
A pharmacopoeia, pharmacopeia, or pharmacopoea (or the typographically obsolete rendering, ''pharmacopœia''), meaning "drug-making", in its modern technical sense, is a
reference work
A reference work is a document, such as a Academic publishing#Scholarly paper, paper, book or periodical literature, periodical (or their electronic publishing, electronic equivalents), to which one can refer for information. The information ...
containing directions for the identification of compound
medicine
Medicine is the science and Praxis (process), practice of caring for patients, managing the Medical diagnosis, diagnosis, prognosis, Preventive medicine, prevention, therapy, treatment, Palliative care, palliation of their injury or disease, ...
s. These are published or sanctioned by a government or a medical or
pharmaceutical
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...
society,
giving the work legal authority within a specified jurisdiction. In a broader sense it is a collection of
pharmaceutical drug specifications. Descriptions of the individual preparations are called
monograph
A monograph is generally a long-form work on one (usually scholarly) subject, or one aspect of a subject, typically created by a single author or artist (or, sometimes, by two or more authors). Traditionally it is in written form and published a ...
s.
Etymology
The term derives from "making of (healing) medicine, drug-making", a compound of "medicine, drug, poison" (), with the verb "to make" (), and the abstract noun suffix
-ία ''-ia''.
In early modern editions of
Latin
Latin ( or ) is a classical language belonging to the Italic languages, Italic branch of the Indo-European languages. Latin was originally spoken by the Latins (Italic tribe), Latins in Latium (now known as Lazio), the lower Tiber area aroun ...
texts, the
Greek
Greek may refer to:
Anything of, from, or related to Greece, a country in Southern Europe:
*Greeks, an ethnic group
*Greek language, a branch of the Indo-European language family
**Proto-Greek language, the assumed last common ancestor of all kno ...
diphthong
A diphthong ( ), also known as a gliding vowel or a vowel glide, is a combination of two adjacent vowel sounds within the same syllable. Technically, a diphthong is a vowel with two different targets: that is, the tongue (and/or other parts of ...
οι (''oi'') is
latinized to its Latin equivalent ''oe'' which is in turn written with the
ligature Ligature may refer to:
Language
* Ligature (writing), a combination of two or more letters into a single symbol (typography and calligraphy)
* Ligature (grammar), a morpheme that links two words
Medicine
* Ligature (medicine), a piece of suture us ...
''œ'', giving the spelling ''pharmacopœia''; in modern
UK English, ''œ'' is written as ''oe'', giving the spelling ''pharmacopoeia'', while in American English ''oe'' becomes ''e'', resulting in ''pharmacopeia''.
Early history
Although older writings exist which deal with
herbal medicine
Herbal medicine (also called herbalism, phytomedicine or phytotherapy) is the study of pharmacognosy and the use of medicinal plants, which are a basis of traditional medicine. Scientific evidence for the effectiveness of many herbal treatments ...
, the major initial work in the field is considered to be the
Edwin Smith Papyrus
The Edwin Smith Papyrus is an ancient Egyptian medical manual, medical text, named after Edwin Smith (Egyptologist), Edwin Smith who bought it in 1862, and the oldest known surgical treatise on trauma (medicine), trauma.
This document, which ma ...
in
Egypt
Egypt ( , ), officially the Arab Republic of Egypt, is a country spanning the Northeast Africa, northeast corner of Africa and Western Asia, southwest corner of Asia via the Sinai Peninsula. It is bordered by the Mediterranean Sea to northe ...
,
Pliny's pharmacopoeia.
A number of early pharmacopoeia books were written by
Persian and Arab physicians. These included ''
The Canon of Medicine
''The Canon of Medicine'' () is an encyclopedia of medicine in five books compiled by Avicenna (, ibn Sina) and completed in 1025. It is among the most influential works of its time. It presents an overview of the contemporary medical knowle ...
'' of
Avicenna
Ibn Sina ( – 22 June 1037), commonly known in the West as Avicenna ( ), was a preeminent philosopher and physician of the Muslim world, flourishing during the Islamic Golden Age, serving in the courts of various Iranian peoples, Iranian ...
in 1025 AD, and works by
Ibn Zuhr
Abū Marwān ‘Abd al-Malik ibn Zuhr (), traditionally known by his Latinized name Avenzoar (; 1094–1162), was an Arab physician, surgeon, and poet. He was born at Seville in medieval Andalusia (present-day Spain), was a contemporary of A ...
(Avenzoar) in the 12th century (and printed in 1491), and
Ibn Baytar in the 14th century. The
Shen-nung pen ts'ao ching (Divine Husbandman's Materia Medica) is the earliest known Chinese pharmacopoeia. The text describes 365 medicines derived from plants, animals, and minerals; according to legend it was written by the Chinese god
Shennong
Shennong ( zh, c=神農, p=Shénnóng), variously translated as "Divine Farmer" or "Divine Husbandman", born , was a mythological Chinese ruler known as the first Yan Emperor who has become a deity in Chinese and Vietnamese folk religion. H ...
. One of the earliest surviving pharmacopoeias from medieval Europe is the
Lorsch Pharmacopoeia
The Lorsch Pharmacopoeia (sometimes called the Lorsch Leechbook, ''Lorscher Arzneibuch'' or Lorsch Book of Remedies) is an extensive medical manuscript composed around Lorsch Abbey during the era of Charlemagne, likely created around 785. It has ...
, which dates to around 800, and draws on classical and post-classical sources.
Pharmacopeial synopsis were recorded in the
Timbuktu manuscripts
Timbuktu Manuscripts, or Tombouctou Manuscripts, is a blanket term for the large number of historically significant manuscripts that have been preserved for centuries in private households in Timbuktu, a city in northern Mali. The collections i ...
of
Mali
Mali, officially the Republic of Mali, is a landlocked country in West Africa. It is the List of African countries by area, eighth-largest country in Africa, with an area of over . The country is bordered to the north by Algeria, to the east b ...
.
China
The earliest extant Chinese pharmacopoeia, the ''
Shennong Ben Cao Jing
''Shennong Bencaojing'' (also ''Classic of the Materia Medica'' or ''Shen-nong's Herbal Classics'' and ''Shen-nung Pen-tsao Ching''; ) is a Chinese book on agriculture and medicinal plants, traditionally attributed to Shennong. Researchers belie ...
'' was compiled between 200-250 AD. It contains descriptions of 365 medications.
The earliest known officially sponsored pharmacopoeia was compiled in 659 AD by a team of 23 pharmaceutical scientists led by Su jing during the
Tang dynasty
The Tang dynasty (, ; zh, c=唐朝), or the Tang Empire, was an Dynasties of China, imperial dynasty of China that ruled from 618 to 907, with an Wu Zhou, interregnum between 690 and 705. It was preceded by the Sui dynasty and followed ...
(618-907 AD) and was called the ''
Xinxiu bencao
The ''Xinxiu bencao'' (), also known as the ''Tang bencao'' (), is a Chinese pharmacopoeia written in the Tang dynasty by a team of officials and physicians headed by editor-in-chief . It borrowed heavily from—and expanded upon—the earlier ...
'' (Newly Revised Canon of Material Medical). The work consists of 20 volumes with one dedicated to the table of contents, and 25 volumes of pictures with one volume dedicated to the table of contents. A third part consisting of seven volumes contained illustrated descriptions. The text contains descriptions of 850 medicines with 114 new ones. The work was used throughout
China
China, officially the People's Republic of China (PRC), is a country in East Asia. With population of China, a population exceeding 1.4 billion, it is the list of countries by population (United Nations), second-most populous country after ...
for the next 400 years.
City pharmacopoeia
A dated work appeared in
Nuremberg
Nuremberg (, ; ; in the local East Franconian dialect: ''Nämberch'' ) is the Franconia#Towns and cities, largest city in Franconia, the List of cities in Bavaria by population, second-largest city in the States of Germany, German state of Bav ...
in 1542; a passing student
Valerius Cordus showed a collection of medical prescriptions, which he had selected from the writings of the most eminent medical authorities, to the physicians of the town, who urged him to print it for the benefit of the
apothecaries
''Apothecary'' () is an archaic English term for a medical professional who formulates and dispenses '' materia medica'' (medicine) to physicians, surgeons and patients. The modern terms ''pharmacist'' and, in British English, ''chemist'' have ...
, and obtained the sanction of the
senatus for his work. A work known as the ''Antidotarium Florentinum'', was published under the authority of the college of medicine of
Florence
Florence ( ; ) is the capital city of the Italy, Italian region of Tuscany. It is also the most populated city in Tuscany, with 362,353 inhabitants, and 989,460 in Metropolitan City of Florence, its metropolitan province as of 2025.
Florence ...
[ in the 16th century. In 1511, the ''Concordie Apothecariorum Barchinone'' was published by the Society of Apothecaries of ]Barcelona
Barcelona ( ; ; ) is a city on the northeastern coast of Spain. It is the capital and largest city of the autonomous community of Catalonia, as well as the second-most populous municipality of Spain. With a population of 1.6 million within c ...
and kept in the School of Pharmacy
Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medication, medicines. It is a miscellaneous science as it ...
of the University of Barcelona
The University of Barcelona (official name in ; UB), formerly also known as Central University of Barcelona (), is a public research university located in the city of Barcelona, Catalonia, Spain. It was established in 1450. With 76,000 students, ...
.
The term ''Pharmacopoeia'' first appears as a distinct title in a work published at Basel
Basel ( ; ), also known as Basle ( ), ; ; ; . is a city in northwestern Switzerland on the river Rhine (at the transition from the High Rhine, High to the Upper Rhine). Basel is Switzerland's List of cities in Switzerland, third-most-populo ...
, Switzerland, in 1561 by A. Foes, but does not appear to have come into general use until the beginning of the 17th century.[
Before 1542, the works principally used by apothecaries were the treatises on simples (basic medicinal ingredients) by ]Avicenna
Ibn Sina ( – 22 June 1037), commonly known in the West as Avicenna ( ), was a preeminent philosopher and physician of the Muslim world, flourishing during the Islamic Golden Age, serving in the courts of various Iranian peoples, Iranian ...
and Serapion; the ''De synonymis'' and ''Quid pro quo'' of Simon Januensis; the ''Liber servitoris'' of Bulchasim Ben Aberazerim, which described preparations made from plants, animals, and minerals, and was the type of the chemical portion of modern pharmacopoeias; and the ''Antidotarium'' of Nicolaus de Salerno, containing Galenic formulations arranged alphabetically. Of this last work, there were two editions in use — Nicolaus magnus and Nicolaus parvus: in the latter, several of the compounds described in the large edition were omitted and the formulae given on a smaller scale.[
Also ]Vesalius
Andries van Wezel (31 December 1514 – 15 October 1564), Latinization of names, latinized as Andreas Vesalius (), was an anatomist and physician who wrote ''De humani corporis fabrica, De Humani Corporis Fabrica Libri Septem'' (''On the fabric ...
claimed he had written some "''dispensariums''" and "''manuals''" on the works of Galenus. Apparently he burnt them. According to recent research communicated at the congresses of the International Society for the History of Medicine by the scholar Francisco Javier González Echeverría,[1998 "The book of work of Michael Servetus for his Dioscorides and his Dispensarium"(Le livre de travail de Michel Servet pour ses Dioscorides et Dispensarium) and "The Dispensarium or Enquiridion, complementary of the Dioscorides of Michael Servetus" ( The Enquiridion, L’oeuvre Le Dispensarium ou Enquiridion complémentaire sur le Dioscorides de Michel Servet) González Echeverría, in: Book of summaries, 36th International Congress on the History of Medicine, Tunis (Livre des Résumés, 36ème Congrès International d’Histoire de la médicine, Tunis), 6–11 September 1998, (two comunicacions), pp. 199, 210.] Michel De Villeneuve ( Michael Servetus) also published a pharmacopoeia. De Villeneuve, fellow student of Vesalius
Andries van Wezel (31 December 1514 – 15 October 1564), Latinization of names, latinized as Andreas Vesalius (), was an anatomist and physician who wrote ''De humani corporis fabrica, De Humani Corporis Fabrica Libri Septem'' (''On the fabric ...
and the best galen
Aelius Galenus or Claudius Galenus (; September 129 – AD), often Anglicization, anglicized as Galen () or Galen of Pergamon, was a Ancient Rome, Roman and Greeks, Greek physician, surgeon, and Philosophy, philosopher. Considered to be one o ...
ist of Paris according to Johann Winter von Andernach, published the anonymous "''Dispensarium or Enquiridion''" in 1543, at Lyon
Lyon (Franco-Provençal: ''Liyon'') is a city in France. It is located at the confluence of the rivers Rhône and Saône, to the northwest of the French Alps, southeast of Paris, north of Marseille, southwest of Geneva, Switzerland, north ...
, France, with Jean Frellon as editor. This work contains 224 original recipes by De Villeneuve and others by Lespleigney and Chappuis. As usual when it comes to pharmacopoeias, this work was complementary to a previous Materia Medica that De Villeneuve published that same year. This finding was communicated by the same scholar in the International Society for the History of Medicine, with agreement of John M. Riddle, one of the foremost experts on Materia Medica-Dioscorides
Pedanius Dioscorides (, ; 40–90 AD), "the father of pharmacognosy", was a Greek physician, pharmacologist, botanist, and author of (in the original , , both meaning "On Materia medica, Medical Material") , a 5-volume Greek encyclopedic phar ...
works.
Nicolaes Tulp, mayor of Amsterdam
Amsterdam ( , ; ; ) is the capital of the Netherlands, capital and Municipalities of the Netherlands, largest city of the Kingdom of the Netherlands. It has a population of 933,680 in June 2024 within the city proper, 1,457,018 in the City Re ...
and respected surgeon general, gathered all of his doctor and chemist friends together and they wrote the first pharmacopoeia of Amsterdam named ''Pharmacopoea Amstelredamensis'' in 1636. This was a combined effort to improve public health after an outbreak of the bubonic plague
Bubonic plague is one of three types of Plague (disease), plague caused by the Bacteria, bacterium ''Yersinia pestis''. One to seven days after exposure to the bacteria, flu-like symptoms develop. These symptoms include fever, headaches, and ...
, and also to limit the number of quack apothecary shops in Amsterdam.
London
Until 1617, such drugs and medicines as were in common use were sold in England
England is a Countries of the United Kingdom, country that is part of the United Kingdom. It is located on the island of Great Britain, of which it covers about 62%, and List of islands of England, more than 100 smaller adjacent islands. It ...
by the apothecaries and grocers. In that year the apothecaries obtained a separate charter, and it was enacted that no grocer should keep an apothecary's shop. The preparation of physicians' prescriptions was thus confined to the apothecaries, upon whom pressure was brought to bear to make them dispense accurately, by the issue of a pharmacopoeia in May 1618 by the College of Physicians
A college (Latin: ''collegium'') may be a tertiary educational institution (sometimes awarding degrees), part of a collegiate university, an institution offering vocational education, a further education institution, or a secondary school ...
, and by the power which the wardens of the apothecaries received in common with the censors of the College of Physicians of examining the shops of apothecaries within of London and destroying all the compounds which they found unfaithfully prepared. This, the first authorized London
London is the Capital city, capital and List of urban areas in the United Kingdom, largest city of both England and the United Kingdom, with a population of in . London metropolitan area, Its wider metropolitan area is the largest in Wester ...
Pharmacopoeia, was selected chiefly from the works of Mezue and Nicolaus de Salerno, but it was found to be so full of errors that the whole edition was cancelled, and a fresh edition was published in the following December.[
At this period the compounds employed in medicine were often heterogeneous mixtures, some of which contained from 20 to 70, or more, ingredients, while a large number of simples were used in consequence of the same substance being supposed to possess different qualities according to the source from which it was derived. Thus crabs' eyes (i.e., ]gastrolith
A gastrolith, also called a stomach stone or gizzard stone, is a rock held inside a gastrointestinal tract. Gastroliths in some species are retained in the muscular gizzard and used to grind food in animals lacking suitable grinding teeth. In ...
s), pearls, oyster shells, and coral
Corals are colonial marine invertebrates within the subphylum Anthozoa of the phylum Cnidaria. They typically form compact Colony (biology), colonies of many identical individual polyp (zoology), polyps. Coral species include the important Coral ...
were supposed to have different properties. Among other ingredients entering into some of these formulae were the excrements of human beings, dogs, mice, geese, and other animals, calculi, human skull, and moss growing on it, blind puppies, earthworm
An earthworm is a soil-dwelling terrestrial invertebrate that belongs to the phylum Annelida. The term is the common name for the largest members of the class (or subclass, depending on the author) Oligochaeta. In classical systems, they we ...
s, etc.[
Although other editions of the London Pharmacopoeia were issued in 1621, 1632, 1639, and 1677, it was not until the edition of 1721, published under the auspices of Sir ]Hans Sloane
Sir Hans Sloane, 1st Baronet, (16 April 1660 – 11 January 1753), was an Irish physician, naturalist, and collector. He had a collection of 71,000 items which he bequeathed to the British nation, thus providing the foundation of the British ...
, that any important alterations were made. In this issue many of the remedies previously in use were omitted, although a good number were still retained, such as dogs' excrement, earthworms, and moss
Mosses are small, non-vascular plant, non-vascular flowerless plants in the taxonomic phylum, division Bryophyta (, ) ''sensu stricto''. Bryophyta (''sensu lato'', Wilhelm Philippe Schimper, Schimp. 1879) may also refer to the parent group bryo ...
from the human skull; the botanical names of herbal remedies were for the first time added to the official ones; the simple distilled waters were ordered of a uniform strength; sweetened spirits, cordials and ratafias were omitted as well as several compounds no longer used in London, although still in vogue elsewhere. A great improvement was effected in the edition published in 1746, in which only those preparations were retained which had received the approval of the majority of the pharmacopoeia committee; to these was added a list of those drugs only which were supposed to be the most efficacious. An attempt was made to simplify further the older formulae by the rejection of superfluous ingredients.[
In the edition published in 1788 the tendency to simplify was carried out to a much greater extent, and the extremely compound medicines which had formed the principal remedies of physicians for 2,000 years were discarded, while a few powerful drugs which had been considered too dangerous to be included in the Pharmacopoeia of 1765 were restored to their previous position. In 1809 the French chemical nomenclature was adopted, and in 1815 a corrected impression of the same was issued. Subsequent editions were published in 1824, 1836, and 1851.][
The first '']Edinburgh Pharmacopoeia
The ''Edinburgh Pharmacopoeia'' was a medical guide consisting of recipes and methods for making medicine. It was first published by the Royal College of Physicians of Edinburgh in 1699 as the ''Pharmacopoea Collegii Regii Medicorum Edimburgens ...
'' was published in 1699 and the last in 1841; the first'' Dublin Pharmacopoeia'' in 1807 and the last in 1850.[
]
National pharmacopoeia origins
The preparations contained in these three pharmacopoeias were not all uniform in strength, a source of much inconvenience and danger to the public, when powerful preparations such as dilute hydrocyanic acid were ordered in the one country and dispensed according to the national pharmacopoeia in another. As a result, the Medical Act 1858
The Medical Act ( 21 & 22 Vict. c. 90), ''An Act to Regulate the Qualifications of Practitioners in Medicine and Surgery'', also referred to as the Medical Act 1858, was an act of the Parliament of the United Kingdom which created the General ...
ordained that the General Medical Council
The General Medical Council (GMC) is a public body that maintains the official register of physician, medical practitioners within the United Kingdom. Its chief responsibility is to "protect, promote and maintain the health and safety of the pu ...
should publish a book containing a list of medicines and compounds, to be called the ''British Pharmacopoeia
The ''British Pharmacopoeia'' (''BP'') is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involve ...
'', which would be a substitute throughout Great Britain and Ireland for the separate pharmacopoeias. Hitherto these had been published in Latin. The first British Pharmacopoeia was published in the English language in 1864, but gave such general dissatisfaction both to the medical profession and to chemists and druggists that the General Medical Council brought out a new and amended edition in 1867. This dissatisfaction was probably owing partly to the fact that the majority of the compilers of the work were not engaged in the practice of pharmacy, and therefore not competent to decide upon the kind of preparations required for the method of their manufacture. The necessity for this element in the construction of a pharmacopoeia is now fully recognized in other countries, in most of which pharmaceutical chemists are represented on the committee for the preparation of the legally recognized manuals.[
There are national and international pharmacopoeias, like the EU and the U.S. pharmacopoeias. The pharmacopeia in the EU is prepared by a governmental organization, and has a specified role in law in the EU. In the U.S., the USP-NF (United States Pharmacopeia – National Formulary) has been issued by a private non-profit organization since 1820 under the authority of a convention that meets periodically that is largely constituted by physicians, pharmacists, and other public health professionals, setting standards published in the compendia through various expert committees. In the U.S. when there is an applicable USP-NF quality monograph, drugs and drug ingredients must conform to the compendial requirements (such as for strength, quality or purity) or be deemed adulterated or misbranded under the Federal food and drug laws.
]
Supranational and international harmonization
Internationalization attempts
Attempts have been made by international pharmaceutical and medical conferences to settle a basis on which a globally international pharmacopoeia could be prepared, but regulatory complexity and regional variation in conditions of pharmacy are hurdles to fully harmonizing across all countries (that is, defining thousands of details that can all be known to work successfully in all places). In addition, some work still continues today, such as under the banner of the (ICH), a tri-regional organisation that represents the drug regulatory authorities of the European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...
, Japan
Japan is an island country in East Asia. Located in the Pacific Ocean off the northeast coast of the Asia, Asian mainland, it is bordered on the west by the Sea of Japan and extends from the Sea of Okhotsk in the north to the East China Sea ...
, and the United States
The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 ...
. Representatives from the Pharmacopoeias of these three regions have met twice yearly since 1990 in the Pharmacopoeial Discussion Group to try to work towards "compendial harmonisation". Specific monographs are proposed, and if accepted, proceed through stages of review and consultation leading to adoption of a common monograph that provides a common set of tests and specifications for a specific material.
International pharmaceutical congresses (1864–1902)
The first international pharmaceutical congress was held in Strasbourg
Strasbourg ( , ; ; ) is the Prefectures in France, prefecture and largest city of the Grand Est Regions of France, region of Geography of France, eastern France, in the historic region of Alsace. It is the prefecture of the Bas-Rhin Departmen ...
in 1867, and emitted the wish that an international pharmacopoeia be compiled.
Brussels Agreements (1902–1951)
The Conference for the Unification of the Formulae of Potent Medicaments was held in Brussels
Brussels, officially the Brussels-Capital Region, (All text and all but one graphic show the English name as Brussels-Capital Region.) is a Communities, regions and language areas of Belgium#Regions, region of Belgium comprising #Municipalit ...
in 1902. It was also the 10th pharmacists' congress. It resulted in the Agreement for the Unification of the Formulae of Potent Medicaments although "it took four years of textual adjustments before the Agreement could enter into force as a multilateral treaty in 19 (mostly European) countries, in December 1906"
A second conference met in Brussels' Academy Palace
The Academy Palace or Palace of the Academies ( ; or ) is a Neoclassical architecture, neoclassical palace in Brussels, Belgium. It was originally built between 1823 and 1828 for William II of the Netherlands, Prince William II of Orange. No ...
in 1925, resulting in a revised international agreement, the Brussels Pharmacopoeia Agreement (1925).
WHO International Pharmacopoeia (1951–present)
The World Health Organization
The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
discontinued and replaced the 1925 Brussels Agreement with the International Pharmacopoeia (Ph.Int.), edited since 1951.
It does not replace a national pharmacopoeia but rather provides a model or template for one and also can be invoked by legislation within a country to serve as that country's regulation.
The European Pharmacopoeia (1964–present)
Countries of the European continent
Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the eas ...
member of the Council of Europe
The Council of Europe (CoE; , CdE) is an international organisation with the goal of upholding human rights, democracy and the Law in Europe, rule of law in Europe. Founded in 1949, it is Europe's oldest intergovernmental organisation, represe ...
(distinct and broader than the EU) have a supranational pharmacopoeia, the European Pharmacopoeia
The ''European Pharmacopoeia'' (''Pharmacopoeia Europaea'', ''Ph. Eur.'') is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of Pharmaceutical drug, ...
(Ph.Eur.); it has not replaced the national pharmacopoeias of European member states but rather helps to harmonize them. However, some smaller European countries have stopped to edit their own pharmacopoeia to rely only on Ph.Eur.
Soviet Union
The Soviet Union
The Union of Soviet Socialist Republics. (USSR), commonly known as the Soviet Union, was a List of former transcontinental countries#Since 1700, transcontinental country that spanned much of Eurasia from 1922 until Dissolution of the Soviet ...
had a nominally supranational pharmacopoeia, the State Pharmacopoeia of the Union of Soviet Socialist Republics (USSRP), although the de facto nature of the nationality of republics within that state differed from the de jure
In law and government, ''de jure'' (; ; ) describes practices that are officially recognized by laws or other formal norms, regardless of whether the practice exists in reality. The phrase is often used in contrast with '' de facto'' ('from fa ...
nature.
Medical preparations, uses, and dosages
Though formerly printed there has been a transition to a situation where pharmaceutical information is available as printed volumes and on the internet
The Internet (or internet) is the Global network, global system of interconnected computer networks that uses the Internet protocol suite (TCP/IP) to communicate between networks and devices. It is a internetworking, network of networks ...
. The rapid increase in knowledge renders necessary frequent new editions, to furnish definite formulae for preparations that have already come into extensive use in medical practice, so as to ensure uniformity of strength, and to give the characters and tests by which their purity and potency may be determined. However each new edition requires several years to carry out numerous experiments for devising suitable formulae, so that current pharmacopoeia are never quite up to date.[
This difficulty has hitherto been met by the publication of such non-official formularies as ''Squire's Companion to the Pharmacopoeia'' and '' Martindale: The complete drug reference'' (formerly ''Martindale's: the extra pharmacopoeia''), in which all new remedies and their preparations, uses and doses are recorded, and in the former the varying strengths of the same preparations in the different pharmacopoeias are also compared (Squire's was incorporated into Martindale in 1952). The need of such works to supplement the Pharmacopoeia is shown by the fact that they are even more largely used than the Pharmacopoeia itself, the first issued in 18 editions and the second in 13 editions at comparatively short intervals. In the UK, the task of elaborating a new Pharmacopoeia is entrusted to a body of a purely medical character, and legally the pharmacist does not, contrary to the practice in other countries, have a voice in the matter. This is notwithstanding the fact that, although the medical practitioner is naturally the best judge of the drug or preparations that will afford the best therapeutic result, they are not as competent as the pharmacist to say how that preparation can be produced in the most effective and satisfactory manner, nor how the purity of drugs can be tested.][
The change occurred with the fourth edition of the British Pharmacopoeia in 1898. A committee of the Royal Pharmaceutical Society of Great Britain was appointed at the request of the ]General Medical Council
The General Medical Council (GMC) is a public body that maintains the official register of physician, medical practitioners within the United Kingdom. Its chief responsibility is to "protect, promote and maintain the health and safety of the pu ...
to advise on pharmaceutical matters. A census of prescriptions was taken to ascertain the relative frequency with which different preparations and drugs were used in prescriptions, and suggestions and criticisms were sought from various medical and pharmaceutical bodies across the British Empire
The British Empire comprised the dominions, Crown colony, colonies, protectorates, League of Nations mandate, mandates, and other Dependent territory, territories ruled or administered by the United Kingdom and its predecessor states. It bega ...
. As regards the purely pharmaceutical part of the work a committee of reference in pharmacy, nominated by the pharmaceutical societies of Great Britain and Ireland (as they were then), was appointed to report to the Pharmacopoeia Committee of the Medical Council.[
Some difficulty has arisen since the passing of the Adulteration of Food and Drugs Act concerning the use of the Pharmacopoeia as a legal standard for the drugs and preparations contained in it. The Pharmacopoeia is defined in the preface as only "intended to afford to the members of the medical profession and those engaged in the preparation of medicines throughout the British Empire one uniform standard and guide whereby the nature and composition of, substances to be used in medicine may be ascertained and determined". It cannot be an encyclopaedia of substances used in medicine, and can be used only as a standard for the substances and preparations contained in it, and for no others. It has been held in the Divisional Courts (Dickins v. Randerson) that the Pharmacopoeia is a standard for official preparations asked for under their pharmacopoeial name. But there are many substances in the Pharmacopoeia which are not only employed in medicine, but have other uses, such as ]sulfur
Sulfur ( American spelling and the preferred IUPAC name) or sulphur ( Commonwealth spelling) is a chemical element; it has symbol S and atomic number 16. It is abundant, multivalent and nonmetallic. Under normal conditions, sulfur atoms ...
, gum benzoin, tragacanth
Tragacanth is a natural gum obtained from the dried sap of several species of Middle Eastern Fabaceae, legumes of the genus ''Astragalus (plant), Astragalus'', including ''Astragalus adscendens, A. adscendens'', ''Astragalus gummifer, A. gummifer ...
, gum arabic
Gum arabic (gum acacia, gum sudani, Senegal gum and by other names) () is a tree gum exuded by two species of '' Acacia sensu lato:'' '' Senegalia senegal,'' and '' Vachellia seyal.'' However, the term "gum arabic" does not indicate a partic ...
, ammonium carbonate, beeswax
Bee hive wax complex
Beeswax (also known as cera alba) is a natural wax produced by honey bees of the genus ''Apis''. The wax is formed into scales by eight wax-producing glands in the abdominal segments of worker bees, which discard it in o ...
, oil of turpentine
Turpentine (which is also called spirit of turpentine, oil of turpentine, terebenthine, terebenthene, terebinthine and, colloquially, turps) is a fluid obtainable by the distillation of resin harvested from living trees, mainly pines. Principall ...
, linseed oil
Linseed oil, also known as flaxseed oil or flax oil (in its edible form), is a colorless to yellowish oil obtained from the dried, ripened seeds of the flax plant (''Linum usitatissimum''). The oil is obtained by pressing, sometimes followed by ...
, and for these a commercial standard of purity as distinct from a medicinal one is needed, since the preparations used in medicine should be of the highest possible degree of purity obtainable, and this standard would be too high and too expensive for ordinary purposes. The use of trade synonyms in the Pharmacopoeia, such as saltpetre for purified potassium nitrate
Potassium nitrate is a chemical compound with a sharp, salty, bitter taste and the chemical formula . It is a potassium salt of nitric acid. This salt consists of potassium cations and nitrate anions , and is therefore an alkali metal nit ...
, and milk of sulfur for precipitated sulfur, is partly answerable for this difficulty, and has proved to be a mistake, since it affords ground for legal prosecution if a chemist sells a drug of ordinary commercial purity for trade purposes, instead of the purified preparation which is official in the Pharmacopoeia for medicinal use. This would not be the case if the trade synonym were omitted. For many drugs and chemicals not in the Pharmacopoeia there is no standard of purity that can be used under the Adulteration of Food and Drugs Act, and for these, as well as for the commercial quality of those drugs and essential oils which are also in the Pharmacopoeia, a legal standard of commercial purity is much needed. This subject formed the basis of discussion at several meetings of the Pharmaceutical Society, and the results have been embodied in a work called ''Suggested Standards for Foods and Drugs'' by C. G. Moor, which indicates the average degree of purity of many drugs and chemicals used in the arts, as well as the highest degree of purity obtainable in commerce of those used in medicine.[
An important step has also been taken in this direction by the publication under the authority of the Council of the Pharmaceutical Society of Great Britain of the '' British Pharmaceutical Codex'' (BPC), in which the characters of and tests for the purity of many unofficial drugs and preparations are given as well as the character of many glandular preparations and antitoxins that have come into use in medicine, but have not yet been introduced into the Pharmacopoeia. This work may also possibly serve as a standard under the Adulteration of Food and Drugs Act for the purity and strength of drugs not included in the Pharmacopoeia and as a standard for the commercial grade of purity of those in the Pharmacopoeia which are used for non-medical purposes.][
Another legal difficulty connected with modern pharmacopoeias is the inclusion in some of them of synthetic chemical remedies, the processes for preparing which have been patented, whilst the substances are sold under trade-mark names. The scientific chemical name is often long and unwieldy, and the physician prefers when writing a prescription to use the shorter name under which it is sold by the ]patent
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an sufficiency of disclosure, enabling discl ...
ees. In this case the pharmacist is compelled to use the more expensive patented article, which may lead to complaints from the patient. If the physician were to use the same article under its pharmacopoeial name when the patented article is prescribed, they would become open to prosecution by the patentee for infringement of patent rights. Hence the only solution is for the physician to use the chemical name (which cannot be patented) as given in the Pharmacopoeia, or, for those synthetic remedies not included in the Pharmacopoeia, the scientific and chemical name given in the ''British Pharmaceutical Codex''.[
]
List of national and supranational pharmacopoeias
In most of the Neo-Latin
Neo-LatinSidwell, Keith ''Classical Latin-Medieval Latin-Neo Latin'' in ; others, throughout. (also known as New Latin and Modern Latin) is the style of written Latin used in original literary, scholarly, and scientific works, first in Italy d ...
names, ''Pharmacopoea'' is the more common spelling, although for several of them, ''Pharmacopoeia'' is common.
See also
* British Pharmacopoeia
The ''British Pharmacopoeia'' (''BP'') is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involve ...
* Erowid
Erowid, also called Erowid Center, is a non-profit educational organization that provides information about psychoactive plants and chemicals.
Erowid documents legal and illegal substances, including their intended and adverse effects. Inform ...
* European Pharmacopoeia
The ''European Pharmacopoeia'' (''Pharmacopoeia Europaea'', ''Ph. Eur.'') is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of Pharmaceutical drug, ...
* (ICH)
* International Pharmaceutical Federation
The International Pharmaceutical Federation or Fédération Internationale Pharmaceutique, abbreviated as FIP, is a non-governmental organization (NGO) with official relations with the World Health Organization. It is the global bo ...
* International Plant Names Index
The International Plant Names Index (IPNI) describes itself as "a database of the names and associated basic bibliographical details of seed plants, ferns and lycophytes." Coverage of plant names is best at the rank of species and genus. It inclu ...
* Japanese Pharmacopoeia
The is the official pharmacopoeia of Japan. It is published by the . The first edition was published on 25 June 1886, with revisions being issued from time to time. The current revision is number 18, issued electronically on 7 June 2021. An off ...
* Iranian National Formulary
* National Formulary
A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. Traditionally, a formulary contained a collection of formulas for the compounding ...
* Pharmacopoeia of the People's Republic of China
* Specification
A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard.
There are different types of technical or engineering specificati ...
* Standards organization
A standards organization, standards body, standards developing organization (SDO), or standards setting organization (SSO) is an organization whose primary function is developing, coordinating, promulgating, revising, amending, reissuing, interpr ...
* The International Pharmacopoeia
* United States Pharmacopeia
The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofi ...
* World Health Organization
The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
* Hamilton's Pharmacopeia
References
Bibliography
*
*
External links
Pharmacopoeial Discussion Group
Medicines Compendium
(archived 3 July 2012)
Pharma Knowledge Park
Website with graphical study of the pharmacopoeia ''Dispensarium'' by Michael Servetus (archived 13 November 2012)
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Medical manuals