Chapter VII: Foreword: The Council on Pharmacy and Chemistry

The Council on Pharmacy and Chemistry was established by the American Medical Association primarily for the purpose of gathering and disseminating such information as would protect the medical profession--and thus the public--in the prescribing of proprietary medicinal articles.

The Council consists of sixteen members, fifteen appointed for a term of five years without pay, and the sixteenth, a secretary, who is also the director of the Chemical Laboratory of the American Medical Association (see Part II).

At the present time (1921) the membership is:

C. L. Alsberg, A.M., M.D., Chief of the Bureau of Chemistry, U. S.
Department of Agriculture, Washington, D. C.

C. W. Edmunds, M.D., Professor of Materia Medica and Therapeutics,
University of Michigan Medical School, Ann Arbor.

R. A. Hatcher, Ph.G., M.D., Professor of Pharmacology, Cornell
University Medical College, New York City.

A. W. Hewlett, M.D., Professor of Medicine, Leland Stanford Junior
University School of Medicine, San Francisco.

John Howland, M.D., Professor of Pediatrics, Johns Hopkins University
Medical Department, Baltimore.

Reid Hunt, M.D., Professor of Pharmacology, Medical School, Harvard
University, Boston.

W. T. Longcope, A.B., M.D., New York.

G. W. McCoy, M.D., Director of the Hygienic Laboratory, U. S. Public
Health Service, Washington, D. C.

Lafayette B. Mendel, Ph.D., Sc.D., Professor of Physiological
Chemistry, Sheffield Scientific School, Yale University, New Haven.

F. G. Novy, Sc.D., M.D., Professor of Bacteriology, University of
Michigan Medical School, Ann Arbor.

W. W. Palmer, B.S., M.D., Bard Professor of Medicine, Columbia
University College of Physicians and Surgeons, New York.

W. A. Puckner, Phar.D., Secretary of the Council, Director of the
Chemical Laboratory of the American Medical Association, Chicago.

L. G. Rowntree, M.D., Sc.D., Professor of Medicine, Mayo Foundation,
Rochester.

G. H. Simmons, M.D., LL.D., Chairman of the Council, Editor of The
Journal of the American Medical Association, Chicago.

Torald Sollmann, M.D., Professor of Pharmacology and Materia Medica,
Western Reserve University School of Medicine, Cleveland.

Julius Stieglitz, Ph.D., Sc.D., Chem.D., Professor of Chemistry,
University of Chicago, Vice-Chairman of the Council, Chicago.

At its first meeting in 1905, the Council began examining the proprietary and nonofficial medicinal preparations offered to physicians of the United States, and authorized the publication of a book (New and Nonofficial Remedies) containing descriptions of those preparations which were deemed worthy of the consideration of physicians. It also issued reports (Reports of the Council on Pharmacy and Chemistry) to the medical profession on those preparations which were not eligible. The Council adopted a set of rules by which to measure the eligibility of each preparation for admission to New and Nonofficial Remedies. These rules were designed primarily to protect the public--through the medical profession--against fraud, undesirable secrecy and objectionable advertising in connection with proprietary medicinal articles. The rules originally adopted have been subjected to revision from time to time to meet changing conditions. For the information of those who wish to familiarize themselves with the work of the Council the rules which are now in force (1921) follow this introduction. A summary is also to be found in the article, “The Work of the Council on Pharmacy and Chemistry, Present and Future,” page 12.

Since 1906, the Council has issued New and Nonofficial Remedies annually. In each issue are listed and described the articles that stand accepted on January 1 of the year of publication. The book describes proprietary medicinal articles on the American market that are found eligible under the rules, and also such nonproprietary, nonofficial articles as give promise of therapeutic usefulness, listing the acceptable brands. Articles of a similar character are grouped together, and each group is preceded by a general discussion for the purpose of comparison.

Since 1908, the Council has also issued an annual volume, “Reports of the Council on Pharmacy and Chemistry,” which contains reports on proprietary medicines that were found inadmissible to New and Nonofficial Remedies. The reports issued prior to 1916--and deemed of sufficient interest to physicians--were reprinted in the Propaganda for Reform in Proprietary Medicines, ninth edition (1916). The more important reports issued from 1916 to 1921, inclusive, are in this volume.

While it is the chief function of the Council to investigate and report on proprietary medicinal preparations, its work has broadened so that the Council’s work may now be characterized as a propaganda for the rational use of drugs. Thus, its Committee on Therapeutic Research encourages the investigation of questions concerning the actions of drugs. These investigations are brought together in the “Annual Reports of the Therapeutic Research Committee.” The Council also has a committee on medical teaching which has issued the publication “Useful Drugs,” a concise, but thorough and up-to-date, discussion of the more important drugs. In addition, the Council appointed a committee to prepare an “Epitome of the U. S. Pharmacopeia and National Formulary,” in which are presented those portions of the United States Pharmacopeia and the National Formulary that are of interest to physicians and in which is given a concise statement of the therapeutic usefulness of such drugs and preparations.

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.

_Rule 3._--DIRECT ADVERTISING.--No article that is advertised to the public will be accepted or retained; but this rule shall not apply to: (_a_) disinfectants, germicides and antiseptics, provided the advertising is limited to conservative recommendations for their use as prophylactic applications to superficial cuts and abrasions of the skin and to the mucous surfaces of the mouth, pharynx and nose (but not to those of the eye, and the gastro-intestinal and genito-urinary tracts) and provided they are not advertised as curative agents (see comments to Rule 3); and (_b_) nonmedicinal food preparations, except when advertised in an objectionable manner.

_Rule 4._--INDIRECT ADVERTISING.--No article will be accepted or retained if the label, package or circular accompanying the package contains the names of diseases in the treatment of which the article is said to be indicated. The therapeutic indications and properties may be stated, provided such statements do not suggest self-medication. Dosage may be indicated. (This rule shall not apply to remedies with which self-medication is altogether improbable, to vaccines and antitoxins or to directions for administering or applying remedies when similar immediate, heroic treatment is indicated.)

_Rule 5._--FALSE CLAIMS AS TO ORIGIN.--No article will be accepted or retained concerning which the manufacturer or his agents make false or misleading statements as to source, raw material from which made, or method of collection or preparation.

_Rule 6._--UNWARRANTED THERAPEUTIC CLAIMS.--No article will be accepted or retained concerning which the manufacturer or his agents make unwarranted, exaggerated or misleading statements as to the therapeutic value.

_Rule 7._--POISONOUS SUBSTANCES.--The principal label on an article containing “poisonous” or “potent” substances must state plainly the amount of each of such ingredients in a given quantity of the product.

_Rule 8._--OBJECTIONABLE NAMES.--Proprietary names for medicinal articles will be recognized only when the Council shall deem the use of such exclusive names to be in the interest of public welfare. Names which are misleading or which suggest diseases, pathologic conditions or therapeutic indications will not be recognized (the provision against therapeutically suggestive names does not apply to serums, vaccines and antitoxins, or to foods). In the case of pharmaceutical preparations or mixtures, the name must be so framed as to indicate the most potent ingredients.

_Rule 9._--PATENTED PRODUCTS AND PROTECTED NAMES.--If the article is patented--either process or product, or both--the number of such patent or patents must be furnished to the Council. Furthermore, if the name of an article is registered, or the label copyrighted, the registration (trademark) number and a copy of the protected label should be furnished the Council. In case of registration in foreign countries, the name under which the article is registered should be supplied.

_Rule 10._--UNSCIENTIFIC AND USELESS ARTICLES.--No article will be accepted or retained which, because of its unscientific composition, is useless or inimical to the best interests of the public or of the medical profession.

Explanatory Comments on the Rules