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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators  Food and Drug Administration (FDA) Final
CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations  Food and Drug Administration (FDA) Final
CPG Sec. 450.200 Drugs - General Provisions and Administrative Procedures for Recognition as Safe and Effective  Food and Drug Administration (FDA) Final
CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products  Food and Drug Administration (FDA) Final
CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines  Food and Drug Administration (FDA) Final
CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products  Food and Drug Administration (FDA) Final
CPG Sec. 450.550 Control and Accountability of Labeling Associated with Tamper-Resistant Packaging of Over-the-Counter Drug Products  Food and Drug Administration (FDA) Final
CPG Sec. 454.100 OTC Ear Drop Preparations  Food and Drug Administration (FDA) Final
CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims  Food and Drug Administration (FDA) Final
CPG Sec. 456.100 Non-Rx Drugs Anti-Obesity Preparations  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.