Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

Compliance Program Guidance Manual

(public access version)

Content updated: 2008-11-24

FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.  These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind FDA or the public. Alternative approaches may be used as long as said approaches satisfy the requirements of applicable statutes and regulations. These programs are intended for FDA personnel but are made available electronically to the public as they become available.

Numerical listing of all FDA Compliance Programs with hyperlinks to those available electronically on FDA websites, organized by these program areas:

Reference: FDA Freedom of Information Act Handbook for Requesting Information and Records from FDA


Foods and Cosmetics

Program # Compliance Program Title On-line Availability
7303.003 Import Acidified and Low Acid Canned Foods Program Link to CFSAN list
7303.037 Domestic and Imported Cheese and Cheese Products Link to CFSAN list
7303.039 National Drug Residue Milk Monitoring Program Link to CFSAN list
7303.803 Domestic Food Safety Link to CFSAN list
7303.803A Domestic Acidified and Low-Acid Canned Foods Link to CFSAN list
7303.819 Imported Foods - General Program Link to CFSAN list
7303.842 Domestic Fish and Fishery Products Inspection Program Link to CFSAN list
7303.844 Import Seafood Products Link to CFSAN list
7303.847 Juice HACCP Inspection Program not on-line
7304.004 Pesticides and Industrial Chemicals in Domestic Foods Link to CFSAN list
7304.016 Pesticides and Industrial Chemicals in Imported Foods Link to CFSAN list
7304.018 Chemotherapeutics in Seafood Compliance Link to CFSAN list
7304.019 Toxic Elements in Food and Foodware Import and Domestic Link to CFSAN list
7304.839 Total Diet Studies Link to CFSAN list
7307.001 Mycotoxins in Domestic Foods Link to CFSAN list
7307.002 Mycotoxins in Imported Foods Link to CFSAN list
7309.006 Imported Foods - Food and Color Additives Link to CFSAN list
7318.002 Retail Food Protection - State Link to CFSAN list
7318.003 Milk Safety Program Link to CFSAN list
7318.004 Molluscan Shellfish Evaluation Link to CFSAN list
7318.029 Interstate Travel Program Link to CFSAN list
7321.002 Medical Foods - Import and Domestic Link to CFSAN list
7321.005 Domestic and Import NLEA, Nutrient Sample Analysis General Food Labeling Program Link to CFSAN list
7321.006 Infant Formula Program - Import and Domestic Link to CFSAN list
7321.008 Food Composition, Standards, Labeling And Economics Dietary Supplements - Import and Domestic Link to CFSAN list
7329.001 Cosmetics Program - Domestic & Imports
Link to CFSAN list

Page Top

Biologics

Program # Compliance Program Title On-line Availability
7341.002 Inspection of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) Link to CBER list
7341.002A Inspection of Tissue Establishments Link to CBER list
7342.001 Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors Link to CBER list
7342.002 Inspection of Source Plasma Establishments Link to CBER list
7342.007 Imported CBER-Regulated Products Link to CBER list
7342.007A Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) Link to CBER list
7342.008 Inspections of Licensed Viral Marker Test Kits Link to CBER list
or Link to PDF version of 7432.008 (3129 kb)
7345.848 Inspection of Biological Drug Products Link to CBER list

Page Top

BIMO

Program # Compliance Program Title On-line Availability
7348.001 In Vivo Bioequivalence Link to HTML version of 7348.001 Link to PDF version of 7348.001 (78 kb)
7348.808 Good Laboratory Practice (Nonclinical Laboratories) Link to HTML version of 7348.808 Link to PDF version of 7348.808 (117 kb)
7348.808A Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit Inspections Link to HTML version of 7348.808A Link to PDF version of 7348.808A (38 kb)
7348.809 Institutional Review Board Link to PDF version of 7348.809 (293 kb)
7348.809A Radioactive Drug Research Committee not on-line
7348.810 Sponsors, Contract Research Organization and Monitors Link to HTML version of 7348.810 Link to PDF version of 7348.810 (80 kb)
7348.811 Clinical Investigators Link to HTML version of 7348.811 Link to PDF version of 7348.811 (2437 kb)

Page Top

Drugs

Program # Compliance Program Title On-line Availability
7346.832 Pre-Approval Inspections/Investigations
Link to PDF version of 7346.832(156kb)
7346.843 Post-Approval Audit Inspections Link to PDF version of 7346.832(159kb)
7352.002 New Drugs (Rx) Not Covered by Approved NDA's not on-line
7352.004 In Vitro Methods Development and Validation for Generic Drugs not on-line
7353.001 Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations Link to HTML version of 7353.001
7356.002 Drug Manufacturing Inspections Link to HTML version of 7356.002   Link to PDF version of 7356.002 (80 kb)
7356.002A Sterile Drug Process Inspections Link to PDF version of 7356.002A (79 kb)
7356.002B Drug Repackers and Relabelers Link to PDF version of 7356.002B (189 kb)
7356.002C Radioactive Drugs Link to PDF version of 7356.002C (187 kb)
7356.002E Compressed Medical Gases Link to PDF version of 7356.002E (249 kb)
7356.002F Active Pharmaceutical Ingredients Link to PDF version of 7356.002F (252 kb)
7356.002M Inspections of Licensed Biological Therapeutic Drug Products Link to PDF version of 7356.002M (89 kb) Link to HTML version of 7353.002M
7356.008 Postmarket Drug Product Surveys not on-line
7356.014 Drug Listing not on-line
7356.014A Drug Listing - Labeling Review not on-line
7356.020 Compendial Monographs Evaluation and Development (CMED) not on-line
7356.020A Compendial Methods Assessment not on-line
7356.021 Drug Quality Reporting System NDA Field Alert Reporting not on-line
7356.022 Enforcement of the Prescription Drug Marketing Act (PDMA) not on-line
7356.818 Government-Wide Quality Assurance not on-line
7361.003 OTC Drug Monograph Implementation Link to PDF version of 7361.003 (76 kb)
7363.001 Fraudulent Drugs Link to PDF version of 7363.001 (69 kb)

Page Top

Veterinary Medicine

Program # Compliance Program Title On-line Availability
7368.001 Pre-Approval Inspection New Animal Drug Applications (NADA) Abbreviated New Animal Drug Applications (ANADA) Link to CVM list
7371.001 Animal Drug Manufacturing Inspections Link to CVM list
7371.002 Illegal Sales of Veterinary Prescription Drugs Link to CVM list
7371.003 Feed Contaminants Program Link to CVM list
7371.004 Feed Manufacturing Compliance Program Link to CVM list
7371.005 Type A Medicated Articles Link to CVM list
7371.006 Illegal Drug Residues in Meat & Poultry Program Link to CVM list
7371.007 Imported Bulk New Animal Drugs Link to CVM list
7371.008 National Drug Residue Milk Monitoring Link to CVM list
7371.009 BSE/Ruminant Feed Ban Inspections Link to CVM list

Page Top

Devices

Program # Compliance Program Title On-line Availability
7382.008 Monitoring Devices of Foreign Origin Import not on-line
7382.013 Conformance Assessment of Devices to Product Specifications in Pre-Market Notifications (510(k)s) not on-line
7382.845 Inspection of Medical Device Manufacturers Link to HTML version of 7382.845 Link to PDF version of 7382.845 by individual section
7383.001 Medical Device Premarket Approval and Postmarket Inspections not on-line
7383.003 510(k) Premarket Approval Inspections not on-line
7385.014 Mammography Facility Inspections Link to PDF version of 7385.014 (497 kb) Link to WORD version of 7385.014 (730 kb)
7386.001 Inspection and Field Testing of Radiation-Emitting Electronic Products Link to PDF version of 7385.014 (1190 kb)
7386.003 Field Compliance Testing of Diagnostic Medical X-Ray Equipment Link to PDF version of 7386.003 (75 kb) Link to WORD version of 7386.003 (143 kb)
 Attachments A-C Link to PDF version of Attachments A-C of 7386.003 (9 kb) Link to WORD version of Attachments A-C of 7386.003 (28 kb)
 Attachment D Link to PDF version of Attachment D of 7386.003 (25 kb) Link to WORD version of Attachment D of 7386.003 (53 kb)
 Attachment E Link to PDF version of Attachments E of 7386.003 (672 kb) Link to WORD version of Attachment E of 7386.003 (126 kb)
 Attachment F Link to PDF version of Attachment F of 7386.003 (30 kb) Link to WORD version of Attachment F of 7386.003 (122 kb)
 Attachment G Link to PDF version of Attachment G of 7386.003 (27 kb) Link to WORD version of Attachment G of 7386.003 (61 kb)
 Attachments H-K Link to PDF version of Attachments H-K of 7386.003 (22 kb) Link to WORD version of Attachments H-K of 7386.003 (46 kb)
 Attachment L Link to PDF version of Attachment L of 7386.003 (7 kb) Link to WORD version of Attachment L of 7386.003 (24 kb)
 Attachment M Link to PDF version of Attachment M of 7386.003 (37 kb) Link to WORD version of Attachment M of 7386.003 (74 kb)
7386.003a Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment Link to CDRH List
or Link to PDF version of 7386.003a (3.51 kb)
7386.006 Compliance Testing of Electronic Products at WEAC not on-line
7386.007 Imported Electronic Product not on-line
7386.007A Imported Non-certified Radiation-Emitting Electronic Products (Special Exemption for Television Receivers, Microwave Ovens, and Certain Class I Laser Products not on-line
7386.008 Medical Device and Radiological Health Use Control and Policy Implementation not on-line
7386.009 Emergency Planning and Response Activities
Part VI
not on-line

Page Top