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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort descending
Compliance Policy Guide Sec. 390.100 Definition of “Commerce” -21 CFR 1000.3(d) 2  Food and Drug Administration (FDA) Final
New/Revised/Withdrawn Guidances 2014  Food and Drug Administration (FDA) Final
Recommended Uniform Screening Panel  Health Resources and Services Administration (HRSA) Final
340B Program Updates  Health Resources and Services Administration (HRSA) Final
Compliance Policy Guide Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)  Food and Drug Administration (FDA) Final
340B Drug Pricing Program Program Integrity  Health Resources and Services Administration (HRSA) Final
CPG Sec. 420.500 Interference with Compendial Tests  Food and Drug Administration (FDA) Final
CPG Sec. 160.800, Year 2000 (Y2K) Computer Compliance  Food and Drug Administration (FDA) Final
340B Drug Pricing Program Annual Recertification  Health Resources and Services Administration (HRSA) Final
Dairy Products Sec. 527.300 Microbial Contaminants & Alkaline Phosphatase Activity  Food and Drug Administration (FDA) Final
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