The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1994 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. |
Citi izdevumi - Skatīt visu
Bieži izmantoti vārdi un frāzes
active ingredient adequate advertisement Agency amended animal appropriate approved Authority citation batch beling chapter clinical closures cluding Code Commission control number Cosmetic Act detoxification distribution distributor dosage form dose Drug Administration drug application Drug Establishment drug listing drug product containers equipment established name evaluation exemption Federal Acquisition Regulation Federal Food Federal Register Food and Drug gram hexachlorophene intended labeling licensed maintenance treatment manufac manufacture manufacturing practice medi medicated article(s medicated feed ment methadone misbranded name or designation narcotic drugs National National Drug Code Office operations oral over-the-counter drug package Packaging and labeling packing paragraph patient patient's record pernicious anemia person potassium permanganate pregnancy Pregnancy Category preparations prescription drugs processing program physician proprietary name quired revised safety sample shipment specific statement storage submitted Subpart SUBTITLE tained tainer testing tion treatment program Type A medicated unit warning
Populāri fragmenti
23. lappuse - ProHance* should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
25. lappuse - 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.
44. lappuse - Indications Based on a review of this drug by the National Academy of Sciences — National Research Council and/or other information, FDA has classified the indications as follows: Effective: For the management of the manifestations of psychotic disorders.
23. lappuse - 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...
37. lappuse - 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...
38. lappuse - Adequate information for such use, including indications, effects, dosages, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all...
50. lappuse - The same information concerning the ingredients of the drug as appears on the label and labeling on or within the package from which the drug is to be dispensed...
41. lappuse - REGULATIONS MAKING EXEMPTIONS SEC. 405. The Secretary shall promulgate regulations exempting from any labeling requirement of this 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...
25. lappuse - 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...
48. lappuse - Within 90 days following the date of publication of this section in the FEDERAL REGISTER, the manufacturer, packer, or distributor of any drug containing...