Ohio Admin. Code 3745-266-510 - 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 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
a U.S. 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
October 5, 2020, 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
a U.S. 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
October 5. 2020, 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
after 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
permit by rule 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
permit by rule 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
permit by rule 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.
;
or
(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 the other requirements
of 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
the owner's or operator's 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 (or other entity) 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.
; and
(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.
;
and
(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 the requirements
in 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
calendar 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 calendar 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.
; and
(b) The department of transportation
(DOT) shipping papers prepared in
accordance with 49 C.F.R.
CFR 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 the requirements of 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
calendar 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.
;
or
(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)]
[i.e., metal-bearing EPA hazardous
waste numbers listed in the appendix to rule
3745-270-03 of the Administative
Code, unless one or more criteria in paragraphs (C)(1) to (C)(6) of rule
3745-270-03 of the
Administrative Code are met, or because such waste is prohibited from being lab
packed due to paragraph (C) of rule
3745-270-42 of the
Administrative Code (i.e., EPA hazardous waste numbers listed in appendix A to
rule 3745-270-42 of the
Administrative Code)], 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, except as provided in paragraph (A)(1)(c)(iii) of rule
3745-266-508 of the
Administrative Code. A nationally recognized electronic system, such as
bar coding or radio frequency identification tag,
may be used to identify the applicable EPA
hazardous waste numbers.
(6)
Shipments. A reverse distributor shall ship evaluated hazardous waste
pharmaceuticals that are destined for a permitted or interim standards
permit by
rule 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
rejected evaluated hazardous waste pharmaceuticals
on-site for up to an additional ninety calendar
days in the on-site accumulation area, provided the rejected
or returned shipment is managed in
accordance with paragraphs (A) and (C) of this
rule 3745-266-510 of the Administrative
Code. Upon receipt of the returned
rejected
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.
; or
(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
calendar 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.
;
and
(d) Within ninety
calendar 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 calendar
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 calendar
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.
; and
(ii) A cover letter signed by the reverse
distributor, or an
the reverse distributor's 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 calendar 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 calendar
days after the date the evaluated hazardous waste pharmaceuticals were accepted
by the initial transporter. The forty-five-day timeframe
time frame
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
reverse distributor does not have confirmation of
delivery.
;
and
(ii) A cover letter
signed by the reverse distributor, or an
the reverse
distributor's 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
is required
to 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 and
3745-205, 3745-65 to 3745-69,
3745-205, and 3745-256, and
rules 3745-50-40 to 3745-50-235
3745-267 of the Administrative Code,
and the permit requirements of Chapter 3745-50 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.
; or
(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."]
Notes
Promulgated Under: 119.03
Statutory Authority: 3734.12
Rule Amplifies: 3734.12
Prior Effective Dates: 10/05/2020
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