BioThrax Vaccine Monograph Listed in USP.Business Editors/Health/Medical Writers LANSING, Mich.--(BUSINESS WIRE)--April 23, 2004 BioPort Corporation, the world's only FDA-licensed manufacturer of the anthrax vaccine An´thrax vac´cine 1. (Veter.) A fluid vaccine obtained by growing a bacterium (Bacillus anthracis, formerly Bacterium anthracis) in beef broth. It is used to immunize animals, esp. cattle. , BioThrax(TM), announced the listing of the Anthrax Vaccine Adsorbed (BioThrax(TM) vaccine) monograph mon·o·graph n. A scholarly piece of writing of essay or book length on a specific, often limited subject. tr.v. mon·o·graphed, mon·o·graph·ing, mon·o·graphs To write a monograph on. in the United States Pharmacopeia United States Pharmacopeia /Unit·ed States Phar·ma·co·peia/ (USP) a legally recognized compendium of standards for drugs, published by The United States Pharmacopeial Convention, Inc., and revised periodically. (USP USP - unique sales point ) National Formulary National Formulary /Na·tion·al For·mu·lary/ (NF) a book of standards for certain pharmaceuticals and preparations that are not included in the USP(United States Pharmacopeia). Na·tion·al Formulary n. Abbr. , issue 27-NF 22 Supplement. The USP is a non-governmental, standards-setting organization consisting of more than 1,000 scientists, practitioners, state associations, colleges of medicine, members of the pharmaceutical industry and others. The USP advances "public health by ensuring the quality and consistency of medicines" and promoting their safe and effective use (http://www.onlinepressroom.net/uspharm/). In a 1997 decision, FDA/CBER underwent plans to remove references to specific vaccine tests from the Code of Regulations. This resulted in a USP decision to develop "full monographs" for vaccines provide manufacturers, practitioners, and patients information on quality parameters of BioThrax(TM) vaccine. In early 2003, BioPort Corporation added the initiative to development a BioThrax(TM) vaccine monograph to its operational plans. USP adoption of the BioThrax(TM) vaccine monograph is the result of a comprehensive review and approval of the vaccine tests, methods, and pharmacopeial phar·ma·co·pe·ial adj. 1. Of or relating to a pharmacopoeia. 2. Relating to a drug in the list of the United States Pharmacopoeia or similar pharmacopoeia. process, and was completed by a USP appointed Vaccine Expert Committee in May 2003. Considering the importance of the BioThrax(TM) vaccine in the effort against bioterrorism bi·o·ter·ror·ism n. The use of biological agents, such as pathogenic organisms or agricultural pests, for terrorist purposes. Bioterrorism and the potential role of the monograph in sustaining public confidence, the USP expedited the publication of the BioThrax(TM) vaccine monograph. This monograph was approved by the Vaccine Expert Committee for publication in Pharmaceutical Forum (PF) in less than one week following submission. It generally takes approximately two to three weeks for Committee approval. The BioThrax(TM) vaccine monograph can be found at: http://www.uspnf.com/uspnf/usp27-nf22s1/default.htm. |
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