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The estimated burden of 594,447 hours at a cost of $71,079,848 (see Table 91, row c) reflects the availability of more accurate data to account for all potential respondents and submissions across the ICRs with burden changes detailed in this section of the final rule and represents a decrease of 40,856 hours and $4,839,401 (see Table 91, row d)

While compounding pharmacies must adhere to strict guidelines, their manufacturing process is more prone to errors like incorrect units of measurement, inappropriate vial or syringe sizes, and other issues