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For example, the following is an excerpt from the Federal Register: "The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review ...
USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
In the European Union, the European Medicines Agency has jurisdiction and the relevant documents are called the "summary of product characteristics" (SPC or SmPC) and the document for end-users is called the "patient information leaflet" or "package leaflet". The SPC is not intended to give general advice about treatment of a condition but does ...
The 1699 Edinburgh Pharmacopoeia. A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography pharmacopœia, meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.
The International Standard Bibliographic Description (ISBD) is a set of rules produced by the International Federation of Library Associations and Institutions (IFLA) to create a bibliographic description in a standard, human-readable form, especially for use in a bibliography or a library catalog.
ISO 690 governs bibliographic references to published material in both print and non-print documents. [3] The current version of the standard was published in 2021 and covers all kinds of information resources, including monographs, serials, contributions, patents, cartographic materials, electronic information resources (including computer software and databases), music, recorded sound ...
Pages in category "Monographs" The following 25 pages are in this category, out of 25 total. This list may not reflect recent changes. ...
Monographs resemble the format of a Summary of Product Characteristics (SPC), [9] [10] which is a basis for the information required for medicinal products, e.g. in the package leaflet. ESCOP herbal monographs provide a selected overview of the published literature.