Current through Register Vol. 24-06, March 15, 2024
(1)
Definitions. The following definitions apply to this section:
"Dangerous waste pharmaceutical" means a pharmaceutical that is
a solid waste, as defined in WAC
173-303-016,
and that exhibits a dangerous waste characteristic, criteria, or is listed as
dangerous waste under WAC
173-303-070.
A pharmaceutical is not a solid waste, as defined in 173-303-016, if it is
legitimately used/reused (e.g., 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 WAC
173-303-016,
if it has a reasonable expectation of being legitimately used/reused (e.g.,
lawfully redistributed for its intended purpose) or reclaimed.
"Evaluated dangerous waste pharmaceutical" means a prescription
dangerous waste pharmaceutical that has been evaluated by a reverse distributor
in accordance with subsection (12)(c) of this section and will not be sent to
another reverse distributor for further evaluation or verification of
manufacture credit.
"Health care facility" means any person that is lawfully
authorized to:
* Provide preventative, diagnostic, therapeutic,
rehabilitative, maintenance or palliative care, and counseling, service,
assessment or procedure with respect to the physical or mental condition, or
functional status, of a human or animal or that affects the structure or
function of the human or animal body; or
* Distribute, sell, or dispense pharmaceuticals, including
over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or
prescription pharmaceuticals. This definition includes, but is not limited to,
wholesale distributors, third-party logistics providers that serve as forward
distributors, military medical logistics facilities, hospitals, psychiatric
hospitals, ambulatory surgical centers, health clinics, physicians' 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 logistic centers.
"Household waste pharmaceutical" means a pharmaceutical that is
a solid waste, as defined in WAC
173-303-016,
but is excluded from being a dangerous waste under WAC
173-303-071(3)(c).
"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 facility. This
definition includes, but is not limited to, 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.
"Noncreditable dangerous waste pharmaceutical" means a
prescription dangerous waste pharmaceutical that does not have a reasonable
expectation to be eligible for manufacturer credit or a nonprescription
dangerous waste pharmaceutical that does not have a reasonable expectation to
be legitimately used/reused or reclaimed. This includes, but is not limited to,
investigational drugs, free samples of pharmaceuticals received by health care
facilities, and residue of pharmaceuticals remaining in empty containers,
pharmaceutical contaminated personal protection equipment, floor sweepings, and
clean-up materials from the spills of pharmaceuticals.
"Nondangerous waste pharmaceutical" means a solid waste
pharmaceutical that does not meet the definition of "dangerous waste
pharmaceutical" in this section.
"Nonpharmaceutical dangerous waste" means a solid waste that is
a dangerous waste as defined by this chapter, but is not a pharmaceutical as
defined in this section.
"Pharmaceutical" means any drug or dietary supplement for use
by humans or animals; any electronic nicotine delivery system (e.g., electronic
cigarette or vaping pen); or any liquid nicotine (e-liquid) packaged for retail
sale for use in electronic nicotine delivery systems (e.g., prefilled
cartridges or vials). This definition includes, but is not limited to, dietary
supplements, as defined by the Federal Food, Drugs and Cosmetic Act;
prescription drugs, as defined by
21
C.F.R. 203.3(y);
over-the-counter drugs; homeopathic drugs; compounded drugs; investigational
new drugs; pharmaceutical remaining in nonempty containers; personal protection
equipment contaminated with pharmaceuticals; and clean-up material from spills
of pharmaceuticals. This definition does not include dental amalgam or
sharps.
"Potentially creditable dangerous waste pharmaceutical" means a
prescription dangerous waste pharmaceutical that has a reasonable expectation
to receive manufacturer credit and is:
(a) In original manufacturer packaging
(except pharmaceuticals that were subject to a recall); and
(b) Undispensed; and
(c) Unexpired or less than one year past
expiration date. This term does not include evaluated dangerous waste
pharmaceuticals or nonprescription pharmaceuticals including, but not limited
to, over-the-counter drugs, homeopathic drugs, and dietary supplements.
"Reverse distributor" means any person that receives and
accumulates prescription pharmaceuticals that are potentially creditable
dangerous waste pharmaceuticals for the purpose of facilitating or verifying
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.
"State-only dangerous waste pharmaceutical" means a dangerous
waste pharmaceutical that only exhibits state criteria under WAC
173-303-100.
(2)
Applicability.
(a) A health care facility that is a small
quantity generator when counting all of its dangerous waste per month,
including both its dangerous waste pharmaceuticals and its nonpharmaceutical
dangerous waste, remains subject to WAC
173-303-170(2)(a)(i)
and
173-303-171
and is not subject to this section except for subsections (6) and (8) of this
section and the optional provisions of subsections (5) and/or (7) of this
section.
(b) A health care facility
that is a small quantity generator when counting all of its dangerous waste per
month, including both its dangerous waste pharmaceuticals and its
nonpharmaceutical dangerous waste, has the option of complying with (d) of this
subsection for its dangerous waste pharmaceuticals in lieu of complying with
WAC
173-303-171
and with the optional provisions of subsection (5) of this section.
(c) A health care facility or reverse
distributor remains subject to all applicable dangerous waste regulations with
respect to the management of its nonpharmaceutical dangerous waste.
(d) With the exception of health care
facilities identified in (a) of this subsection, a health care facility is
subject to the following with respect to its dangerous waste pharmaceuticals in
lieu of this chapter:
(i) Subsections (3) and
(6) through (10) of this section with respect to the management of:
(A) Noncreditable dangerous waste
pharmaceuticals; and
(B)
Potentially creditable dangerous waste pharmaceuticals if they are not destined
for a reverse distributor.
(ii) Subsections (3)(a), (4), (6) through
(8), and (11) of this section with respect to the management of potentially
creditable dangerous waste pharmaceuticals that are prescription
pharmaceuticals and are destined for a reverse distributor.
(e) A reverse distributor is
subject to subsections (6) through (15) of this section with respect to the
management of dangerous waste pharmaceuticals.
(f) Dangerous waste pharmaceuticals generated
or managed by entities other than health care facilities and reverse
distributors (e.g., pharmaceutical manufacturers and reverse logistics centers)
are not subject to this section. These generators are subject to this chapter
for the generation and accumulation of dangerous wastes, including dangerous
waste pharmaceuticals.
(g) The
following are not subject to this chapter except as specified:
(i) Pharmaceuticals that are not solid waste,
as defined by WAC
173-303-016,
because they are legitimately used/ reused (e.g., lawfully donated for their
intended purpose) or reclaimed.
(ii) Over-the-counter pharmaceuticals,
dietary supplements, or homeopathic drugs that are not solid wastes, as defined
in WAC
173-303-016,
because they have a reasonable expectation of being legitimately used/reused
(e.g., lawfully redistributed for their intended purpose) or
reclaimed.
(iii) Pharmaceuticals
being managed in accordance with a recall strategy that has been approved by
the Food and Drug Administration in accordance with 21 C.F.R. Part 7, Subpart
C. This subpart does apply to the management of the recalled dangerous waste
pharmaceuticals after the Food and Drug Administration approves the destruction
of the recalled items.
(iv)
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 C.F.R. Part 1115. This subpart does apply to the management
of the recalled dangerous waste pharmaceuticals after the Consumer Product
Safety Commission approves the destruction of the recalled items.
(v) 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.
(vi) Investigational new drugs for which an
investiga-tional new drug application is in effect in accordance with the Food
and Drug Administration's regulations in 21 C.F.R. Part 312. This subpart does
apply to the management of the inves-tigational 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 dangerous waste.
(vii) 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 subsection (7)(a)(ii) and (b) of
this section.
(3)
Standards for health care
facilities managing non-creditable dangerous waste pharmaceuticals.
(a) Notification and withdrawal from this
section for health care facilities managing dangerous waste pharmaceuticals.
(i) Notification. A health care facility must
notify the department, using the Washington State Dangerous Waste Site
Identification Form, that it is a health care facility operating under this
section. A health care facility is not required to fill out Box 11 (description
of hazardous/dangerous waste) on the Washington State Dangerous Waste Site
Identification Form with respect to its dangerous waste pharmaceuticals. A
health care facility must submit a separate notification (Washington State
Dangerous Waste Site Identification Form) for each site or EPA/state
identification number.
(A) A health care
facility that already has an EPA/state identification number must notify the
department, using the Washington State Dangerous Waste Site Identification
Form, that it is a health care facility within sixty days of becoming subject
to this section.
(B) A health care
facility that does not have an EPA/state identification number must obtain one
by notifying the department, using the Washington State Dangerous Waste Site
Identification Form, that it is a health care facility within sixty days of
becoming subject to this section.
(C) A health care facility must keep a copy
of its notification on file for as long as the health care facility is subject
to this section.
(ii)
Withdrawal. A health care facility that operated under this section, but is no
longer subject to this section, because it is a small quantity generator under
WAC
173-303-171,
and elects to withdraw from this section, must notify the department using the
Washington State Dangerous Waste Site Identification Form, that it is no longer
operating under this section. A health care facility is not required to fill
out Box 11 (description of hazardous/dangerous waste) on the Washington State
Dangerous Waste Site Identification Form with respect to its dangerous waste
pharmaceuticals. A health care facility must submit a separate notification
(Washington State Dangerous Waste Site Identification Form) for each site or
EPA/state identification number.
(A) A health
care facility must submit the Washington State Dangerous Waste Site
Identification Form notifying that it is withdrawing from this section before
it begins operating under WAC
173-303-171.
(B) A health care facility must keep a copy
of its withdrawal on file for five years from the date of signature on the
notification of its withdrawal.
(b) Training of personnel managing
noncreditable dangerous waste pharmaceuticals at health care facilities. A
health care facility must ensure that all personnel that manage noncreditable
dangerous waste pharmaceuticals are thoroughly familiar with proper waste
handling and emergency procedures relevant to their responsibilities during
normal facility operations and emergencies.
(c) Dangerous waste determination for
noncreditable pharmaceuticals. A health care facility that generates a solid
waste that is a noncreditable pharmaceutical must determine whether that
pharmaceutical is a dangerous waste pharmaceutical in order to determine
whether the waste is subject to this section. A health care facility may choose
to manage its nondangerous waste pharmaceuticals under this section.
(d) Standards for containers used to
accumulate noncred-itable dangerous waste pharmaceuticals at health care
facilities.
(i) A health care facility must
place noncreditable dangerous 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 reasonably
foreseeable conditions.
(ii) A
health care facility that manages ignitable or reactive noncreditable dangerous
waste pharmaceuticals, or that mixes or commingles incompatible noncreditable
dangerous waste pharmaceuticals must manage the container so that it does not
have the potential to:
(A) Generate extreme
heat or pressure, fire or explosion, or violent reaction;
(B) Produce uncontrolled toxic mists, fumes,
dusts, or gases in sufficient quantities to threaten human health;
(C) Produce uncontrolled flammable fumes or
gases in sufficient quantities to pose a risk of fire or explosions;
(D) Damage the structural integrity of the
container;
(E) Through other like
means threaten human health or the environment.
(iii) A health care facility must keep
containers of non-creditable dangerous waste pharmaceuticals closed and secured
in a manner that prevents unauthorized access to its contents.
(iv) A health care facility may accumulate
noncreditable dangerous waste pharmaceuticals and noncreditable nondan-gerous
waste pharmaceuticals in the same container, except that noncreditable
dangerous waste pharmaceuticals prohibited from being combusted because of 40
C.F.R. Part 268.3(c) must be accumulated in separate containers and labeled
with all applicable dangerous waste numbers (i.e., dangerous waste
codes).
(e) Labeling
containers used to accumulate noncredit-able dangerous waste pharmaceuticals at
health care facilities. A health care facility must label or clearly mark each
container of noncreditable dangerous waste pharmaceuticals with the phrase
"Hazardous Waste Pharmaceuticals" or "Dangerous Waste
Pharmaceuticals."
(f) Maximum
accumulation time for noncreditable dangerous waste pharmaceutical at health
care facilities.
(i) A health care facility
may accumulate noncreditable dangerous waste pharmaceuticals on-site for one
year or less without a permit or having interim status.
(ii) A health care facility that accumulates
noncreditable dangerous waste pharmaceuticals on-site must demonstrate the
length of time that the noncreditable dangerous waste pharmaceuticals have been
accumulating, starting from the date it first becomes a waste. A health care
facility may make this demonstration by any of the following methods:
(A) Marking or labeling the container of
noncreditable dangerous waste pharmaceuticals with the date that the
non-creditable dangerous waste pharmaceuticals first became a waste;
(B) Maintaining an inventory system that
identifies the date the noncreditable dangerous waste pharmaceuticals first
became a waste;
(C) Placing the
noncreditable dangerous waste pharmaceuticals in a specific area and
identifying the earliest date that any of the noncreditable dangerous waste
pharmaceuticals became waste.
(g) Land disposal restrictions for
noncreditable dangerous waste pharmaceuticals. The noncreditable dangerous
waste pharmaceuticals generated by a health care facility are subject to the
land disposal restrictions of 40 C.F.R. Part 268. A health care facility that
generates noncreditable dangerous waste pharmaceuticals must comply with the
land disposal restrictions of 40 C.F.R. Part 268.7(a) (as adopted by WAC
173-303-140(2)(c)
and(d) ), except that it is not required to
identify the dangerous waste numbers (i.e., dangerous waste codes) on the land
disposal restrictions notification.
(h) Procedures for health care facilities for
managing rejected shipments of noncreditable dangerous waste pharmaceuticals. A
health care facility that sends a shipment of noncreditable dangerous 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
provision of WAC
173-303-370(5)
may accumulate the returned noncreditable dangerous waste pharmaceuticals
on-site for up to an additional ninety days provided the rejected or returned
shipment is managed in accordance with (d) and (e) of this subsection. Upon
receipt of the returned shipment, the health care facility must:
(i) Sign either:
(A) Item 18c of the original manifest, if the
original manifest was used for the returned shipment; or
(B) Item 20 on the new manifest, if a new
manifest was used for the returned shipment;
(ii) Provide the transporter a copy of the
manifest;
(iii) Within thirty days
of receipt of the rejected shipment, send a copy of the manifest to the
designated facility that returned the shipment to the health care facility;
and
(iv) Within ninety days of
receipt of the rejected shipment, transport or offer for transport the returned
shipment in accordance with the shipping standard of subsection (9)(a) through
(c) of this section.
(i)
Annual reporting for health care facilities for non-creditable dangerous waste
pharmaceuticals. Health care facilities are not subject to annual reporting
requirements under WAC
173-303-220(1),
with respect to noncreditable dangerous waste pharmaceuticals managed under
this section.
(j) Exception
reporting by health care facilities for a missing copy of the manifest in
regard to noncreditable dangerous waste pharmaceuticals for shipments to a
designated facility. If a health care facility does not receive a copy of the
manifest with the signature of the owner or operator of the designated facility
within sixty days of the date the noncred-itable dangerous waste
pharmaceuticals were accepted by the initial transporter, the health care
facility must submit:
(i) A legible copy of
the original manifest, indicating that the health care facility has not
received confirmation of delivery, to the department's regional office in which
the health care facility is located; and
(ii) A handwritten or typed note on the
manifest itself, or on an attached sheet of paper, stating that the return copy
was not received and explaining the efforts taken to locate the noncreditable
dangerous waste pharmaceutical and the results of those
efforts.
(k) Exception
reporting by health care facilities for shipments rejected by the designated
facility and shipped to an alternative facility in regard to noncreditable
dangerous waste pharmaceuticals. If a health care facility does not receive a
copy of the manifest for a rejected shipment of the noncreditable dangerous
waste pharmaceuticals that is forwarded by the designated facility to an
alternate facility (using appropriate manifest procedures), with the signature
of the owner or operator of the alternate facility, within sixty days of the
date the noncreditable dangerous waste pharmaceutical was accepted by the
initial transporter forwarding the shipment of noncreditable dangerous waste
pharmaceuticals from the designated facility to the alternate facility, the
health care facility must submit:
(i) A
legible copy of the original manifest, indicating that the health care facility
has not received confirmation of delivery, to the department's regional office
in which the health care facility is located; and
(ii) A handwritten or typed note on the
manifest itself, or on an attached sheet of paper, stating that the return copy
was not received and explaining the efforts taken to locate the noncreditable
dangerous waste pharmaceuticals and the results of those efforts.
(l) Additional reports by health
care facilities in regard to noncreditable dangerous waste pharmaceuticals. The
department may require the health care facilities to furnish additional reports
concerning the quantities, types, and disposition of noncreditable dangerous
waste pharmaceuticals.
(m)
Recordkeeping by health care facilities for noncred-itable dangerous waste
pharmaceuticals. A health care facility must comply with WAC
173-303-210
and keep all records for five years in regards to noncreditable dangerous waste
pharmaceuticals. The periods of retention referred to in this paragraph are
extended automatically during the course of any unresolved enforcement action
regarding the regulated activity, or as requested by the department. All
records must be readily available upon request by an authorized state
inspector.
(n) Response to spill of
noncreditable dangerous waste pharmaceuticals at health care facilities. A
health care facility must immediately contain all spills of noncreditable
dangerous waste pharmaceuticals and manage the spill clean-up material as
noncreditable dangerous waste pharmaceuticals in accordance with the
requirements of this section.
(o)
Accepting noncreditable dangerous waste pharmaceuticals from an off-site health
care facility that is a small quantity generator. A health care facility may
accept non-creditable dangerous waste pharmaceuticals from an off-site health
care facility that is a small quantity generator under WAC
173-303-171,
without a permit or without having interim status, provided the receiving
health care facility:
(i) Is under the
control of the same person (as defined in WAC
173-303-040 ) as the
small quantity generator health care facility that is sending the noncreditable
dangerous waste pharmaceuticals off-site or has a contractual or other
documented business relationship whereby the receiving health care facility
supplies pharmaceuticals to the small quantity generator health care
facility;
(ii) Is operating under
this section for the management of its noncreditable dangerous waste
pharmaceuticals;
(iii) Manages the
noncreditable dangerous waste pharmaceuticals that it receives from off-site in
compliance with this section; and
(iv) Keeps records of the noncreditable
dangerous waste pharmaceuticals shipments it receives from off-site for five
years from the date the shipment is received.
(4)
Standards for health care
facilities managing potentially creditable dangerous waste
pharmaceuticals.
(a) Dangerous waste
determinations for potentially creditable pharmaceuticals. A health care
facility that generates a solid waste that is a potentially creditable
pharmaceutical must determine whether that potentially creditable
pharmaceutical is a potentially creditable dangerous waste pharmaceutical. A
health care facility may choose to manage its potentially creditable
nondangerous waste pharmaceuticals as potentially creditable dangerous waste
pharmaceutical under this section.
(b) Accepting potentially creditable
dangerous waste pharmaceuticals from an off-site health care facility that is a
small quantity generator. A health care facility may accept potentially
creditable dangerous waste pharmaceuticals from an off-site health care
facility that is a small quantity generator under WAC
173-303-171,
without a permit or without having interim status, provided the receiving
health care facility:
(i) Is under the
control of the same person (as defined in WAC
173-303-040 ) as the
small quantity generator health care facility that is sending the potentially
creditable dangerous waste pharmaceuticals off-site or has a contractual or
other documented business relationship whereby the receiving health care
facility supplies pharmaceuticals to the small quantity generator health care
facility;
(ii) Is operating under
this section for the management of its potentially creditable dangerous waste
pharmaceuticals;
(iii) Manages the
potentially creditable dangerous waste pharmaceuticals that it receives from
off-site in compliance with this section; and
(iv) Keeps records of the potentially
creditable dangerous waste pharmaceuticals shipments it receives from off-site
for five years from the date the shipment is received.
(c) Prohibition. Health care facilities are
prohibited from sending dangerous waste other than potentially creditable
dangerous waste pharmaceuticals to a reverse distributor.
(d) Annual reporting by health care
facilities. Health care facilities are not subject to the annual reporting
requirements of WAC
173-303-220(1),
with respect to potentially creditable dangerous waste pharmaceuticals managed
under this section.
(e)
Recordkeeping by health care facilities.
(i)
A health care facility that initiates a shipment of potentially creditable
dangerous waste pharmaceuticals to a reverse distributor must keep the
following records (paper or electronic) for each shipment of potentially
creditable dangerous waste pharmaceuticals for five years from date of
shipment:
(A) The confirmation of delivery;
and
(B) The shipping papers
prepared in accordance with 49 C.F.R. Part 172, Subpart C, if
applicable.
(ii) The
periods of retention referred to in this subsection are extended automatically
during the course of any unresolved enforcement actions regarding the regulated
activity, or as requested by the department.
(iii) All records must be readily available
upon request by an authorized state inspector.
(f) Response to spill of potentially
creditable dangerous waste pharmaceuticals at health care facilities. A health
care facility must immediately contain all spills of potentially creditable
dangerous waste pharmaceuticals and manage the spill clean-up material as
noncreditable dangerous waste pharmaceuticals in accordance with the
requirements of this section.
(5)
Health care facilities that are
small quantity generators for both dangerous waste pharmaceuticals and
nonpharmaceutical dangerous waste.
(a)
Potentially creditable dangerous waste pharmaceuticals. A health care facility
that is a small quantity generator for both dangerous waste pharmaceuticals and
nonpharma-ceutical dangerous waste may send its potentially creditable
dangerous waste pharmaceuticals to a reverse distributor.
(b) Off-site collection of dangerous waste
pharmaceuticals generated by a health care facility that is a small quantity
generator. A health care facility that is a small quantity generator for both
dangerous waste pharmaceuticals and non-pharmaceutical dangerous waste may send
its dangerous waste pharmaceuticals to another health care facility, provided:
(i) The receiving health care facility meets
the conditions in subsections (3)(o) and (4)(b) of this section, as applicable;
or
(ii) The small quantity
generator health care facility meets the conditions in WAC
173-303-171(1)(e)(ix)
and the receiving large quantity generator meets the conditions in WAC
173-303-200(15).
(c) Long-term care facilities that are small
quantity generators. A long-term care facility that is a small quantity
generator for both dangerous waste pharmaceuticals and non-pharmaceutical
dangerous waste may dispose of its dangerous waste pharmaceuticals (excluding
contaminated personal protection equipment or clean-up materials) in an on-site
collection receptacle of an authorized collector (as defined by the Drug
Enforcement Administration) that is registered with the Drug Enforcement
Administration provided the contents are collected, stored, transported,
destroyed, and disposed of in compliance with all applicable Drug Enforcement
Administration regulations for controlled substances.
(6)
Prohibition of sewering dangerous
waste pharmaceuticals. All health care facilities, including small
quantity generators operating under WAC
173-303-171
in lieu of this section, and reverse distributors are prohibited from
discharging dangerous waste pharmaceuticals to a sewer system that passes
through to a publicly owned treatment works or to an on-site disposal system.
Health care facilities and reverse distributors remain subject to the
prohibitions in
40 C.F.R.
403.5(b) of the Clean Water
Act.
(7)
Conditional
exemptions for dangerous waste pharmaceuticals that are also controlled
substances and household waste pharmaceuticals collected in a take-back event
or program.
(a) Conditional
exemptions. Provided the conditions of (b) of this subsection are met, the
following are exempt from this chapter except for WAC
173-303-050,
173-303-145,
and
173-303-960:
(i) Dangerous waste pharmaceuticals that are
also listed on a schedule of controlled substances by the Drug Enforcement
Administration in 21 C.F.R. Part 1308; and
(ii) Household waste pharmaceuticals that are
collected in a take-back event or program, including those that are collected
by an authorized collector (as defined by the Drug Enforcement Administration)
registered with the Drug Enforcement Administration that commingles the
household waste pharmaceuticals with controlled substances from an ultimate
user (as defined by the Drug Enforcement Administration).
(b) Conditions for exemption. The dangerous
waste pharmaceuticals must be:
(i) Managed in
compliance with the sewer prohibition of subsection (6) of this section;
and
(ii) Collected, stored,
transported, and disposed of in compliance with all applicable Drug Enforcement
Administration regulations for controlled substances; and
(iii) Destroyed by a method that Drug
Enforcement Administration has publicly deemed in writing to meet their
nonretrievable standard of destruction or combusted at one of the following:
(A) A permitted large municipal waste
combustor, subject to 40 C.F.R. Part 62, Subpart FFF or applicable state plan
for existing large municipal waste combustors, or 40 C.F.R. Part 60, Subpart Eb
for new large municipal waste combustors; or
(B) A permitted small municipal waste
combustor, subject to 40 C.F.R. Part 62, Subpart JJJ or applicable state plan
for existing small municipal waste combustors, or 40 C.F.R. Part 60, Subparts
AAAA for new small municipal waste combustors; or
(C) A permitted hospital, medical and
infectious waste incinerator, subject to 40 C.F.R. Part 62, Subpart HHH or
applicable state plan for existing hospital, medical and infectious waste
incinerators, or 40 C.F.R. Part 60, Subpart Ec for new hospital, medical and
infectious waste incinerators; or
(D) A permitted commercial and industrial
solid waste incinerator, subject to 40 C.F.R. Part 62, Subpart III or
applicable state plan for existing commercial and industrial solid waste
incinerators, or 40 C.F.R. Part 60, Subpart CCCC for new commercial and
industrial solid waste incinerators.
(E) A permitted dangerous (hazardous) waste
combustor subject to 40 C.F.R. Part 63, Subpart EEE.
(8)
Residues of
dangerous waste pharmaceuticals in empty containers.
(a) Stock, dispensing and unit-dose
containers. A stock bottle, dispensing bottle, vial, or ampule (not to exceed
one liter or ten thousand 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 dangerous 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.
(b) Syringes. A syringe is considered empty
and the residues are not regulated as dangerous waste under this section
provided the contents have been removed by fully depressing the plunger of the
syringe. If a syringe is not empty, the syringe must be placed with its
remaining dangerous waste pharmaceuticals into a container that is managed and
disposed of as a noncreditable dangerous waste pharmaceutical under this
section and any applicable federal, state, and local requirements for sharps
containers and medical waste.
(c)
Intravenous (IV) bags.
(i) An IV bag is
considered empty and the residues are not regulated as dangerous waste provided
the pharmaceuticals in the IV bag have been fully administered to a
patient.
(ii) If an IV bag is not
empty, the IV bag must be placed with its remaining dangerous waste
pharmaceuticals into a container that is managed and disposed of as a
noncreditable dangerous waste pharmaceutical under this section, unless the IV
bag held nonacute dangerous waste pharmaceutical and is empty as defined in WAC
173-303-160(2)(a).
(iii) If an IV bag is not empty and held an
acute hazardous waste or a toxic EHW waste, the IV bag must be placed with its
remaining dangerous waste pharmaceuticals into a container that is managed and
disposed of as a noncreditable dangerous waste pharmaceutical under this
section, unless the IV bag is empty as defined by WAC
173-303-160(2)(b).
(d) Other containers, including delivery
devices.
(i) Nonacute dangerous waste
pharmaceuticals remaining in all other types of unused, partially administered,
or fully administered containers must be managed as noncredit-able dangerous
waste pharmaceuticals under this section, unless the container that held
nonacute dangerous waste pharmaceuticals is empty as defined in WAC
173-303-160(2)(a).
This includes, but is not limited to, residues in inhalers, aerosol cans,
nebulizers, tubes of ointments, gels, or creams.
(ii) Acute hazardous waste pharmaceuticals
and toxic EHW dangerous waste pharmaceuticals remaining in all other types of
unused, partially administered, or fully administered containers must be
managed and disposed as noncred-itable dangerous waste pharmaceuticals under
this section, unless the container that held acute dangerous waste
pharmaceuticals or toxic EHW dangerous waste pharmaceuticals is empty as
defined in WAC
173-303-160(2)(b).
This includes, but is not limited to, residues in inhalers, aerosol cans,
nebulizers, tubes of ointments, gels, or creams.
(9)
Shipping noncreditable dangerous
waste pharmaceuticals from a health care facility or evaluated dangerous waste
pharmaceuticals from a reverse distributor.
(a) A health care facility must ship
noncreditable dangerous waste pharmaceuticals and a reverse distributor must
ship evaluated dangerous waste pharmaceuticals off-site to a designated
facility (such as a permitted or interim status treatment, storage or disposal
facility).
(i) The following pretransport
requirements, before transporting or offering for transport off-site must be
complied with:
(A) Packaging. Package the
waste in accordance with the applicable U.S. Department of Transportation
regulations on hazardous materials under 49 C.F.R. Parts 173, 178, and
180.
(B) Labeling. Label each
package in accordance with the applicable U.S. Department of Transportation
regulations on hazardous materials under 49 C.F.R. Part 172, Subpart
E.
(C) Marking.
(I) Mark each package of dangerous waste
pharmaceuticals in accordance with the applicable U.S. Department of
Transportation regulations on hazardous materials under 49 C.F.R. Part 172,
Subpart D.
(II) Mark each container
of one hundred nineteen gallons or less used in such transportation with the
following words and information in accordance with the requirements of
49 C.F.R.
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. Health care Facility's or Reverse
distributor's Name and Address
___________________________________
Health care Facility's or Reverse distributor's EPA
Identification Number
______________________________
Manifest Tracking Number
___________________________
(III) Labpacks. Labpacks that will be
incinerated in compliance with
40 C.F.R.
268.42(c) are not required
to be marked with dangerous waste number(s), except for D004, D005, D006, 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 dangerous waste numbers.
(D) Placarding. Placard or offer the initial
transporter the appropriate placards according to U.S. Department of
Transportation regulations for hazardous materials under 49 C.F.R. Part 172,
Subpart F.
(ii)
Manifesting. The health care facility and reverse distributor must comply with
the manifest requirements of WAC
173-303-180, except
that:
(A) A health care facility shipping
noncreditable dangerous waste pharmaceuticals is not required to list all
applicable dangerous waste numbers (i.e., dangerous waste codes) in Item 13 EPA
Form 8700-22.
(B) A health care
facility shipping noncreditable dangerous waste pharmaceuticals must write the
word "PHRM" in Item 13 on EPA Form 8700-22.
(b) Exporting noncreditable dangerous waste
pharmaceuticals or evaluated dangerous waste pharmaceuticals. A health care
facility or reverse distributor that exports non-creditable dangerous waste
pharmaceuticals or evaluated dangerous waste pharmaceuticals is subject to WAC
173-303-230(1).
(c) Importing noncreditable dangerous waste
pharmaceuticals or evaluated dangerous waste pharmaceuticals. Any person that
imports noncreditable dangerous waste pharmaceuticals or evaluated dangerous
waste pharmaceuticals is subject to WAC
173-303-230(2)
and 40 C.F.R. Part 262, Subpart H. A health care facility or reverse
distributor may not accept imported noncreditable dangerous waste
pharmaceuticals or evaluated dangerous waste pharmaceuticals unless they have a
permit or interim status that allow them to accept dangerous waste from
off-site.
(10)
Disposal of state-only dangerous waste pharmaceuticals.
(a) As an alternative to off-site disposal at
a designated facility (such as a permitted or interim status treatment,
storage, or disposal facility) state-only dangerous waste pharmaceuticals may
be disposed at one of the following types of units provided (b) through (d) of
this subsection are complied with:
(i) A
combustor or incinerator listed in subsection (7)(b)(iii)(A) through (E) of
this section; or
(ii) As an option
for law enforcement agencies, incinerate in a controlled combustion unit with a
heat input rate greater than 250 million British thermal units/hour, and a
combustion zone temperature greater than 1500 degrees Fahrenheit.
(b) The state-only dangerous waste
pharmaceuticals are managed in compliance with all applicable requirements of
this section.
(c) If a uniform
hazardous waste manifest is not being used, a document must accompany the
state-only noncredit-able dangerous waste pharmaceuticals during transit which:
(i) Identifies the type and amount of
state-only noncred-itable dangerous waste pharmaceuticals;
(ii) The date of shipment;
(iii) The identity of the health care
facility or reverse distributor; and
(iv) The facility to which it is
directed.
(d) The health
care facility or reverse distributor has on file a letter or copy of a letter
signed by the local regulatory or permitting authority that the receiving
incinerator or combustion facility may accept the waste.
(11)
Shipping potentially creditable
dangerous waste pharmaceuticals from a health care facility or reverse
distributor to a reverse distributor.
(a) Shipping potentially creditable dangerous
waste pharmaceuticals. A health care facility or a reverse distributor who
transports or offers for transport potentially creditable dangerous waste
pharmaceuticals off-site to a reverse distributor must comply with all
applicable U.S. Department of Transportation regulations in 49 C.F.R. Parts 171
through 180 for any potentially creditable dangerous waste pharmaceutical that
meets the definition of hazardous materials in
49 C.F.R.
171.8.
(b) Delivery confirmation. Upon receipt of
each shipment of potentially creditable dangerous waste pharmaceuticals, the
receiving reverse distributor must provide confirmation (paper or electronic)
to the health care facility or reverse distributor that initiated the shipment
that the shipment of potentially creditable dangerous waste pharmaceuticals has
arrived at its destination and is under the custody and control of the reverse
distributor.
(c) Procedures for
when delivery confirmation is not received within thirty-five calendar days. If
a health care facility or reverse distributor initiates a shipment of
potentially creditable dangerous waste pharmaceuticals to a reverse distributor
and does not receive delivery confirmation within thirty-five calendar days
from the date that the shipment of potentially creditable dangerous waste
pharmaceuticals was sent, the health care facility or reverse distributor that
initiated the shipment must contact the carrier and the intended recipient
(i.e., the reverse distributor) promptly to report that the delivery
confirmation was not received and to determine the status of the potentially
creditable dangerous waste pharmaceuticals.
(d) Exporting potentially creditable
dangerous waste pharmaceuticals. A health care facility or reverse distributor
that sends potentially creditable dangerous waste pharmaceuticals to a foreign
destination must comply with WAC
173-303-230(1)
in addition to (a) through (c) of this subsection.
(e) Importing potentially creditable
dangerous waste pharmaceuticals. Any person that imports potentially creditable
dangerous waste pharmaceuticals into the United States is subject to (a)
through (c) of this subsection in lieu of WAC
173-303-230(2).
Immediately after potentially creditable dangerous waste pharmaceuticals enter
the United States, they are subject to all applicable requirements of this
section.
(12)
Standards for reverse distributors managing potentially creditable
dangerous waste pharmaceuticals and evaluated dangerous waste
pharmaceuticals. A reverse distributor may accept potentially creditable
dangerous waste pharmaceuticals from off-site (not evaluated dangerous waste
pharmaceuticals from off-site) and accumulate potentially creditable dangerous
waste pharmaceuticals and evaluated dangerous waste pharmaceuticals on-site
without a dangerous waste permit or interim status, provided that it complies
with the requirements of subsections (13) through (15) of this section and with
the following conditions.
(a) Notification.
(i) A reverse distributor that already has an
EPA/state identification number must notify the department, using the
Washington State Dangerous Waste Site Identification Form, that it is a reverse
distributor (as defined in subsection (1) of this section) operating under this
section, within sixty days of the effective date of this section, or within
sixty days of becoming subject to this section.
(ii) A reverse distributor that does not have
an EPA/state identification number must obtain one by notifying the department,
using the Washington State Dangerous Waste Site Identification Form, that it is
a reverse distributor (as defined in subsection (1) of this section) operating
under this section, within sixty days of the effective date of this section, or
within sixty days of becoming subject to this section.
(b) Inventory by the reverse distributor. A
reverse distributor must maintain a current inventory of all the potentially
creditable dangerous waste pharmaceuticals and evaluated dangerous waste
pharmaceuticals that are accumulated on-site.
(i) A reverse distributor must inventory each
potentially creditable dangerous waste pharmaceuticals within thirty calendar
days of each waste arriving at the reverse distributor.
(ii) The inventory must include the identity
(e.g., name or national drug code) and quantity of each potentially creditable
dangerous waste pharmaceutical and evaluated dangerous waste
pharmaceutical.
(iii) If the
reverse distributor already 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 subsection.
(c) Evaluation by a reverse distributor that
is not a manufacturer. A reverse distributor that is not a pharmaceutical
manufacturer must evaluate potentially creditable dangerous waste
pharmaceutical within thirty calendar days 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 facility.
(i) A potentially creditable dangerous waste
pharmaceutical that is destined for another reverse distributor is still
considered a "potentially creditable dangerous waste pharmaceutical" and must
be managed in accordance with the requirements of subsection (13) of this
section in addition to the requirements of this subsection.
(ii) A potentially creditable dangerous waste
pharmaceutical that is destined for a permitted or interim status treatment,
storage or disposal facility is considered an "evaluated dangerous waste
pharmaceutical" and must be managed in accordance with the requirements of
subsection (14) of this section in addition to the requirements of this
subsection.
(d)
Evaluation by a reverse distributor that is a manufacturer. A reverse
distributor that is a pharmaceutical manufacturer must evaluate a potentially
creditable dangerous waste pharmaceutical to verify manufacturer credit within
thirty calendar days of the waste arriving at the facility and following the
evaluation must manage the evaluated dangerous waste pharmaceutical in
accordance with the requirements of subsection (14) of this section in addition
to the requirements of this subsection.
(e) Maximum accumulation time for dangerous
waste pharmaceuticals at a reverse distributor.
(i) A reverse distributor may accumulate
potentially creditable dangerous waste pharmaceuticals and evaluated dangerous
waste pharmaceuticals on-site for one hundred eighty calendar days or less. The
one hundred eighty days start after the potentially creditable dangerous waste
pharmaceuticals have been evaluated and applies to all dangerous waste
pharmaceuticals accumulated on-site, regardless of whether they are destined
for another reverse distributor (i.e., potentially creditable dangerous waste
pharmaceuticals) or a permitted or interim status treatment, storage, or
disposal facility (i.e., evaluated dangerous waste pharmaceuticals).
(ii) Aging pharmaceuticals. Unexpired
pharmaceuticals that are otherwise creditable but are awaiting their expiration
date (i.e., aging in a holding morgue) can be accumulated for up to one hundred
eighty days after the expiration date, provided that the unexpired
pharmaceuticals are managed in accordance with (a) through (j) of this
subsection and the container labeling and management standards in subsection
(14)(d)(i) through (vi) of this section.
(f) Security at the reverse distributor
facility. A reverse distributor must prevent unknowing entry and minimize the
possibility for the unauthorized entry into the portion of the facility where
potentially creditable dangerous waste pharmaceuticals and evaluated dangerous
waste pharmaceuticals are kept.
(i) Examples
of methods that may be used to prevent unknowing entry and minimize the
possibility for unauthorized entry include, but are not limited to:
(A) A twenty-four-hour continuous monitoring
surveillance system;
(B) An
artificial barrier such as a fence; or
(C) A means to control entry, such as keycard
access.
(ii) If the
reverse distributor already 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 security measures pursuant to this
subsection.
(g)
Contingency plan and emergency procedures at a reverse distributor. A reverse
distributor that accepts potentially creditable dangerous waste pharmaceuticals
from off-site must prepare a contingency plan and comply with other
requirements of WAC 172-303-201.
(h) Closure of a reverse distributor. When
closing an area where a reverse distributor accumulates potentially creditable
dangerous waste pharmaceuticals or evaluated dangerous waste pharmaceuticals,
the reverse distributor must comply with WAC
173-303-200(12)(a)
through (c).
(i) Reporting by a reverse distributor.
(i) Unauthorized waste report. A reverse
distributor must submit an unauthorized waste report if the reverse distributor
receives waste from off-site that it is not authorized to receive (e.g.,
nonpharmaceutical dangerous waste, regulated medical waste). The reverse
distributor must prepare and submit an unauthorized waste report to the
department's regional office it is located in within forty-five calendar days
after the unauthorized waste arrives at the reverse distributor and must send a
copy of the unauthorized waste report to the health care facility (or other
entity) that sent the unauthorized waste. The reverse distributor must manage
the unauthorized waste in accordance with all applicable regulations. The
unauthorized waste report must be signed by the owner or operator of the
reverse distributor and contain the following information:
(A) The EPA/state identification number, name
and address of the reverse distributor;
(B) The date the reverse distributor received
the unauthorized waste;
(C) The
EPA/state identification number, name and address of the health care facility
that shipped the unauthorized waste, if available;
(D) A description and the quantity of each
unauthorized waste the reverse distributor received;
(E) The method of treatment, storage, or
disposal for each unauthorized waste; and
(F) A brief explanation of why the waste was
unauthorized, if known.
(ii) Additional reports. The department may
require reverse distributors to furnish additional reports and documents of
potentially creditable dangerous waste pharmaceuticals and evaluated dangerous
waste pharmaceuticals.
(j) Recordkeeping by reverse distributors. A
reverse distributor must keep the following records (paper or electronic)
readily available upon request by an inspector. The periods of retention
referred to in this subsection are extended automatically during the course of
any unresolved enforcement actions regarding the regulated activity, or as
requested by the department.
(i) A copy of
its notification on file for as long as the facility is subject to this
section;
(ii) A copy of the
delivery confirmation and the shipping papers for each shipment of potentially
creditable dangerous waste pharmaceuticals that it receives, and a copy of each
unauthorized waste report, for at least five years from the date the shipment
arrives at the reverse distributor;
(iii) A copy of its current inventory for as
long as the facility is subject to this section.
(13)
Additional standards for reverse
distributors managing potentially creditable dangerous waste pharmaceuticals
destined for another reverse distributor. A reverse distributor that
does not have a permit or interim status must comply with the following
conditions, in addition to the requirements of subsection (12) of this section,
for the management of potentially creditable dangerous waste pharmaceuticals
that are destined for another reverse distributor for further evaluation or
verification of manufacturer credit:
(a) A
reverse distributor that receives potentially creditable dangerous waste
pharmaceuticals from a health care facility must send those potentially
creditable dangerous waste pharmaceuticals to another reverse distributor
within one hundred eighty days after the potentially creditable dangerous waste
pharmaceuticals have been evaluated or follow subsection (14) of this section
for evaluated dangerous waste pharmaceuticals.
(b) A reverse distributor that receives
potentially creditable dangerous waste pharmaceuticals from another reverse
distributor must send those potentially creditable dangerous waste
pharmaceuticals to a reverse distributor that is a pharmaceutical manufacturer
within one hundred eighty days after the potentially creditable dangerous waste
pharmaceuticals have been evaluated or follow subsection (14) of this section
for evaluated dangerous waste pharmaceuticals.
(c) A reverse distributor must ship
potentially creditable dangerous waste pharmaceuticals destined for another
reverse distributor in accordance with subsection (11) of this
section.
(d) Recordkeeping by
reverse distributors. A reverse distributor must keep the following records
(paper or electronic) readily available upon request by an inspector for each
shipment of potentially creditable dangerous waste pharmaceuticals that it
initiates to another reverse distributor, for at least five years from the date
of shipment. The periods of retention referred to in this subsection are
extended automatically during the course of any unresolved, enforcement actions
regarding the regulated activity, or as requested by the department.
(i) The confirmation of delivery;
and
(ii) The DOT shipping papers
prepared in accordance with 49 C.F.R. Part 172, Subpart C, if
applicable.
(14)
Additional standards for reverse
distributors managing evaluated dangerous waste pharmaceuticals. A
reverse distributor that does not have a permit or interim status must comply
with the following conditions, in addition to the requirements of subsection
(12) of this section, for the management of evaluated dangerous waste
pharmaceuticals:
(a) Accumulation area at the
reverse distributor. A reverse distributor must designate an on-site
accumulation area where it will accumulate evaluated dangerous waste
pharmaceuticals.
(b) Inspections of
on-site accumulation area. A reverse distributor must inspect its on-site
accumulation area at least once every seven days, looking at containers for
leaks and for deterioration caused by corrosion or other factors, as well as
for signs of diversion.
(c)
Personnel training at a reverse distributor. Personnel at a reverse distributor
that handle evaluated dangerous waste pharmaceuticals are subject to the
training requirements of WAC
173-303-200(9).
(d) Labeling and management of containers at
on-site accumulation areas. A reverse distributor accumulating evaluated
dangerous waste pharmaceuticals in containers in an on-site accumulation area
must:
(i) Label the containers with the words,
"hazardous waste pharmaceuticals" or "dangerous waste
pharmaceuticals";
(ii) Ensure the
containers are in good condition and managed to prevent leaks;
(iii) Use containers that are made of or
lined with materials which will not react with, and are otherwise compatible
with, the evaluated dangerous waste pharmaceuticals, so that the ability of the
container to contain the waste is not impaired;
(iv) Keep containers closed, if holding
liquid or gel evaluated dangerous waste pharmaceuticals. If the liquid or gel
evaluated dangerous waste pharmaceuticals are in their original, intact, sealed
packaging; or repackaged, intact, sealed packaging, they are considered to meet
the closed container standard;
(v)
Manage any container of ignitable or reactive evaluated dangerous waste
pharmaceuticals, or any container of commingled incompatible evaluated
dangerous waste pharmaceuticals so that the container does not have the
potential to:
(A) Generate extreme heat or
pressure, fire or explosion, or violent reaction;
(B) Produce uncontrolled toxic mists, fumes,
dusts, or gas in sufficient quantities to threaten human health;
(C) Produce uncontrolled flammable fumes or
gases in sufficient quantities to pose a risk of fire or explosions;
(D) Damage the structural integrity of the
container of dangerous waste pharmaceuticals; or
(E) Through other like means threaten human
health or the environment; and
(vi) Accumulate evaluated dangerous waste
pharmaceuticals that are prohibited from being combusted because of the
dilution prohibition of
40 C.F.R.
268.3(c) (e.g., arsenic
trioxide (P012)) in separate containers from other evaluated dangerous waste
pharmaceuticals at the reverse distributor.
(e) Dangerous waste numbers. Prior to
shipping evaluated dangerous waste pharmaceuticals off-site, all containers
must be marked with the applicable dangerous waste numbers (i.e., dangerous
waste codes). A nationally recognized electronic system, such as bar coding or
radio frequency identification, may be used to identify the dangerous waste
number(s).
(f) Shipments. A reverse
distributor must ship evaluated dangerous waste pharmaceuticals that are
destined for a permitted or interim status treatment, storage or disposal
facility with the applicable shipping standards in subsection (9)(a) or (b) of
this section.
(g) Procedures for a
reverse distributor for managing rejected shipments. A reverse distributor that
sends a shipment of evaluated dangerous 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 provision of WAC
173-303-370(5),
may accumulate the evaluated dangerous waste pharmaceuticals on-site for up to
an additional ninety days in the on-site accumulation area provided the
rejected or returned shipment is managed in accordance with subsection (12) of
this section and the requirements of this subsection. Upon receipt of the
returned shipment, the reverse distributor must:
(i) Sign either:
(A) Item 18c of the original manifest, if the
original manifest was used for the returned shipment; or
(B) Item 20 of the new manifest, if a new
manifest was used for the returned shipment;
(ii) Provide the transporter a copy of the
manifest;
(iii) Within thirty days
of receipt of the rejected shipment of the evaluated dangerous waste
pharmaceuticals, send a copy of the manifest to the designated facility that
returned the shipment to the reverse distributor; and
(iv) Within ninety days of receipt of the
rejected shipment, transport or offer for transport the returned shipment of
evaluated dangerous waste pharmaceuticals in accordance with the applicable
shipping standards of subsection (9)(a) or (b) of this section.
(h) Land disposal
restrictions. Evaluated dangerous waste pharmaceuticals are subject to the land
disposal restrictions of 40 C.F.R. Part 268. A reverse distributor that accepts
potentially creditable dangerous waste pharmaceuticals from off-site must
comply with the land disposal restrictions in accordance with 40 C.F.R. Part
268.7(a) requirements, as adopted by WAC
173-303-140(2)(c) and
(d).
(i) Annual reporting by a reverse distributor
for evaluated dangerous waste pharmaceuticals. A reverse distributor that ships
evaluated dangerous waste pharmaceuticals off-site must prepare and submit an
annual report to the department, according to the instructions on the Dangerous
Waste Annual Report form, no later than March 1st for the preceding calendar
year.
(j) Exception reporting by a
reverse distributor for a missing copy of the manifest.
(i) For shipments from a reverse distributor
to a designated facility.
(A) If a reverse
distributor does not receive a copy of the manifest with the signature of the
owner or operator of the designated facility within thirty-five days of the
date the evaluated dangerous waste pharmaceuticals were accepted by the initial
transporter, the reverse distributor must contact the transporter or the owner
or operator of the designated facility to determine the status of the evaluated
dangerous waste pharmaceuticals.
(B) A reverse distributor must submit an
exception report to the department's regional office in which the reverse
distributor is located if it has not received a copy of the manifest with the
signature of the owner or operator of the designated facility within forty-five
days of the date the evaluated dangerous waste pharmaceutical was accepted by
the initial transporter. The exception report must include:
(I) A legible copy of the manifest for which
the reverse distributor does not have confirmation of delivery; and
(II) A cover letter signed by the reverse
distributor, or its authorized representative, explaining the efforts taken to
locate the evaluated dangerous waste pharmaceutical and the results of those
efforts.
(ii)
For shipments rejected by the designated facility and shipped to an alternate
facility.
(A) A reverse distributor that does
not receive a copy of the manifest with the signature of the owner or operator
of the alternate facility within thirty-five days of the date the evaluated
dangerous waste pharmaceuticals were accepted by the initial transporter must
contact the transporter or the owner or operator of the alternate facility to
determine the status of the dangerous waste. The thirty-five-day time frame
begins the date the evaluated dangerous waste pharmaceuticals are accepted by
the transporter forwarding the dangerous waste shipment from the designated
facility to the alternate facility.
(B) A reverse distributor must submit an
exception report to the department's regional office in which the reverse
distributor is located if it has not received a copy of the manifest with the
signature of the owner or operator of the designated facility within forty-five
days of the date the evaluated dangerous waste pharmaceutical were accepted by
the initial transporter. The forty-five-day time frame begins the date the
evaluated dangerous waste pharmaceuticals are accepted by the transporter
forwarding the dangerous waste shipment from the designated facility to the
alternate facility. The exception report must include:
(I) A legible copy of the manifest for which
the generator does not have confirmation of delivery; and
(II) A cover letter signed by the reverse
distributor, or its authorized representative, explaining the efforts taken to
locate the evaluated dangerous waste pharmaceutical and the results of those
efforts.
(k) Recordkeeping by a reverse distributor
for evaluated dangerous waste pharmaceuticals.
(i) A reverse distributor must keep a log
(written or electronic) of the inspections of the on-site accumulation area, as
required by (b) of this subsection. This log must be retained as a record for
at least five years from the date of the inspection.
(ii) A reverse distributor must keep a copy
of each manifest signed in accordance with WAC
173-303-180(3)(a)
for five years or until it receives a signed copy from the designated facility
that received the evaluated dangerous waste pharmaceutical. This signed copy
must be retained as a record for at least five years from the date the
evaluated dangerous waste pharmaceutical was accepted by the initial
transporter.
(iii) A reverse
distributor must keep a copy of each annual report for at least five years from
the due date of the report.
(iv) A
reverse distributor must keep a copy of each exception report for at least five
years from the submission of the report.
(v) A reverse distributor must keep records
to document personnel training, in accordance with WAC
173-303-200(9)(b).
(vi) All records must be readily available
upon request by an inspector. The periods of retention referred to in this
subsection are extended automatically during the course of any unresolved
enforcement action regarding the regulated activity, or as required by the
department.
(15)
When a reverse distributor must
have a permit. A reverse distributor is an operator of a dangerous waste
treatment, storage, or disposal facility and is subject to the requirements of
WAC
173-303-600
and the permit requirements of WAC
173-303-800
if the reverse distributor:
(i) Does not meet
the conditions of subsections (12) through (15) of this section;
(ii) Accepts manifested dangerous waste from
off-site; or
(iii) Treats or
disposes of dangerous waste pharmaceuticals on-site.