| Title and Format |
Type |
Issue Date |
| Bar Code Label Requirements--Questions and Answers (PDF - 101 KB) |
Final |
10/5/2006 |
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 82 KB)
|
Draft |
9/3/2003 |
| Compressed Medical Gases |
Final |
2/1989 |
| Computerized Systems Used in Clinical Investigations (PDF - 53 KB) |
Final |
5/10/2007 |
| Current Good Manufacturing Practice for Combination Products (PDF - 350 KB) |
Draft |
9/29/2004 |
| Current Good Manufacturing Practice for Medical Gases (PDF - 437 KB) |
Draft |
5/6/2003 |
| Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132 KB) |
Final |
7/14/2008 |
| Dosage Delivery Devices for OTC Liquid Drug Products (PDF -93 KB) |
Draft |
11/04/2009 |
|
| Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (PDF - 88 KB) |
Final |
6/27/1997 |
| Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 19 KB) |
Draft |
5/27/2005 |
| Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF - 110 KB) |
Final |
1/11/2006 |
| General Principles of Process Validation |
Final |
5/1987 |
/tr> |
| Good Laboratory Practice Regulations Questions and Answers (PDF - 2 MB) |
Final |
3/2/1998 |
| Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory (PDF - 19 KB) |
Final |
4/5/2001 |
| Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24) (PDF - 3 MB) Draft released for comment |
Draft |
8/29/2006 |
| Guideline for Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices (PDF - 4 MB) |
Final |
Posted 3/2/1998 |
| Investigating Out-of-Specification Test Results for Pharmaceutical Production (PDF - 98 KB) |
Final |
10/11/2006 |
| Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150 KB) |
Draft |
4/17/1998 |
| Marketed Unapproved Drugs -- Compliance Policy Guide (PDF - 66 KB) |
Final |
6/8/2006 |
| Monitoring of Clinical Investigations (PDF - 433 KB) |
Final |
Posted 3/2/1998 |
| Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (PDF - 3 MB) |
Final |
Posted 3/2/1998 |
| Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF - 215 KB) |
Final |
9/3/2003 |
| PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 315 KB) |
Final |
9/29/2004 |
| PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 277 KB) |
Draft |
9/15/2005 |
|
Pharmaceutical Components at Risk for Melamine Contamination (PDF - 137 KB)
|
Final |
8/6/2009 |
| Pharmacy Compounding -- Compliance Policy Guide (PDF - 793 KB) |
Final |
5/2002 |
| Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8 KB) |
Final |
8/23/1999 |
| Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment (PDF - 297 KB)
|
Draft |
11/2003 |
| Preparation of Investigational New Drug Products (Human and Animal)(PDF - 795 KB) |
Final |
11/1992 |
|
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics (PDF - 38 KB)
|
Final |
3/2006 |
| Process Validation: General Principles and Practices (PDF - 194 KB) |
Draft |
11/17/2008 |
| Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 443 KB) |
Final |
9/27/2006 |
Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs
(updated 6/29/2009 |
Final |
8/4/2004 |
| Review of FDA's Implementation of the Drug Export Amendments of 1986 (PDF - 2 MB) |
Final |
11/1989 |
| Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF - 734 KB) |
Final |
9/29/2004 |
| Street Drug Alternatives (PDF - 11 KB) |
Final |
3/2000 |
| Testing of Glycerin for Diethylene Glycol (PDF - 36 KB) |
Final |
5/1/2007 |
| The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Good Manufacturing Practice (CGMP)(PDF - 28 KB) |
Draft |
10/18/2007 |
