Department of Pharmacy Noakhali Science & Technology University

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Noakhali Science and Technology University
Department of Pharmacy
Course Title: Introduction to Pharmacy
Course Code: 1101
Assignment Name: Drug Standards.
Date: 03-04-2018
Submitted to: Fahad Hussain,assistant professor at dep. of pharmacy at NSTU.
Submitted by:
 Md. MokabbirHossain Uchsas
Roll: ASH1803004M

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DRUG STANDARDS
Drug Information: The Pharmacist has the knowledge and expertise to
provide detailed information on medicines to members of the health
professions and the public. Also pharmacists provide an information
service within the company.
Pharmacopeia: A book published usually under the jurisdiction of the
government and containing a list of drugs, their formulas, methods for
making medicinal preparations, requirements and tests for their strength
and purity, and other related information.
Pharmacopoeias and Formularies: Pharmacopoeias are authoritative
treatises on drugs and preparations, their description, formulation,
analytic composition, physical constants, main chemical properties used
in identification, standards for strength, purity, and dosage, chemical tests
for determining identity and purity, etc. They are usually published under

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governmental jurisdiction. They differ from formularies in that they are
far more complete; formularies simply list drugs or collections of
formulas for the compounding of medicinal preparations. However,
sometimes the terms "pharmacopoeia" and "formulary" are used
interchangeably.
In addition to serving as current reference sources, pharmacopoeias and
formularies provide an historical record of pharmacy practice, drug use,
and drug availability.
NLM collects the national pharmacopoeias of the world insofar as
possible. Other formularies are more selectively acquired, with emphasis
on those likely to be of historical interest. Hospital formularies, which list
all drugs commonly stocked in a hospital pharmacy, generally are not
collected.[1]
USP: The United States Pharmacopeia (USP) is
a pharmacopeia (compendium of drug information) for the United
States published annually by the United States Pharmacopeial
Convention (usually also called the USP), a nonprofit organization that
owns the trademark and copyright. The USP is published in a combined
volume with the National Formulary (a formulary) as the USP-NF. If a
drug ingredient or drug product has an applicable USP quality standard
(in the form of a USP-NF monograph), it must conform in order to use the
designation "USP" or "NF." Drugs subject to USP standards include both
human drugs (prescription, over-the-counter, or otherwise), as well as
animal drugs. USP-NF standards also have a role in U.S. federal law; a
drug or drug ingredient with a name recognized in USP-NF is deemed
adulterated if it does not satisfy compendial standards for strength, quality
or purity. USP also sets standards for dietary supplements, and food
ingredients (as part of the Food Chemicals Codex). USP has no role in
enforcing its standards; enforcement is the responsibility of Food and

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Drug Administration (FDA) and other government authorities in the U.S.
and elsewhere.[2]
BP : The British Pharmacopoeia (BP)is the national pharmacopoeia of
the United Kingdom. It is an annual published collection of quality
standards for UK medicinal substances. It is used by individuals
and organisations involved in pharmaceutical
research, development, manufacture and testing.
Pharmacopoeial standards are publicly available and legally enforceable
standards of quality for medicinal products and their constituents. The
British Pharmacopoeia is an important statutory component in the control
of medicines which complements and assists the licensing and inspection
processes of the Medicines and Healthcare products Regulatory
Agency (MHRA) of the United Kingdom. Together with the British
National Formulary (BNF), the British Pharmacopoeia defines the UK's
pharmaceutical standards.
Pharmacopoeial standards are compliance requirements; that is, they
provide the means for an independent judgement as to the overall quality
United States Pharmacopeia
Type Nonprofit
Founded 1820
Headquarters Rockville, Maryland, USA
Key people Ronald T. Piervincenzi, Chief Executive Officer

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of an article, and apply throughout the shelf-life of a product. Inclusion of
a substance in a pharmacopoeia does not indicate that it is either safe or
effective for the treatment of any disease.[3]
BNF: The British National Formulary (BNF) is a United Kingdom
(UK) pharmaceutical reference book that contains a wide spectrum of
information and advice on prescribing and pharmacology, along with
specific facts and details about many medicines available on the
UK National Health Service (NHS). Information within the BNF
includes indication(s), contraindications, side effects, doses, legal
classification, names and prices of available proprietary
and generic formulations, and any other notable points. Though it is a
national formulary, it nevertheless also includes entries for some
medicines which are not available under the NHS, and must be prescribed
and/or purchased privately. A symbol clearly denotes such drugs in their
entry.
It is used by pharmacists and doctors (both general practitioners (GPs)
and specialist practitioners), and by other prescribing healthcare
professionals (such as nurses, pharmacy technicians, paramedics,
and dentists); as a reference for correct dosage, indication, interactions
and side effects of drugs. It is also used as a reassurance by those
administering drugs, for example a nurse on a hospital ward, and even for
patients and others seeking an authoritative source of advice on any aspect
of pharmacotherapy.
The British Pharmacopoeia (BP) specifies quality standards for the
making of drugs listed in the BNF.[4]
British Pharmacopoeia
Headquarters London, United Kingdom
Website www.Pharmacopoeia.com

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BDNF : Bangladesh National Formulary is an official book of drug and
related items used in Bangladesh. It contains information for prescribing
and dispensing of drugs such as names, indication, side-effects, cautions,
dosages from. BDNF was first published by the directortate of drug
administration, ministry of health and family welfare in 2001. Later
newer version was published in 2006.[5]
Drugmonograph:A publication that specifies for a drug (or class of rela
ted drugs) the kinds and amounts of ingredients it may contain, thecondit
British National Formulary
The standard cover design is easily identified, with each six-monthly edition
distinguished by a different jacket colour. The previous edition (BNF 73
(March 2017)) is shown
Author British Medical Association, and
Royal Pharmaceutical Society
Country United Kingdom
Language British English
Subject Medicine, Pharmacy
Genre Clinical Pharmacy reference
Publisher BMJ Group, and
Pharmaceutical Press

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ions and limitations for which it may be offered, directions for use, warn
ings, and other information that its labeling mustcontain.
The monograph may contain important information concerning interacti
ons with other drugs. [6]
Drug regulation and control: Reviews the legislative basis of the
regulation of clinical investigation and the approval of new drugs as a
foundation for examination of some current policy issues facing the FDA.

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Intentions and stipulations of the major legislation passed by Congress,
including the Pure Food and Drug Act of 1906, the Food, Drug, and
Cosmetic Act of 1938, and the New Drug amendments of 1962 are
described, and their basic policies outlined.
The major regulations rooted in that legislation and other guidelines
representing FDA implementation are identified and discussed, including
new drug regulations, guidelines for clinical investigations, and other
aspects of the drug approval process. Proposed legislation affecting new
drug development and clinical investigations, and FDA administrative
proposals affecting revised new drug applications, monitoring of research,
institutional review boards, informed consent, clinical investigations, and
obligations of the sponsor or monitor are examined. Current problems and
proposals involving larger societal issues are also discussed, such as the
therapeutic use of investigational drugs, state drug legislation on
marijuana and laetrile, the alleged drug lag, orphan drugs, and

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international cooperation in drug development. The paper focuses
throughout on concern about human subject protection and validation of
research data.[7]

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References:
1. US. National Library of Medicine, national institute of health.
2. NS Pharmacopeial convention (2014-01-18) “Ron Piervinecenzi
Ph.D, Named Next. CEO of USP . PR. Newswire.
3. Medicine Act 1968 Legistation. Gov.uk. Her majestys govt. of the UK.
Retrieved 7november2016.
4. Anon (1957). British Nationl Formulary 1976-8, British Medical
Journal.
5. Bentleys Text book of Pharmaceutics : A. Owen Bentley, and E A
Rawlins.
6. Olivia Pulsinelli (4 March 2014). "BP to create new Houston-
based business to manage onshore U.S. assets".Houston Business
Journal. Retrieved 10 April.
7. "Across Atlantic, Much Ado About Oil Company's Name". The
New York Times.12 June 2010.Archived from the originalon 17 June
2010. Retrieved 17 June 2010.