Inspections, Compliance, Enforcement, and Criminal Investigations
-
Chapter 4 - Human 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 460 - Pharmacy Issues
Sub Chapter 470 - Post Approval Issues
Sub Chapter 480 - Stability/Expiration
-
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 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420.200 Compendium Revisions and Deletions CPG Sec. 420.300 Changes in Compendial Specifications and NDA Supplements withdrawn on 8/30/12 CPG Sec. 420.400 Performance of Tests for Compendial Requirements on Compendial Products CPG Sec. 420.500 Interference with Compendial Tests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 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
-
-
-