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Encounters with Linnaeus? Modernisation of pharmacopoeia through Bernard Read and Zhao Yuhuang up to the present 1
Published in Vivienne Lo, Michael Stanley-Baker, Dolly Yang, Routledge Handbook of Chinese Medicine, 2022
Scientists and historians, traders and regulators use two different genres to communicate in Chinese about the various medicinal materials and pharmaceutical products at distinct stages of production and identification: ‘materia medica’ (bencao 本草) and ‘pharmacopoeia’ (yaodian 藥典). ‘Materia medica’ includes crude drugs, pharmaceuticals, and raw materials – but the term also denotes documents about these materials and products, i.e. a genre of textual records archiving them in a corpus of knowledge. ‘Pharmacopoeia’ now refers to another specific genre: the standard volume of Pharmaceuticals that scientists and a particular nation-state (e.g. the ‘British Pharmacopoeia’) recognise for pharma-trade. In Chinese, the second character dian 典 of yaodian 藥典 has legal connotations and can thus mean a ‘code’ in law, or refer to a reference work, such as an encyclopaedia or, later, dictionary. This indicates that the pharmaceutical content in such a volume was derived from a range of texts across the four classical Chinese historical sources, i.e. classics (jing 經), histories (shi 史), masters (zi 子), and collectanea (ji 集). The Chinese term pharmacopoeia thus refers explicitly to the orthodoxy of the text, while alluding to its encyclopaedic scale and heterogeneous content.
Fenugreek Based Products in USA, Australia, Canada, and India
Published in Dilip Ghosh, Prasad Thakurdesai, Fenugreek, 2022
Savita Nimse, Sanjeevani Deshkar
The D and C Act extends the control over licensing, manufacture, labeling, packing, and quality of Ayurvedic products. Schedule “T” of the act describes the GMP requirements for the manufacturer of herbal medicines. The official pharmacopoeias and formularies are available for the quality standards of the medicines.
A Futuristic View
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
Despite the problems, the disappointments, the frustrations, the financial setbacks, and the unforeseeable mishaps, progress toward that ultimate goal of a cure for every ill will continue unabated. In the creation of the final edition of the pharmacopoeia, clinical pharmacology will have played a critical role in every sense.
Pharmacopeial Standards for the Quality Control of Botanical Dietary Supplements in the United States
Published in Journal of Dietary Supplements, 2023
Nandakumara Sarma, Roy Upton, Ulrich Rose, De-an Guo, Robin Marles, Ikhlas Khan, Gabriel Giancaspro
A pharmacopeia is a compendium of standards and specifications for drugs, excipients, dietary supplements and herbal medicines, amongst others. Typically, a pharmacopeial standard is a combination of a documentary standard, such as a monograph or general chapter, and an associated physical reference standard (RS). The specifications and analytical procedures used to define a specific article, including packaging and labeling requirements, are included in pharmacopeial monograph standards. Monographs provide tests, methods, and acceptance criteria to define the identity, composition, and limits of contaminants of the article (1). The core purpose of a monograph is to help ensure that products and their ingredients are of a consistent quality. Pharmacopeial standards, developed with input from industry, academic, health professional and government stakeholders to ensure their needs are being met, can be used as an impartial, science-based resource for helping to ensure DS quality and ingredient integrity. Pharmacopeial standards are generally developed through a transparent process that includes an open public comment phase during which essential feedback is collected from stakeholders. Pharmacopeial standards are considered public standards since they are transparent and open for adoption by any manufacturer, compared to private specifications based on confidential business information, which are not open to the public.
Cannabis for cancer – illusion or the tip of an iceberg: a review of the evidence for the use of Cannabis and synthetic cannabinoids in oncology
Published in Expert Opinion on Investigational Drugs, 2019
Cannabis has been used as a healing herb and mild-altering drug since ancient times. In the 28th century B.C., Chinese Emperor Shen Nung prescribed Cannabis for ailments involving the loss of yin, such as malaria, constipation, rheumatism and absentmindedness, to heal the body by restoring harmony between opposing forces yin and yang. Centuries later the Greek historian Herodotus chronicled Cannabis-based burial customs, while Indian folklore called it the ‘drink of warriors.’ [1] With the advent of Cannabis cultivation in the New World, the burgeoning plant became a prosperous cash crop, used in clothing, rope, and paper. Moreover, it registered in the American Pharmacopeia in the late 19th century for a broad range of indications, but with cautions regarding ‘alarming effects’ associated with overdose [1]. Thereafter, rising tensions among physicians and law-makers led to restrictions on Cannabis use in the form of tariffs and strict registration requirements, until ultimately the Controlled Substances Act in 1970 assigned Cannabis Schedule I status, alongside heroin and lysergic acid diethylamide [2].
Supplement Regulation for Sports Nutrition Supplements
Published in Journal of Legal Medicine, 2018
Again, the testing process does not need to reach the level that the FDA uses to approve pharmaceuticals.115 Nevertheless, the FDA should utilize the tools that are already available such as independent testing facilitates, which can check for product consistency and purity, as well as test individual ingredients for safety.116 The FDA could impose a requirement for manufacturers to submit their products to independent testing facilities before they can be labeled and sold.117 The United States Pharmacopeia (USP) is one such testing facility that works to bridge the gap between pharmaceutical drug standards and supplement standards.118 USP currently tests products when companies contact USP and USP currently markets their services as a “competitive edge.”119 Products that bear the black and yellow USP label “signal to the public that what’s on their label is what’s in the bottle.”120 This process is a bit costly, with prices ranging from $3,000 to $15,000 per product plus and initial fee of $15,000 and one-cent label fee per bottle.121 However, when compared to the profit that retailers are generating, these costs are insignificant.122