Applicability

1. A health care facility that is a very small quantity generator when counting all of its hazardous waste, including both its hazardous waste pharmaceuticals and its nonpharmaceutical hazardous waste, remains subject to section 33.1-24-03-26 and is not subject to sections 33.1-24-05-310 through 33.1-24-05-320, except for sections 33.1-24-05-315 and 33.1-24-05-317, and the optional provisions of section 33.1-24-05-314. 2. A health care facility that is a very small quantity generator when counting all of its hazardous waste, including both its hazardous waste pharmaceuticals and its nonpharmaceutical hazardous waste, has the option of complying with subsection 4 for the management of its hazardous waste pharmaceuticals as an alternative to complying with section 33.1-24-03-26 and the optional provisions of section 33.1-24-05-314. 3. A health care facility or reverse distributor remains subject to all applicable hazardous waste regulations with respect to the management of its nonpharmaceuticals hazardous waste. 4. With the exception of health care facilities identified in subsection 1, a health care facility is subject to the following in lieu of chapters 33.1-24-03 and 33.1-24-04, and sections 33.1-24-05-01 through 33.1-24-05-190, 33.1-24-05-300 through 33.1-24-05-309, 33.1-24-05-400 through 33.1-24-05-524, 33.1-24-05-550 through 33.1-24-05-559, and 33.1-24-05-800 through 33.1-24-05-819: a. Sections 33.1-24-05-312 and 33.1-24-05-315 through 33.1-24-05-318 with respect to the management of: (1) Noncreditable hazardous waste pharmaceuticals; and (2) Potentially creditable hazardous waste pharmaceuticals if they are not destined for a reverse distributor. b. Subsection 1 of section 33.1-24-05-312, section 33.1-24-05-313, sections 33.1-24-05-315 through 33.1-24-05-317, and section 33.1-24-05-319 with respect to the management of potentially creditable hazardous waste pharmaceuticals that are prescription pharmaceuticals and are destined for a reverse distributor. 5. A reverse distributor is subject to sections 33.1-24-05-310 through 33.1-24-05-320 in lieu of chapters 33.1-24-03 and 33.1-24-04, and sections 33.1-24-05-01 through 33.1-24-05-190, 33.1-24-05-300 through 33.1-24-05-309, 33.1-24-05-400 through 33.1-24-05-524, 33.1-24-05-550 through 33.1-24-05-559, and 33.1-24-05-800 through 33.1-24-05-819 with respect to the management of hazardous waste pharmaceuticals. 6. Hazardous waste pharmaceuticals generated or managed by entities other than health care facilities and reverse distributors, e.g., pharmaceutical manufacturers and reverse logistics centers, are not subject to sections 33.1-24-05-310 through 33.1-24-05-320. Other generators are subject to chapter 33.1-24-03 for the generation and accumulation of hazardous wastes, including hazardous waste pharmaceuticals. 7. The following are not subject to chapters 33.1-24-01 through 33.1-24-07 except as specified: a. Pharmaceuticals that are not solid waste, as defined by section 33.1-24-02-02, because they are legitimately used or reused, e.g., lawfully donated for their intended purpose, or reclaimed. b. Over-the-counter pharmaceuticals, dietary supplements, or homeopathic drugs that are not solid wastes as defined by section 33.1-24-02-02 because they have a reasonable expectation of being legitimately used or reused, e.g., lawfully redistributed for their intended purpose, or reclaimed. c. Pharmaceuticals being managed in accordance with a recall strategy that has been approved by the food and drug administration in accordance with title 21, Code of Federal Regulations, part 7, subpart C. This subpart does apply to the management of the recalled hazardous waste pharmaceuticals after the food and drug administration approves the destruction of the recalled items. d. Pharmaceuticals being managed in accordance with a recall corrective action plan that has been accepted by the consumer product safety commission in accordance with title 16, Code of Federal Regulations, part 1115. Sections 33.1-24-05-310 through 33.1-24-05-320 do not apply to the management of the recalled hazardous waste pharmaceuticals after the consumer product safety commission approves the destruction of the recalled items. e. 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. f. Investigational new drugs for which an investigational new drug application is in effect in accordance with the food and drug administration's regulations in title 21, Code of Federal Regulations, part 312. Sections 33.1-24-05-310 through 33.1-24-05-320 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. g. 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 subdivision a of subsection 1 of section 33.1-24-05-316 and subsection 2 of section 33.1-24-05-316.