Document

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

ICR 200712-0910-013 · OMB 0910-0045 · Object 5469001.

Document Viewer [htm]

Status: The document is viewable through fallback artifacts while conversion repair continues in the background.

Queue: A repair attempt failed. The document remains flagged for retry and verification. (priority 90 · attempts 1 · next 2026-04-17 18:31:59)

Missing: pdf

Download: Source copy (htm)

Primary: htmlSource: text/html
Loading document viewer…
Document Metadata
File Typetext/html
File TitleRegistration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Conversion Statefailed_conversion
Extracted Text
Table of Contents
    • Regulatory Guidance Drug Registration and Listing 
    • Draft Guidance for Registration and Listing forms 
    • Introduction 
    • Summary of Registration and Listing requirements 
    • Form FDA 2656 
    • Form FDA 2657 
 
    • Drug Listing Procedures for Kits 
 
    • Sample Listing Form - Gas Companies  
 
    • Form FDA 2658 
    • ANNEX A - Code of Federal Regulations 
    • ANNEX B - The Drug Listing Act of 1972 Information Bulletin 
    • ANNEX C - District Offices 
    • ANNEX D - Abbreviations 
 
    • State and Territory Abbreviations 
 
    • Table I - Dosage Forms 
 
    • Table II - Routes of Administration 
 
    • Table III - Unit Codes 
 
    • Table IV - Package Type Codes 
    • ANNEX E - Glossary of Terms 
 
Last Updated: 8/11/2006 
CDER Home Page