Electronic Drug Registration and Listing

Reed Tech How-to Guides for eDRL are designed to help you understand and meet the FDA’s requirements for electronic drug registration and listing with step by step instructions and ways to simplify and expedite the process.   Choose which guide fits your organization’s needs:  Contract Manufacturer, OTC Drug Distributor, or Prescription Drug Distributor.

The eDRL How-to Guide answers questions like:

  • Who is responsible to list a drug product?
  • How to obtain Drug Listing and National Drug Codes (NDCs)?
  • What are the prerequisites for drug listing submissions?
  • What are the elements of a drug listing submission?
  • What are the manufacturer’s listing and enforcement issues?

We hope you find this reference information as a helpful resource to your team. If you have questions about Drug Listings for OTC, prescription or other scenarios, contact us. We are here to help. Email: Pharma@ReedTech.com

A How-to Guide for Contract Manufacturing Organizations

Contents

Introduction
4 About FDA’s Electronic Drug Registration and Listing (eDRL)
5 Manufacturers’ Listings and Distributor’s Listings
6 Who is responsible to list a drug product
7 NDC Directory and DailyMed Publication
8 Manufacturer’s Listings Enforcement and Import Issues
9 Drug Listing and National Drug Codes (NDCs)
10 Prerequisites for drug listing submission
11 Elements of a drug listing submission
14 Conversion, submission and maintenance
15 Next Steps

A How-to Guide for OTC Drug Distributors

Contents

3 Introduction
4 About FDA’s Electronic Drug Registration and Listing (eDRL)
5 Who is responsible to list a drug product
6 Drug Listing and National Drug Codes (NDCs)
7 Prerequisites for drug listing submission
8 Elements of a drug listing submission
11 Conversion, submission and maintenance
12 Next Steps

A How-to Guide for Prescription Drug Distributors

Contents

3 Introduction
4 About FDA’s Electronic Drug Registration and Listing (eDRL)
5 Who is responsible to list a drug product
6 Drug Listing and National Drug Codes (NDCs)
7 Prerequisites for drug listing submission
8 Elements of a drug listing submission
11 Conversion, submission and maintenance
12 Next Steps