How and Why the United States Pharmacopeia was Created

The term "pharmacopeia" was created from two Greek words: pharmakon, meaning drug or medicine, and poiein, meaning to make, the combination of which indicates any recipe or formula or other standards required to make or prepare a drug. The term was first used in 1580 in connection with a local book of drug standards in Bergamo, Italy. From that time on, countless city, state, and national pharmacopeias were published by various European pharmaceutical societies. As time passed, the value of a uniform set of national drug standards became apparent. In Great Britain, for example, three city pharmacopeias-the London, the Edinburgh, and the Dublin-were official until 1864, when they were replaced by the British Pharmacopoeia (BP).

In the U.S., drug standards were first provided on a national basis in 1820, when the first United States Pharmacopeia (USP) was published. However, the need for drug standards was recognized in this country long before the first USP was published. For convenience and because of their familiarity with them, colonial physicians and apothecaries used the pharmacopeias and other references of their various homelands. The first American pharmacopeia was the so-called Lititz Pharmacopeia, published in 1778 at Lititz, Pennsylvania, for use by the Military Hospital of the United States Army. It was a 32-page booklet containing information on 84 internal and 16 external drugs and preparations.

During the last decade of the 18th century, several attempts were made by various local medical societies to collate drug information, set appropriate standards, and prepare an extensive American pharmacopeia of the drugs in use at that time. In 1808, the Massachusetts Medical Society published a 272-page pharmacopeia containing information or monographs on 536 drugs and pharmaceutical preparations. Included were monographs on many drugs indigenous to America, which were not described in the European pharmacopeias of the day.

Planning for the First USP

On January 6, 1817, Lyman Spalding, a physician from New York City, submitted a plan to the Medical Society of the County of New York for the creation of a national pharmacopeia. Spalding's efforts were later to result in his being recognized as the 'Father of the United States Pharmacopeia". He proposed dividing the U.S. as then known into four geographic districts-northern, middle, southern, and western. The plan provided for a convention in each of these districts, to be composed of delegates from all medical societies and medical schools within them. Where there was as yet no incorporated medical society or medical school, voluntary associations of physicians and surgeons were invited to assist in the undertaking. Each district's convention was to draft a pharmacopeia and appoint delegates to a general convention to be held later in Washington, DC. At the general convention, the four district pharmacopeias were to be compiled into a single, national pharmacopeia.

Draft pharmacopeias were submitted to the convention by only the northern and middle districts. These were reviewed, consolidated, and adopted by the first United States Pharmacopeial Convention assembled in Washington, DC, on January 1, 1820.

First Published USP

The first USP was published on December 15, 1820, in English and Latin, then the international language of medicine, to render the book more intelligible to physicians and pharmacists of any nationality. Within its 272 pages were listed 217 drugs considered worthy of recognition; many of them were taken from the Massachusetts Pharmacopeia, which is considered by some to be the precursor to the USP. The objective of the first USP was stated in its preface and remains important. It reads in part:

Preface to the First USP

It is the object of a pharmacopeia to select from among substances, which possess medicinal power, those, the utility of which is most fully established and best understood; and to form from them preparations and compositions, in which their powers may be exerted to the greatest advantage. It should likewise distinguish those articles by convenient and definite names, such as may prevent trouble or uncertainty in the intercourse of physicians and apothecaries.

Revision Every 10 Years, then Every 5 Years

Before adjourning, the convention adopted a constitution and bylaws, with provisions for subsequent meetings of the convention leading to a revised USP every 10 years. As many new drugs entered use, the need for more frequent issuance of standards became increasingly apparent. In 1900, the Pharmacopeial Convention granted authority to issue supplements to the USP whenever necessary to maintain satisfactory standards. At the 1940 meeting of the convention, it was decided to revise the USP every 5 years while maintaining the use of periodic supplements.

Physicians and Pharmacists Involved

The first United States Pharmacopeial Convention was composed exclusively of physicians. In 1830 and again in 1840, prominent pharmacists were invited to assist in the revision, and in recognition of their contributions, pharmacists were awarded full membership in the convention of 1850 and have participated regularly ever since. By 1870, the USP was so nearly in the hands of pharmacists that vigorous efforts were required to revive interest in it among physicians. The present constitution and bylaws of the United States Pharmacopeial Convention provide for accredited delegates representing educational institutions, professional and scientific organizations, divisions of governmental bodies, non-U.S. international organizations and pharmacopeial bodies, persons who possess special scientific competence or knowledge of emerging technologies, and public members. Of the eight elected members of the board of trustees, at least two must be representatives of the medical sciences, two others must be representatives of the pharmaceutical sciences, one must be a public member, and three shall serve without restriction concerning their affiliation.

After the appearance of the first USP, the art and science of both pharmacy and medicine changed remarkably. Before 1820, drugs to treat disease had been the same for centuries. The USP of 1820 reflected the fact that the apothecary of that day was competent at collecting and identifying botanical drugs and preparing from them the mixtures and preparations required by the physician. The individual pharmacist seemed fulfilled as he applied his total art to the creation of elegant pharmaceutical preparations from crude botanical materials. It was a time that would never be seen again because of the impending upsurge in technologic capabilities and the steady development of the basic sciences, particularly synthetic organic chemistry.

The second half of the 19th century brought great and far-reaching changes. The industrial revolution was in full swing in the U.S. The steam engine, which used water power to turn mills that powdered crude botanical drugs, was replaced by the gas, diesel, or electric motor. New machinery was substituted for the old whenever possible, and, often, machinery from other industries was adapted to the special needs of pharmaceutical manufacturing. Mixers from the baking industry, centrifugal machines from the laundry industry, and sugarcoating pans from the candy industry were a few examples of improvisations. Production increased rapidly, but the new industry had to wait for the scientific revolution before it could claim newer and better drugs for mankind. A symbiosis between science and the advancing technology was needed.

By 1880, the industrial manufacture of chemicals and pharmaceutical products had become well established in this country, and the pharmacist was relying heavily on commercial sources for drug supply. Synthetic organic chemistry began to have its influence on drug therapy. The isolation of some active constituents of plant drugs led to the knowledge of their chemical structure. From this arose methods of synthetically duplicating the same structures, as well as manipulating molecular structure to produce organic chemicals yet undiscovered in nature. In 1872, the synthesis of salicylic acid from phenol inaugurated the synthesis of a group of analgesic compounds including acetylsalicylic acid (aspirin), which was introduced into medicine in 1899. Among other chemicals synthesized for the first time were sleep-producing derivatives of barbituric acid called barbiturates. This new source of drugs—synthetic organic chemistry—welcomed the turn into the 20th century.

Until this time, drugs created through the genius of the synthetic organic chemist relieved a host of maladies, but none had been found to be curative—none, that is, until 1910, when arsphenamine, a specific agent against syphilis, was introduced to medical science. This was the start of an era of chemotherapy, an era in which the diseases of humans became curable through the use of specific chemical agents. The concepts, discoveries, and inspirational work that led mankind to this glorious period are credited to Paul Ehrlich, the German bacteriologist who together with a Japanese colleague, Sahachiro Hata, discovered arsphenamine. Today, many of our drugs originate in the flask of the synthetic organic chemist.

The advancement of science, both basic and applied, led to drugs of a more complex nature and to more of them. The standards advanced by the USP were more than ever needed to protect the public by ensuring the purity and uniformity of drugs.

Next week, Continuation on how and why the USP was started (Part 2B)

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Did You Know (On Passing Tests and Failures) ...The following?

"A telegram from George, dear."
"Well did he pass the examination this time"?
"No, but he is almost at the top of the list of those who failed." (Anon)

Lord Bulwer's life as a succession of failures, crowned with a final triumph. His first novel was a failure; his first drama was a failure; so were his first speeches and poems. But he fought both defeat and ridicule and finally won a place with Thackeray and Dickens.

Daniel Webster could not make a speech until years of persistent effort. Finally, he became one of America's greatest orators.

Washington lost more battles than he won. But he triumphed in the end.

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