OFFICIAL RULES OF THE COUNCIL ON PHARMACY AND CHEMISTRY
[May 1, 1921]
Introduction
The following rules have been adopted by the Council primarily with the object of protecting the medical profession and the public against fraud, undesirable secrecy and objectionable advertising in connection with proprietary medicinal articles.
New and Nonofficial Remedies.—The book New and Nonofficial Remedies contains a description of proprietary articles which have been accepted as conforming to the rules of the Council; and of such simple nonproprietary and nonofficial substances as seem of sufficient importance to warrant their inclusion.
Mixtures.—For admission to N. N. R., proprietary pharmaceutical mixtures must comply with the rules; and, to determine such compliance, they will be investigated by the Council. The Council, however, endorses the principle that prescriptions should be written on the basis of the therapeutic effects of the individual ingredients. For this reason, it includes in this book only those mixtures that present some real advantage. There is also an appendix in which are included those proprietary articles which, so far as known to the Council, comply with the rules, but which do not possess sufficient originality to be admitted to the body of the book.
Rules Governing the Admission of Proprietary Articles to the Book New and Nonofficial Remedies
Definition of Proprietary Articles.—The term “proprietary article,” in this place, shall mean any chemical, drug or similar preparation used in the treatment of diseases, if such article is protected against free competition, as to name, product, composition or process of manufacture, by secrecy, patent, copyright, or by any other means.
Rule 1.—Composition.—No article will be accepted for inclusion in the book New and Nonofficial Remedies, or retained therein, unless its composition be furnished to the Council for publication. For simple substances, the scientific name and the chemical formula, rational or structural, if known, should be supplied. For mixtures, the amount of each active medicinal ingredient in a given quantity of the article must be stated. The general composition of the vehicle, its alcoholic percentage, and the identity of the preservatives must be furnished.
Rule 2.—Identification.—No article will be accepted or retained unless suitable tests for determining its composition are furnished to the Council. In the case of chemical compounds, these shall consist of tests for identity and purity. In the case of mixtures, description of methods for determining the amount and active strength of the potent ingredients shall be furnished, if practicable.