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Topic: United States Pharmacopoeia

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	About USP
		USP's contributions to public health are enriched by the participation and oversight of volunteers representing pharmacy, medicine, and other healthcare professions as well as academia, government, the pharmaceutical industry, health plans, and consumer organizations.
		USP disseminates its standards to pharmaceutical manufacturers, pharmacists, and other users through its USP–NF and other publications, official USP Reference Standards materials, and Pharmacopeial Education courses.
		USP also partners with the U.S. Agency for International Development in worldwide projects that help to assure drug quality and proper drug use in many developing countries.
	www.usp.org /aboutUSP (488 words)

	United States Pharmacopea
		The U.S. Pharmacopoeia can, therefore, best be thought of as a medical cookbook; one that dictates the exact formula, parts of the plant, and the exact method of preparation of base drugs for pharmaceutical use.
		The U.S.P. dealt with this problem by dictating the exact parts of the plant that were to be used and the exact method of manufacture.
		Of interest to the historian is the fact that the U.S.P. (even thought it was technically created by a private society) would eventually be enshrined into United States federal law, and soon became the envy of the world.
	antiquecannabisbook.com /Appendix/AppendixC.htm (951 words)

	United States Pharmacopeia - Wikipedia, the free encyclopedia
		The United States Pharmacopeia is a compendium of quality control tests for drugs and excipients to be introduced into a medicinal formulation.
		Therefore, in case of a dispute those methods for, amongst others, identification, assay and purity determination of a drug substance or excipient which are stated in the USP will be the legally binding ones.
		The initials USP are affixed to materials' names to indicate that they conform to the specifications in the USP and may be used medicinally.
	en.wikipedia.org /wiki/United_States_Pharmacopoeia (164 words)

	WYLIE: CHAPTER VIII
		The food-law specifically recognizes the United States Pharmacopoeia, both as to the standard of quality of the remedies described therein and the methods of analysis by which the purity of remedies is established.
		Its activities, therefore, are specifically prescribed by the Congress of the United States as one of the methods of administering the Food and Drugs Act.
		There had been going through the papers and being stated by the chemists, and so forth, that the best use to which we could put benzoate of soda, and the use to which it generally was put, was to preserve decaying vegetables and fruits.
	www.soilandhealth.org /03sov/0303critic/030305wylie/030305ch8.html (1629 words)

	Iowa Code 2003: Section 126.10
		However, to the extent that compliance with subparagraph (1), subparagraph subdivision (b) or this subparagraph is impracticable, exemptions shall be allowed under rules or regulations adopted by the board or the secretary under the federal Act.
		If it is a color additive, the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with the packaging and labeling requirements applicable to that color additive, as contained in regulations adopted under section 706 of the federal Act.
		It is sold, distributed, or used in violation of regulations adopted pursuant to section 520(e) of the federal Act.
	www.legis.state.ia.us /IACODE/2003/126/10.html (1316 words)

	International GMPs - A Detailed Background (Site not responding. Last check: 2007-10-12)
		Originally pharmacopoeias were collections of recipes to assure consistent communication between physician and pharmacists, but have transformed over time into a book of standards describing the quality specifications a raw material and pharmaceutical product.
		The USP was the work of the medical profession and was the first book of drug standards from a professional source to achieve national acceptance and ultimately was recognized in law by the United States Congress as the “official book of drug standards”.
		Additional influential pharmacopoeias worth noting, either due to the sizes of their populations or to the extent of their export trade in pharmaceuticals, are those of China, India and Japan.
	www.globepharm.org /international-GMPs/drug-quality.html (774 words)

	Manila Bulletin Online (Site not responding. Last check: 2007-10-12)
		In 1989, the Pharmacopoeia Discussion Group (PDG) was formed with representatives from the European Directorate for the Quality of Medicines in the Council of Europe (EDQM), the United States Pharmacopoeia Convention, Inc. (USPC), and the Japanese Pharmacopoeia in the Ministry of Health and Welfare â” now the Ministry of Health, Labour, and Welfare (MHLW).
		The European Pharmacopoeia was inaugurated in 1964 under the auspices of the Council of Europe in accordance with the terms of the Convention on the Elaboration of a European Pharmacopoeia.
		The pharmacopoeia was declared official in April 1, 2001 and the 15th edition is expected in 2006.
	www.mb.com.ph /issues/2006/05/21/OPED2006052164636.html (996 words)

	Assuring Quality and Performance of Sustained and Controlled Release Parenterals: Workshop Report
		USP apparatus 1 (basket) and 2 (paddle) were designed for immediate- and modified-release oral formulations.
		USP apparatus 5 (paddle over disc), 6 (cylinder) and 7 (reciprocating holder) were designed for the transdermal route.
		Unit to unit reproducibility of the drug product is a main concern, since particle size distribution, crystallinity, morphology as well as other physical and chemical parameters may vary with slight changes in the reconstitution procedure(s).
	www.aapspharmsci.org /view.asp?art=ps040207 (5621 words)

	CHAPTER 33. PURE FOOD AND DRUGS (Site not responding. Last check: 2007-10-12)
		No dealer shall be prosecuted under this chapter when the dealer can establish a guaranty signed by the wholesaler, jobber, manufacturer or other party residing in the United States from whom the dealer purchases such articles to the effect that the same is not adulterated or misbranded within the meaning of this chapter.
		The State Board of Pharmacy shall enforce all the provisions of this chapter and shall promulgate rules and regulations for carrying out the same so far as they relate to drugs, including proper methods for handling volatile and variable drugs.
		(b) In case of failure to convict the charge of the State Chemist, the costs of the justice of the peace and the costs and actual expenses endorsed upon the warrant shall be paid by the county in which the prosecution is conducted.
	www.delcode.state.de.us /title16/c033/index.htm (2603 words)

	S.C. Code of Laws Title 39 Chapter 23 Adulterated, Misbranded Or New Drugs And Devices - www.scstatehouse.net-LPITS (Site not responding. Last check: 2007-10-12)
		The State of South Carolina and the South Carolina Legislative Council make no warranty as to the accuracy of the data, or changes which may have been enacted since the 2005 Regular Session or which took effect after this database was prepared and users rely on the data entirely at their own risk.
		Drugs removed from the prescription requirements of the Federal act by regulations issued thereunder may also by regulations issued by the Commissioner of Health and Environmental Control, be removed from the requirements of paragraph (1) of this subsection.
		(A) For purposes of this section, "sample" means a unit of a drug which is not intended by the manufacturer to be sold and which is intended to promote the sale of the drug.
	www.scstatehouse.net /code/t39c023.htm (2258 words)

	United States v Writers & Research, Inc.
		Appeal from judgment of the United States District Court, for the Western District of New York, Michael A. Telesca, Judge, convicting defendant of conspiracy under 18 U.S.C. ß 371 (1988) and multiple counts of causing the introduction of an unapproved new drug into interstate commerce under 21 U.S.C. ßß 331(d) (1988).
		To the contrary, as we stated in Quill, we are extremely reluctant to identify a new fundamental right in the absence of a clear direction from the Supreme Court.
		For the reasons stated herein, we affirm the judgment of the district court.
	www.quackwatch.org /02ConsumerProtection/FDAActions/pixleyappeal.html (1863 words)

	A Fact Sheet on Homeopathy \| Citizens for Health
		In homeopathy, health is viewed as a state of physical, mental, emotional and social balance or equilibrium and not merely the absence of disease or pathologic signs and symptoms.
		Historically in the United States of America, the manufacture and the sale of drugs are regulated at the federal level and the physician practice of medicine is regulated at the state level.
		The Homeopathic Pharmacopoeia of the United States (HPUS) was first published in 1897 by the American Institute of Homeopathy (1844), the oldest extant national medical association in the United States.
	www.citizens.org /healthy-news/a-fact-sheet-on-homeopathy (5615 words)

	CBI - Pharmacopoeia
		The Pharmacopoeia series is the only authoritative collection of standards for medicines and is an essential reference point for everyone involved in their research, development or manufacture.
		The British Pharmacopoeia (BP) 2007 is the authoritative, current collection of standards for UK medicinal substances and the official source of all UK quality standards.
		The purpose of the Pharmacopoeia is to promote public health, by the provision of recognised common standards for use by healthcare professionals and others concerned
	www.tso.co.uk /cbi/bookstore.asp?FO=1167771&DI=556894 (682 words)

	Public Law 60
		No registered pharmacist may be the proprietor of more than one place of business, unless he or she keeps, at each place of business of which he or she is the proprietor, at all times when open, a registered pharmacist or a registered assistant pharmacist.
		No registered pharmacist doing business or employed in any other state, is permitted to open shop in this state, unless he or she keeps, at all times when open, a registered pharmacist or a registered assistant pharmacist in each shop operated in this state.
		A license issued hereunder shall be the property of the state and loaned to the licensee and it shall be kept posted in a conspicuous place on the licensed premises.
	www.rilin.state.ri.us /PublicLaws/Law01/Law01060.htm (7572 words)

	HES - The Homeopathic Pharmacopoeia and the Assurance of Quality
		Yet, the primary function of HPCUS is to produce a document that allows for the standardized manufacture of homeopathic drugs in the United States; and more importantly, to define methods that assure the high quality of homeopathic medicines to professionals, consumers and government alike.
		The drug must be prepared according to the specifications of the General Pharmacy and relevant sections of the Homeopathic Pharmacopoeia of the United States.
		The submitted documentation must be in an approved format as set forth in the relevant sections of the Homeopathic Pharmacopoeia of the United States, and must include any data relevant to toxicity.
	www.homeopathic.com /articles/intro/hpus.php (1901 words)

	TSO Online Bookshop - Pharmacopoeia
		United States Pharmacopoeia 30 - National Formulary 25
		United States Pharmacopoeia 30 - National Formulary 25 CD-ROM
		The purpose of the Pharmacopoeia is to promote public health, by the provision of recognised common standards for use by healthcare professionals and others concerned...more
	www.tsoshop.co.uk /bookstore.asp?FO=1167771&trackid=001080 (673 words)

	Assuring Quality and Performance of Sustained and Controlled Release Parenterals: EUFEPS Workshop Report
		USP apparatus 1 and 2 suffer from problems with sample containment and although this can be overcome by use of a sinker for monolithic depots and dialysis tubing to contain dispersed systems (such as, microspheres), these solutions in themselves create additional problems.
		USP apparatus 5 (paddle over disc), 6 (cylinder) and 7 (reciprocating holder) were designed for the transdermal route and do not offer any advantages for parenteral delivery systems.
		Participants agreed that USP apparatus 4 was the most suitable of the currently available USP apparatus for controlled and sustained release parenterals.
	www.aapsj.org /view.asp?art=ps060111 (6807 words)

	Pure Food and Drug Act of 1906
		That the term "drug," as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals.
		If in package form, and the contents are stated in terms of weight or measure, they are not plainly and correctly stated on the outside of the package.
		The proceedings of such libel cases shall conform, as near as may be, to the proceedings in admiralty, except that either party may demand trial by jury of any issue of fact joined in any such case, and all such proceedings shall be at the suit of and in the name of the United States.
	coursesa.matrix.msu.edu /~hst203/documents/pure.html (532 words)

	Chapter 047
		of the United States, it shall be subject to the requirements of the United States Pharmacopoeia
		United States, and not to those of the United States Pharmacopoeia.
		subsequently be included within the classifications stated in chapters 28 and 30 of this title.
	www.rilin.state.ri.us /PublicLaws/Law03/Law03047.htm (1636 words)

	Glossary related to Compliance for Analytical Laboratories: U-Z (Site not responding. Last check: 2007-10-12)
		United States Pharmacopoeia (USP) Official compendium recognized by the Federal Food, Drug, and cosmetic Act.
		The USP is the official pharmacopoeia of the United States and several other countries.
		Written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.
	www.labcompliance.com /glossary/u-z-glossary.htm (975 words)

	DIESEL FUEL Manufacturing Process (Site not responding. Last check: 2007-10-12)
		USP's are standards that drugs and vitamins must meet if sold in the United States that mainly apply to disintegration of tablets and weight variation.
		USP standards for weight can be applied to any herbal dietary supplement even though they are written and required by law for drugs and vitamins.
		There are no laws in place in the United States for herbal dietary supplement manufactures to comply with any standards on manufacturing, and quality of product sold.
	www.getdiesel.net /usp24.htm (253 words)

	The History of Drug Regulation in the United States
		The food and drug marketplace was so corrupt that some states began to hire their own chemists to certify the quality and purity of foods and drugs sold within their states, and to defend against the sale of adulterated and inferior foods and drugs from outside.
		He worked tirelessly for decades to amalgamate the efforts of state food and drug officials, the General Federation of Women's Clubs, and the national associations of physicians and pharmacists toward a comprehensive federal law.
		While the 1906 act identified the United States Pharmacopoeia and the National Formulary as the official compendia for drug standards, the law permitted the marketing of nonstandard drugs as long as the label stated the specific variation from the standard.
	www.fda.gov /cder/centennial/history.htm (3819 words)

	Iowa Code 1999: Section 126.2
		Recognized as a device in the official United States Pharmacopoeia National Formulary or any supplement to it.
		Intended for use in the diagnosis of diseases or other conditions, or in the cure, mitigation, treatment, or prevention of diseases or other conditions in a human.
		An article recognized as a drug in the official United States Pharmacopoeia National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to either document.
	www.legis.state.ia.us /IACODE/1999/126/2.html (583 words)

	PHARMACISTS (Site not responding. Last check: 2007-10-12)
		shall mean the current revisions of the Pharmacopoeia of the United States, Homeopathic Pharmacopoeia of the United States, or official National Formulary or its successor.
		Any disciplinary action taken in other states, territories and countries shall be reported to the board on the biennial registration application or within ninety days of final disposition, whichever is sooner.
		Multiple licensure shall be noted by the board on the pharmacist's record, and such state, territory or county shall be notified by the board of any disciplinary actions taken against said pharmacists in this Commonwealth.
	members.aol.com /StatutesPA/63.Cp.11.html (981 words)

	Title 5 USC
		The United States Code, the master rule book of rules, contains in Title 5 a mechanism granting any interested party the legal right to petition any agency of Government for change.
		This was the official national standard, as published in The National Formulary and remained in the United States Pharmacopoeia until the 11th edition, published in 1930.
		In the United States, as commissioned by Congress, unless a drug is listed in the US Pharmacopoeia and The National Formulary, it may not be used and is not legal to use.
	altereduniv.com /Usc5.htm (322 words)

	CBI - Pharmacopoeia
		United States Pharmacopoeia 29 - National Formulary 24, CD-ROM
		United States Pharmacopoeia 30 - National Formulary 25 - CD-ROM
		United States Pharmacopoeia 29 - National Formulary 24
	www.tso.co.uk /cbi/bookstore.asp?FO=1167771&DI=556894 (184 words)

	Chapter 5 FD&C Act Subchapter A Drugs and Devices
		For purposes of this paragraph and subsection (d), the term ''drug sample'' means a unit of a drug, subject to subsection (b), which is not intended to be sold and is intended to promote the sale of the drug.
		Forms, receipts, and records required to be maintained under this subparagraph shall be made available by the drug manufacturer or authorized distributor of record to Federal and State officials engaged in the regulation of drugs and in the enforcement of laws applicable to drugs.
		No individual who is in the regular full-time employ of the United States and engaged in the administration of this Act may be a voting member of any panel.
	biotech.law.lsu.edu /blaw/FDA/fdcact5a.htm (11695 words)

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