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The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
The United States Pharmacopeia (USP) is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself.
For instance, for the shipping and storage of pharmaceuticals, the United States Pharmacopeia-National Formulary (USP-NF) defines controlled room temperature as between 20 and 25 °C (68 and 77 °F), with excursions between 15 and 30 °C (59 and 86 °F) allowed, provided the mean kinetic temperature does not exceed 25 °C (77 °F). [17]
Pharmacopeial reference standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where pharmacopoeial tests or assays call for the use of a pharmacopoeial reference standard, only those results obtained using the specified pharmacopoeial reference standard are conclusive.
In 2013, the first recommendations for auxiliary label usage in the United States were published as USP Chapter <17>. [4] This included a recommendation to limit the use of auxiliary labels to evidence-based labels with critical information, and without pictures unless evidence shows increased efficacy when a picture is used.
This page was last edited on 12 February 2008, at 17:40 (UTC).; Text is available under the Creative Commons Attribution-ShareAlike 4.0 License; additional terms may apply.
USP: United States Pharmacopeia USP DI: U.S. Pharmacopeia Dispensing Information USP-DQI: USP Drug Quality and Information Progarm USP-IV: U.S. Pharmacopeia’s Ingredient Verification Program USP–NF: U.S. Pharmacopeia–National Formulary . Gene Nygaard 19:20, 4 Mar 2005 (UTC) I renamed (moved) the page--Ryanjo 01:43, 29 June 2006 (UTC)
USP Regulatory Standards [ edit ] For drugs sold in the United States, the U.S. Pharmacopeia (USP) defines standards for moisture transmission of drug packaging.