R 299.9824 Hazardous waste pharmaceuticals and hazardous waste ENDS; applicability.

Rule 824. (1) A healthcare facility or ENDS retailer that is a very small quantity generator when counting all its hazardous waste, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, shall comply with all the following requirements: (a) R 299.9304. (b) The optional provisions of R 299.9827. (c) R 299.9828. (d) R 299.9830. (2) A healthcare facility or ENDS retailer that is a very small quantity generator when counting all its hazardous waste, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, may comply with subrule (4) of this rule for management of its hazardous waste pharmaceuticals and hazardous waste ENDS instead of R 299.9304 and the optional provisions of R 299.9827. (3) A healthcare facility, ENDS retailer, or reverse distributor is subject to all applicable hazardous waste regulations for management of its non-pharmaceutical hazardous waste. (4) With the exception of healthcare facilities and ENDS retailers identified in subrule (1) of this rule, a healthcare facility or ENDS retailer is subject to all the following requirements instead of parts 3 to 7 of these rules: (a) R 299.9825 and R 299.9828 to R 299.9831 for management of the following: (i) Non-creditable hazardous waste. (ii) Potentially creditable hazardous waste pharmaceuticals if they are not destined for a reverse distributor. (b) R 299.9825(1), R 299.9826, R 299.9828 to R 299.9830, and R 299.9832 for management of potentially creditable hazardous waste pharmaceuticals that are prescription pharmaceuticals and destined for a reverse distributor. (5) A reverse distributor is subject to R 299.9828 to R 299.9833 instead of parts 3 to 7 of these rules for management of hazardous waste pharmaceuticals. (6) Hazardous waste pharmaceuticals and hazardous waste ENDS generated or managed by entities other than healthcare facilities, ENDS retailers, or reverse distributors are subject to part 3 of these rules for the generation and accumulation of hazardous wastes, including hazardous waste pharmaceuticals and hazardous waste ENDS. (7) The following are not subject to these rules, except as specified: (a) Pharmaceuticals and ENDS that are not wastes because they are legitimately used or reused or reclaimed. (b) Non-prescription pharmaceuticals and ENDS that are not wastes because they have a reasonable expectation of being legitimately used, reused, or reclaimed. (c) Pharmaceuticals and ENDS being managed in accordance with a recall strategy that has been approved by the FDA under 21 CFR part 7, subpart C. R 299.9824 to R 299.9833 apply to the management of the recalled hazardous waste pharmaceuticals and hazardous waste ENDS after the FDA approves the destruction of the recalled items. (d) Pharmaceuticals and ENDS managed in accordance with a recall corrective action plan that has been accepted by the Consumer Product Safety Commission under 16 CFR part 1115. R 299.9824 to R 299.9833 apply to the management of the recalled hazardous waste pharmaceuticals and hazardous waste ENDS after the Consumer Product Safety Commission approves the destruction of the recalled items. (e) Pharmaceuticals and ENDS 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 and ENDS. (f) Investigational new drugs for which an investigational new drug application is in effect in accordance with the FDA’s regulations in 21 CFR part 312. R 299.9824 to R 299.9833 do apply to the management of the investigational new drug after the decision is made to discard the drug or the FDA approves the destruction of the drug if the drug is a hazardous waste. (g) Household waste pharmaceuticals and household waste ENDS, including those that have been collected by an authorized collector, if the authorized collector complies with the conditional exemption in R 299.9829(1). (8) The provisions of 16 CFR part 1115; 21 CFR part 7, subpart C; and 21 CFR part 312 are adopted by reference in R 299.11004.