Scope. This regulation and Regulations .33—.49 of this chapter: Establish requirements for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors; and Identify certain pharmaceuticals that are excluded from regulation under COMAR 26.13.01—.10. Defined Terms. The following terms used in this regulation and Regulations .33—.49 of this chapter have the meaning stated in COMAR 26.13.01.03B: “Evaluated hazardous waste pharmaceutical”; “Hazardous waste pharmaceutical”; “Healthcare facility”; “Household waste pharmaceutical”; “Long-term care facility”; “Non-creditable hazardous waste pharmaceutical”; “Non-hazardous waste pharmaceutical”; “Non-pharmaceutical hazardous waste”; “Pharmaceutical”; “Potentially creditable hazardous waste pharmaceutical”; and “Reverse distributor”. Excluded Materials and Wastes. Except as specified in this section, the following pharmaceuticals are not subject to regulation under COMAR 26.13.01—26.13.10: A pharmaceutical that is not a solid waste, as defined in COMAR 26.13.02.02, because the pharmaceutical is to be: Reclaimed; or Legitimately used or legitimately reused, such as by being lawfully donated for use for the pharmaceutical’s intended purpose; An over-the-counter pharmaceutical, a dietary supplement, or a homeopathic drug that is not a solid waste, as defined in COMAR 26.13.02.02, because: The material is going to be reclaimed; or There is a reasonable expectation that the material will be legitimately used or legitimately reused, such as by being lawfully redistributed for use for its intended purpose; A pharmaceutical that is being managed in accordance with a recall strategy that has been approved by the U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 7, Subpart C, except that this regulation and Regulations .33—.49 of this chapter apply to the management of the recalled hazardous waste pharmaceutical after the FDA approves the destruction of the recalled pharmaceutical; A pharmaceutical that is being managed in accordance with a recall corrective action plan that has been accepted by the U.S. Consumer Product Safety Commission (CPSC) in accordance with 16 CFR Part 1115, except that this regulation and Regulations .33—.49 of this chapter apply to the management of the recalled hazardous waste pharmaceutical after the CPSC approves the destruction of the recalled pharmaceutical; A pharmaceutical that is being stored during an investigation, during a judicial proceeding, or according to a preservation order until either: The investigation, judicial proceeding, or preservation order has concluded, and a decision is made to discard the pharmaceutical; or A decision is made to discard the pharmaceutical before the investigation, judicial proceeding, or preservation order has concluded; An investigational new drug for which an investigational new drug application is in effect in accordance with the FDA’s regulations in 21 CFR Part 312, except that this regulation and Regulations .33—.49 of this chapter apply to the management of the drug if: The drug, if discarded, would meet the definition of hazardous waste; and A decision has been made to discard the investigational new drug, or the FDA has approved the destruction of the investigational new drug; and A household waste pharmaceutical, including a household waste pharmaceutical that has been collected by an authorized collector as defined by the U.S. Drug Enforcement Administration if the authorized collector complies with the conditional exemption in Regulations .34A(2) and B of this chapter. The residue of a hazardous waste pharmaceutical that remains in a stock container, dispensing container, unit dose container, syringe, or intravenous bag that is empty according to the criteria in Regulation .35 of this chapter is not regulated as hazardous waste. Excluded Facilities. A healthcare facility that is a very small quantity generator under federal regulations, as described in COMAR 26.13.03.01-1B, when counting all of the hazardous waste it generates in a calendar month, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste: Is subject to: Regulation .33 of this chapter, which prohibits the discharge of hazardous waste pharmaceuticals to sewer systems that discharge to publicly owned treatment works; and Regulation .35 of this chapter, which concerns residues of hazardous waste pharmaceuticals in empty containers; Has the option of complying with the requirements of §E(3) of this regulation for the management of the facility’s hazardous waste pharmaceuticals, as an alternative to managing the hazardous waste pharmaceuticals in accordance with COMAR 26.13.02.05 and the optional provisions of Regulation .36 of this chapter; Unless the facility voluntarily elects to manage hazardous waste pharmaceuticals in accordance with the regulations specified in §E(3) of this regulation: Shall manage the hazardous waste pharmaceuticals it generates in accordance with COMAR 26.13.02.05; May comply with the optional provisions of Regulation .36 of this chapter; and Is not subject to the requirements of §E(3) of this regulation; and Shall manage the non-pharmaceutical hazardous waste it generates in accordance with: COMAR 26.13.03 if the amount of non-pharmaceutical hazardous waste accumulated by the facility prevents the facility from being classified as a Maryland-defined small quantity generator, as specified in COMAR 26.13.03.01A-3(1); or COMAR 26.13.02.05 if the amount of non-pharmaceutical hazardous waste accumulated by the facility allows the facility to be classified as a Maryland-defined small quantity generator. A long-term care facility with 20 beds or fewer: Is presumed to be a very small quantity generator under federal regulations with respect to all of the hazardous waste it generates in a calendar month, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, unless the Department is able to demonstrate otherwise; and Shall comply with §D(1) of this regulation unless the Department demonstrates that the facility does not qualify as a very small quantity generator under federal regulations, taking into account both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, in which case the facility shall comply with the requirements of §§E(3) and E(4) of this regulation. Applicability — Healthcare Facilities and Management of Hazardous Waste Pharmaceuticals. Based on the criteria specified in COMAR 26.13.03.01-1B, a healthcare facility is subject to the requirements specified in §E(3) of this regulation if, in a calendar month: The facility: Meets the criteria to be classified as a federally-defined large quantity generator or a federally-defined small quantity generator based on the amount of non-pharmaceutical hazardous waste generated in a calendar month; and Generates any quantity of hazardous waste pharmaceuticals; The facility: Meets the criteria to be classified as a very small quantity generator under federal regulations, counting only the non-pharmaceutical hazardous waste generated by the facility; and Generates a quantity of hazardous waste pharmaceuticals that exceeds the criteria to be classified as a very small quantity generator under federal regulations, taking into account only the hazardous waste pharmaceuticals generated by the facility; or The total amount of hazardous waste that the facility generates, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, exceeds the criteria to be classified as a very small quantity generator under federal regulations. §F of this regulation provides a summary, in a tabular format, of the criteria specified in §E(1) of this regulation. A healthcare facility identified in §E(1) of this regulation is subject to the following instead of COMAR 26.13.02—26.13.06 in managing hazardous waste pharmaceuticals: Regulations .33—.35, .37—.45, and .47 of this chapter with respect to the management of: Non-creditable hazardous waste pharmaceuticals; and Potentially creditable hazardous waste pharmaceuticals if they are not destined for a reverse distributor; and Regulations .33—.35, .37, .38, .46, and .48 of this chapter with respect to the management of potentially creditable hazardous waste pharmaceuticals that are prescription pharmaceuticals and are destined for a reverse distributor. A healthcare facility shall manage its non-pharmaceutical hazardous waste in accordance with all applicable requirements of COMAR 26.13.01—26.13.10 based on whether the facility is a fully regulated generator or a Maryland-defined small quantity generator, as defined in COMAR 26.13.01.03B, taking into account the total amount of hazardous waste generated and accumulated, including both pharmaceutical hazardous waste and non-pharmaceutical hazardous waste. Summary Table — Applicability to Healthcare Facilities. Table 1 of §F(3) of this regulation: Summarizes, for most generators, the criteria on the amount of hazardous waste generated in a calendar month that determine whether a healthcare facility is subject to the requirements specified in §E(3) of this regulation; and Identifies the federal hazardous waste generator category that applies to the facility. If a healthcare facility also generates any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill, into or on any land or water, of any acute hazardous waste listed in COMAR 26.13.02.16 or COMAR 26.13.02.19E, the facility shall also consider that waste in determining the facility’s federal generator category for the purposes of §E(1) of this regulation, based on the criteria in COMAR 26.13.03.01-1B. Table 1. Agency Note: In Table 1 of §F(3) of this regulation, “<” means less than; “≤” means less than or equal, “>” means greater than, and “≥” means greater than or equal. Applicability — Reverse Distributors. A reverse distributor: Is subject to Regulations .33—.35 and .47—.49 of this chapter instead of COMAR 26.13.03—26.13.06 with respect to the management of hazardous waste pharmaceuticals; and Shall manage its non-pharmaceutical hazardous waste in accordance with all applicable requirements of COMAR 26.13.01—26.13.10. Applicability — Other Entities. An entity other than a healthcare facility or a reverse distributor that generates or manages a hazardous waste pharmaceutical, such as a pharmaceutical manufacturer or a reverse logistics center: Is not subject to Regulations .33—.49 of this chapter; and Shall manage the hazardous waste pharmaceutical in accordance with the applicable requirements of COMAR 26.13.03.