Introduction.—The Council on Pharmacy and Chemistry was established in February, 1905, by the American Medical Association, primarily for the purpose of gathering and disseminating such information as will protect the medical profession in the prescribing of proprietary medicinal articles. In pursuance of this object, the Council examines the articles on the market as to their compliance with definite rules designed to prevent fraud, undesirable secrecy and the abuses which arise from advertising directly or indirectly to the laity. Such articles as appear to conform to the rules are accepted; and their essential features are described in the annual publication of the Council, New and Nonofficial Remedies, if they come within the scope of this book. These descriptions are based in part on investigations made by, or under, the direction of the Council, but in part also on evidence or information supplied by the manufacturer or his agents. Such interested statements are examined critically, and are admitted only if they appear to be in conformity with the evidence. It is, however, manifestly impossible for the Council to investigate the composition of every complex pharmaceutical mixture, or to check thoroughly every therapeutic claim; it can give only an unbiased judgment on the available evidence. Criticisms and corrections of the descriptions which may aid in the revision of the matter will be appreciated. The Council judges an article entirely by the facts in evidence at the time of its admission. Previous noncompliance with the rules (short of intentional fraud) does not prevent the favorable consideration of an article which is in accord with existing rules. Infringements of the rules after acceptance of an article for New and Nonofficial Remedies, or the discovery that the Council’s information was incorrect, will cause the acceptance to be reconsidered. An article is accepted for New and Nonofficial Remedies, and will continue to be included in the book, with the understanding that serious violations of the rules, after acceptance, will be followed by the omission of the article and publication of the reasons for such omission. The Council desires physicians to understand that the admission of an article does not imply a recommendation. Acceptance simply means that no conflict with the rules has been found by the Council.
Duration of Acceptance.—Unless an agreement to the contrary is made at the time of acceptance, articles admitted to New and Nonofficial Remedies will be retained for a period of three years, provided that during that period they comply with the rules and regulations which were in force at the time of their acceptance. At the end of this period all articles will be carefully reexamined for compliance with existing rules. Particular weight will be given to the question as to whether recent evidence has substantiated claims as to the therapeutic value of any preparation, this evidence to consist partly of recent statements in the literature and partly of the general esteem in which the preparation is held by clinical consultants of the Council. The reacceptance of articles after such reexamination shall be for three years unless a shorter period is specified. Any amendments to the rules, by specific requirements or by interpretation, which may be made after the acceptance of an article, shall not apply to such article until the period of acceptance has elapsed. At the end of this period the article, if it is not eligible under the amended rules, will be omitted.
The Scope of New and Nonofficial Remedies and Appendix.—To aid physicians and manufacturers in deciding what articles come within the scope of this book, or, in other words, to enable physicians to recognize whether an article which is not described in New and Nonofficial Remedies has been omitted because it does not need admission or because it has been rejected, the Council furnishes the following more detailed definitions:
Official Articles.—Articles official in the U. S. P. or N. F. do not require consideration by the Council if they are marketed under the official name and if no unestablished therapeutic claims are made for them.
These do not require consideration by the Council, since standards for them are provided in these books, and enforced under the provisions of the federal Food and Drugs Act, except that they may be mentioned for information. Consideration by the Council becomes necessary if a U. S. P. or N. F. product is offered for sale under a name other than that, or the synonyms, under which the product is described in one of these books of standards, or if the proprietors or their agents advance claims that the product possesses therapeutic properties other than those commonly accredited to it.
Modifications of U. S. P. and N. F. Products.—A pharmacopeial or National Formulary product which is marketed under the official title or synonym, but with well-founded claims that its purity, permanence, palatability or other physical properties excel the official standard, may, if no extraordinary therapeutic properties are asserted, be considered as an official article and held not to be within the scope of New and Nonofficial Remedies. When such products are marketed under the claim that they possess therapeutic properties other than those commonly accredited to the U. S. P. or N. F. products of which they are modifications, they shall be subject to the consideration of the Council.
Specifically Exempted Preparations.—Foods, in general, unless marketed with the claim that they possess therapeutic properties shall not, at the present time, be considered by the Council. Mechanical appliances, at the present time, shall not be considered by the Council. Mineral waters (natural), at the present time, shall not be considered by the Council. With these exceptions, products which in the judgment of the Council are manufactured and marketed in conformity to the principles underlying the rules of the Council may be accepted for N. N. R. Products which are manufactured and marketed in a manner which does not conform to the principles underlying the rules of the Council shall not be accepted for N. N. R. The burden of proof in establishing claims for therapeutic properties of products considered by the Council shall lie with the proprietor or, when a foreign made product, with the agent who markets the product in the United States. To avoid confusion with nonofficial substances marketed under similar names, the Council recommends that official substances be prescribed by their official titles, followed by the abbreviation “U. S. P.” or “N. F.”; thus: Tinctura Nucis Vomicae, U. S. P.; Elixir Gentianae, N. F.
Substances Described in New and Nonofficial Remedies.—In the body of the book will be described simple proprietary substances and their preparations; proprietary mixtures if they have originality or other important qualities which, in the judgment of the Council, entitle them to such place, and important, nonproprietary, unofficial articles. The Council recommends that when the latter are prescribed, they be indicated by the abbreviation, “N. N. R.,” thus insuring to the prescriber the quality of these articles laid down in the book.
Proprietary Mixtures.—A mixture will be considered as proprietary, and therefore requiring consideration by the Council for admission to the book or appendix, if it contains any proprietary article; if it is marketed under a name which is in any way protected, or if its manufacturer claims for it any unusual therapeutic qualities. Proprietary mixtures which are marketed in conformity with the rules are listed in the appendix of the book under the names of the respective manufacturers. Such proprietary mixtures are not admitted to the body of the book, save in the exceptional cases cited in the preceding paragraph.