Sub Chapter 400 - General
400.100 Drugs, Human - Failure to Register CPG 7132.07
400.200 Consistent Application of CGMP Determinations CPG
7132.12
400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs
400.325 Candy "Pills" Representation as Drug CPG
7132.04
400.335 Fructose-Containing Drugs CPG 7123b.02
400.400 Conditions Under Which Homeopathic Drugs May be
Marketed
CPG 7132.15
400.500 Identical or Similar Product Names CPG 7132b.14
400.600 Drugs - Declaration of Quantity of Active CPG
7132.03
400.700 Drug Product Entries in Periodic Publications CPG 7132b.17
400.800 Collection and Charitable Distribution of Drugs CPG
7132.08
400.900 Class I Recalls of Prescription Drugs CPG 7132.01
Sub Chapter 410 - Bulk Drugs
410.100 Finished Dosage Form Drug Products in Bulk Containers
- Applications of Current Good Manufacturing Practice Regulations CPG 7132a.06
Sub Chapter 420 - Compendial /Test
Requirements
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
420.200 Compendium Revisions and Deletions CPG 7132.02
420.300 Changes in Compendial Specifications and NDA CPG
7132c.04
420.400 Performance of Tests for Compendial Requirements on
Compendial Products CPG 7132.05
420.500 Interference with Compendial Tests CPG 7132a.01
Sub Chapter 425 - Computerized Drug
Processing
425.100 Computerized Drug Processing; CGMP Applicability to
Hardware and Software CPG 7132a.17
425.200 Computerized Drug Processing; Vendor Responsibility CPG
7132a.12
425.300 Computerized Drug Processing; Source Code for Process
Control Application Programs CPG 7132a.15
425.400 Computerized Drug Processing; Input/Output Checking CPG
7132a.07
425.500 Computerized Drug Processing; Identification of
"Persons" on Batch Production and Control Records CPG 7132a.08
Sub Chapter 430 - Labeling and Repackaging
430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage
Forms CPG 7132b.10
430.200 Repacking of Drug Products - Testing/Examination under
CGMPs
CPG 7132.13
430.300 Labeling Shipping Containers of Drugs CPG 7132b.13
430.400 Urinary Preparations - Misbranding - Lack of Rx Legend
and Claims
CPG 7132b.04
Sub Chapter 435 - Medical Gases
435.100 Compressed Medical Gases - Warning Letters for
Specific Violations Covering Liquid and Gaseous Oxygen CPG 7132a.16
Sub Chapter 440 - 448 New Drugs
440.100 Marketed New Drugs Without Approved NDAs CPG 7132c.02
06/20/2006 This CPG supersedes section 440.100, Marketed New Drugs Without Approved NDAs or ANDAs (CPG 7132c.02)
442.100 New Drugs - Export CPG 7132c.01
444.100 Recovery of Investigational New Drugs from Clinical
Investigators CPG 7132c.05
446.100 Regulatory Action Regarding Approved New Drug and
Antibiotic Drug Products Subjected to Additional Processing or other Manipulations CPG
7132c.06
448.100 Reconditioning of New Drugs Which Do Not Have Approved
NDAs/ANDAs CPG 7132c.03
Sub Chapter 450 - 457 OTC
450.100 CGMP Enforcement Policy - OTC vs Rx Drugs CPG 7132.10
450.200 Drugs - General Provisions and Administrative Procedures
for Recognition as Safe and Effective CPG 7132b.15
450.300 OTC Drugs - General Provisions and Administrative
Procedures for Marketing Combination Products CPG 7132b.16
450.400 Labeling and Distribution of OTC Drugs in Vending
Machines CPG 7132b.06
450.500 Tamper-Resistant Packing Requirements for Certain
Over-the-Counter (OTC) Human Drug Products CPG 7132a.17
450.550 Control and Accountability of Labeling Associated with
Tamper-Resistant Packaging of Over-the-Counter Drug Products CPG 7132.14
454.100 OTC Ear Drop Preparations CPG 7132b.01
455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full
Disclosure and Claims CPG 7132b.12
456.100 Non-Rx Drugs Anti-Obesity Preparations CPG 7132b.05
457.100 Pangamic Acid and Pangamic Acid Products Unsafe for Food
and Drug Use CPG 7121.01
Sub Chapter 460 - Pharmacy Issues
460.100 Hospital Pharmacies - Status as Drug
Manufacturer CPG 7132.06
460.200 Pharmacy Compounding (Reissued 05/29/2002)
460.300 Return of Unused Prescription Drugs
to Pharmacy Stock CPG 7132.09
460.400 Computerized Prescription Recordkeeping
by Pharmacies CPG 7132b.09
460.425 Prescription Status when Telephoned
to Recording Machine CPG 7132b.08
460.450 Status of Mail-Order Filling of Prescriptions
CPG 7132b.07
460.500 Prescription Drugs for Ship's Medicine
Chests CPG 7132.11
460.600 Content Uniformity Testing of Tablets
and Capsules CPG 7132a.14
460.700 Controlled Release Dosage Form Drugs
- Rate of Release of Active Ingredients CPG 7132a.02 (Revoked - Obsolete
- Superseded by 21 CFR 310.502(a)(14) )
460.800 Parametric Release - Terminally Heat
Sterilized Drug Products CPG 7132a.13
Sub Chapter 470 - Post Approval Issues
470.100 Orders for Post-Approval Record Reviews CPG 7132c.07
Sub Chapter 480 - Stability/Expiration
480.100 Requirements for Expiration Dating and Stability
Testing
CPG 7132a.04
480.200 Expiration Dating of Unit Dose Repackaged Drugs CPG
7132b.11
480.300 Lack of Expiration Date of Stability Data CPG 7132a.10
Sub Chapter 490 - Validation
490.100 Process Validation Requirements for
Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market
Approval CPG 7132c.08 |
