(a)Test protocols - (1)General requirements - (i)Requirements for packaging. As specified in § 1700.15(b) , special packaging is required to meet the child test requirements and the applicable adult test requirements of this § 1700.20 . (ii)Condition of packages to be tested - (A)Tamper-resistant feature. Any tamper-resistant feature of the package to be tested shall be removed prior to testing unless it is part of the package's child-resistant design. Where a package is supplied to the consumer
(a) A determination whether a listed drug that has been voluntarily withdrawn from sale was withdrawn for safety or effectiveness reasons may be made by the agency at any time after the drug has been voluntarily withdrawn from sale, but must be made: (1) Prior to approving an abbreviated new drug application that refers to the listed drug; (2) Whenever a listed drug is voluntarily withdrawn from sale and abbreviated new drug applications that referred to the listed drug have been approved; and (3)