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 In this section:

                Manual of Compliance Policy Guides

Manual of Compliance Policy Guides: Foreword

                        Chapter 1 - General
          Chapter 2 - Biologics
          Chapter 3 - Devices
          Chapter 4 - Human Drugs
          Chapter 5 - Food, Colors, and Cosmetics
          Chapter 6 -  Veterinary Medicine
          CPG Revision/Update History Home
          Inspections, Compliance, Enforcement, and Criminal Investigations
          Compliance Manuals
          Manual of Compliance Policy Guides
          Chapter 4 - Human DrugsManual of Compliance Policy Guides Chapter 4 - Human Drugs
  
  	
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    PrintSub Chapter 400 - General

Sub Chapter 410 - Bulk Drugs

Sub Chapter 420 - Compendial /Test Requirements

Sub Chapter 425 - Computerized Drug Processing

Sub Chapter 430 - Labeling and Repackaging

Sub Chapter 440 - 448 - New Drugs

Sub Chapter 450 - 457 - OTC

Sub Chapter 460 - Pharmacy Issues

Sub Chapter 470 - Post Approval Issues

Sub Chapter 480 - Stability/Expiration

Sub Chapter 490 - Validation



Sub Chapter 400 - General

CPG Sec. 400.100 Drugs, Human - Failure to Register
	CPG Sec. 400.200 Consistent Application of CGMP Determinations
	CPG Sec. 400.210 Drugs, Radiofrequency Identification
	CPG Sec. 400.325 Candy "Pills" Representation as Drug
	CPG Sec. 400.335 Fructose-Containing Drugs
	CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed
	CPG Sec. 400.500 Identical or Similar Product Names
	CPG Sec. 400.600 Drugs - Declaration of Quantity of Active Ingredient by Both Metric and Apothecary Systems
	CPG Sec. 400.700 Drug Product Entries in Periodic Publications
	CPG Sec. 400.800 Collection and Charitable Distribution of Drugs
	CPG Sec. 400.900 Class I Recalls of Prescription DrugsSub Chapter 410 - Bulk Drugs

CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations*Sub Chapter 420 - Compendial /Test Requirements

CPG Sec. 420.100 Adulteration of Drugs Under Section 501(b) and 501(c) of the Act. *Direct Reference Seizure Authority for Adulterated Drugs Under Section 501(b)*
	CPG Sec. 420.200 Compendium Revisions and Deletions
	Com•CPG Sec. 420.300 Changes in Compendial Specifications and NDA Supplements withdrawn on 8/30/12
	CPG Sec. 420.400 Performance of Tests for Compendial Requirements on Compendial Products
	CPG Sec. 420.500 *Interference with Compendial Tests* (revised 11/14/2012) (PDF - 91KB)Sub Chapter 425 - Computerized Drug Processing

CPG Sec. 425.100 Computerized Drug Processing; CGMP Applicability to Hardware and Software*
	CPG Sec. 425.200 Computerized Drug Processing; Vendor Responsibility
	CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs
	CPG Sec. 425.400 Computerized Drug Processing; Input/Output Checking
	CPG Sec. 425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control RecordsSub Chapter 430 - Labeling and Repackaging

CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms
	CPG Sec. 430.200 Repacking of Drug Products - Testing/Examination under CGMPs
	CPG Sec. 430.300 Labeling Shipping Containers of Drugs
	CPG Sec. 430.400 Urinary Preparations - Misbranding - Lack of Rx Legend and ClaimsSub Chapter 440 - 448 - New Drugs

CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs and ANDAs
	CPG Sec. 442.100 New Drugs - Export
	CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators
	CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations
	CPG Sec. 448.100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAsSub Chapter 450 - 457 - OTC

CPG Sec. 450.100 CGMP Enforcement Policy - OTC vs Rx Drugs
	CPG Sec. 450.200 Drugs - General Provisions and Administrative Procedures for Recognition as Safe and Effective
	CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products
	CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines
	CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products
	CPG Sec. 450.550 Control and Accountability of Labeling Associated with Tamper-Resistant Packaging of Over-the-Counter Drug Products
	CPG Sec. 454.100 OTC Ear Drop Preparations
	CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims
	CPG Sec. 456.100 Non-Rx Drugs Anti-Obesity Preparations
	CPG Sec. 457.100 Pangamic Acid and Pangamic Acid Products Unsafe for Food and Drug UseSub Chapter 460 - Pharmacy Issues

CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer
	CPG Sec. 460.200 Pharmacy Compounding (Withdrawn December 4, 2013)
	CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock
	CPG Sec. 460.400 Computerized Prescription Recordkeeping by Pharmacies
	CPG Sec. 460.425 Prescription Status when Telephoned to Recording Machine
	CPG Sec. 460.450 Status of Mail-Order Filling of Prescriptions
	CPG Sec. 460.500 Prescription Drugs for Ship's Medicine Chests
	CPG Sec. 460.600 Content Uniformity Testing of Tablets and Capsules
	CPG Sec. 460.700 Controlled Release Dosage Form Drugs - Rate of Release of Active IngredientsChapter 4 Continued

Chapter 4 Human Drugs, Sub Chapters 470 - 490 (continued)

                                                                                  Content current as of:
      04/24/2019
              
              
Regulated Product(s)
		 DrugsManual of Compliance Policy Guides: Foreword

          
                        Chapter 1 - General
          Chapter 2 - Biologics
          Chapter 3 - Devices
          Chapter 4 - Human Drugs
          Chapter 5 - Food, Colors, and Cosmetics
          Chapter 6 -  Veterinary Medicine
          CPG Revision/Update History
 
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