21 CFR Part 207 - Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

What it says

Owners or operators of establishments that manufacture, prepare, propagate, compound or process drugs in the United States, or drugs imported into the United States, must register with FDA and list the drugs they make. Registration and listing information must be submitted electronically, kept current, and updated on a schedule that includes an annual review. Foreign establishments must identify a United States agent.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Registration and listing are separate from approval, so being listed does not mean FDA has approved a product.
• Contract manufacturers, packagers and labelers can be covered, not just the application holder.
• Listing information needs to match the products actually being made, so changes should trigger an update.

What FDA inspectors look for

• Whether the establishment is registered and its information is current.
• Whether products manufactured are properly listed.
• Whether contract and foreign sites are identified accurately.

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