Ohio Administrative Code
Title 3745 - Ohio Environmental Protection Agency
Chapter 3745-266 - Disposal Standards
Section 3745-266-510 - Standards for the management of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals at reverse distributors
Universal Citation: OH Admin Code 3745-266-510
Current through all regulations passed and filed through December 16, 2024
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 an Ohio hazardous waste permit or without having permit by rule, provided that the reverse distributor complies with the following conditions:
(A) Standards for reverse distributors that manage potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.
(1)
Notification. A
reverse distributor shall notify Ohio EPA, using Ohio EPA form EPA 9029, that
the reverse distributor is a reverse distributor operating in accordance with
rules 3745-266-500 to
3745-266-510 of the
Administrative Code.
(a)
A reverse distributor that already has an EPA
identification number shall notify Ohio EPA, using Ohio EPA form EPA 9029, that
the reverse distributor is a "reverse distributor," as defined in rule
3745-266-500 of the
Administrative Code, within sixty days after the first effective date of rules
3745-266-500 to
3745-266-510 of the
Administrative Code, or within sixty days after becoming subject to rules
3745-266-500 to
3745-266-510 of the
Administrative Code.
(b)
A reverse distributor that does not have an EPA
identification number shall obtain one by notifying Ohio EPA, using Ohio EPA
form EPA 9029, that the reverse distributor is a "reverse distributor," as
defined in rule
3745-266-500 of the
Administrative Code, within sixty days after the first effective date of rules
3745-266-500 to
3745-266-510 of the
Administrative Code, or within sixty days after becoming subject to rules
3745-266-500 to
3745-266-510 of the
Administrative Code.
(2)
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.
(a)
A reverse
distributor shall inventory each potentially creditable hazardous waste
pharmaceutical within thirty calendar days of each waste arriving at the
reverse distributor.
(b)
The inventory shall include the identity (e.g., name or
national drug code) and quantity of each potentially creditable hazardous waste
pharmaceutical and evaluated hazardous waste pharmaceutical.
(c)
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 reverse distributor is not required to provide a separate inventory
pursuant to this rule.
(3)
Evaluation by a
reverse distributor that is not a manufacturer. A reverse distributor that is
not a pharmaceutical manufacturer shall evaluate a potentially creditable
hazardous waste pharmaceutical within thirty calendar days after the waste's
arrival at the reverse distributor to establish whether the waste is destined
for another reverse distributor for further evaluation or verification of
manufacturer credit or for a permitted or interim standards treatment, storage,
or disposal facility.
(a)
A potentially creditable hazardous waste pharmaceutical
that is destined for another reverse distributor is still considered a
"potentially creditable hazardous waste pharmaceutical" and shall be managed in
accordance with paragraph (B) of this rule.
(b)
A potentially
creditable hazardous waste pharmaceutical that is destined for a permitted or
interim standards treatment, storage, or disposal facility is considered an
"evaluated hazardous waste pharmaceutical" and shall be managed in accordance
with paragraph (C) of this rule.
(4)
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 thirty calendar days
after the waste's arrival at the facility and following the evaluation shall
manage the evaluated hazardous waste pharmaceuticals in accordance with
paragraph (C) of this rule.
(5)
Maximum
accumulation time for hazardous waste pharmaceuticals at a reverse
distributor.
(a)
A reverse distributor may accumulate potentially
creditable hazardous waste pharmaceuticals and evaluated hazardous waste
pharmaceuticals on-site for one hundred eighty calendar days or less. The one
hundred eighty days start after the potentially creditable hazardous waste
pharmaceutical has been evaluated and applies to all hazardous waste
pharmaceuticals accumulated on-site, regardless of whether the hazardous waste
pharmaceuticals are destined for another reverse distributor (i.e., potentially
creditable hazardous waste pharmaceuticals) or a permitted or interim standards
treatment, storage, or disposal facility (i.e., evaluated hazardous waste
pharmaceuticals).
(b)
Aging pharmaceuticals. Unexpired pharmaceuticals that
are otherwise creditable but are awaiting the 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 paragraph (A) of this rule and the container labeling and
management standards in paragraph (C)(4) of this rule.
(6)
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.
(a)
Examples of methods that may be used to prevent
unknowing entry and minimize the possibility for unauthorized entry include,
but are not limited to, the following:
(i)
A
twenty-four-hour continuous monitoring surveillance system.
(ii)
An artificial
barrier such as a fence.
(iii)
A means to
control entry, such as keycard access.
(b)
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 reverse distributor is not required to
provide separate security measures pursuant to this rule.
(7)
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 comply with rules
3745-52-250 to
3745-52-265 of the
Administrative Code.
(8)
Closure of a reverse distributor. When closing an area
where a reverse distributor accumulates potentially creditable hazardous waste
pharmaceuticals or evaluated hazardous waste pharmaceuticals, the reverse
distributor shall comply with paragraphs (A)(8)(b) and (A)(8)(c) of rule
3745-52-17 of the Administrative
Code.
(9)
Reporting by a reverse distributor.
(a)
Unauthorized
waste report. A reverse distributor shall submit an unauthorized waste report
if the reverse distributor receives waste from off-site that the reverse
distributor is not authorized to receive (e.g., non-pharmaceutical hazardous
waste, regulated medical waste). The reverse distributor shall prepare and
submit an unauthorized waste report to the director within forty-five calendar
days 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 entity) that sent the unauthorized waste. The reverse distributor shall
manage the unauthorized waste in accordance with all applicable rules. The
unauthorized waste report shall be signed by the owner or operator of the
reverse distributor, or an authorized representative, and contain all of the
following information:
(i)
The U.S. EPA identification number, name, and address
of the reverse distributor.
(ii)
The date the
reverse distributor received the unauthorized waste.
(iii)
The U.S. EPA
identification number, name, and address of the healthcare facility that
shipped the unauthorized waste, if available.
(iv)
A description
and the quantity of each unauthorized waste the reverse distributor
received.
(v)
The method of treatment, storage, or disposal for each
unauthorized waste.
(vi)
A brief explanation of why the waste was unauthorized,
if known.
(b)
Additional reports. The director may require reverse
distributors to submit additional reports concerning the quantities and
disposition of potentially creditable hazardous waste pharmaceuticals and
evaluated hazardous waste pharmaceuticals.
(10)
Recordkeeping by
reverse distributors. A reverse distributor shall keep all of the following
records (paper or electronic) readily available upon request by an inspector.
The periods of retention referred to in this rule are extended automatically
during the course of any unresolved enforcement action regarding the regulated
activity, or as requested by the director.
(a)
A copy of the
reverse distributor's notification on file for as long as the facility is
subject to rules
3745-266-500 to
3745-266-510 of the
Administrative Code.
(b)
A copy of the delivery confirmation and the shipping
papers for each shipment of potentially creditable hazardous waste
pharmaceuticals that the reverse distributor receives, and a copy of each
unauthorized waste report, for at least three years after the date the shipment
arrives at the reverse distributor.
(c)
A copy of the
reverse distributor's current inventory for as long as the facility is subject
to rules
3745-266-500 to
3745-266-510 of the
Administrative Code.
(B) Additional standards for reverse distributors that manage potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor. A reverse distributor that does not have an Ohio hazardous waste permit or permit by rule shall comply with the following conditions, in addition to paragraph (A) of this rule, for the management of potentially creditable hazardous waste pharmaceuticals that are destined for another reverse distributor for further evaluation or verification of manufacturer credit:
(1)
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 one hundred eighty days after the potentially creditable hazardous waste
pharmaceuticals have been evaluated, or follow paragraph (C) of this rule for
evaluated hazardous waste pharmaceuticals.
(2)
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 one hundred eighty days after the
potentially creditable hazardous waste pharmaceuticals have been evaluated, or
follow paragraph (C) of this rule for evaluated hazardous waste
pharmaceuticals.
(3)
A reverse distributor shall ship potentially creditable
hazardous waste pharmaceuticals destined for another reverse distributor in
accordance with rule
3745-266-509 of the
Administrative Code.
(4)
Recordkeeping by reverse distributors. 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 the reverse distributor
initiates to another reverse distributor, for at least three years after the
date of shipment. The periods of retention referred to in this rule are
extended automatically during the course of any unresolved enforcement action
regarding the regulated activity, or as requested by the director.
(a)
The confirmation
of delivery.
(b)
The department of transportation (DOT) shipping papers
prepared in accordance with 49 C.F.R. Part 172 subpart C, if
applicable.
(C) Additional standards for reverse distributors that manage evaluated hazardous waste pharmaceuticals. A reverse distributor that does not have an Ohio hazardous waste permit or permit by rule shall comply with the following conditions, in addition to paragraph (A) of this rule, for the management of evaluated hazardous waste pharmaceuticals:
(1)
Accumulation area at the reverse distributor. A reverse
distributor shall designate an on-site accumulation area where the reverse
distributor shall accumulate evaluated hazardous waste
pharmaceuticals.
(2)
Inspections of on-site accumulation area. A reverse
distributor shall inspect the reverse distributor's 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.
(3)
Personnel training at a reverse distributor. Personnel
at a reverse distributor who handle evaluated hazardous waste pharmaceuticals
are subject to the training requirements of paragraph (A)(7) of rule
3745-52-17 of the Administrative
Code.
(4)
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:
(a)
Label the containers with the words, "Hazardous Waste
Pharmaceuticals."
(b)
Ensure the containers are in good condition and managed
to prevent leaks.
(c)
Use containers that are made of or lined with materials
which shall 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.
(d)
Keep containers
closed, if holding liquid or gel evaluated hazardous waste pharmaceuticals. If
the liquid or gel evaluated hazardous waste pharmaceuticals are in the
original, intact, sealed packaging; or repackaged, intact, sealed packaging,
the evaluated hazardous waste pharmaceuticals are considered to meet the closed
container standard.
(e)
Manage any container of ignitable or reactive evaluated
hazardous waste pharmaceuticals, or any container of commingled incompatible
evaluated hazardous waste pharmaceuticals, so that the container does not have
the potential to do any of the following:
(i)
Generate extreme
heat or pressure, fire or explosion, or violent reaction.
(ii)
Produce
uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to
threaten human health.
(iii)
Produce uncontrolled flammable fumes or gases in
sufficient quantities to pose a risk of fire or explosions.
(iv)
Damage the
structural integrity of the container of hazardous waste
pharmaceuticals.
(v)
Through other like means threaten human health or the
environment.
(f)
Accumulate evaluated hazardous waste pharmaceuticals
that are prohibited from being combusted because of the dilution prohibition of
paragraph (C) of rule
3745-270-03 of the
Administrative Code [e.g., arsenic trioxide (P012)] in separate containers from
other evaluated hazardous waste pharmaceuticals at the reverse
distributor.
(5)
EPA hazardous waste numbers. Prior to shipping
evaluated hazardous waste pharmaceuticals off-site, all containers shall be
marked with the applicable EPA hazardous waste numbers. A nationally recognized
electronic system, such as bar coding or radio frequency identification, may be
used to identify the EPA hazardous waste numbers.
(6)
Shipments. A
reverse distributor shall ship evaluated hazardous waste pharmaceuticals that
are destined for a permitted or interim standards treatment, storage, or
disposal facility in accordance with the applicable shipping standards in
paragraph (A) or (B) of rule
3745-266-508 of the
Administrative Code.
(7)
Procedures for a reverse distributor to manage rejected
shipments. A reverse distributor that sends a shipment of evaluated 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 of rule
3745-54-72 or
3745-65-72 of the Administrative
Code, may accumulate the returned evaluated hazardous 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
paragraphs (A) and (C) of rule
3745-266-510 of the
Administrative Code. Upon receipt of the returned shipment, the reverse
distributor shall do all of the following:
(a)
Sign either of
the following:
(i)
Item 18c of the original manifest, if the original
manifest was used for the returned shipment.
(ii)
Item 20 of the
new manifest, if a new manifest was used for the returned
shipment.
(b)
Provide the transporter a copy of the
manifest.
(c)
Within thirty days after receipt of the rejected
shipment of the evaluated hazardous waste pharmaceuticals, send a copy of the
manifest to the designated facility that returned the shipment to the reverse
distributor.
(d)
Within ninety days after receipt of the rejected
shipment, transport or offer for transport the returned shipment of evaluated
hazardous waste pharmaceuticals in accordance with the applicable shipping
standards of paragraph (A) or (B) of rule
3745-266-508 of the
Administrative Code.
(8)
Land disposal
restrictions. Evaluated hazardous waste pharmaceuticals are subject to the land
disposal restrictions of Chapter 3745-270 of the Administrative Code. A reverse
distributor that accepts potentially creditable hazardous waste pharmaceuticals
from off-site shall comply with the land disposal restrictions in accordance
with paragraph (A) of rule
3745-270-07 of the
Administrative Code.
(9)
Reporting by a reverse distributor for evaluated
hazardous waste pharmaceuticals.
(a)
Biennial reporting by a reverse distributor. A reverse
distributor that ships evaluated hazardous waste pharmaceuticals off-site shall
prepare and submit a single copy of a biennial report to the director by March
first of each even numbered year in accordance with rule
3745-52-41 of the Administrative
Code.
(b)
Exception reporting by a reverse distributor for a
missing copy of the manifest.
(i)
For shipments from a reverse distributor to a
designated facility, the reverse distributor shall do the following:
(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 after the
date the evaluated hazardous waste pharmaceuticals were accepted by the initial
transporter, the reverse distributor shall contact the transporter or the owner
or operator of the designated facility to determine the status of the evaluated
hazardous waste pharmaceuticals.
(b)
A reverse
distributor shall submit an exception report to the director if the reverse
distributor has not received a copy of the manifest with the signature of the
owner or operator of the designated facility within forty-five days after the
date the evaluated hazardous waste pharmaceutical was accepted by the initial
transporter. The exception report shall include both of the following:
(i)
A legible copy of
the manifest for which the reverse distributor does not have confirmation of
delivery.
(ii)
A cover letter signed by the reverse distributor, or an
authorized representative, explaining the efforts taken to locate the evaluated
hazardous waste pharmaceuticals and the results of those
efforts.
(ii)
For shipments
rejected by the designated facility and shipped to an alternate facility, the
reverse distributor shall do the following:
(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 after
the date the evaluated hazardous waste pharmaceuticals were accepted by the
initial transporter shall contact the transporter or the owner or operator of
the alternate facility to determine the status of the hazardous waste. The
thirty-five-day time frame begins the date the evaluated hazardous waste
pharmaceuticals are accepted by the transporter forwarding the hazardous waste
shipment from the designated facility to the alternate
facility.
(b)
A reverse distributor shall submit an exception report
to the director if the reverse distributor has not received a copy of the
manifest with the signature of the owner or operator of the alternate facility
within forty-five days after the date the evaluated hazardous waste
pharmaceuticals were accepted by the initial transporter. The forty-five-day
timeframe begins the date the evaluated hazardous waste pharmaceuticals are
accepted by the transporter forwarding the hazardous waste pharmaceutical
shipment from the designated facility to the alternate facility. The exception
report shall include both of the following:
(i)
A legible copy of
the manifest for which the generator does not have confirmation of
delivery.
(ii)
A cover letter signed by the reverse distributor, or an
authorized representative, explaining the efforts taken to locate the evaluated
hazardous waste pharmaceuticals and the results of those
efforts.
(10)
Recordkeeping by
a reverse distributor for evaluated hazardous waste pharmaceuticals.
(a)
A reverse
distributor shall keep a log (written or electronic) of the inspections of the
on-site accumulation area, required by paragraph (C) (2) of this rule. This log
shall be retained as a record for at least three years after the date of the
inspection.
(b)
A reverse distributor shall keep a copy of each
manifest signed in accordance with paragraph (A) of rule
3745-52-23 of the Administrative
Code for three years or until the reverse distributor receives a signed copy
from the designated facility that received the evaluated hazardous waste
pharmaceutical. This signed copy shall be retained as a record for at least
three years after the date the evaluated hazardous waste pharmaceutical was
accepted by the initial transporter.
(c)
A reverse
distributor shall keep a copy of each biennial report for at least three years
after the due date of the report.
(d)
A reverse
distributor shall keep a copy of each exception report for at least three years
after the submittal of the report.
(e)
A reverse
distributor shall keep records to document personnel training, in accordance
with paragraph (A)(7)(d) of rule
3745-52-17 of the Administrative
Code.
(f)
All records shall be readily available upon request by
an inspector. The periods of retention referred to in this rule are extended
automatically during the course of any unresolved enforcement action regarding
the regulated activity, or as requested by the director.
(D) When a reverse distributor shall have a permit. A reverse distributor is an operator of a hazardous waste treatment, storage, or disposal facility and is subject to the requirements of Chapters 3745-54 to 3745-57, 3745-65 to 3745-69, 3745-205, and 3745-256 and rules 3745-50-40 to 3745-50-235 of the Administrative Code, if the reverse distributor does any of the following:
(1)
Does not meet the conditions of this rule.
(2)
Accepts
manifested hazardous waste from off-site.
(3)
Treats or
disposes of hazardous waste pharmaceuticals on-site.
[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see rule 3745-50-11 of the Administrative Code titled "Incorporated by reference."]
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