(a) A healthcare facility that is a very small quantity generator when counting all of its hazardous waste, including both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, remains subject to 40 Code of Federal Regulations (CFR) §262.14 as adopted under §335.53 of this title (relating to General Standards Applicable to Generators of Hazardous Waste) and is not subject to this subchapter, except for §335.761 and §335.765 of this title (relating to Prohibition of Sewering Hazardous Waste Pharmaceuticals; and Residues of Hazardous Waste Pharmaceuticals in Empty Containers) and the optional provisions of §335.759 of this title (relating to Healthcare Facilities That Are Very Small Quantity Generators for Both Hazardous Waste Pharmaceuticals and Non-pharmaceutical Hazardous Waste).     
      (b) A healthcare facility that is a very small quantity generator when counting all of its hazardous waste, including both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, has the option of complying with subsection (d) of this section for the management of its hazardous waste pharmaceuticals as an alternative to complying with 40 CFR §262.14 as adopted in §335.53 of this title and the optional provisions of §335.759 of this title.     
      (c) A healthcare facility or reverse distributor remains subject to all applicable hazardous waste regulations for the management of its non-pharmaceutical hazardous waste.     
      (d) Unless a healthcare facility is managing waste in compliance with subsection (a) of this section, a healthcare facility is subject to this subsection instead of Subchapters C, D, E, and F of this chapter (relating to Standards Applicable to Generators of Hazardous Waste; Standards Applicable to Transporters of Hazardous Waste; Interim Standards for Owners and Operators of Hazardous Waste Treatment, Storage, or Disposal Facilities; and Permitting Standards for Owners and Operators of Hazardous Waste Treatment, Storage, or Disposal Facilities) except as provided in this subchapter.      
        (1) A healthcare facility managing potentially creditable hazardous waste pharmaceuticals that are not destined for a reverse distributor or non-creditable hazardous waste pharmaceuticals must comply with §335.755 of this title (relating to Standards for Healthcare Facilities Managing Non-Creditable Hazardous Waste Pharmaceuticals) and §§335.761, 335.763, 335.765, and 335.767 of this title (relating to Prohibition of Sewering Hazardous Waste Pharmaceuticals; Conditional Exemptions for Hazardous Waste Pharmaceuticals that are Controlled Substances and Household Waste Pharmaceuticals Collected in a Take-back Event or Program; Residues of Hazardous Waste Pharmaceuticals in Empty Containers; and Shipping Non-Creditable Hazardous Waste Pharmaceuticals from a Healthcare Facility or Evaluated Hazardous Waste Pharmaceuticals from a Reverse Distributor).       
        (2) A healthcare facility managing potentially creditable hazardous waste pharmaceuticals that are prescription pharmaceuticals and are destined for a reverse distributor must comply with §335.755(a) and §335.757 (relating to Standards for Healthcare Facilities Managing Potentially Creditable Hazardous Waste Pharmaceuticals), §§335.761, 335.763, 335.765, and 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).       
      (e) A reverse distributor is subject to §§335.761, 335.763, 335.765, 335.767, 335.769, and 335.771 of this title (relating to Standards for the Management of Potentially Creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals by Reverse Distributors) of this title in lieu of Subchapters C, D, E or F of this chapter for the management of hazardous waste pharmaceuticals.     
      (f) Hazardous waste pharmaceuticals generated or managed by entities other than healthcare facilities and reverse distributors (e.g., pharmaceutical manufacturers and reverse logistics centers) are not subject to this subchapter. Other generators are subject to Subchapter C of this chapter for the generation and accumulation of hazardous wastes, including hazardous waste pharmaceuticals.     
      (g) Except as specified in this subsection and §335.4 of this title (relating to General Prohibitions), and unless the Commission finds or the executive director determines that industrial solid waste or recycling requirements are necessary to protect human health, the environment, or property, the following are not subject to this chapter:      
        (1) pharmaceuticals that are not solid waste, as defined by §335.1 of this title (relating to Definitions), because they are legitimately used/reused (e.g., lawfully donated for their intended purpose) or reclaimed;       
        (2) over-the-counter pharmaceuticals, dietary supplements, or homeopathic drugs that are not solid wastes, as defined in §335.1 of this title, because they have a reasonable expectation of being legitimately used/reused (e.g., lawfully redistributed for their intended purpose) or reclaimed;       
        (3) pharmaceuticals being managed in accordance with a recall strategy that has been approved by the Food and Drug Administration (FDA) in accordance with 21 CFR Part 7, Subpart C, until the FDA approves the destruction of the pharmaceuticals or the pharmaceuticals are discarded;       
        (4) pharmaceuticals being managed in accordance with a recall corrective action plan that has been accepted by the Consumer Product Safety Commission in accordance with 16 CFR Part 1115, until the Consumer Product Safety Commission approves the destruction of the recalled pharmaceuticals;       
        (5) pharmaceuticals stored according to a preservation order, or stored in accordance with a litigation hold pursuant to an investigation or judicial proceeding until after the preservation order, investigation, or judicial proceeding has concluded or the pharmaceuticals are discarded;       
        (6) investigational new drugs for which an investigational new drug application is in effect in accordance with the Food and Drug Administration's regulations in 21 CFR Part 312, until the decision is made to discard the investigational new drug or the Food and Drug Administration approves the destruction of the investigational new drug, if the investigational new drug is a hazardous waste; and       
        (7) household waste pharmaceuticals, including those that have been collected by an authorized collector (as defined by the Drug Enforcement Administration), provided the authorized collector complies with the conditional exemption in §335.763(a)(2) and §335.763(b) of this title.       
      (h) Healthcare facilities and reverse distributors regulated under this subchapter remain subject to Subchapter A of this chapter (relating to Industrial Solid Waste and Municipal Hazardous Waste in General), Subchapter B of this chapter (relating to Hazardous Waste Management General Provisions), Subchapter O of this chapter (relating to Land Disposal Restrictions), and Subchapter R of this chapter (relating to Waste Classification), except as provided under this subchapter.     
     Source Note:        The provisions of this §335.753 adopted to be effective February 3, 2022, 47 TexReg 318