The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 2001 The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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Page 18
... antibodies or antigens to retroviruses . These products are sub- ject to the reporting requirements for devices . ( 1 ) Disclaimer . A report or information submitted by a licensed manufacturer under this section ( and any release by ...
... antibodies or antigens to retroviruses . These products are sub- ject to the reporting requirements for devices . ( 1 ) Disclaimer . A report or information submitted by a licensed manufacturer under this section ( and any release by ...
Page 20
... radioactive coupled antibody , which means a prod- uct that consists of an antibody com- ponent coupled with a radionuclide component ( or an antibody component intended solely to be 20 § 601.2 21 CFR Ch . I ( 4-1-01 Edition )
... radioactive coupled antibody , which means a prod- uct that consists of an antibody com- ponent coupled with a radionuclide component ( or an antibody component intended solely to be 20 § 601.2 21 CFR Ch . I ( 4-1-01 Edition )
Page 21
... antibody product for in vivo use , or therapeutic recombinant DNA - derived product , an applicant shall submit a biologics license appli- cation in accordance with paragraph ( a ) of this section except that the fol- lowing sections in ...
... antibody product for in vivo use , or therapeutic recombinant DNA - derived product , an applicant shall submit a biologics license appli- cation in accordance with paragraph ( a ) of this section except that the fol- lowing sections in ...
Page 45
... Antibody screening and re- verse grouping cells . Hepatitis test reagents Syphilis serology reagents Enzymes Frequency of testing Each day of use . Do. Do. Do. Each run . Do. Each day of use . ( d ) Supplies and reagents that do not ...
... Antibody screening and re- verse grouping cells . Hepatitis test reagents Syphilis serology reagents Enzymes Frequency of testing Each day of use . Do. Do. Do. Each run . Do. Each day of use . ( d ) Supplies and reagents that do not ...
Page 46
... antibody to human immunodeficiency virus ( HIV ) or otherwise is determined to be un- suitable when tested in accordance with §610.45 of this chapter . Procedures to quarantine in - house Whole Blood , blood components , Source Plasma ...
... antibody to human immunodeficiency virus ( HIV ) or otherwise is determined to be un- suitable when tested in accordance with §610.45 of this chapter . Procedures to quarantine in - house Whole Blood , blood components , Source Plasma ...
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Common terms and phrases
Allergenic amended at 49 antibody antigen applicable approved Authority citation revised biological product Biologics Evaluation biologics license bithionol blood and blood blood components blood product listing censed Center for Biologics chapter clinical colder collection Commission container label control number cosmetic product Cryoprecipitated date of manufacture Department Director donor Drug Administration effective date establishment Evaluation and Research facturer Federal Acquisition Regulation Federal Register final container final product Food and Drug Globulin Health hepatitis B surface Human ingredient introductory text licensed manufacturer manufac ment metic milliliters Office package label paragraph plasmapheresis plateletpheresis Platelets postmarketing potency prescribed procedures processing prod proper name radiopharmaceutical Red Blood Cells requirements Rockville Pike safety salicylanilides sample serum Service source material Source Plasma specific standards statement sterile submitted Subpart surface antigen tainer temperature tion transfusion ture unit Vaccine Whole Blood
Popular passages
Page 173 - Advisory Council on Historic Preservation African Development Foundation Federal Acquisition Regulation Agency for International Development, United States Federal Acquisition Regulation Agricultural Marketing Service Agricultural Research Service Agriculture Department Agricultural Marketing Service Agricultural Research Service Animal and Plant Health Inspection Service Chief Financial Officer, Office of Commodity Credit Corporation Cooperative State Research, Education, and Extension Service Economic...
Page 42 - Personnel, medical, or similar files, the disclosure of which would constitute an unwarranted invasion of personal privacy...
Page 160 - SUBTITLE C — REGULATIONS RELATING TO FOREIGN TRADE AGREEMENTS XX Office of the United States Trade Representative (Parts 2000— 2099) SUBTITLE D — REGULATIONS RELATING TO TELECOMMUNICATIONS AND INFORMATION...
Page 148 - Warning — Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120° F. Keep out of reach of children. (2) In the case of products intended for use by children, the phrase "except under adult supervision...
Page 173 - ... and Nutrition Service Food Safety and Inspection Service Foreign Agricultural Service Forest Service Grain Inspection, Packers and Stockyards Administration Information Resources Management, Office of Inspector General, Office of National Agricultural Library National Agricultural Statistics Service Natural Resources Conservation Service Operations, Office of Procurement and Property Management, Office of Rural Business-Cooperative Service Rural Development Administration Rural Housing Service...
Page 174 - Community Planning and Development, Office of Assistant Secretary for Community Services, Office of Comptroller of the Currency Construction Industry Collective Bargaining Commission Consumer Product Safety Commission Cooperative State Research, Education, and Extension Service Copyright Office...
Page 165 - XIX Central Intelligence Agency (Parts 1900—1999) XX Information Security Oversight Office, National Archives and Records Administration (Parts 2000—2099) XXI National Security Council (Parts 2100—2199) XXIV Office of Science and Technology Policy (Parts 2400—2499...
Page 158 - World Agricultural Outlook Board, Department of Agriculture (Parts 3800—3899) XLI [Reserved] XLII Rural Business-Cooperative Service and Rural Utilities Service, Department of Agriculture (Parts...
Page 167 - VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799) Title 41— Public Contracts and Property Management SUBTITLE B — OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS 50 Public Contracts, Department of Labor (Parts 50-1—50-999) 51 Committee for Purchase From People Who Are Blind or Severely Disabled (Parts 51-1—51-99) 60 Office of Federal Contract Compliance Programs, Equal Employment Opportunity...
Page 44 - Equipment used for the manufacture, processing, packaging, bulk shipment, labeling, holding, or control of medicated premixes or their components shall be maintained in a clean and orderly manner and shall be of suitable design, size, construction, and location to facilitate maintenance and operation for its intended purpose.