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58054 Federal Register / Vol . 80 , No . 186 / Friday, September 25 , 2015 / Proposed Rules is , the study investigated whether the referred to as a "bingo card. " The results to 4000 containers per month to exceed concentration of warfarin in the indicate that the concentration of the the 1 kg threshold to bean LQG. residues of warfarin pill bottles was active pharmaceutical ingredient. The results for nicotine residues were greater than 0. 3 % and therefore met the warfarin in the residues in plastic similar. For containers of gum and listing criteria for P001 or whether the bottles was usually over the 0 . 3 % patches , the weight of total residues residues were at or below 0. 3 % and concentration. However, the ranged from 9s of lit id although the therefore met the listing criteria for concentration of warfarin in the two containers of liquid nicotine U248 . Although nicotine is not a residues on blister packs , including the solution contained more residues-1301 concentration-based P-listing, packaging 30-pack blister pack, was consistently and 1616 mg. Although nicotine is not from nicotine-containing products were below 0 .3 % . Overall , in the majority of a concentration-based listing, it is worth also investigated to determine total cases , the warfarin within the residues noting that the active pharmaceutical remaining residues. was present at a high enough ingredient of nicotine in the residues The researchers collected a total of 59 concentration to be considered P001 (33 was below the quantifiable limit of 1 . 5 samples containers , including 44 of 44 samples , 75 percent of the pg/ml in 8 of the 15 samples and for the sample containers that had held samples) . other 7 samples , the concentration of warfarin pills but had been fully nicotine ranged from 0.01-0 .09% 4 dispensed and another 15 sample However, the results also confirm the iv , EPA 's Office of Research and containers from nicotine-containing results from the first two stakeholders. Development. Finally , EPA's ORD products. The samples included That is , the total weight of residues conducted an analysis to evaluate warfarin and nicotine from several remaining in the containers after they whether simply removing a drug from manufacturers , in a range of dose were emptied of the warfarin pills is the container is equivalent to triple strengths and in various container types . negligible. For the plastic bottles , the rinsing the container. ORD's results are The residues were solvent-extracted and total weight of residue ranged from 4 . 3-- summarized in Table 11 , but the Final then dried by rotary evaporation to 82. 3 mg . For the single-dose blister Project Report containing the full results determine the total weight of residues . packs, the total weight of residue ranged is in the docket for this proposed Subsequently , the residues were re- from 3 . 5-7 . 6 mg. And for the 30-pack rulemaking (EPA I3Q—RCRA-2007-- dissolved in methanol and analyzed blister pack , the total weight ranged 0932 ) . ORD analyzed three different F- using HPLC to determine the from 134 . 8-273 mg. Taking the smallest listed pharmaceuticals: Warfarin , concentration of the active amount of residue of 3 . 5 mg, it would nicotine and physostigmine salicylates pharmaceutical within the residues . take close to 300 ,000 containers per Table 11 lists the 18 different The majority of warfarin containers month to exceed the 1 kg threshold to combinations of active pharmaceutical were plastic bottles , but some containers be an LQG. Even on the conservative ingredients , form , dosage strengths and were blister packs and three samples side, taking the largest amount of packaging combinations that ORD were 30-pill blister packs , sometimes residue of 273 mg , it would take close analyzed. TABLE 11 -PHARMACEUTICAL COMBINATIONS TESTED By EPA's ORD Active pharmaceutical Manufacturer/Brand name Form Dosage Packaging type ingredient Warfarin . . . . . .. . ..... . . .... . . Taro Pharmaceutical Industries, Ltd. . . .. . . . . . . .. . Tablet 4444. . . 1 mg . . .. .. . . . Plastic bottle. Tablet 4444 . . . 5 mg .. .. . .. . . Plastic bottle. Tablet 4444. . . 10 mg 4444. . . Plastic bottle. Tablet 4444 . . . 2 mg ... . 400. 0 Single-dose blister pack. Upsher-Smith/Jantoven .. . . .. . . . .. . ..... . . . . . . . .. . . .. . . . . Tablet 4444. .. 1 mg .. . . .. .. . Single-dose blister pack Tablet 4444 .. . 10 mg . ... .. . Single-dose blister pack. Nicotine . . . . . . . . . . . . . . . . . .. . . . GlaxoSmithKiine/Nicorette . . . . . .. . . .. .. . .. . ... . . ... . .. . Gum .. .. . . . . . 2 mg .. .. .. . .. Single-dose blister pack. Gum .. . . . .. .. 4 mg . . . . .. . .. Single-dose blister pack. Rugby Laboratories . . . . . . . .. . . . . . . .. . . . .. .. . . . . . . . . . . . . . . . . Gum . .. .. . . .. 2 mg .. .. .. . . . Single-dose blister pack. Gum .. .. . . . .. 4 mg . . . . . ... . Single-dose blister pack. GlaxoSmithKiine/Nicorette . . . . .. . . .. . . . . . . . . ... . . .. . . .. Lozenge . . . 2 mg . . ... . ... Plastic vial Lozenge . . . 4 mg . .. . . . . . . Plastic vial . Rugby Laboratories . .. . . .. . ... . . .. .. . . . .. . .. . . . . . . . .. . .. .. . Patch . . . .. . .. 7 mg .. . . . . . .. Peet-off plastic. HabitrolPatch . .. . .. .. 14 mg 4444 .. . Peet-off plastic. .. .. . . . . ... .. . . . . . . . . .. . . . . . . . . . . . . . .. Rugby Laboratories .. . . . . . . .. . . . . . . . . . . .. .. . . . . . . . .. . . . . . . . Patch . . .. . . .. 21 mg 4444 . . . Peel-off plastic. Pfizer/Nicotrol . . .. . . . .. . . . . . . .. .. . . . . . . . . . .. .. . . . . .. . . . . . . . .. . . Spray 4444 . . . 10 mg/mi . . Glass vial. Inhaler 4444 . . 10 mg 0909 .40 Plastic container. Physostigmine Salicy- Akron Inc. Liquid 4444 . . . 1 mg/ml . . . . Glass ampoule. late. All combinations in Table 11 were (2) The " maximum possible weight of (3) Thermal gravimetric analysis analyzed in triplicate using the residual drug/total residual/container" (TGA) was used to qualitatively evaluate following three-step approach: was calculated for each compound and the presence of active pharmaceutical (1 ) After removing the tablets , gum, packaging combination . This calculated ingredient in the residuals removed lozenges , etc from the containers , the result was used to infer a theoretical from the containers before and after amount of total residuals remaining in upper limit for the amount of active triple-rinsing. the container was determined using a pharmaceutical compound in the total With respect to the weight of the ' due remaining in the container, and remaining residuals in the containers , sensitive balance to weigh the container res before and after triple r}nsing, ORD 's results are similar to the results