A reverse distributor must notify on Form 8700-12 within 60 days of becoming subject; keep a current inventory, inventorying each potentially creditable item within 30 calendar days of arrival; evaluate each within 30 calendar days of arrival (a non-manufacturer deciding whether it goes to another reverse distributor or is an evaluated hazardous waste pharmaceutical for a TSDF; a manufacturer verifying credit); accumulate for no more than 180 calendar days after evaluation (aging unexpired items may wait up to 180 days after expiry); secure the areas where they are kept against unknowing and unauthorised entry; prepare a contingency plan and meet Part 262 Subpart M if accepting waste from off site; close accumulation areas under 262.17(a)(8)(ii) and (iii); submit an unauthorised waste report to the Regional Administrator within 45 calendar days when it receives waste it may not accept (such as non-pharmaceutical hazardous waste or regulated medical waste), copying the sender, and manage that waste properly; and keep records of its notification, inventories and more. Items going to another reverse distributor must be sent within 180 days after evaluation (to a manufacturer reverse distributor if received from another reverse distributor) under 266.509 with delivery confirmations kept three years. Evaluated hazardous waste pharmaceuticals must be kept in a designated on-site accumulation area inspected at least every seven calendar days for leaks, deterioration and signs of diversion; handled by staff trained under 262.17(a)(7); in containers labelled "hazardous waste pharmaceuticals", in good condition, compatible, closed if holding liquids or gels, and managed against dangerous reactions; marked with waste codes before shipment; shipped under 266.508; with rejected loads handled as specified; subject to Part 268 and the 268.7(a) notice; reported in a Biennial Report by March 1 of even years and by exception reports if the signed manifest does not arrive within 45 calendar days (and further steps at 60 days); and documented through a three-year inspection log, manifests, reports and training records. A reverse distributor that fails these conditions, accepts manifested waste from off site, or treats or disposes on site is a TSDF needing a permit.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.