| (C) A copy of its current inventory for as long as
the facility is subject to this subchapter.
(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 must comply with the following conditions,
in addition to the requirements in subsection (a) of this section,
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
must 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 (c) of this section for evaluated hazardous waste
pharmaceuticals.
(2) A reverse distributor that receives potentially
creditable hazardous waste pharmaceuticals from another reverse distributor
must 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 (c) of this section for evaluated
hazardous waste pharmaceuticals.
(3) A reverse distributor must ship potentially creditable
hazardous waste pharmaceuticals destined for another reverse distributor
in accordance with §335.769 of this title (relating to Shipping
Potentially Creditable Hazardous Waste Pharmaceuticals from a Healthcare
Facility or a Reverse Distributor to a Reverse Distributor).
(4) 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 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 this section
are extended automatically during the course of any unresolved enforcement
action regarding the regulated activity, or as requested by the executive
director.
(A) The confirmation of delivery; and
(B) 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 must comply with the following
conditions, in addition to the requirements of subsection (a) of this
section, for the management of evaluated hazardous waste pharmaceuticals:
(1) Accumulation area at the reverse distributor. A
reverse distributor must designate an on-site accumulation area where
it will accumulate evaluated hazardous waste pharmaceuticals.
(2) 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.
(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 40 CFR §262.17(a)(7)
as adopted under §335.53 of this title.
(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
must:
(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 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;
(D) 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;
(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:
(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; and
(F) Accumulate evaluated hazardous waste pharmaceuticals
that are prohibited from being combusted because of the dilution prohibition
of 40 CFR §268.3(c) as adopted under §335.431 of this title
(relating to Purpose, Scope, and Applicability) (e.g., arsenic trioxide
(P012)) in separate containers from other evaluated hazardous waste
pharmaceuticals at the reverse distributor.
(5) United States Environmental Protection Agency (EPA)
hazardous waste numbers. Prior to shipping evaluated hazardous waste
pharmaceuticals off-site, all containers must 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 number(s).
(6) Shipments. A reverse distributor must 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 §335.767(a) or (b)
of this title (relating to Shipping Non-Creditable Hazardous Waste
Pharmaceuticals from a Healthcare Facility or Evaluated Hazardous
Waste Pharmaceuticals from a Reverse Distributor).
(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 40
CFR §264.72 as adopted under §335.152 of this title (relating
to Standards) or 40 CFR §265.72 as adopted under §335.112
of this title (relating to Standards) 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 subsection (a) or
(c) of this section. Upon receipt of the returned shipment, the reverse
distributor must:
(A) Sign either:
(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 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
(D) 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 §335.767(a) or (b) of this title.
(8) Land disposal restrictions. Evaluated hazardous
waste pharmaceuticals are subject to the land disposal restrictions
of 40 CFR Part 268 as adopted under Subchapter O of this chapter (relating
to Land Disposal Restrictions). A reverse distributor that accepts
potentially creditable hazardous waste pharmaceuticals from off-site
must comply with the land disposal restrictions in accordance with
40 CFR §268.7(a) as adopted under §335.431 of this title
(relating to Purpose, Scope, and Applicability).
(9) Reporting by a reverse distributor for evaluated
hazardous waste pharmaceuticals. Reverse distributors are subject
to the following reporting requirements.
(A) A reverse distributor that ships evaluated hazardous
waste pharmaceuticals off-site must:
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