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  1. Guidance, Compliance & Regulatory Information (Biologics)

Biologics Establishment Registration

Blood Establishments

All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65. A list of every blood product manufactured, prepared, or processed for commercial distribution must also be submitted. Products must be registered and listed within 5 days of beginning operation, and annually between November 15 and December 31. Blood product listings must be updated every June and December.

Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) Establishments

Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under Section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Establishments must register and list their HCT/Ps within 5 days of beginning operation and registration must be updated annually in December.

The August 31, 2016 final rule titled 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 amended FDA’s regulations governing drug establishment registration and drug listing, including establishment registration and listing for HCT/Ps. Manufacturers of HCT/Ps that are regulated as drugs, devices, and/or biological products under section 351 of the PHS Act or under the Food, Drug, and Cosmetic Act, must register and list their products in accordance with 21 CFR Part 207 or 807, as applicable, rather than 21 CFR Part 1271. Please refer to the Drug Establishment Registration and Listing or Device Registration and Listing webpages for additional information.

Note: FDA does not require establishments that manufacture drugs (including biological products) and devices that are HCT/Ps for use under an investigational new drug application (IND) (21 CFR Part 312) or an investigational device exemption (IDE) (21 CFR Part 812) to register and list their HCT/Ps until the HCT/P is approved through a biologics license application (BLA), new drug application (NDA), or premarket approval application (PMA); or cleared through a premarket notification submission (510(k)).

Establishment Registration

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Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

[email protected]

(800) 835-4709
(240) 402-8010

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