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PSR is a Federal Rule.

  • States do not have the ability to change it.

  • It must be incorporated into state regs.

    • By simple adoption. Adoption by referencing the Federal Rule means any changes made on a Federal Level are automatically mirrored on the State Level.

    • Until adopted at state level, FDA is the lead.

    • Final Step is to establish DEM authority of the rule.

    • Needs to be done by 2019.