The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 2000 - Administrative law 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 20
... Clinical Pharmacology . Indications and Usage . Contraindications . Warnings . Precautions . Adverse Reactions . Drug Abuse and Dependence . Overdosage . Dosage and Administration . How Supplied . ( 2 ) The labeling may contain the fol ...
... Clinical Pharmacology . Indications and Usage . Contraindications . Warnings . Precautions . Adverse Reactions . Drug Abuse and Dependence . Overdosage . Dosage and Administration . How Supplied . ( 2 ) The labeling may contain the fol ...
Page 21
... clinical stud- ies to be pertinent to clinical use may be included under this section of the la- beling only under the following cir- cumstances : ( i ) In vitro data for anti - infective drugs may be included if the data are ...
... clinical stud- ies to be pertinent to clinical use may be included under this section of the la- beling only under the following cir- cumstances : ( i ) In vitro data for anti - infective drugs may be included if the data are ...
Page 22
... clinical data , but serious animal tox- icity may also be the basis of a boxed warning in the absence of clinical data . If a boxed warning is required , its loca- tion will be specified by the Food and Drug Administration . The ...
... clinical data , but serious animal tox- icity may also be the basis of a boxed warning in the absence of clinical data . If a boxed warning is required , its loca- tion will be specified by the Food and Drug Administration . The ...
Page 26
... Clinical Pharmacology " or " Clinical Studies " section . As appro- priate , this information shall also be contained in the " Contraindications , " " Warnings , " and elsewhere in the " Precautions " sections . ( iii ) If there are ...
... Clinical Pharmacology " or " Clinical Studies " section . As appro- priate , this information shall also be contained in the " Contraindications , " " Warnings , " and elsewhere in the " Precautions " sections . ( iii ) If there are ...
Page 27
... Clinical Pharma- cology " or the " Clinical Studies " sec- tion . As appropriate , this information shall also be contained in " Contra- indications , " " Warnings , " and else- where in “ Precautions . ' ( ii ) Specific statements on ...
... Clinical Pharma- cology " or the " Clinical Studies " sec- tion . As appropriate , this information shall also be contained in " Contra- indications , " " Warnings , " and else- where in “ Precautions . ' ( ii ) Specific statements on ...
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active ingredient adequate advertisement amended appropriate approved batch beling chapter clinical closures Code components control number Cosmetic Act Department distribution distributor of record dosage form dose Drug Administration drug application Drug Facts drug listing drug prod drug products containing drug sample equipment estab established name exemption facture Federal Acquisition Regulation Federal Food Food and Drug gram health care entity hexachlorophene human labeling licensed practitioner maintenance treatment manufac manufacturer manufacturing practice medicated article(s medicated feed Medication Guide ment methadone misbranded narcotic narcotic drugs National Drug Code Office oral OTC drug products over-the-counter drug package Packaging and labeling paragraph patient patient's record pediatric pernicious anemia person potassium permanganate prescription drug program physician proprietary name quantity quired regulations request Service sodium sodium phosphate specific storage submitted tainer taining tamper-evident testing tients tion treatment program Type A medicated unit wholesale
Popular passages
Page 24 - ProHance* should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ProHance" is administered to a nursing woman.
Page 211 - 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 25 - Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Lortab 7.5/500 tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Page 16 - USP) 2.5. 5, and 10 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen In patients who also have aspirin hypersensitivity.
Page 24 - There are. however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed...
Page 186 - Board of Governors of the Federal Reserve System (Part 6801) LIX National Aeronautics and Space Administration (Part 6901) LX United States Postal Service (Part 7001) LXI National Labor Relations Board (Part 7101...
Page 25 - Nursing Mothers: It is not known whether this drug is excreted in human milk Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman...
Page 51 - Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions...
Page 195 - 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...
Page 54 - Act (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or repacking establishment.