Which regulatory path governs the manufacturing and listing of drug establishments and products?

• A. DEA registration for controlled substances
• B. GMPs under 21 CFR Part 210
• C. FDA device registration
• D. FDA Drug Establishment Registration and Listing regulations (21 CFR Part 207)

Answer: (D)

Registering drug establishments and listing drug products is governed by FDA Drug Establishment Registration and Listing regulations (21 CFR Part 207). This framework requires every establishment involved in manufacturing, preparing, propagating, compounding, or processing drug products to register with FDA and to list each drug product in commerce, including details like active ingredients, dosage form, and route of administration. This creates an up-to-date FDA registry of who is making and distributing drugs, aiding oversight, safety monitoring, and recalls if needed.

The other options address different regulatory realms: DEA registration covers handling of controlled substances, not the general drug establishment listing; good manufacturing practices under Part 210 (and related parts) set manufacturing quality standards, not the listing process; device registration applies to medical devices, not drug products.