2016-20471: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs

Summary

The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.

The agency’s own summary, as published.

What this changes

Amends 9 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 20 Public Information
• 21 CFR 201 Labeling
• 21 CFR 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code
• 21 CFR 314 Applications for FDA Approval to Market a New Drug
• 21 CFR 514 New Animal Drug Applications
• 21 CFR 515 Medicated Feed Mill License
• 21 CFR 601 Licensing
• 21 CFR 607 Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
• 21 CFR 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products