For use beginning 10/1/2023
This directive provides instructions to inspection program personnel (IPP) for conducting the General Labeling task in the Public Health Information System (PHIS). This directive is being reissued to align with the expansion of generic labelling approval eligibility established by the final rule, “Prior Label Approval System: Expansion of Generic Label Approval” [88 FR 2798], which is effective as of March 20,2023. This revision also clarifies that, as part of the General Labeling task, IPP are to routinely verify that establishments make required modifications to their labels prior to use in commerce.
This directive provides instructions to inspection program personnel (IPP) for conducting the General Labeling task in the Public Health Information System (PHIS). This directive is being reissued to align with the expansion of generic labelling approval eligibility established by the final rule, “Prior Label Approval System: Expansion of Generic Label Approval” [88 FR 2798], which is effective as of March 20,2023. This revision also clarifies that, as part of the General Labeling task, IPP are to routinely verify that establishments make required modifications to their labels prior to use in commerce.
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