Pharmacopeia revision

Committee of Revision, Eecithin, Fhe Ended States Pharmacopeia U.S. Pharmacopeial Convention, RockviUe, Md., 1990, p. 1572. 

The CnitedSfates Pharmacopeia (USP) and the Hationa/Pormu/aTy (NP) ate the recognized standards for potency and purity for most common dmg products. The USP was first pubflshed in 1833 the NP in 1887. Upon adoption of the first Pood and Dmg Act in 1906 these compendia became official, ie, they pubflsh the legal standards of quaUty, purity, and strength. The 1980 editions of USP(XX) and NP(XV) were combined for the first time revisions take place every five years. USPXXIII/NFXVIII is effective as of 1995. 

Ended States Pharmacopeia, 19th Revision, United States Pharmacopeia Convention, Inc., Rockville, Md., 1975, p. 574. 

United States Pharmacopeia (1995) 23rd revision. Rockville MD US Pharmacopeial Convention. 

United States Pharmacopeia (1995) 23rd revision. Rockville, MD US Pharmacopeial Convention. (Note the section dealing with microbial limit tests.)... 

The United States Pharmacopeia 19th Revision. United States Pharmacopeial Convention, Inc, Rockvill, Md. 

A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (If the method employed is in the current revision of the United States Pharmacopeia, National Formulary, Association of Official Analytical Chemists, Book of Methods, or in other recognized standard references, or is detailed in an approved new drug application and the referenced method is not modified, a statement indicating the method and reference will suffice). The suitability of all testing methods used shall be verified under actual conditions of use. 

Since the U.S. Congress passed Dietary Supplement Health and Education Act in October 1994, the landscape of the dietary supplement industry has changed in the United States dramatically. In fact, as early as the late 1980s, the U.S. Pharmacopeia s elected Council of Experts (then known as the USP Committee of Revision) was evoking great interest in the development and establishment of public standards for the multitude of multivitamin and multivitamin-mineral combination products as well other nutritional supplement products marketed in the United States. 

Alternative methods are possible the three regional pharmacopeias (United States, European, and Japanese) allow an individual laboratory able to do the official method to validate an alternative method of analysis. The latter is chosen usually for speed, eonvenience, or expense but also to incorporate an existing database when a new or revised pharmaeopeial method is adopted. Under those provisions, a laboratory ean validate a method from another pharmacopeia, thereby avoiding duplication of routine work. In all three cases, only the official method could be used in eompli-ance or contest. One point of harmonization is to avoid even the more remote in-stanees of duplieative testing in addition to international produet registration. 

One of the earliest references to USP s commitment to international harmonization may be found in the historical introduction to the 3rd revision [1] of the U.S. Pharmacopeia (1851) The new Dublin and London Pharmacopoeias were compared with our own, with a view of introducing uniformity wherever more important considerations did not seem to forbid the requisite modifications.. .. Note that uniformity for its own sake was not the sine qua non. 

Awareness of the Committee of Revision in 1851 of the importance of keeping the Pharmacopeia up-to-date may have been enhanced because of the enactment of the Drug Import Act in 1848, which mandated that drugs imported into the United States had to meet the standards of the county of origin and had to comply with the... 

Harmonization of pharmacopeial standards as a practical matter began at the International Congresses of Pharmacy between 1865 and 1910 [2], but the first formal attempt can be traced to 1902. Both USP President Horatio C. Wood, M.D., and Frederick M. Power, Ph.D., an American chemist of the Wellcome Chemical Research Laboratories of London, were appointed by the U.S. Secretary of State as delegates to represent the United States government at the International Conference for the Unification of the Formulae for Heroic Medicines, a conference of 19 countries from Europe and North America [3]. The second conference occurred in 1918. The 3rd in 1925 was attended by 31 countries from all continents except Asia and Australia. They drafted a new International Convention, which came in force in 1929. It revised the 1902 agreements on 77 heroic medicines and introduced the concept of maximum dose. It also requested that the League of Nations create a permanent secretariat of pharmacopeias [4]. Andrew G. DuMez, Ph.D., represented the USP, and was officially appointed by the U.S. Public Health Service to represent the United States at this conference [4,5]. An expert committee of the League of Nations planned a third conference for 1938, but it was never convened because of World War II [2]. 

Because revision programs run on different schedules, one should compare only the current texts of two or more pharmacopeias whenever possible divergence of mandatory requirements is an issue. The official pharmacopeial texts should be compared. 

The United States Pharmacopeial Convention, nc.. Abstract of the Proceedings of the National Convention of 1910 for Revising the Pharmacopeia, Washington, 1910. 

The basic sterilization procedures involve the application of dry or moist heat, the use of sterilizing radiation or, more recently, the use of intense bright light. A valuable source of information is the section on Sterilization and Sterility Assurance of Compendial Articles in the General Information Chapter (<1211>) of the United States Pharmacopeia, now in its 28th revision. Since it is now revised on an annual basis the interested reader is referred to the latest edition for up-to-date information. 

The Stage 4 draft and the commentary are published in the revision document of each pharmacopeia in a section entitled International Harmonization. The draft is published in its entirety. 

USP. Pharmacopeia of the United States of America, 15th Revision, p. 375. 

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