United States Pharmacopeial Convention Records, 1819-2005 (bulk 1900-2005)


European pharmacopeias were chiefly relied upon prior to the appearance of the first United States Pharmacopeia. The few works that had been brought out were of value only to the area where they originated. In 1778, there had been a small pharmacopeia published for use at a military hospital of the United States Army. On October 3, 1805, counsellors of the Massachusetts Medical Society appointed a committee to draft a pharmacopeia suited to the needs of their section of the country. This work was issued some time in the early part of 1808, and is considered the precursor of the Pharmacopeia of the United States.

The formulation of a national pharmacopeia had been an airy hope of the medical profession since the publication of the Pharmacopeia of the Massachusetts Medical Society in 1808. In January 1817, Dr. Lyman Spalding of New York City proposed to establish four pharmacopeial districts - Northern, Middle, Southern, and Western - in the United States. In each of these districts, a Convention, composed of delegates from medical societies within them, would be called. Each district would draft a pharmacopeia and appoint delegates to a General Convention to be held in Washington, D.C. This general plan was carried through and the first United States Pharmacopoeial Convention (USPC) assembled in the capital.

Drafts of pharmacopeias were submitted to this Convention by the Northern and Middle districts. These were reviewed and consolidated, and after adoption referred to a Publication Committee. The first Pharmacopoeia of the United States (USP) was published December 15, 1820. The first edition was brought out in both Latin and English so as to render it more intelligible to foreigners. Except for titles, Latin was discontinued in the 1840 Revision. Before adjourning, the first Convention adopted a Constitution and By-Laws with provisions for meeting of the Convention and a revised Pharmacopeia every ten years.

Revolutionary changes have taken place in the Pharmacopeia since that time. During the first decades, membership in the USPC was composed entirely of physicians. In 1830, pharmacists were invited to assist in the revision. Since 1940, the Revision Committee has consisted of sixty persons, two-thirds in pharmaceutical and allied sciences and one-third qualified in medical sciences.

An important change took place in 1900 when the Pharmacopoeial Convention was incorporated in the District of Columbia (June 11, 1900) with the purpose of “establishing one uniform standard and guide for the use of those engaged in the practice of medicine and pharmacy in the United States....” The whole organizational structure was revolutionized. A Board of Trustees was established to provide general business management. The Committee of Revision was now permitted to consider any product of definite composition which is in common use by the medical profession, the identity, purity, or strength of which can be determined.

The first Food and Drug Act (1906) gave full legal recognition by the United States government, and the force of federal law, to the USP. As a result, the use of the USP was greatly increased making interim additions and corrections necessary. In 1942, a resolution was passed marking the full scale program of “continuous revision,” under which a new Pharmacopeia appears every five years and a bound supplement halfway between. If any situations requiring immediate attention occur, an Interim Revision or sheet supplement is issued. With this decision it became necessary the chairman be made a full-time permanent Director of Pharmacopeial Revision. This position is filled through an election by each outgoing Board of Trustees.

A permanent headquarters to house the Director and the pharmacopeial staff and facilities was purchased in New York City, and dedicated in 1950.

The USP headquarters moved in 1968 from New York to Bethesda, on the outskirts of Washington, D.C. Thereafter the headquarters staff was reorganized, and to direct the over-all operation a new post of Executive Director was created (1970 Convention), with William Heller as the first occupant. The Director of Revision (who previously held this responsibility) was continued as a separate scientific administrator of the standards program, under the Executive Director, with Thomas Macek accepting the post upon the retirement of Lloyd C. Miller.

The Convention of 1970 set important new policy directions, such as: broadening the USP's projected publishing activity beyond the traditional concept of drug standards; dealing with the knotty problem of standardizing the biological availability of USP drugs; and exploring the controversial idea of merging the standard-setting programs of the U.S. Pharmacopeia and the National Formulary. Some of the changes proved to be so divisive that the unusual step was taken of convoking a special interim Convention, which met in Washington in April 1973.

Tensions among USPC members prompted a special meeting of delegates in April 1973, after Edward S. Brady of the California Pharmaceutical Association obtained the necessary petitions to call the meeting. The petition attacked the management of the USPC and urged the executive committee to review the actions of the Board of Trustees since the 1970 convention. Specific charges included rejection of the joint committee proposal to merge the USP and National Formulary, the possible financial jeopardy of the organization, the role of the delegates in determining USP policy, and the termination of the employment of director of revision.

This special meeting proved to be a watershed in USPC history, as delegates and member organizations voiced their views on these issues. Motions were put forth urging the takeover of the Drug Standards Laboratory (DSL) and the merger of the United States Pharmacopeia and the National Formulary. The Drug Standards Laboratory had been sponsored equally by the American Pharmaceutical Association (APhA), the American Medical Association (AMA) and USPC and had been physically administered by the APhA. On January 1, 1975, the laboratory was officially purchased by the USPC and became the National Drug Research and Testing Laboratory. The laboratory drafts and/or reviews monographs and individual tests, “as an independent nucleus for the national network of pharmaco-industrial and academic laboratories that provide scientific input for creating the standards to which drugs recognized as 'official' will be held.”

Another result of the special meeting in 1973 was negotiations between USPC and APhA which resulted in the purchase of the National Formulary on January 2, 1975. This enabled the USPC to physically incorporate the United States Pharmacopeia and the National Formulary into one volume, while still maintaining separate, distinct functions and revision structures. By publishing and reviewing the USP-NF and the United States Adopted Names (USAN), the USPC, a private non-profit institution, controls the standards-setting mechanism of the United States, while the Food and Drug Administration (FDA) is the governmental drug enforcement agency which is responsible for the maintenance of these standards.