Utah Admin. Code R315-266-510 - Hazardous Waste Pharmaceuticals - Standards for the Management of Potentially Creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals at Reverse Distributors
A
(a) Standards for reverse distributors
managing potentially creditable hazardous waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals.
(1)
Notification. A reverse distributor shall notify the Director , using the Site
Identification Form, EPA Form 8700-12, that it is a reverse distributor
operating under Sections R315-266-500 through R315-266-510.
(i) A reverse distributor that already has an
EPA identification number shall notify the Director , using the Site
Identification Form, EPA Form 8700-12, that it is a reverse distributor , as
defined in Section R315-266-500, within 60 days of the effective date of
Sections R315-266-500 through R315-266-510, or within 60 days of becoming
subject to Sections R315-266-500 through R315-266-510.
(ii) A reverse distributor that does not have
an EPA identification number shall obtain one by notifying the Director , using
the Site Identification Form, EPA Form 8700-12, that it is a reverse
distributor , as defined in Section R315-266-500, within 60 days of the
effective date of Sections R315-266-500 through R315-266-510, or within 60 days
of becoming subject to Sections R315-266-500 through R315-266-510.
(2) Inventory by the reverse
distributor . A reverse distributor shall maintain a current inventory of the
potentially creditable hazardous waste pharmaceuticals and evaluated hazardous
waste pharmaceuticals that are accumulated on site.
(i) A reverse distributor shall inventory
each potentially creditable hazardous waste pharmaceutical within 30 calendar
days of each waste arriving at the reverse distributor .
(ii) The inventory shall include the
identity, for example, name or national drug code, and quantity of each
potentially creditable hazardous waste pharmaceutical and evaluated hazardous
waste pharmaceutical .
(iii) If the
reverse distributor already meets the inventory requirements of Subsection
R315-266-510(a)(2) because of other regulatory requirements, such as State
Board of Pharmacy regulations, the facility is not required to provide a
separate inventory pursuant to Section R315-266-510.
(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 30 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 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 Subsection R315-266-510(b).
(ii) A potentially creditable hazardous waste
pharmaceutical that is destined for a permitted or interim status treatment,
storage or disposal facility is considered an "evaluated hazardous waste
pharmaceutical " and shall be managed in accordance with Subsection
R315-266-501(c).
(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
30 calendar days of the waste arriving at the facility and following the
evaluation shall manage the evaluated hazardous waste pharmaceuticals in
accordance with Subsection R315-266-501(c).
(5) Maximum accumulation time for hazardous
waste pharmaceuticals at a reverse distributor .
(i) A reverse distributor may accumulate
potentially creditable hazardous waste pharmaceuticals and evaluated hazardous
waste pharmaceuticals on site for 180 calendar days or less. The 180 days start
after the potentially creditable hazardous waste pharmaceutical has been
evaluated and applies to any hazardous waste pharmaceuticals accumulated on
site, regardless of whether they are destined for another reverse distributor ,
that is potentially creditable hazardous waste pharmaceuticals, or a permitted
or interim status treatment, storage, or disposal facility , that is evaluated
hazardous waste pharmaceuticals.
(ii) Aging pharmaceuticals. Unexpired
pharmaceuticals that are otherwise creditable but are awaiting their expiration
date, in other words, aging in a holding morgue, can be accumulated for up to
180 days after the expiration date, provided that the unexpired pharmaceuticals
are managed in accordance with Subsection R315-266-510(a) and the container
labeling and management standards in Subsections R315-266-510(c)(4)(i) through
R315-266-510(c)(4)(vi).
(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.
(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 24-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 Subsection
R315-266-510(a)(6) 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 Section
R315-266-510.
(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 Sections
R315-262-250
through
R315-262-265.
(8) Closure of a reverse distributor . If
closing an area where a reverse distributor accumulates potentially creditable
hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals,
the reverse distributor shall comply with Subsections
R315-262-17(a)(8)(ii)
and
R315-262-17(a)(8)(iii).
(9) Reporting by a reverse distributor .
(i) Unauthorized waste report. A reverse
distributor shall submit an unauthorized waste report if the reverse
distributor receives waste from off site that it is not authorized to receive,
for example, non-pharmaceutical hazardous waste , regulated medical waste . The
reverse distributor shall prepare and submit an unauthorized waste report to
the Director within 45 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
applicable rules. The unauthorized waste report shall be signed by the owner or
operator of the reverse distributor , or its authorized representative, and
contain the following information:
(A) the
EPA identification number, name and address of the reverse
distributor ;
(B) the date the
reverse distributor received the unauthorized waste ;
(C) the EPA identification number, name, and
address of the healthcare 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 Director may
require reverse distributors to furnish 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 certain records, paper or
electronic, readily available upon request by an inspector. The periods of
retention referred to in Section R315-266-510 are extended automatically during
the course of any unresolved enforcement action regarding the regulated
activity , or as requested by the Director . A reverse distributor shall keep the
following records:
(i) a copy of its
notification on file for as long as the facility is subject to Sections
R315-266-500 through R315-266-510;
(ii) a copy of the delivery confirmation and
the shipping papers for each shipment of potentially creditable hazardous waste
pharmaceuticals that it receives, and a copy of each unauthorized waste report,
for at least three years from the date the shipment arrives at the reverse
distributor ; and
(iii) a copy of
its current inventory for as long as the facility is subject to Sections
R315-266-500 through R315-266-510.
(b) Additional standards for reverse
distributors managing potentially creditable hazardous waste pharmaceuticals
destined for another reverse distributor . A reverse distributor that does not
have a permit or interim status shall comply with the following conditions, in
addition to the requirements in Subsection R315-266-510(a), 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 180 days after the
potentially creditable hazardous waste pharmaceuticals have been evaluated or
follow Subsection R315-266-510(c) 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 180 days after the potentially creditable
hazardous waste pharmaceuticals have been evaluated or follow Subsection
R315-266-510(c) for evaluated hazardous waste pharmaceuticals.
(3) A reverse distributor shall ship
potentially creditable hazardous waste pharmaceuticals destined for another
reverse distributor in accordance with Section R315-266-509.
(4) Recordkeeping by reverse distributors. A
reverse distributor shall keep certain records, paper or electronic, readily
available upon request by an inspector for each shipment of potentially
creditable hazardous waste pharmaceuticals that it initiates to another reverse
distributor , for at least three years from the date of shipment.
The periods of retention referred to in Section R315-266-510
are extended automatically during the course of any unresolved enforcement
action regarding the regulated
(i) the confirmation of delivery;
and
(ii) the DOT shipping papers
prepared in accordance with 49 CFR part 172 subpart C, if applicable.
(c) Additional
standards for reverse distributors managing evaluated hazardous waste
pharmaceuticals. A reverse distributor that does not have a permit or interim
status shall comply with the following conditions, in addition to the
requirements of Subsection R315-266-510(a), 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 it will accumulate evaluated
hazardous waste pharmaceuticals.
(2) Inspections of on-site accumulation area.
A reverse distributor shall 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.
(3) Personnel training at a reverse
distributor . Personnel at a reverse distributor that handle evaluated hazardous
waste pharmaceuticals are subject to the training requirements of Subsection
R315-262-17(a)(7).
(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:
(i) label the containers with the
words, "hazardous 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 hazardous 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 hazardous waste pharmaceuticals. If the liquid or gel
evaluated hazardous 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 hazardous waste
pharmaceuticals, or any container of commingled incompatible evaluated
hazardous 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 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 of hazardous waste pharmaceuticals; or
(E) through other like means threaten human
health or the environment; and
(vi) accumulate evaluated hazardous waste
pharmaceuticals that are prohibited from being combusted because of the
dilution prohibition of Subsection
R315-268-3(c),
for example, arsenic trioxide (P012), in separate containers from other
evaluated hazardous waste pharmaceuticals at the reverse distributor .
(5) Hazardous waste numbers. Prior
to shipping evaluated hazardous waste pharmaceuticals off site, each container
shall be marked with the applicable hazardous waste numbers, in other words
hazardous waste codes. 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 status treatment,
storage or disposal facility in accordance with the applicable shipping
standards in Subsections R315-266-508(a) or R315-266-508(b).
(7) Procedures for a reverse distributor for
managing 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 Section
R315-264-72
or
R315-265-72,
may accumulate the returned evaluated hazardous waste pharmaceuticals on site
for up to an additional 90 days in the on-site accumulation area provided the
rejected or returned shipment is managed in accordance with Subsections
R315-266-510(a) and R315-266-510(c). Upon receipt of the returned shipment, the
reverse distributor shall:
(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 30 days of
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
(iv) within 90 days of 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 Subsection R315-266-508(a) or R315-266-508(b).
(8) Land disposal restrictions.
Evaluated hazardous waste pharmaceuticals are subject to the land disposal
restrictions of Rule R315-268. A reverse distributor that accepts potentially
creditable hazardous waste pharmaceuticals from off-site shall comply with the
land disposal restrictions in accordance with the requirements of Subsection
R315-268-7(a).
(9) Reporting by a reverse distributor for
evaluated hazardous waste pharmaceuticals.
(i) 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 1 of each even numbered year in accordance with
Section
R315-262-41.
(ii) Exception reporting by a reverse
distributor for a missing copy of the manifest.
(A) For shipments from a reverse distributor
to a designated facility .
(I) 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 35 days of 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.
(II) A reverse distributor shall submit an
exception report to the Director if it has not received a copy of the manifest
with the signature of the owner or operator of the designated facility within
45 days of the date the evaluated hazardous waste pharmaceutical was accepted
by the initial transporter. The exception report shall include:
(1) a legible copy of the manifest for which
the reverse distributor does not have confirmation of delivery; and
(2) a cover letter signed by the reverse
distributor , or its authorized representative, explaining the efforts taken to
locate the evaluated hazardous waste pharmaceuticals and the results of those
efforts.
(B)
For shipments rejected by the designated facility and shipped to an alternate
facility .
(I) 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 35 days of 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 35-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 .
(II) A reverse
distributor shall submit an Exception Report to the Director if it has not
received a copy of the manifest with the signature of the owner or operator of
the alternate facility within 45 days of the date the evaluated hazardous waste
pharmaceuticals were accepted by the initial transporter. The 45-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:
(1) a legible copy of the manifest
for which the generator does not have confirmation of delivery; and
(2) a cover letter signed by the reverse
distributor , or its 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.
(i) A reverse distributor shall keep a log,
written or electronic, of the inspections of the on-site accumulation area,
required by Subsection R315-266-510(c)(2). This log shall be retained as a
record for at least three years from the date of the inspection .
(ii) A reverse distributor shall keep a copy
of each manifest signed in accordance with Subsection
R315-262-23(a)
for three years or until it 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 from the date the
evaluated hazardous waste pharmaceutical was accepted by the initial
transporter.
(iii) A reverse
distributor shall keep a copy of each biennial report for at least three years
from the due date of the report.
(iv) A reverse distributor shall keep a copy
of each exception report for at least three years from the submission of the
report.
(v) A reverse distributor
shall keep records to document personnel training, in accordance with
Subsection
R315-262-17(a)(7)(iv).
(vi) Records shall be readily available upon
request by an inspector. The periods of retention referred to in Section
R315-266-510 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 Rules R315-264, and R315-265, and the permit
requirements of Rule R315-270, if the reverse distributor :
(1) does not meet the conditions of Section
R315-266-510;
(2) accepts
manifested hazardous waste from off site; or
(3) treats or disposes of hazardous waste
pharmaceuticals on site.
Notes
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