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 3
... licensing of wholesale pre- scription drug distributors Imprinting of solid oral dosage form drug products for human use ...... Registration of producers of drugs and listing of drugs in commercial distribution 208 210 Medication Guides ...
... licensing of wholesale pre- scription drug distributors Imprinting of solid oral dosage form drug products for human use ...... Registration of producers of drugs and listing of drugs in commercial distribution 208 210 Medication Guides ...
Page 11
... licensed by law and for which it is advertised solely to such practitioner . ( b ) Quantity of dose , including usual quantities for each of the uses for which it is intended and usual quan- tities for persons of different ages and ...
... licensed by law and for which it is advertised solely to such practitioner . ( b ) Quantity of dose , including usual quantities for each of the uses for which it is intended and usual quan- tities for persons of different ages and ...
Page 12
... licensed practitioners , in the case of a prescrip- tion drug , and to the layman , in the case of a nonprescription drug . ( 2 ) A statement of the percentage of an ingredient in a drug shall , if the term percent is used without ...
... licensed practitioners , in the case of a prescrip- tion drug , and to the layman , in the case of a nonprescription drug . ( 2 ) A statement of the percentage of an ingredient in a drug shall , if the term percent is used without ...
Page 48
... licensed by law to administer or prescribe such drugs ; and ( 2 ) It is to be dispensed in accordance with section 503 ( b ) ( b ) The label of the drug bears : ( 1 ) The statement " Caution : Federal law prohibits dispensing without ...
... licensed by law to administer or prescribe such drugs ; and ( 2 ) It is to be dispensed in accordance with section 503 ( b ) ( b ) The label of the drug bears : ( 1 ) The statement " Caution : Federal law prohibits dispensing without ...
Page 50
... licensed veterinarian ; or ( iii ) In the possession of a licensed veterinarian for use in the course of his professional practice ; and ( 2 ) To be dispensed in accordance with section 503 ( f ) of the act . ( b ) The label of the drug ...
... licensed veterinarian ; or ( iii ) In the possession of a licensed veterinarian for use in the course of his professional practice ; and ( 2 ) To be dispensed in accordance with section 503 ( f ) of the act . ( b ) The label of the drug ...
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Common terms and phrases
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.