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In November 2018, the Food and Drug Administration proposed a plan to address the youth e-cigarette epidemic, which includes limiting the sale of most flavored e-cigarettes to adult-only stores and online
At least 1 month prior to the issuance of a report with the reconciled rebate amount for an applicable period specified in paragraph (d)(1)(ii) of this section, CMS will conduct a preliminary reconciliation of the rebate amount for an applicable period based on the ( information specified in paragraphs (d)(1)(i)(A) through (G) of this section, and CMS will provide the information specified in paragraphs (d)(1)(i)(A) through (G) to the manufacturer of a Part D rebatable drug for the applicable period, if applicable: (A) Updated total number of rebatable units, including updates submitted by a prescription drug plan (PDP) or Medicare Advantage Prescription Drug (MA-PD) plan sponsor and updates to 340B units (as applicable to the dates of service and applicable periods specified in 428.203(b)(2)(i)(A) and (B)), or units otherwise excluded as specified in 428.203(b)
They could not be regulated as drugs or therapeutic products (Franck et al., 2014)
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