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doi: 10.1016/j.jjcc.2019.04.006

While some data points may not change, we proposed to review the data to determine if there are any updates in the data and use the updated data in the reconciliation to provide a reconciled rebate amount to the manufacturer

Similarly, at 428.202(c)(4), we proposed that for a subsequently approved drug for which there are no quarters during the first calendar year beginning after the drug's first marketed date for which AMP has been reported under section 1927(b)(3) of the Act, the payment amount benchmark period would be the first calendar year in which such drug has at least 1 quarter of AMP reported

The preservative in bacteriostatic water helps reduce this risk, making it a more suitable choice in these cases