FDA Drug Labeling Requirements & Regulations

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Drug Listing Electronic FDA Drug Registration System Labeling and Ingredients Reviews Drug Master Files Certificate of Registration

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Label / Ingredient Reviews and Graphic Design Step 1 of 3

Registrar Corp can assist you with U.S. FDA labeling requirements. Please complete the form below:

Consumers will see my label

I have a shipment detained due to labeling violations

I have not yet designed a label and I would like assistance

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Type of Business (Select all that apply): *
	Manufacturer - Owns or operates an establishment that manufactures a drug. This term includes, but is not limited to, control laboratories, contract laboratories, contract manufacturers, contract packers, contract labelers, and other entities that manufacture a drug.
	Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
	Repacker - Packages finished drugs from bulk or repackages drugs made by a manufacturer into different containers (excluding shipping containers).
	Distributor - Any company engaged in distributing private label drugs (your company name appears on the label).
	Other - Contract Testing Lab, Medical Gas Transfiller, Contract Assembler, Manufacturing Pharmacy, Fulfillment Packager, Contract Sterilizer, and Regional Admixture Pharmacy.

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U.S. FDA Regulations:

U.S. FDA Drug Labeling: 21 C.F.R. Part 201 Subparts A and C

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.


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