Where the petition for an exemption is based upon an allegation that the applicable special packaging standard is incompatible with the particular substance or would seriously and adversely compromise the utility or stability of a substance, the petitioner shall submit adequate evidence to support the allegation.
If the allegation of incompatibility is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice.
If the allegation of incompatibility is based upon the fact that the shelf life of the product limits package choice, the petition shall outline the particular limitation and shall include a description of a time schedule to re-establish shelf-life data.
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