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 Drugs

Sub 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
• CPG Sec. 420.300 Changes in Compendial Specifications and NDA Supplements withdrawn on 8/30/12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

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 Records

Sub 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 Claims

Sub Chapter 435 - Medical Gases

• CPG Sec. 435.100 Compressed Medical Gases - *Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen*

Sub 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/ANDAs

Sub 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 Use

Sub Chapter 460 - Pharmacy Issues

• CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer
• CPG Sec. 460.200 Pharmacy Compounding (Reissued 05/29/2002)
• 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 Ingredients

• Chapter 4 - Human Drugs (continued)