).
NR 666.507(4)
(4)
Other containers, including delivery devices. Hazardous waste pharmaceuticals remaining in all other t
ypes of unused, partially administered, or fully administered containers shall be managed as non
-creditable hazardous waste pharmaceuticals under this subchapter, unless the container held non
-acute hazardous waste pharmaceuticals and is empty as defined in s.
NR 661.0007 (2) (a) or
(b). Examples of containers and delivery devices containing residues may include inhalers, aerosol cans, nebulizers, tubes of ointments, gels, or creams.
NR 666.507 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20.
NR 666.508
NR 666.508 Shipping non-creditable hazardous waste pharmaceuticals from a healthcare facility or evaluated hazardous waste pharmaceuticals from a reverse distributor. NR 666.508(1)(1)
Shipping non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals. A healthcare facility shall ship non-creditable hazardous waste pharmaceuticals and a reverse distributor shall ship evaluated hazardous waste pharmaceuticals off-site to a designated facility, for example a license or interim status treatment, storage, or disposal facilit
y, in compliance with all of the following:
NR 666.508(1)(a)
(a)
Pretransport. Before transporting or offering hazardous waste for transportation off-site, a healthcare facility or reverse distributor shall do all of the following:
NR 666.508(1)(a)2.
2. `Labeling.'
Label each package in accordance with the applicable U.S. department of transportation regulations on hazardous materials under
49 CFR part 172 subpart E.
NR 666.508(1)(a)3.a.a. Mark each package of hazardous waste in accordance with the applicable U.S. department of transportation regulations on hazardous materials under
49 CFR part 172 subpart D.
NR 666.508(1)(a)3.b.
b. Mark each container of 119 gallons or less used in such transportation with the following words and information in accordance with the requirements of
49 CFR 172.304:
“HAZARDOUS WASTE—Federal Law Prohibits Improper Disposal. If found, contact the nearest police or public safety authority or the U.S. Environmental Protection Agency.
Healthcare Facility's or Reverse distributor's Name and Address _____________.
Healthcare Facility's or Reverse distributor's EPA Identification Number_____________.
Manifest Tracking Number_____________.”
NR 666.508(1)(a)3.c.
c. Lab packs that will be incinerated in compliance with s.
NR 668.42 (3) are not required to be marked with EPA hazardous waste numbers, except D004, D005, D
006, D007, D008, D010, and D011, where applicable. A nationally
recognized electronic
system, such as bar coding or radio frequency identification, may
be used to identify
the EPA hazardous waste numbers
.
NR 666.508(1)(a)4.
4. `Placarding.' Placard or offer the initial transporter the appropriate placards according to U.S. department of transportation regulations for hazardous materials under
49 CFR part 172, subpart F
.
NR 666.508(1)(b)1.
1. A healthcare facility
shipping non
-creditable hazardous waste pharmaceuticals is not required to list all applicable EPA hazardous waste numbers, or hazardous waste codes, in Item 13 of EPA form 8700
-22.
NR 666.508(1)(b)2.
2. A healthcare facility shipping non
-creditable hazardous waste pharmaceuticals shall write the word “PHARMS” in Item 13 of EPA form 8700
-22.
NR 666.508(2)
(2)
Exports. A healthcare facility
or reverse distributor that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to subch.
H of ch. NR 662.
NR 666.508(3)
(3)
Imports. Any
person that imports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to subch.
H of ch. NR 662. A healthcare facility
or reverse distributor may
not accept imported non
-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals unless they have a license or interim status that allows them to accept hazardous waste from off
-site
.
NR 666.508 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20.
NR 666.509
NR 666.509 Shipping potentially creditable hazardous waste pharmaceuticals from a healthcare facility or a reverse distributor to a reverse distributor. NR 666.509(1)(1)
Shipping potentially creditable hazardous waste pharmaceuticals. A healthcare facility or a reverse distributor who transports or offers for transport potentially
creditable hazardous waste pharmaceuticals off-site to a reverse distributor shall comply
with all applicable U.S. department of transportation regulations in
49 CFR parts 171 to
180 for a
ny
potentially
creditable hazardous waste pharmaceutical that meets the definition of hazardous material in
49 CFR 171.8.
NR 666.509 Note
Note: For purposes of the department of transportation regulations, a material is considered a hazardous waste if it is subject to the hazardous waste manifest requirements specified in ch.
NR 662. Because a potentially creditable hazardous waste pharmaceutical does not require a manifest, it is not considered hazardous waste under the department of transportation regulations.
NR 666.509(2)
(2)
Delivery confirmation. Upon receipt of each shipment of potentially
creditable hazardous waste pharmaceuticals, the receiving reverse distributor shall provide confirmation, paper or electronic, to the healthcare facility
or reverse distributor that initiated the shipment that the shipment of potentially
creditable hazardous waste pharmaceuticals has arrived at its destination and is under the custo
dy and control of the reverse distributor
.
NR 666.509(3)
(3)
Procedures for when delivery confirmation is not received within 35 calendar days. If a healthcare facility or reverse distributor initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor and does not receive delivery confirmation within 35 calendar da
ys from the date that the shipment of potentially
creditable hazardous waste pharmaceuticals was sent, the healthcare facility
or reverse distributor that initiated the shipment shall contact the carrier and the intended recipient , that is the reverse distributor, promptly
to report that the delivery confirmation was not received and to determine the status of the potentially
creditable hazardous waste pharmaceuticals.
NR 666.509(4)
(4)
Exporting potentially creditable hazardous waste pharmaceuticals. A healthcare facility or reverse distributor that sends potentially
creditable hazardous waste pharmaceuticals to a foreign destination shall comply
with the applicable sections of subch.
H of ch. NR 662, except the manifesting requirement under s.
NR 662.083 (3), in addition to subs.
(1) to
(3).
NR 666.509(5)
(5)
Importing potentially creditable hazardous waste pharmaceuticals. Any person that imports potentially
creditable hazardous waste pharmaceuticals into the United States is subject to subs.
(1) to
(3) in lieu of subch.
H of ch. NR 662. Immediate
ly after the potentially
creditable hazardous waste pharmaceuticals enter the United States, they
are subject to all applicable requirements of this subchapter.
NR 666.509 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20; correction in (1) made under s.
35.17, Stats.,
Register August 2020 No. 776.
NR 666.510
NR 666.510 Standards for the management of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals at reverse distributors. A reverse distributor may accept potentially
creditable hazardous waste pharmaceuticals from off
-site and accumulate potentially
creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals on-site without a hazardous waste permit or without having interim status, provided that the reverse distributor complies with all of the following conditions:
NR 666.510(1)
(1)
Standards for reverse distributors managing potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals. NR 666.510(1)(a)
(a)
Notification. A reverse distributor shall notify
the department using the site identification form EPA form 8700
-12
, that it is a reverse distributor operating under this subchapter. A reverse distributor shall do one of the following:
NR 666.510(1)(a)1.
1. A reverse distributor 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 reverse distributor, as defined in s.
NR 666.500, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter.
NR 666.510(1)(a)2.
2. A reverse distributor 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 reverse distributor, as defined in s.
NR 666.500, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter.
NR 666.510(1)(b)
(b)
Inventory by the reverse distributor. A reverse distributor shall maintain a current inventory
of all the potentially
creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that are accumulated on-site
.
NR 666.510(1)(b)1.
1. A reverse distributor shall inventory
each potentially
creditable hazardous waste pharmaceutical within 30 calendar da
ys of each waste arriving at the reverse distributor
.
NR 666.510(1)(b)2.
2. The inventory
shall include the identity, for example name or national drug code, and quantity
of each potentially
creditable hazardous waste pharmaceutical and evaluated hazardous waste pharmaceutical.
NR 666.510(1)(b)3.
3. If the reverse distributor alrea
dy
meets the inventory requirements of this paragraph because of other regulatory requirements, such as state board of pharmacy regulations, the facility
is not required to provide a separate inventory
pursuant to this section.
NR 666.510(1)(c)
(c)
Evaluation by a reverse distributor that is not a manufacturer. A reverse distributor who is not a pharmaceutical manufacturer shall evaluate a potentially
creditable hazardous waste pharmaceutical within 30 calendar da
ys of the waste arriving at the reverse distributor to establish whether it is destined for another reverse distributor for further evaluation or verification of manufacturer credit or for a permitted or interim status treatment, storage, or disposal facilit
y. A potentially
creditable hazardous waste pharmaceutical sent to a reverse distributor that is not a pharmaceutical manufacturer is subject to one of the following:
NR 666.510(1)(c)1.
1. A potentially creditable hazardous waste pharmaceutical that is destined for another reverse distributor is still considered a potential
ly creditable hazardous waste pharmaceutical and shall be managed in accordance with sub
. (2).
NR 666.510(1)(c)2.
2. A potentially creditable hazardous waste pharmaceutical that is destined for a licensed or interim status treatment, storage, or disposal facility
is considered an evaluated hazardous waste pharmaceutical and shall be managed in accordance with sub.
(3).
NR 666.510(1)(d)
(d)
Evaluation by a reverse distributor that is a manufacturer. A reverse distributor that is a pharmaceutical manufacturer shall evaluate a potentially creditable hazardous waste pharmaceutical to verify
manufacturer credit within 30 calendar da
ys of the waste arriving at the facili
ty
and following the evaluation shall manage the evaluated hazardous waste pharmaceuticals in accordance with sub.
(3).
NR 666.510(1)(e)
(e)
Maximum accumulation time for hazardous waste pharmaceuticals at a reverse distributor. NR 666.510(1)(e)1.
1. A reverse distributor may accumulate potentially
creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site for 180 calendar da
ys or less. The 180 calendar days start after the potential
ly
creditable hazardous waste pharmaceutical has been evaluated and applies to all hazardous waste pharmaceuticals accumulated on-site, regardless of whether they are destined for another reverse distributor, such as potentially creditable hazardous waste pharmaceuticals, or a permitted or interim status treatment, storage
, or disposal facility, such as evaluated hazardous waste pharmaceuticals.
NR 666.510(1)(e)2.
2. Unexpired pharmaceuticals that are otherwise creditable but are awaiting their expiration date, by aging in a holding morgue
, can be accumulated for up to 180 calendar days after the expiration date, provided that the unexpired pharmaceuticals are managed in accordance with this subsection and the container labeling and management standards specified in sub.
(3) (d) 1. to
6. NR 666.510(1)(f)
(f)
Security at the reverse distributor facility. A reverse distributor shall prevent unknowing entry
and minimize the possibility
for the unauthorized entry
into the portion of the facility
where potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals are kept. Examples of methods that may
be used to prevent unknowing entry
and minimize the possibility
for unauthorized entry
include any of the following:
NR 666.510(1)(f)4.
4. If the reverse distributor alrea
dy
meets the security
requirements of this paragraph because of other regulatory requirements, such as drug enforcement administration or state board of pharmacy
regulations, the facility
is not required to provide separate securi
ty
measures pursuant to this section.
NR 666.510(1)(g)
(g)
Contingency plan and emergency procedures at a reverse distributor. A reverse distributor that accepts potentially
creditable hazardous waste pharmaceuticals from off
-site shall prepare a contingency
plan and comp
ly
with the other requirements under subch.
M of ch. NR 662.
NR 666.510(1)(h)
(h)
Closure of a reverse distributor. When closing an area where a reverse distributor accumulates potential
ly
creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, the reverse distributor shall comply
with s.
NR 662.017 (1) (h) 2. and
3. NR 666.510(1)(i)1.1. `Unauthorized waste report.' A reverse distributor shall submit an unauthorized waste report if the reverse distributor receives waste from off-site that it is not authorized to receive, such as non-pharmaceutical hazardous waste, or regulated medical waste. The reverse distributor shall prepare and submit an unauthorized waste report to the department within 45 calendar da
ys after the unauthorized waste arrives at the reverse distributor and shall send a copy
of the unauthorized waste report to the healthcare facility
or other entit
y that sent the unauthorized waste. The reverse distributor shall manage the unauthorized waste in accordance with all applicable regulations. The unauthorized waste report shall be signed by
the owner or operator of the reverse distributor, or its authorized representative, and contain all of the following information:
NR 666.510(1)(i)1.a.
a. The EPA identification number, name, and address of the reverse distributor
.
NR 666.510(1)(i)1.c.
c. The EPA identification number, name, and address of the healthcare facility
that shipped the unauthorized waste, if available.
NR 666.510(1)(i)1.d.
d. A description and the quantity
of each unauthorized waste the reverse distributor received.
NR 666.510(1)(i)2.
2. `Additional reports.' The department may require reverse distributors to furnish additional reports concerning the quantities and disposition of potentially
creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.
NR 666.510(1)(j)
(j)
Recordkeeping by reverse distributors. The periods of retention referred to in this section are extended automatically
during the course of a
ny unresolved enforcement action regarding the regulated activit
y, or as requested by
the department. A reverse distributor shall keep all of the following records, paper or electronic, readily available upon request
by
an inspector:
NR 666.510(1)(j)1.
1. A co
py
of its notification on file for as long as the facility
is subject to this subchapter.
NR 666.510(1)(j)2.
2. A co
py
of the delivery confirmation and the shipping papers for each shipment of potentially
creditable hazardous waste pharmaceuticals that it receives, and a co
py
of each unauthorized waste report, for at least 3
years from the date the shipment arrives at the reverse distributor
.
NR 666.510(1)(j)3.
3. A co
py
of its current inventory for as long as the facili
ty
is subject to this subchapter.
NR 666.510(2)
(2)
Additional standards for reverse distributors managing potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor. A reverse distributor that does not have a license or interim status shall comply
with all of the following conditions, in addition to the requirements specified in sub.
(1), for the management of potentially creditable hazardous waste pharmaceuticals that are destined for another reverse distributor for further evaluation or verification of manufacturer credit:
NR 666.510(2)(a)
(a) A reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from a healthcare facility
shall send those potentially
creditable hazardous waste pharmaceuticals to another reverse distributor within 180 calendar days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow sub.
(3) for evaluated hazardous waste pharmaceuticals.
NR 666.510(2)(b)
(b) A reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from another reverse distributor shall send those potentially
creditable hazardous waste pharmaceuticals to a reverse distributor that is a pharmaceutical manufacturer within 180 calendar days after the potentially
creditable hazardous waste pharmaceuticals have been evaluated or follow sub.
(3) for evaluated hazardous waste pharmaceuticals.
NR 666.510(2)(c)
(c) A reverse distributor shall ship potentially
creditable hazardous waste pharmaceuticals destined for another reverse distributor in accordance with s.
NR 666.509.
NR 666.510(2)(d)
(d) The periods of retention referred to in this paragraph are extended automatical
ly
during the course of a
ny
unresolved enforcement action regarding the regulated activit
y, or as requested by
the department. A reverse distributor shall keep all of the following records, paper or electronic, readily available upon request
by
an inspector for each shipment of potentially
creditable hazardous waste pharmaceuticals that it initiates to another reverse distributor, for at least 3
years from the date of shipment:
NR 666.510(3)
(3)
Additional standards for reverse distributors managing evaluated hazardous waste pharmaceuticals. A reverse distributor that does not have a license or interim status shall comply with all of the following conditions, in addition to the requirements of sub.
(1), for the management of evaluated hazardous waste pharmaceuticals:
NR 666.510(3)(a)
(a)
Accumulation area at the reverse distributor. A reverse distributor shall designate an on
-site accumulation area where it will accumulate evaluated hazardous waste pharmaceuticals.
NR 666.510(3)(b)
(b)
Inspections of on-site accumulation area. A reverse distributor shall inspect its on
-site accumulation area at least once every
7 calendar da
ys, looking at containers for leaks and for deterioration caused
by
corrosion or other factors, as well as for signs of diversion.
NR 666.510(3)(c)
(c)
Personnel training at a reverse distributor. Personnel at a reverse distributor who handle evaluated hazardous waste pharmaceuticals are subject to the training requirements under s.
NR 662.017 (1) (g).
NR 666.510(3)(d)
(d)
Labeling and management of containers at on-site accumulation areas. A reverse distributor accumulating evaluated hazardous waste pharmaceuticals in containers in an on
-site accumulation area shall do all of the following:
NR 666.510(3)(d)1.
1. Label the containers with the words, “hazardous waste pharmaceuticals."
NR 666.510(3)(d)2.
2. Ensure the containers are in good condition and managed to prevent leaks.
NR 666.510(3)(d)3.
3. Use containers that are made of or lined with materials that will not react with, and are otherwise compatible with, the evaluated hazardous waste pharmaceuticals, so that the ability of the container to contain the waste is not impaired.
NR 666.510(3)(d)4.
4. Keep containers closed, if the container is holding liquid or gel evaluated hazardous waste pharmaceuticals. If the liquid or gel evaluated hazardous waste pharmaceuticals are in their original, intact, sealed packaging or repackaged in intact, sealed packaging, they are considered to meet the closed container standard.
NR 666.510(3)(d)5.
5. Manage a
ny
container of ignitable or reactive evaluated hazardous waste pharmaceuticals, or a
ny container of commingled incompatible evaluated hazardous waste pharmaceuticals so that the container does not have the potential to do any of the following:
