DRUG STANDARDS AND THE USP – Flashcards
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What does the USP stand for?
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United States Pharmacopoeia
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Pharmacopoeia comes from the Greek "pharmakon" and "poiein". What do these words mean?
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pharmakon - drug poiein - make
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Organized sets of monographs and books of standards are known as
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Pharmacopeias and formularies
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In 1820 the first edition of The Pharmacopoeia of the United States was published. T/F?
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True
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In 1820 a group of physicians met for a pharmacopeial convention, a scientific nonprofit organization, currently headquartered where?
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Rockville, Maryland
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What were the physicians trying to create at the pharmacopeia convention?
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A Compendium of the best therapeutic products, Giving products useful names, Provide recipes for their preparation
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The USP started as a compendium of recipes but eventually changed into what?
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A compendium of documentary standards to establish the identity of an article through tests for strength, quality, and purity.
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Standards or Monographs are written documents that describe an item. T/F?
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True
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Standards and Monographs include what types of information?
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name, packaging, storage and labeling of ingredient or preparation and information on specific test results needed to ensure that the ingredient matches the label.
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Manufacturers must do ID tests on ingredients to make sure that test results match the results on the monographs. Pharmacist are exempt from this. T/F?
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True
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Between the years of 1820-1942 how often was the USP published?
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10 year intervals
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Between the years of 1942-2000 how often was the USP published?
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5 year intervals
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Starting in the year 2002 how often was the USP published?
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annually
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What does NF stand for
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The National Formulary
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In 1852 there was more than one authoritative and recognized book of drug standards. T/F?
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False: The only authoritative and recognized book of drug standards at this time was the 3rd version of the USP
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The American Pharmaceutical Association (APhA) was organized in 1852 T/F?
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True
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The scope of the USP was open to all drugs. T/F?
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False: Scope was restricted to drugs of established therapeutic merit.
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Because of the strict selectivity many drugs and formulas that were accepted and used in the medical profession were not granted admission to early revisions of the USP. T/F?
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True
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Pharmacists prepared a formulary containing many of the popular drugs and formulas that were denied admission in the USP, that was published in 1888 known as?
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The National Formulary of Unofficial Preparations
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The title of the formulary was changed to the National Formulary (NF) in 1906 when President Theodore Roosevelt signed into law the first federal Pure Food and Drug act. T/F?
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True
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The US Pharmacopeia and the National Formulary became the official standard for drugs in the US. When?
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In 1906 when the Pure Food and Drug Act
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In 1938 the federal food drug and cosmetic act, a revision of the 1906 act, recognized the USP-NF as the official compendia of drug standards. T/F?
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True
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The Food and Drug Administration is responsible for the enforcement of
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The Food Drug and cosmetic act
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In 1975 the United states Pharmacopeia Convention, Inc. purchased what? What occurred because of this purchase?
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Purchased the National formulary. Purchase created one book USP-NF, that the US Pharmacopeia Convention now owns.
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The first compendium, compromising the USP XX and NF XV became official in 1980. T/F?
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True
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USP 23 - NF18 became the first edition to drop use of roman numerals in favor of Arabic numerals. T/F?
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True
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The USP 23-NF 18 became official in what year?
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1995
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In 2002 with USP 25 - NF20 what began to happen?
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USP-NF was published annually
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What is publication schedule of the USP-NF each year?
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1 main addition and 2 supplements are published. the 2 supplemental editions are issued separately a few months after the first edition.
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A bimonthly ONLINE journal where USP publishers proposed revisions to USP-NF seeking public review and content.
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Pharmacopeial Forum (PF)
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All monographs on the therapeutically active drug appear where in the USP-NF?
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The USP section
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Pharmaceutical agents (excipients) appear in the USP section of the USP-NF. T/F?
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False: Pharmaceutical agents appear in the NF version of the USP-NF
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In addition to monographs the USP includes what?
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General chapters
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Each general chapter of the USP-NF is assigned a number, which appears in brackets along with the chapter name. T/F?
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True
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2 parts general chapters are divided into include:
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1. General tests and assays chapters: info on basic test procedures 2. General info chapters: broad scope guidance advise.
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General Tests and Assays chapters are -, these chapters are considered Official monographs. which means what?
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These monographs are requirements and official laws and must be followed as laws.
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General Information include chapters + are considered interpretive. which means?
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They contain no official standards and do not have to be followed as laws. Just there to provide information.
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What general chapter provides Guidance on applying good compounding practices in the preparation of nonsterile compounded formulations for dispensing /administering to humans/animals.
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Pharmaceutical compounding- Nonsterile Prepareations
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What general chapter provides procedures and requirements for compounding sterile preparations.
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<797 Pharmaceutical Compounding -sterile preparations.
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What general chapter provides general guidance and assistance to pharmacists in performing the necessary calculations when preparing or compounding any pharmaceutical drug.
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Pharmaceutical Calculations in Prescription Compounding
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What general chapter provides quality assurance program as a system of steps and actions that must be taken to ensure the maintenance of proper standards in compound preparations?
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Quality Assurance in Pharmaceutical Compounding
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What general chapter provides information about acceptable balances and volumetric apparatus (i.e. burets pipets cylinders, conical graduates, medicine droppers) used to weigh or measure medicinal and other substances required in pharmaceutical compounding.
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Prescription balances and volumetric Apparatus
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General Information chapters + can not be changed to laws at any time? T/F?
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False: any general information chapters can be changed to laws at any given time.
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New proposed compounding general chapters include:
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hazardous Drugs - Handling in healthcare settings Compounding for investigational studies to guide compounding practitioners in the extemporaneous compounding of drugs used in investigational studies.
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What other countries have published their own pharmacopeias?
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Britain (BP) Europe (EP or Eur) Japan (JP)
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Other countries that have their own pharmacopeia are used within that country's legal jurisdiction. T/F?
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True
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Countries that do not have their own pharmacopeia usually adopt another country's to regulate drug standards. Name an example of a country that does this.
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Canada uses the USP-NF Standards
