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TITLE 30ENVIRONMENTAL QUALITY
PART 1TEXAS COMMISSION ON ENVIRONMENTAL QUALITY
CHAPTER 335INDUSTRIAL SOLID WASTE AND MUNICIPAL HAZARDOUS WASTE
SUBCHAPTER WMANAGEMENT STANDARDS FOR HAZARDOUS WASTE PHARMACEUTICALS
RULE §335.771Standards for the Management of Potentially Creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals by Reverse Distributors

(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.

(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:

Cont'd...

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