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The National Council for Prescription Drug Programs (NCPDP) is an American nonprofit standards development organization representing most sectors of the U.S. pharmacy services industry. It was founded in 1977 as the extension of a Drug Ad Hoc Committee that made recommendations for the U.S. National Drug Code (NDC).
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.
The organization's nearly 60,000 members include pharmacists, student pharmacists, and pharmacy technicians. [1] ASHP maintains a national database on U.S. drug shortages that is published on their website.
under 10.90(b) that provides information about how to prepare a summary. The summary required under this paragraph may be used by FDA or the applicant to prepare the Summary Basis of Approval document for public disclosure (under 314.430(e)(2)(ii)) when the application is approved.
Pharmacy and Poisons Board of Hong Kong (PPBHK) 2016 Hungary: National Institute of Pharmacy and Nutrition (OGYÉI) 1995 Iceland: Icelandic Medicines Agency (IMA) 1995 Indonesia: National Agency for Drug and Food Control (NADFC) Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM) 2012 Iran: Iran Food and Drug Administration (IFDA) 2018 ...
Pharmacy and Therapeutics (P&T) is a committee at a hospital or a health insurance plan that decides which drugs will appear on that entity's drug formulary. The committee usually consists of healthcare providers involved in prescribing, dispensing, and administering medications, as well as administrators who evaluate medication use. [ 1 ]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
USP 800 (Hazardous Drugs—Handling in Healthcare Settings) is a guideline created by the United States Pharmacopeia Convention (USP), as one of their General Chapters through which the USP "sets quality standards for medicines, dietary supplements and food ingredients".