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CMS intends to apply this unit exclusion at the month level and would exclude all units of a generic drug that ceases to meet the definition of a Part D rebatable drug beginning with the first day of the first month when a therapeutically equivalent drug approved under a 505(j) ANDA is marketed based on the marketing start date in the NDC Directory or when the reference listed drug, or an authorized generic of the reference listed drug is marketed based on the marketing start date in the NDC Directory

2 People with diabetes are especially affected by tobacco smoke

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This exemption shall not apply to any retailer with four or more violations per location within a one-year period, or if the retailer knowingly allows the employee(s) to sell tobacco to minors

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