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Compliance
Regulatory Procedures Manual March 2004


Regulatory Procedures Manual March 2004
Effective May 6, 2004
Chapter Descriptions


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Introduction (PDF PDF Icon, 63 kb)

Ch. 1 – REGULATORY ORGANIZATION – An overview of offices involved in compliance related functions within FDA. (PDF PDF Icon, 448 kb)

Ch. 2 – FDA AUTHORITY – Selected Amendments to the Federal Food, Drug, and Cosmetic Act and other laws of interest. (PDF PDF Icon, 383 kb)

Ch. 3 – COMMISSIONING AND WORK SHARING – Commissioning of Federal, State, and local officials, acceptance of a state’s commission, and work sharing initiatives. (PDF PDF Icon, 854 kb)

Ch. 4 – ADVISORY ACTIONS – Procedures for Warning Letters and Untitled Letters. (PDF PDF Icon, 1.87 mb)

Ch. 5 – ADMINISTRATIVE ACTIONS – Procedures for: Citation; Section 305 Meetings; Detentions of Foods; Administrative Detentions of Devices; Revocation or Suspension of Biologic Licenses; Orders for Retention, Recall, and/or Destruction of Human Tissue; and Civil Money Penalties. (PDF PDF Icon, 554 kb)

Ch. 6 – JUDICIAL ACTIONS – Procedures for: Seizures; Injunctions; Inspection Warrants; Search Warrants; Prosecution; and Civil Penalties under Subchapter C of the Federal Food, Drug, and Cosmetic Act. (PDF PDF Icon, 1.8 mb)

Ch. 7 – RECALL PROCEDURES - Procedures for Agency units to initiate, review, classify, publish, audit, and terminate recall actions. (PDF , 623 kb)

Ch. 8 – EMERGENCY PROCEDURES - Emergency management procedures for FDA’s headquarters and field personnel. (PDF , 281 kb)

Ch. 9 – IMPORT OPERATIONS/ACTIONS – Includes: Import Procedures; Coverage of Personal Importations; Importation of Biological Products; Warehouse Entries; Release Notices; Automatic Detentions; Notice of Detention and Hearing; Responses to Notice of Detention and Hearing; Notice of Refusal of Admission; Reconditioning; Supervisory Charges; Bond Actions; Import Information Directives; Priority Enforcement Strategy for Problem Importers; Import for Export; Importations for Trade Shows/Fairs, Exhibits and Special Events; Communication Concerning Assessment of Civil Monetary Penalties by U.S. Customs Service in Cases Involving Imported Food; Notice of Sampling; and, Granting and Denying Transportation and Exportation (T&E;) Entries. (Chapter 9 is currently being revised. Until revisions have been completed, please see the version of this chapter at: www.fda.gov/ora/compliance_ref/rpm_new2/ch9/default.htm)

Ch. 10 – OTHER PROCEDURES – Includes: Prior Notice; Establishment Inspection Report (EIR) Conclusions and Decisions; Interstate Travel Program (ITP) Classifications and Administrative Actions; Reporting and Monitoring; Ad Hoc Committees; the Appeal Process; Expert Support for Cases; Testimony; Production and Certification of Records; and the Application Integrity Policy. (PDF , 409 kb)

Ch. 11 – GLOSSARY – Terms and Acronyms used in the RPM. (PDF , 235 kb)

APPENDIX A - RPM CHANGE REQUEST FORM (PDF , 70 kb)