(a) 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 a hazardous waste permit or
without having interim status, provided that it complies with the
conditions in this section. The following standards apply to reverse
distributors managing potentially creditable hazardous waste pharmaceuticals
and evaluated hazardous waste pharmaceuticals.
(1) Registration. A reverse distributor must register
with the executive director in accordance with §335.6 of this
title (relating to Notification Requirements) using a method approved
by the executive director within 60 days of becoming subject to this
chapter.
(2) Inventory by the reverse distributor. A reverse
distributor must 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 must inventory each potentially
creditable hazardous waste pharmaceutical within 30 calendar days
of each waste arriving at the reverse distributor.
(B) The inventory must 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) A reverse distributor that meets the inventory
requirements of this paragraph by complying with other regulatory
requirements, such as the Texas State Board of Pharmacy regulations,
is not required to provide a separate inventory pursuant to this section.
(3) Evaluation by a reverse distributor that is not
a manufacturer. A reverse distributor that is not a pharmaceutical
manufacturer must 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.
(A) A potentially creditable hazardous waste pharmaceutical
that is destined for another reverse distributor is still considered
a "potentially creditable hazardous waste pharmaceutical" and must
be managed in accordance with subsection (b) of this section.
(B) 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 must be managed in accordance with subsection (c) of this section.
(4) Evaluation by a reverse distributor that is a manufacturer.
A reverse distributor that is a pharmaceutical manufacturer must evaluate
a potentially creditable hazardous waste pharmaceutical to verify
manufacturer credit within 30 calendar days of the waste arriving
at the facility. Following the evaluation, the reverse distributor
must manage the evaluated hazardous waste pharmaceuticals in accordance
with subsection (c) of this section.
(5) Maximum accumulation time. The maximum accumulation
time for hazardous waste pharmaceuticals at a reverse distributor
is outlined in subparagraphs (A) and (B) of this paragraph.
(A) 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 all hazardous waste pharmaceuticals
accumulated on site, regardless of whether they are destined for another
reverse distributor (i.e., potentially creditable hazardous waste
pharmaceuticals) or a permitted or interim status treatment, storage,
or disposal facility (i.e., evaluated hazardous waste pharmaceuticals).
(B) 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 180 days after the expiration date, provided
that the unexpired pharmaceuticals are managed in accordance with
subsection (a) of this section and the container labeling and management
standards in §335.771(c)(4)(A) - (F).
(6) 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 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:
(i) a 24-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 subsection because of other regulatory requirements,
such as Drug Enforcement Administration or Texas State Board of Pharmacy
regulations, the facility is not required to provide separate security
measures pursuant to this section.
(7) Contingency plan and emergency procedures at a
reverse distributor. A reverse distributor that accepts potentially
creditable hazardous waste pharmaceuticals from off-site must prepare
a contingency plan and comply with the other requirements of 40 Code
of Federal Regulations (CFR) Part 262, Subpart M as adopted under §335.61
of this title (relating to Preparedness, Prevention, and Emergency
Procedures for Large Quantity Generators).
(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 must comply with §335.8 of this title
(relating to Closure and Remediation) and 40 CFR §262.17(a)(8)(ii)
and (iii) as adopted under §335.53 of this title (relating to
General Standards Applicable to Generators of Hazardous Waste).
(9) Reporting. Reverse distributors are subject to
the following reporting requirements.
(A) 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., non-pharmaceutical hazardous
waste, regulated medical waste). The reverse distributor must prepare
and submit an unauthorized waste report to the executive director
within 45 calendar days after the unauthorized waste arrives at the
reverse distributor and must send a copy of the unauthorized waste
report to the healthcare 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, or its authorized representative, and contain the following
information:
(i) the United States Environmental Protection Agency
(EPA) identification number, name and address of the reverse distributor;
(ii) the date the reverse distributor received the
unauthorized waste;
(iii) the 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; and
(vi) a brief explanation of why the waste was unauthorized,
if known.
(B) The executive 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 must keep the following records (paper or electronic)
readily available upon request by an inspector. 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) A copy of its notification on file for as long
as the facility is subject to this subchapter;
(B) 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;
Cont'd... |