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Inspections, Compliance, Enforcement, and Criminal Investigations
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Chapter 4 - Human Drugs
Sub 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 435 - Medical Gases
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
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Sub Chapter 400 - General
- CPG Sec. 400.100 Drugs, Human - Failure to Register (CPG 7132.07)
- CPG Sec. 400.200 Consistent Application of CGMP Determinations (CPG 7132.12)
- CPG Sec. 400.210, Drugs, Radiofrequency Identification (CPG 7132.12)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (CPG 7132.04)
- CPG Sec. 400.335 Fructose-Containing Drugs (CPG 7123b.02)
- CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)
- CPG Sec. 400.500 Identical or Similar Product Names (CPG 7132b.14)
- CPG Sec. 400.600 Drugs - Declaration of Quantity of Active (CPG 7132.03)
- CPG Sec. 400.700 Drug Product Entries in Periodic Publications (CPG 7132b.17)
- CPG Sec. 400.800 Collection and Charitable Distribution of Drugs (CPG 7132.08)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (CPG 7132.01)
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Sub Chapter 410 - Bulk Drugs
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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 7132a.03)
- CPG Sec. 420.200 Compendium Revisions and Deletions (CPG 7132.02)
- CPG Sec. 420.300 Changes in Compendial Specifications and NDA (CPG 7132c.04)
- CPG Sec. 420.400 Performance of Tests for Compendial Requirements on Compendial Products (CPG 7132.05)
- CPG Sec. 420.500 Interference with Compendial Tests (CPG 7132a.01)
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Sub Chapter 425 - Computerized Drug Processing
- CPG Sec. 425.100 Computerized Drug Processing; CGMP Applicability to Hardware and Software (CPG 7132a.17)
- CPG Sec. 425.200 Computerized Drug Processing; Vendor Responsibility (CPG 7132a.12)
- CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (CPG 7132a.15)
- CPG Sec. 425.400 Computerized Drug Processing; Input/Output Checking (CPG 7132a.07)
- CPG Sec. 425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control Records (CPG 7132a.08)
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Sub Chapter 430 - Labeling and Repackaging
- CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms (CPG 7132b.10)
- CPG Sec. 430.200 Repacking of Drug Products - Testing/Examination under CGMPs (CPG 7132.13)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (CPG 7132b.13)
- CPG Sec. 430.400 Urinary Preparations - Misbranding - Lack of Rx Legend and Claims (CPG 7132b.04)
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Sub Chapter 435 - Medical Gases
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Sub Chapter 440 - 448 - New Drugs
- CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs (CPG 7132c.02)
- CPG Sec. 442.100 New Drugs - Export (CPG 7132c.01)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (CPG 7132c.05)
- CPG Sec. 446.100 Regulatory Action Regarding Approved New Drug and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (CPG 7132c.06)
- CPG Sec. 448.100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAs (CPG 7132c.03)
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Sub Chapter 450 - 457 - OTC
- CPG Sec. 450.100 CGMP Enforcement Policy - OTC vs Rx Drugs (CPG 7132.10)
- CPG Sec. 450.200 Drugs - General Provisions and Administrative Procedures for Recognition as Safe and Effective (CPG 7132b.15)
- CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products (CPG 7132b.16)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (CPG 7132b.06)
- 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 7132b.01)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (CPG 7132b.12)
- CPG Sec. 456.100 Non-Rx Drugs Anti-Obesity Preparations (CPG 7132b.05)
- CPG Sec. 457.100 Pangamic Acid and Pangamic Acid Products Unsafe for Food and Drug Use (CPG 7121.01)
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Sub Chapter 460 - Pharmacy Issues
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (CPG 7132.06)
- CPG Sec. 460.200 Pharmacy Compounding (Reissued 05/29/2002) (CPG 7132.16)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (CPG 7132.09)
- CPG Sec. 460.400 Computerized Prescription Recordkeeping by Pharmacies (CPG 7132b.09)
- CPG Sec. 460.425 Prescription Status when Telephoned to Recording Machine (CPG 7132b.08)
- CPG Sec. 460.450 Status of Mail-Order Filling of Prescriptions (CPG 7132b.07)
- CPG Sec. 460.500 Prescription Drugs for Ship's Medicine Chests (CPG 7132.11)
- 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 (CPG 7132a.02)
- CPG Sec. 460.800 Parametric Release - Terminally Heat Sterilized Drug Products (CPG 7132a.13)
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