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Contraindicated in pregnancy: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
[96] [97] [98] In 2014, however, the FDA has developed a "Pregnancy and Lactation Labeling Rule (PLLR)" which requires product labels to include specific information related to the safety and effectiveness of medications to pregnant and lactating women. This ruling has removed the requirement of stating pregnancy categories in prescription drug ...
[1] [2] The FDA has long worked to classify and license new medications. Its Drug Evaluation and Research Center categorizes these medications based on both their chemical and therapeutic classes. [3] In several major drug classification systems, these four types of classifications are organized into a hierarchy. [4]
The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. The drug or other substance has a currently [1] accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
The drug or other substance has a high potential for abuse. The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug or other substances may lead to severe psychological or physical dependence.
The drug or other substance has a currently accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. The complete list of Schedule IV substances is as follows.
The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. The complete list of Schedule I substances is as follows. [1]
The Generic Product Identifier (GPI) is a 14-character hierarchical classification system created by Wolters Kluwer's Medi-Span that identifies drugs from their primary therapeutic use down to the unique interchangeable product regardless of manufacturer or package size. The code consists of seven subsets, each providing increasingly more ...