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Competing Interests: Competing interests: None declared.

Introduction: Medications are compounded when a formulation of a medication is needed but not commercially available. Regulatory oversight of compounding is piecemeal and compounding errors have resulted in patient harm. We review compounding in the United States (US), including a history of compounding, a critique of current regulatory oversight, and a systematic review of compounding errors recorded in the literature., Methods: We gathered reports of compounding errors occurring in the US from 1990 to 2020 from PubMed, Embase, several relevant conference abstracts, and the US Food and Drug Administration "Drug Alerts and Statements" repository. We categorized reports into errors of "contamination," suprapotency," and "subpotency." Errors were also subdivided by whether they resulted in morbidity and mortality. We reported demographic, medication, and outcome data where available., Results: We screened 2155 reports and identified 63 errors. Twenty-one of 63 were errors of concentration, harming 36 patients. Twenty-seven of 63 were contamination errors, harming 1119 patients. Fifteen errors did not result in any identified harm., Discussion: Compounding errors are attributed to contamination or concentration. Concentration errors predominantly result from compounding a prescription for a single patient, and disproportionately affect children. Contamination errors largely occur during bulk distribution of compounded medications for parenteral use, and affect more patients. The burden falls on the government, pharmacy industry, and medical providers to reduce the risk of patient harm caused by compounding errors., Conclusion: In the US, drug compounding is important in ensuring access to vital medications, but has the potential to cause patient harm without adequate safeguards.

This paper reports a pioneering study of an unknown historical drug formulation preserved in the Spezieria of Santa Maria della Scala in Rome, founded at the end of the seventeenth century by the Discalced Carmelites. Due to limited literature related to pharmaceutical remedies and drugs of the Early Modern Era (between the XV and XVIII centuries) and the complexity in their formulations, the study of these drugs represents a great challenge. The untargeted nature of the selected drug required a multi-analytical approach with complementary techniques to formulate a compositional hypothesis: FT-IR spectroscopy, gas chromatography-associated/mass spectrometry (GC-MS) and nuclear magnetic resonance (NMR) were successfully employed to identify different organic compounds. Systematic archaeobotanical research was performed as well, allowing us to acquire data related to the possible genus of plants from which these natural compounds derive and their geographical origin. The unknown drug formulation turned out to be a complex mixture used as an ointment with an anti-inflammatory purpose. It mainly contains a mixture of Venetian turpentine; a Pine resin (colophony) from the Pinaceae family; an exudate of a plant from South America, whose identified components are triterpenic compounds such as alpha- and beta-amyrins, betulin and lupeol; and saturated fatty acids which act as carriers and/or to reduce the viscosity of abovementioned exudates and resins. The study of historical drugs is important not only in order to know the practices handed down by the speziali in the past but also to reconstruct historical recipes, which can inspire new dermatological, cosmetic, hygienic and current healing products.Graphical abstract.

In the late nineteenth century, as in other regions of Argentina and Latin America, the Santa Fe press featured a growing number of offers of health products such as tonics, pills and syrups. Aimed at a lay audience, these claimed to cure a series of conditions defined as belonging to "modern life." This article analyzes the discursive dimension of the advertisements printed between 1890 and 1918: how they organized meanings associated with these conditions, an issue that is inscribed within a broad line of research aimed at analyzing social representations of health and disease, and how they participated in the different social spheres in the constitution of modern-day Argentina.

Transdermal patches are now widely used as cosmetic, topical and transdermal delivery systems. These patches represent a key outcome from the growth in skin science, technology and expertise developed through trial and error, clinical observation and evidence-based studies that date back to the first existing human records. This review begins with the earliest topical therapies and traces topical delivery to the present-day transdermal patches, describing along the way the initial trials, devices and drug delivery systems that underpin current transdermal patches and their actives. This is followed by consideration of the evolution in the various patch designs and their limitations as well as requirements for actives to be used for transdermal delivery. The properties of and issues associated with the use of currently marketed products, such as variability, safety and regulatory aspects, are then described. The review concludes by examining future prospects for transdermal patches and drug delivery systems, such as the combination of active delivery systems with patches, minimally invasive microneedle patches and cutaneous solutions, including metered-dose systems., (© 2015 The British Pharmacological Society.)

With nine consecutive issues published from 1821 to 1836, the Formulaire concepted by Magendie as a usual tool for the medical precriptions, was first dedicated to the new chemical pharmaceuticals, mainly the pure alcaloids, strychnine, quinine and morphine, extracted from raw products. As well he included mineral chemicals, hydrocyanates, iodine and bromide, all supported by newly achieved works, from Pelletier, Caventou and others. Magendie perfectly skilled in animal experimentation, developped and standardized the as far as to evaluate the activity and safety degrees of these new components. It clearly anticipated the evaluation plan determined by the law for the registration of the new drugs in the twentieth century.

This article outlines the history of the commerce in medicinal plants and plant-based remedies from the Spanish American territories in the eighteenth century. It maps the routes used to transport the plants from Spanish America to Europe and, along the arteries of European commerce, colonialism and proselytism, into societies across the Americas, Asia and Africa. Inquiring into the causes of the global 'spread' of American remedies, it argues that medicinal plants like ipecacuanha, guaiacum, sarsaparilla, jalap root and cinchona moved with relative ease into Parisian medicine chests, Moroccan court pharmacies and Manila dispensaries alike, because of their 'exotic' charisma, the force of centuries-old medical habits, and the increasingly measurable effectiveness of many of these plants by the late eighteenth century. Ultimately and primarily, however, it was because the disease environments of these widely separated places, their medical systems and materia medica had long become entangled by the eighteenth century.

The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE) issues and related implications, it has come to be utilized widely by the pharmaceutical industry in drug discovery and development as well. This brief manuscript will relate the story of the BCS development. While much of the ground work for the BCS goes back to the pharmacokinetic and drug absorption research by Gordon Amidon (GLA) in the 1970s and 1980s, the realization of the need for a classification or categorization of drug and drug products for setting dissolution standards became apparent to GLA during his 1990-1991 sabbatical year at the FDA. Initiated at the invitation of the then CEDR director, Dr. Carl Peck, to become a visiting scientist at the FDA, the goal was to promote regulatory research at the FDA, in my case, in biopharmaceutics, and to develop a science-based system to simplify regulatory requirements.

SUMMARY During this period, the authority was exerted by Parmentier, as the head and chief pharmacist for the French armies. For the military hospitals scattered all over Europe, he organised the pharmacies services rules, with technical and financial concerns. The first aid devices on the battlefield included a special box for pharmacy containing ressucitation and siccative items for the wounds, and immediately available for the surgeon's use. The qualified pharmacy staff exhibited large variations, from 200 to 1.100 people in 1812.

Between 1944 and 1989--the period of communist power in Poland--the national pharmaceutical market experienced several dramatic changes. The country was a prodigious importer of drugs following the Second World War, with a large portion of the medicine received being donated by various aid organisations. In the 1960s, Poland became a significant exporter of drugs to the Eastern Bloc countries, but dropped down the list of meaningful producers again after the post-1989 transformation. For four and a half decades the pharmaceutical market in Poland had been a scene of political and ideological struggle. The companies, owned and controlled by the state, were poorly managed, being neither innovative nor competitive. This fact, along with the state's irrational and inconsequent drug policy, caused an almost permanent shortage in drug supplies for patients: ironic for a socialist system in which universal and free health care was a basic principle.

This essay examines three medieval pharmaceutical treatises purportedly authored by Yūhannā ibn Māsawayh (anglicized to John Mesue) and traces their immense influence on the development of pharmacy in early modem Europe and the Hispanic world. Despite the importance of these works throughout the early modern period, Mesue is relatively unknown in the history of pharmacy and medicine, and his exact identity remains unclear. This essay argues that "Mesue" was most likely a pseudonym used by an unknown author of the Latin West and that the three works were crafted to meet the demands of the developing "medical marketplace" of late thirteenth-century Europe, where the manuscripts first appeared. At the same time, however, as the Arabic reference of the pseudonym suggests, these treatises were clearly products of the medieval Islamic world, including many innovations that would provide the basis for the theory and practice of pharmacy for centuries and arguably formed part of the artisanal epistemological influence on the Scientific Revolution.

Modern tablet compression was instituted in England in 1844 by William Brockedon (1787-1854). The first tablets made according to Brockedon´s procedures contained watersoluble salts and were most likely compressed without expedients. In USA a watershed occurred around 1887 when starch (amylum maydis) was introduced to disperse tablets in aqueous milieu in order to corroborate bioavailability of drugs in the almentary canal. About the same time great advances in tablet production were introduced by the British firm Burroughs Wellcome and Co. In Denmark on the other hand tablet production remained on low scale until after 1920. As Icelandic pharmacies and drug firms modelled themselves mostly upon Danish firms tablet production was first instituted in Iceland around 1930. The first tablet machines in Iceland were hand-driven. More efficent machines came after 1945. Around 1960 three sizeable tablet producers were in Iceland; now there is only one. Numbers of individual tablet species (generic and proprietary) on the market rose from less than 10 in 1913 to 500 in 1965, with wide variations in numbers in between. Tablets have not wiped out other medicinal forms for peroral use but most new peroral drugs have been marketed in the form of tablets during the last decades.

Pharmaceutical firms attribute high prices and high profits to costs associated with researching and developing the next generation of life-saving drugs. Using data from annual reports, this article tests the validity of this claim. We find that while pharmaceutical firms do invest in R&D, they also enjoy strong rents; between 1988 and 2009, pharmaceuticals enjoyed profits of 3 to 37 times the all-industry average, depending on the years, while investing proportionately less in R&D than other high-R&D firms. Costs of pharmaceutical drugs have successfully flown below the radar in much of the current health care debate, with producers managing to obstruct alternative sourcing as well as payment cuts. While health care is examined for savings in other areas, sustained high pharmaceutical profits suggest that as a new health care policy develops in the U.S., the pharmaceutical industry should not be excluded from examination for significant savings in health care costs.

In December 1698 Sir John Clerk, second baronet of Penicuik, visited Cosimo III of Medici, Grand Duke of Tuscany, while on his Grand Tour of Europe - an essential part of the broader education of the gentleman at this time. The Duke presented him with a wooden medicine chest, in which the original medicines in their labelled containers are still to be found. The chest is Italian in origin, but many of the preparations it contains existed in various forms in European - including Scottish - formulations from that time. This paper outlines the context of the period, the state of medicine and pharmacy in Scotland, and examines the contents of the box. It is rare for such a complete chest to survive from this period in Scotland - most surviving examples date from at least the mid-eighteenth century. It offers a unique opportunity to investigate some of the medicines of the period.

In recent years the attention of society, the media and politicians has focused on the negative phenomenon of the occurrence of an enormous amount of new psychoactive substances flooding the European market. In Poland and in Europe they are known under the name 'legal highs' or 'smart drugs'. In many countries these compounds present a serious social and health problem. The core of the problem is the fact that in the light of the law these substances are legal, while actually they imitate the eff ect of illegal narcotics. Smart drugs are sold allegedly as 'products not intended for human consumption', under the cover of 'collector's commodities', 'incense sticks' or 'bath salts'. Efforts undertaken by many countries, including Poland, are biased towards gaining control over this pathological phenomenon by placing the subsequent substances on the list of prohibited agents. However, the resilient chemical and pharmaceutical industry still remains one step ahead by introducing new derivatives of already banned products, practically identical in action. The presented article is an attempt to bring closer the problem of smart drugs in Poland, from the occurrence of this alarming phenomenon, through the spread of sales in shops all over Poland, to a series of changes in the Polish anti-narcotic law, drastic actions of closing the shops throughout the entire country, and transferring the sale of smart drugs to the internet.

We develop and estimate a model of market demand for a new pharmaceutical, whose quality is learned through prescriptions by forward-looking physicians. We use a panel of antiulcer prescriptions from Italian physicians between 1990 and 1992 and focus on a new molecule available since 1990. We solve the model by calculating physicians' optimal decision rules as functions of their beliefs about the new pharmaceutical. According to our counterfactuals, physicians' initial pessimism and uncertainty can have large, negative effects on their propensity to prescribe the new drug and on expected health outcomes. In contrast, subsidizing the new good can mitigate informational losses.

The Faculty of Pharmacy of Santiago de Compostela was founded in 1857, but research activities did not start until the beginning of the 20th century. The new Spanish regulations promoting the experimentation at universities and the stages of professors and recently graduated students outside Spain contributed to generate a remarkable research group in a provincial university. The excessive university centralism at that time in Spain and the characteristics of the headquarters of the faculty -- a 16th century Renaissance palace -- hindered, in general, the research development. However, the scientific spirit of professors and students, and their work were imposed and they achieved an estimable status in pharmacy research in Galicia. The facilities were the staff's highest priority and it raised more than a protest. A remarkable investment in apparatuses and laboratory materials was carried out and researchers started to publish original research papers in local journals, such as the "Revista de farmacia," published by their own University. In the previous years to the Spanish Civil War (1936) the research status in drug development and the background of the staff and students were important, allowing them to join the military laboratory that Franco's army created at the faculty of pharmacy. The research work continued in a small scale and was specially focused on the production of "copy drugs" coping European specific drugs which were scarce at that time. The first third of the 20th century was the germ of the great research prestige that the Faculty of Pharmacy of Santiago de Compostela enjoys at present.

The C. T. Williamson spoon with manufactured products from a pharmaceutical company engraved on the bowl of the spoon is one of the earliest examples of a manufacturer marketing products via a drug delivery device. The Burroughs, Wellcome and Company, a British corporation using initially an American patented, and later a British patented, Williamson corkscrew spoon marketed British manufactured medicinal products in the U.S. and England to physicians and pharmacists in the late nineteenth and early twentieth century. Other corkscrew spoons were manufactured in this era without product specific notations contained on the spoons. 40 These corkscrew spoons, such as the Williamson and Noe patented apparatuses, helped patients in more easily consuming liquid medications. They also were items potentially favored by physicians and pharmacists for patient's pro- vided liquid medications. Finally, they allowed patients to open corked containers, consume liquid dosage amounts, and hopefully more appropriately comply with necessary regimens in the late nineteenth and early twentieth century. Not surprisingly, Burroughs, Wellcome and Company used the Williamson spoon to successfully market company products to physicians, pharmacists, and patients on several continents.

At the beginning of the 19th century, every medical discovery had to be examined by the School of Medicine in Paris according to the regulation of the 'secret medicines'. The members of the commission made the analysis of the formula or the suggested method and reported their conclusion before an assembly of professors. 1070 reports were proposed between 1795 and 1821 but about forty Pinel's reports remain unknown. Some of them deal with many subjects: epilepsy, dropsy, ringworm...in which Pinel shows his important knowledge beyond his usual medical sphere, his critical mind especially in the methodology of clinical tests.

The nineteenth century brought the progressive demarcation of the professions devoted to the healing arts in Brazil, with a emphasis on rights and responsibilities. Academic medicine made a growing distinction between those who prescribed medicine and those who engaged in making or selling it. The article explores this process, with an emphasis on pharmaceutical practice in the province of Bahia in the latter half of the century. Within this context, it addresses changes and constancies in laws and in their local enforcement as well as relations between pharmacists, on the one hand, and, on the other, the government, physicians, and those who made or sold medicine illegally or without authorization.

This Article explores the evolution and interaction of the legal and cultural categories "food" and "drug" from the late nineteenth century to the present. The federal statutory definitions of "food" and "drug" have always been ambiguous and plastic, providing the FDA with significant regulatory flexibility. Nevertheless, the agency is not necessarily free to interpret the definitions however it chooses. "Food" and "drug" are not only product classes defined by food and drug law, but also fundamental cultural concepts. This Article demonstrates that the FDA, as well as Congress and the courts, have operated within a constraining cultural matrix that has limited their freedom to impose their preferred understandings of these categories on American society. Nonetheless, history also provides ample evidence that lawmakers possess substantial power to mold the legal categories of "food" and "drug" so as to advance desired policies. One explanation for this regulatory flexibility in the face of deep-seated cultural conceptions is the indeterminate nature of the extralegal notions of "food" and "drug." The terms, as commonly understood, embrace nebulous, overlapping, and constantly evolving realms. Moreover, the relationship between culture and law is not a one-way street with respect to these categories. Although the regulatory apparatus has always had to take into account the extralegal understandings of "food" and "drug," the law in turn has exerted significant influence over their meaning in broader culture.

Therapeutic substances, their development, testing, application and effects, have in recent years become a central topic of the history of medicine, history of science, and science and technology studies. This paper provides an overview of the literature on this topic through the four-fold perspective of individual substances, industry, patients, and regulation. It introduces the recently established, DFG-funded research network "Pharmaceuticals in the 20th Century" and sketches current methodological approaches to the history of therapeutic substances. At present it appears to be particularly promising to adopt an approach which uses substances or groups of substances as a heuristic device for exploring their complex networks and interdependencies.

In the Casanatense Library - Rome, few years ago, a manuscript was found, written in Danzig in 1645, containing a great number of glass recipes but also recipes of alchemic and metallurgical subject and about forty recipes of practical medicine. If the generality of recipes were published in 2004, the medical recipes are here transcribed and commented with the help of experts in pharmaceutical chemistry and in medicine history. The medicine recipes of the manuscript are typical of the therapeutic technique in use in the 17th century, deriving from an empirical knowledge and from a magic-popular heritage that accompanied the medical doctrine till modern era.

Offering images of pharmaceutical products and marketing strategies, pharmacy almanacs are a valuable source when researching the history of medications. The article analyzes the idea of science that was presented in these almanacs and demonstrates how this research source is pertinent to the history both of science and of advertising in Brazil.

The use of materials of biological origin in medicine has a long history. These materials, including tissue, organ and microbial extracts, blood and its derivatives, antibodies and hormones, share the feature that for much of the last century the ability to characterize and quantify the active substance was limited. Quantification of these substances depends on biological standardization, a discipline that was refined to a science by the Medical Research Council from the 1920s onwards, and which, with contributions from several prominent Fellows of the Royal Society, including principally Sir Henry Dale, the UK has led the world to the present date.

Mithridatium and the related product Theriac were both regarded from the time of their original formulations in the 2nd Century BC and the 1st Century AD respectively, until the mid 18th Century as universal panaceas. Any failure of these products to achieve the desired therapeutic result was attributed to defective composition or manufacture. As a result measures were introduced to ensure the quality of ingredients used in these products composition, the establishment of standard formulations and assurance of the competence of the manufacturer. Manufacture frequently was required to take place in public. Doubts about the efficacy of these panaceas arose in the mid 18th century and concerns of the adverse nature of interactions between the numerous ingredients surfaced in Heberden's treatise of 1745, as result of which these products disappeared from Editions of The London Pharmacopoeia after 1746. Subsequently, arising from these concerns for safety and efficacy, a call was made in 1799 for the establishment of a Public Committee of eminent physicians to scrutinise all new products prior to their launch to an gullible public. The concepts developed in the history of Mithridatium form the basis of modern medicines regulation.