Introduction to Pharmacy
Drug Standards
A drug reference standard is a standardized
substance which is used as a measurement
base for similar substances.
Drug reference Standards are highly
characterized specimens of drug substances,
excipients, reportable impurities, degradation
products, compendial reagents, and
performance calibrators.
They are explicitly required in many
Pharmacopeial assays and tests and are
provided solely for such use.
• Pharmacopoeia: Pharmacopoeia (literally, "drug-
making"), in its modern technical sense, is a book
containing directions for the identification of compound
medicines, and published by the authority of a
government or a medical or pharmaceutical society.
• Monographs: Descriptions of preparations are called
monographs. In a broader sense it is a reference work
for pharmaceutical drug specifications.
• Formulary: A drug formulary is a list of prescription
drugs, both generic and brand name, used by
practitioners to identify drugs that offer the greatest
overall value. Drugs considered for the formulary are
evaluated by a committee of local experts and are
chosen for their safety and effectiveness.
Pharmacopoeia
European Pharmacopoeia (Ph. Eur.)
The European Pharmacopoeia (Ph. Eur.) is a published
collection of monographs that describe both the individual and
general quality standards for ingredients, dosage forms and
methods of analysis for medicines. The objective of the Ph.
Eur. is to provide common quality standards throughout
Europe to control the quality of medicines and substances
used to manufacture them. These standards apply to
medicines for both human and veterinary use.
Author: Council of Europe
Edition: Every three years
Volume: Two
Availability: Print, electronic and USB stick versions
Language: English and French
British Pharmacopoeia (BP)
The British Pharmacopoeia (BP) is the official,
authoritative collection of standards for UK medicinal
substances for human and veterinary use. It is used by
individuals and organizations involved in
pharmaceutical research, development, manufacturing
and testing.
Author: British Pharmacopoeia Commission
Secretariat of the Medicines and Healthcare
Products Regulatory Agency (MHRA)
Edition: Annually
Volume: Six
Availability: Print and electronic versions in both
on-line and CD-ROM
Language: British English
Contents of BP: The current edition of the British Pharmacopoeia
comprises six volumes which contain nearly 3,000 monographs for
drug substances, excipients and formulated preparation.
Volumes I and II
– Medicinal Substances
Volume III
– Formulated Preparations
– Blood related Preparations
– Immunological Products
– Radiopharmaceutical Preparations
– Surgical Materials
– Homeopathic Preparations
Volume IV
– Appendices
– Infrared Reference Spectra
– Index
Volume V
– British Pharmacopoeia (Veterinary)
Volume VI
– (CD-ROM version)
United States Pharmacopeia (USP)
The United States Pharmacopeia (USP) is the official
pharmacopeia of the United States that sets standards
for the identity, strength, quality, purity, packaging, and
labeling for drug substances, dosage forms, and other
therapeutic products, including nutritionals and dietary
supplements. USP now jointly published with National
Formulary as USP-NF.
Author: US Pharmacopeial Convention
Edition: Yearly
Volume: Four
Availability: Print, online and USB flash drive
Language: English and Spanish
International Pharmacopoeia (Ph. Int.)
The International Pharmacopoeia (Ph. Int.) is
published by World Health Organization (WHO)
with the aim to achieve a wide global
harmonization of quality specifications for selected
pharmaceutical products, excipients and dosage
forms.
Japanese Pharmacopoeia (JP)
The Japanese Pharmacopoeia (JP) is the official
Pharmacopoeia of Japan. It is published by the
Pharmaceuticals and Medical Devices Agency
under the authority of the Ministry of Health,
Labour and Welfare.
Indian Pharmacopoeia (IP)
Indian Pharmacopoeia Commission (IPC) is
an autonomous institution of the Ministry of
Health and Family Welfare which sets
standards for all drugs that are
manufactured, sold and consumed in India.
The set of standards are published under
the title Indian Pharmacopoeia (IP) which
has been modeled over and historically
follows from the British Pharmacopoeia. The
IP 2014 is presented in four volumes.
Formulary
British National Formulary (BNF)
The British National Formulary (BNF) is a 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 National
Health Service (NHS), including indication(s), contraindications,
side effects, doses, legal classification, names and prices of
available proprietary and generic formulations, and any other
notable points.
Author: Royal Pharmaceutical Society
Edition: Twice a year, in March and September. As a custom,
the colour of each edition is radically different to the previous;
edition 63 was blue, edition 64 was red, edition 65 was purple,
edition 66 was blue, and edition 67 is green.
Availability: Print and electronic (online) versions
Language: British English
National Formulary (NF)
The National Formulary (NF), established in 1888 by
the American Pharmaceutical Association, includes
standards for excipients, botanicals, and other
similar products. USP purchased the NF in 1975,
combining the two publications under one cover,
creating the USP-NF.
Author: US Pharmacopeial Convention
Edition: Yearly with USP as USP-NF
Availability: Print and electronic (online) versions
Language: English and Spanish
Australian Pharmaceutical Formulary (APF)
The Australian Pharmaceutical Formulary (APF) is
the official drug formulary used by pharmacists in
Australia. The title of the APF has been extended
to the Australian Pharmaceutical Formulary and
Handbook.
Author: Pharmaceutical Society of Australia
Edition: Every few years
Availability: Print and electronic (online)
versions
Language: English
Bangladesh National Formulary (BDNF)
• BDNF is the official drug formulary used by
pharmacists, physicians and other health care
professionals in Bangladesh. Drugs that are
prescribed in Bangladesh and registered with the
Drug Administration are included in the BDNF.
• BDNF is a joint publication of Bangladesh Medical
Association (BMA), Bangladesh Pharmaceutical
Society (BPS) and Directorate of Drug
Administration (DDA). First edition was published
in 2001, then in 2003 and 2006. A new edition is
released every few years.
What is the difference between the USP
and the National Formulary?
The United States Pharmacopeia is a compendium
of quality control tests for drugs and excipients
to be introduced into a medicinal formulation. It
is published every year by the United States
Pharmacopoeial Convention.
It forms the basis of enforcement actions by the
U.S. Food and Drug Administration (USFDA)
and the U.S. Drug Enforcement Administration
and is the official pharmacopoeia of the U.S.A.
and several other nations.
What is the difference between the USP
and the National Formulary?
A National Formulary is a manual containing a list
of medicines that are approved for prescription
throughout the country, indicating which
products are interchangeable. It includes key
information on the composition, description,
selection, prescribing, dispensing and
administration of medicines.
What is the difference between the USP
and the National Formulary?
In some countries, there are regional or provincial
formularies instead of or in addition to the
national formulary.
By the turn of the millennium, 156 countries had
national or provincial essential medicines lists
and 135 countries had national treatment
guidelines and/or formulary manuals.
