21 C.F.R. PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F--BIOLOGICS
PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
Subpart A--GENERAL PROVISIONS
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Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
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Subpart B--PROCEDURES FOR DOMESTIC BLOOD PRODUCT ESTABLISHMENTS
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Who must register and submit a blood product list.
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Times for establishment registration and blood product listing.
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How and where to register establishments and list blood products.
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Information required for establishment registration and blood product listing.
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Amendments to establishment registration.
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Updating blood product listing information.
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Additional blood product listing information.
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Notification of registrant; blood product establishment registration number and NDC Labeler Code.
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Inspection of establishment registrations and blood product listings.
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Misbranding by reference to establishment registration or to registration number.
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Subpart C--PROCEDURES FOR FOREIGN BLOOD PRODUCT ESTABLISHMENTS
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Establishment registration and blood product listing requirements for foreign blood product establishments.
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Subpart D--EXEMPTIONS
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Exemptions for blood product establishments.
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