Texas Administrative Code › Title 30 - ENVIRONMENTAL QUALITY › Part 1 - TEXAS COMMISSION ON ENVIRONMENTAL QUALITY › Chapter 335 - INDUSTRIAL SOLID WASTE AND MUNICIPAL HAZARDOUS WASTE › Subchapter W - MANAGEMENT STANDARDS FOR HAZARDOUS WASTE PHARMACEUTICALS › Section 335.771 - Standards for the Management of Potentially Creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals by Reverse Distributors

Current through Reg. 49, No. 28; July 12, 2024
(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;
(C) A copy of its current inventory for as
				  long as the facility is subject to this subchapter.