"ridiculous remedies" and to emphasize the standards for "simples" (i.e., individual items or ingredients).
In the United States, the general policy of the U.S.P. from the first edition in 1820 was "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." This policy has followed in each succeeding decennial edition, yet "despite steadfastness in admitting only drugs of established merit, the number of U.S.P. drugs has risen steadily . . ." (U.S.P. XVIII, pp. xxv-xxvi).
What is In a Pharmacopeia
As noted above, the early pharmacopeias consisted largely of collections of prescriptions in use, just as a cookbook contains a collection of recipes and instructions for preparing various dishes.
While there are some in U.S.P. XVIII, they form a small part of the collection. Examples are "Cherry Syrup," p. 106; "Citric Acid Syrup," p. 135; "Coal Tar Ointment," p. 136; "Cocoa Syrup," p. 139; "Cold Cream," p. 143; "Diphenhydramine Hydrochloride Elixir," pp. 208-9; "Glycyrrhiza Syrup," p. 287; "Paragoric," p. 474; "Ringer's Injection," p. 593; "Sulfur Ointment," p. 701; "Wild Cherry Syrup," p. 781; and "Zinc Oxide Ointment," p. 785. Some of these are flavorings and vehicles to which one or another therapeutic agent is added.
This change in content from prescriptions to ingredient items no doubt is a reflection of the trend in pharmacy over the decades. The apothecary today rarely "compounds" prescriptions; most medications are produced by pharmaceutical manufacturers who are able to apply better controls from the testing of raw materials, through the manufacture of ingredients, to the compounding of the medication and the testing of the product. Since much of this is now performed by automatic machinery in large volume, a much higher degree of uniformity at much lower unit cost can be realized than would be possible by the older method of compounding by hand with mortar and pestle.
This trend is paralleled elsewhere. In the early days of opticianry, ophthalmic lenses for eyeglasses were ground and polished to prescription by the optician. Today, ophthalmic lenses are mass-produced in a wide range of optical strengths, in small increments of difference in diopters, with the volume in each strength determined by statistical data about the visual needs of the population to be served. Today the optician merely selects a standard lens of the strength called for by the prescription, cuts it to the shape and size required by the eyeglass frame, grinds the edges (not the optical surface) and fits the lens to the frame. As with prescriptions for medicine, this arrangement provides a much higher level of uniformity and reliability, at much lower unit cost, than would be possible with the old hand method. Custom tailoring and shoemaking have followed the same path.
Similarly, the prescriptions found in the Merck Manual (12th Ed., 1972), at pp. 1849-1893 reflect this trend in pharmaceutical manufacture; by and large the prescriptions are of single articles without the "recipe" for compounding.
Articles in the U.S.P. as "Drugs"
The difficulty with any attempt to apply the statutory term "drugs" as a comprehensive noun for all the chemicals, substances and materials in the U.S.P. is evident from the fact that a very large number of them have multifarious characteristics, qualities and uses other than the medicinal ones to which the word "drug" naturally applies.
"Water" is recognized (p. 776) as H 2O, with a molecular weight of 18.02, and described as a "clear, colorless, odorless liquid." After a number of assay specifications it is put in the category of "Pharmaceutic aid (solvent)."
Further on in the book, under the section on "General Information and Procedures," an explanation for recognizing "water" is given:
"Inasmuch as water is used more copiously and widely than any other substance in pharmaceutical manufacturing, its quality is of the utmost importance. Adequate control over the quality of the water supply involves exceptional difficulties, since the basic source, usually a municipal system, is influenced by many and varied factors. * * *
"In view of the fact that water is required for a variety of purposes ranging from the needs of [pharmaceutical] manufacturing processes to the final preparation of therapeutic agents just prior to their administration to patients, the Pharmacopeia provides five monographs for water, as follows: