Section R315-266-501 - Hazardous Waste Pharmaceuticals - Applicability(a) A healthcare facility that is a very small quantity generator when counting its hazardous waste, including both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, remains subject to Section R315-262-14 and is not subject to Sections R315-266-500 through R315-266-510, except for Sections R315-266-505 and R315-266-507 and the optional provisions of Section R315-266-504.(b) A healthcare facility that is a very small quantity generator when counting its hazardous waste, including both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, has the option of complying with Subsection R315-266-501(d) for the management of its hazardous waste pharmaceuticals as an alternative to complying with Section R315-262-14 and the optional provisions of Section R315-266-504.(c) A healthcare facility or reverse distributor remains subject to the applicable hazardous waste rules with respect to the management of its non-pharmaceutical hazardous waste.(d) With the exception of healthcare facilities identified in Subsection R315-266-501(a), a healthcare facility is subject to the following in lieu of Rules R315-262 through R315-265: (1) Sections R315-266-502 and R315-266-505 through R315-266-508 with respect to the management of: (i) non-creditable hazardous waste pharmaceuticals; and(ii) potentially creditable hazardous waste pharmaceuticals if they are not destined for a reverse distributor.(2) Subsections R315-266-502(a), R315-266-503, R315-266-505 through R315-266-507 and R315-266-509 with respect to the management of potentially creditable hazardous waste pharmaceuticals that are prescription pharmaceuticals and are destined for a reverse distributor.(e) A reverse distributor is subject to Sections R315-266-505 through R315-266-510 in lieu of Rules R315-262 through R315-265 with respect to the management of hazardous waste pharmaceuticals.(f) Hazardous waste pharmaceuticals generated or managed by entities other than healthcare facilities and reverse distributors, that is pharmaceutical manufacturers and reverse logistics centers, are not subject to Sections R315-266-500 through R315-266-510. Other generators are subject to Rule R315-262 for the generation and accumulation of hazardous wastes, including hazardous waste pharmaceuticals.(g) The following are not subject to Rules R315-260 through R315-273, except as specified: (1) Pharmaceuticals that are not solid waste, as defined by Section R315-261-2, because they are legitimately used or reused, for example, 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 by Section R315-261-2, because they have a reasonable expectation of being legitimately used or reused, for example, 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 in accordance with 21 CFR part 7 subpart C. Sections R315-266-500 through R315-266-510 do apply to the management of the recalled hazardous waste pharmaceuticals after the Food and Drug Administration approves the destruction of the recalled items.(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. Sections R315-266-500 through R315-266-510 do apply to the management of the recalled hazardous waste pharmaceuticals after the Consumer Product Safety Commission approves the destruction of the recalled items. (5) Pharmaceuticals stored according to a preservation order, or during an investigation or judicial proceeding until after the preservation order, investigation, or judicial proceeding has concluded or a decision is made to discard the pharmaceuticals or both.(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. Sections R315-266-500 through R315-266-510 do apply to the management of the investigational new drug after 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.(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 Subsections R315-266-506(a)(2) and R315-266-506(b).Utah Admin. Code R315-266-501
Adopted by Utah State Bulletin Number 2020-19, effective 9/14/2020