drug monograph


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drug monograph

A publication that specifies for a drug (or class of related drugs) the kinds and amounts of ingredients it may contain, the conditions and limitations for which it may be offered, directions for use, warnings, and other information that its labeling must contain. The monograph may contain important information concerning interactions with other drugs.
See also: monograph
References in periodicals archive ?
One major source of information for tertiary literature sources, such as drug monographs, is the FDA-approved package insert.
A petitioner can request that FDA amend any condition of use allowed by an OTC drug monograph. One limitation is that the condition must have existed in the marketplace prior to 1975.
The drug monographs in 5MinuteConsult contain content from Facts & Comparisons, a trusted drug information resource for pharmacists, but critical information from that source is missing.
This edition also has new entries in the index, more on prescribing and dispensing, changes to drug monographs, removed section numbering, dose and classification changes, deleted and new preparations, and other changes.
Crane's experience includes all phases of the marketing, labeling and distribution of both OTC drugs and dietary supplements, with special emphasis on the labeling requirements mandated in the OTC drug monographs and the associated format and content regulations.
• Overview of the OTC Drug Monographs and Their Importance
The number of available drugs has increased by a wide margin, further necessitating this comprehensive index divided into fifteen sections: drug monographs, standard medical abbreviations, calculations, common systems of weights and measures, approximate practical equivalents, international system of units, normal laboratory values, FDA pregnancy categories, controlled substances summary, medical terminology glossary, oral dosage forms that should not be crushed or chewed, drug names that look alike and sound alike, discontinued drugs, common abbreviations of chemotherapy regimens, and a manufacturer and distributor listing.
Over a thousand drug monographs and nearly forty fields of information for each pack an extensive review which includes red highlights and an organization that lends to quick look-up reference.
Drug monographs are frequent in all chapters with specific information regarding actions, drug interactions, contraindications, dosage and administration.
Epocrates Rx--contains drug monographs and information about drug interactions, medical news and some clinical articles Radiology 2.0: One night in the ED--a teaching tool based on clinical cases Skyscape: RxDrugs and Outlines in Clinical Medicine Skyscape produce a great range of Apps, not all are free (e.g.
Updates to this new, thick 'pocket' tote include 18 new drug monographs, 38 new chemotherapy routines, special updates on new cancer therapies and safe handling of hazardous drugs, and more.
These may include updating individual standards and/or updating or creating new general chapters dealing with impurities that apply to all O-T-C drug monographs (USP activities), as well as developing new regulatory approaches and FDA guidances (or using a combination of approaches).