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

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.

Nonproprietary Mixtures of Official Substances.—Since the ingredients of such mixtures do not require consideration by the Council, and since the mixtures are not open to the proprietary abuses which call for the work of the Council, it is not necessary that they should be investigated by the Council. The physician must judge whether such mixtures should be directed to be prepared by the pharmacist, or whether he is justified in ordering a ready-made preparation. If he decides to use a ready-made, nonproprietary preparation, he must judge for himself whether it is marketed in accordance with the rules. It should, however, be remembered that the application of a trade name to any substance makes it proprietary.

Explanation of Rule 1: Composition

Secrecy Objectionable.—It is not only the right but also the duty of the physician to know the essential composition of what he prescribes; the Council cannot compromise on this proposition.

Vehicles and Preservatives.—In the case of mixtures, not only the potent ingredient, but also the general character of the vehicle, the presence of alcohol, and the identity of preservatives, or of any other substance, whether added or present as an impurity, must be stated if these can under any circumstances affect the therapeutic action of the article. This, as a rule, does not mean the publication of trade secrets, such as flavors or the details of the working formula.

Trade Secrets.—Furthermore, trade secrets will not be received as confidential by the Council, since it accepts information only with the distinct understanding that this may be freely published, at its discretion.

Inspection of Factories.—The Council does not accept invitations to inspect factories; its concern is with the finished products.

On the other hand, the Council requires that the information be complete and accurate as to medicinal ingredients.

Unofficial Constituents.—Unofficial constituents of proprietary mixtures must be presented by the manufacturer in the regular way and must be acted on by the Council before the preparations containing them can be accepted.

Fraud.—When it appears that a manufacturer has made a deliberately false statement concerning a product, he is asked to furnish an explanation; and if this is not satisfactory, the product will not be accepted, even if the false statement is subsequently corrected or omitted.

Testimonials.—The foregoing paragraph applies not only to statements made to the Council, but also to statements furnished to physicians by the manufacturer or his agents, even when these statements are in the guise of testimonials.

Explanation of Rule 2: Identification

In order to avoid errors in the case of chemical compounds, and to guard against adulterations, lack of potency or strength, and the mistaking of one chemical for another, it is necessary to have at hand suitable tests.

Tests, etc.—If these facts have appeared in the literature, or in standard textbooks, reference to them will be sufficient; but with new chemicals, especially synthetics, the manufacturer or his representatives will be required to supply such tests for publication, as will assure an intelligent opinion of these products.

Physiologic Standard­ization.—In cases in which chemical methods of identification are unknown or unreliable, physiologic standard­ization should be employed. The Council considers the phrase “physiologically standardized” or “assayed” as misleading unless the standard and method are published in sufficient detail to permit of their control by independent investigators. It is evident that when no standard is published, it is impossible to know whether the quality is high or low, and the conscientious manufacturer who sets for himself a high standard is placed on a level with the dishonest or careless one who adopts a low standard. Again, if the process of standard­ization is not published, it is impossible to learn, without actual trial, the relative value of one preparation as compared with that of another manufacturer, or to confirm or disprove the statements of the manufacturer as to the quality of his product.

Standard­ization of Disinfectants and Germicides.—No disinfectant or germicide of the phenol type will be accepted for New and Non­official Remedies whose phenol coefficient, determined according to the method of the Hygienic Laboratory, U. S. P. H. S., is not stated on the label of the preparation.

Explanation of Rule 3: Direct Advertising

Lay Advertising.—The impossibility of controlling the irresponsible claims which are usually made in advertisements to the public, the well-known dangers of suggesting by descriptions of symptoms to the minds of the people that they are suffering from the many diseases described, the dangers of the unconscious and innocent formation of a drug habit, and the evils of harmful self-medication, including the dangers of the spread of many infectious and contagious diseases when hidden from the physician, and similar well-known considerations, are the reasons for discouraging, in the interest, and for the safety, of the public, this reprehensible form of exploitation. Advertising in medical journals, etc., distributed solely to physicians, does not come within the scope of this rule.

Exceptions.—In the case of subjects on which the public should be instructed, as the use of disinfectants, germicides, antiseptics and foods, advertisements to the public, if not in objectionable forms, are considered admissible. In no case shall such advertisements include recommendations for use as curative agents, nor shall the names of any diseases be mentioned in exploitation. If the preparation is sufficiently toxic to require caution in its use to prevent poisoning, this fact shall be stated on the label. On account of the deplorable results which would follow any abuse of this privilege, the conscientious cooperation of manufacturers and their agents in adhering strictly to the limitations laid down is asked; and for the same reason the acceptance of an article which is so advertised as to infringe on these limitations in any essential way (as by naming diseases or by making false and exaggerated claims) shall be summarily rescinded, and the reasons for such action may be published without notice to manufacturer or agent. A disinfectant, germicide or antiseptic will be accepted for description in New and Non­official Remedies, and an article of this class which has already been accepted will continue to be included in New and Non­official Remedies only on the explicit understanding by the manufacturer and agent that such infringements of the rule will be followed by deletion of the article and by publication of the facts as described.

Foods.—We may divide the foods into three groups. The first group contains the ordinary foods, including the well-known breakfast foods. These do not come under the supervision of the Council in any way. The second group includes a large and important class of manufactured products, such as invalid and infant foods, which in a sense stand between the first and third groups. The public has the same interest in these foods that the physician has, and usually is supplied with full information concerning them. While the primary recommendation of these articles should naturally come from the physician, it cannot be expected that their continued use should depend on repeated prescriptions. Information concerning this group of foods would come naturally and properly from a physician, and the collection and dissemination of this information may very properly be included in the work of this Council. As the products in this class are used extensively, it is not proper to limit their advertising to medical journals, but the advertising should be permitted in the lay press so long as it is conducted in a manner compatible with the rules of the Council. The third group includes medicinal foods proper, such as predigested foods. These have a relatively low food value and are characterized by a high alcohol or preservative content. They frequently contain strictly medicinal substances, or food substances for which distinct therapeutic properties are claimed. These products should be used only on the advice of the physician, and the advertisements should be restricted as in the case of ordinary medicines.

Advertisements in Foreign Countries.—The Council deals primarily, in the interest of the public and of the medical profession, with articles proposed for admission to New and Non­official Remedies, and, in determining the status of any article, must take into consideration any statements made regarding it or any method of advertising it employed by the manufacturer or his authorized agents or representatives, whether in this country or abroad. The Council will not regard as within its scope, however, questions concerning the marketing of articles (except the matter of direct advertising to the laity and unwarranted claims or mis­rep­re­sen­ta­tions) in any country which has a public body corresponding to this Council.

Explanation of Rule 4: Indirect Advertising

Matter Distributed Solely to Physicians.—It should be remembered that the sole intent of this rule is to protect the physician, so that in prescribing a proprietary medicine he shall not unconsciously advertise proprietary preparations. The rule imposes no restriction on the legitimate methods of bringing a remedy to the attention of the profession, such as advertising in medical journals, circulars and other printed matter distributed solely to physicians. The rule applies only to the package as it may reach the patient.

Naming Diseases on Labels.—The naming of diseases on the label or package is not necessary, as is shown by the very large number of proprietary products which have been successfully introduced without resorting to this expedient. This method of popularizing a proprietary remedy with the laity is most objectionable, and should not be tolerated in any form. In general, therapeutic indications should be omitted from the label and package. The Council will not insist on this point, however, when such indications are so given as not to promote self-medication, particularly in diseases which require expert diagnosis and supervision. It will be considered an infringement of the rule if an article be marketed in bottles which have the name of the article blown into the glass, or if otherwise the name or initials or other distinctive mark of the article is permanently stamped on the container, on the article itself, or is on the stoppers or seals. Articles which are marketed in any of these ways are not accepted for New and Non­official Remedies. Readily removable labels are not objectionable, nor is the permanent affixing of the firm’s initials or name to the trade package if such initials or name is not suggestive of the article. The Council does not countenance the use of an accepted article for advertising other articles which have not been accepted by the Council.

Explanation of Rule 5: False Claims as to Origin

Source.—No false or misleading statement in regard to an article can be permitted concerning the source of material from which it is made, or the persons by whom it is made. Some glaring frauds of this nature have been perpetrated in the past, and this rule is intended to prevent such imposition.

Explanation of Rule 6: Unwarranted Therapeutic Claims

Therapeutic Questions.—This rule insists that the claims of manufacturers or agents concerning the therapeutic properties of their products must be compatible with demonstrable facts. Manufacturers will be held responsible for all statements made or quoted in their advertising “literature” regarding their products. Recognizing the existence of honest differences of opinion on many therapeutic questions, the Council desires to be liberal in the application of this rule. It is natural that a manufacturer should be partial toward his own product, and a moderate degree of emphasis in advertising may not be objectionable. The Council, however, will not admit claims which are neither in harmony with already accepted facts nor supported by acceptable evidence. In doubtful cases the Council considers these questions with the advice and cooperation of its staff of clinical consultants.

Clinical Evidence.—To be acceptable, the clinical evidence must offer objective data with such citation of authority as will enable the Council to confirm the facts and establish the scientific value of the conclusions drawn. Clinical data are worthless when the author is not cited. The facts on which claims with regard to the value of a remedy are based must have been rendered accessible for investigation and confirmation by disinterested observers, either through publication or through the records of a hospital or other institution.

Explanation of Rule 7: Poisonous Substances

Poisons.—For the information of the pharmacist or dispenser, and to enable him to safeguard the interests of the patient and the physician, all articles containing such potent agents as the poisonous alkaloids and other organic substances and the salts of some of the metals should have the exact amount of these ingredients which is contained in the average adult dose stated on the label.

Explanation of Rule 8: Objectionable Names

“Coined” Names.—Many of the abuses connected with proprietary medicines arise from “coined” proprietary trade names. Such names will not be recognized by the Council unless in particular instances the Council shall deem their use to be in the interest of public welfare. In every such exception the burden of proof, both for establishing and for continuing the exception, lies with those who market the product.

Proprietary (“Trade”) Names When Permitted.—In consideration of the benefits which may come from the discovery of a therapeutic agent, the Council concedes to the person or firm which, by right of discovery, controls such a product the right to name it. The Council will offer no opposition to an arbitrary name for such a new product, provided it is not misleading, thera­peutically suggestive, or otherwise subversive of scientific pharmacy and therapeutics. If the discovery that a previously known substance has therapeutic value is deemed of sufficient importance, the Council may recognize a name for such a substance if the name is applied by the person who makes the discovery; or, with the consent of the discoverer or in the absence of any protest on his part, the Council may recognize a name applied by the firm which first makes such a product available to physicians. In the interest of rational drug therapy, the Council recommends that trade names be coined so as to indicate the potent element or constituent.

Scientific Names.—When the proprietary or trade name for an article is considered insufficiently descriptive of its chemical composition or pharmaceutical character, the Council may require as a condition for the acceptance of such articles that a descriptive scientific name satisfactory to the Council appear on the labels, circulars and advertisements for such an article. For all definite chemical substances it is required that the scientific name be given prominence on the labels, in circulars and advertisements.

Proprietary Names for Unoriginal Articles.—Proprietary names will not be recognized for articles which are included in the U. S. Pharmacopeia or National Formulary or for unessential modifications of such articles. Neither will proprietary names be recognized for substances or mixtures which are described in medical or pharmaceutical publications. In the marketing of unoriginal articles, the legitimate interests of the producer are fully served by identifying such products by appending the name or initials of the manufacturer or agent, or by the use of a general brand mark. No objection will be made by the Council to the use of such brand marks, provided that in no case shall such mark be used as a designation for an individual article.

For any product which, by reason of the absence or lapse of patent rights or for other reasons, is open to manufacture by more than one firm, the Council reserves the right to select a common name and to provide standards of identity, purity and strength, and then will accept such article only if it is marketed under the title adopted as the N. N. R. name or the name under which such article was introduced (to which may be appended the firm’s identifying mark).

N. N. R. to U. S. P.—When an article which has been accepted for New and Non­official Remedies is admitted to the U. S. Pharmacopeia or National Formulary, it will be omitted from New and Non­official Remedies one year after such standard­ization if the name of such article is used in these standards either as the main title for the product or as a synonym. If the name under which the article is described in New and Non­official Remedies is not used in these books of standards, the proprietary preparation will be retained provided the official name is given prominence on the labels and in the circulars and advertisements of such article. When the Council adopts a common name for an article that has been admitted under another name, it will be continued under the older name only on condition that the Council name be given prominence on the label and in the circulars and advertisements for such article.

Pharmaceutical Preparations and Mixtures.—These, with rare exceptions, are not original in composition and there is seldom any reason why they should be endowed with arbitrary names. On the contrary, it is important that the prescriber should be reminded constantly of their potent ingredients.

Thera­peutically Suggestive Names.—Articles bearing thera­peutically suggestive names will not be accepted for New and Non­official Remedies, first, because they are likely to lead physicians into prescribing names instead of remedies, and second, because they tend to encourage unwarranted self-medication by the laity. Even if the name is at first apparently meaningless to the public, its meaning will soon be understood because patients soon learn the technical names applied to their diseases and symptoms. The prohibition against thera­peutically suggestive names is not applied to serums, vaccines and antitoxins, because the accepted nomenclature of the specific organisms used in their preparation makes this unavoidable and because self-medication with them is improbable.

Explanation of Rule 9: Patents, Trademarks, Copyrights, Etc.

Protection.—This information is important as a means of determining the legal status of medicinal articles and as an aid to their ready recognition in current publications.

Explanation of Rule 10: Unscientific and Useless Articles

Unscientific Compounds.—The use of articles which are unessential modifications of official or established nonproprietary articles is unscientific and serves no useful purpose. The Council will not accept products which are scientifically unsound and which, therefore, must be considered useless or inimical to the best interest of the medical profession and the public. This class includes compounds or mixtures containing an excessive number of active ingredients; those compounds or mixtures the components of which are of no probable assistance to one another, and those articles which are of no therapeutic value.

Unessential Modifications of Official Substances.—The subterfuge of obtaining proprietary rights over an official or established nonproprietary product, by introducing unessential modifications, also tends to confusion and abuses, and such articles will not be admitted by the Council. Essential and important modifications, however, will receive recognition. (The Council interprets the term “established nonproprietary product” as applying to a preparation of any formula which has been published through any recognized or reasonably accessible channel of publication, prior to its appropriation or modification by a manufacturer.) Duplicates of biologic products accepted under the name of the manufacturers will not be accepted under the names of the distributors.

THE COUNCIL ON PHARMACY AND CHEMISTRY, PRESENT AND FUTURE [A]

W. A. Puckner, Phar.D.

Secretary, Council on Pharmacy and Chemistry

The World War marked an epoch in the existence of the Council on Pharmacy and Chemistry, as it did in all human endeavors. The information and experience which had been accumulated by the Council during its thirteen years’ existence was drawn on by our government, directly or indirectly, and it also received consideration in England, France,[1] Belgium, Holland,[2] Italy,[3] Sweden and elsewhere. In the world wide readjustment that has begun, the efforts of the Council, past and present, will influence the plans of those who engage in the manufacture or sale of medicines, and, undoubtedly, will be the incentive to the establishment of similar bodies in other countries.

As secretary of the Council almost from the time of its organization in 1905,[4] and knowing the work of its members and its collaborators, I am firmly convinced that this body has deserved the endorsement and support given it by the American medical profession. I welcome this opportunity to present an outline of the Council’s past activities and to speak of some of the problems of the future, because I feel assured that a knowledge of its endeavor to improve drug therapy will increase the profession’s confidence in the Council and add to the number of its supporters.

THE COUNCIL’S ACTIVITIES

Organized primarily for the purpose of putting a stop to false declarations with regard to the composition of proprietary medicines, the Council’s activities have broadened until its work may be characterized as “a propaganda for the rational use of drugs.” The following are some of its activities:

1. New and Non­official Remedies.—This is an annual volume, issued by the Council. It describes both proprietary and nonofficial, nonproprietary drugs which are deemed worthy of consideration by the medical profession. To be admitted to this book, a preparation must comply with certain definite rules which stipulate, in effect, that its composition be declared, that no untrue or grossly exaggerated claims be made for it, and that it shall give promise of having therapeutic value.

With the exception of a few which are still under consideration, the Council has considered all proprietaries whose owners or accredited agents have requested that an examination of the products be made, and it has admitted to the book those which were found eligible. In addition, the Council has examined all of the more important or widely exploited proprietaries, even when no examination was requested, and it has admitted those of this group which were found eligible. Further, the Council has admitted to the book certain nonofficial, nonproprietary articles which seemed to give promise of therapeutic usefulness, and it has established standards for the control of their identity and purity, and listed those brands which complied with these standards.

As most proprietary medicines are of a more or less experimental nature, they are accepted for inclusion in New and Non­official Remedies only for a limited time—usually a period of three years. At the expiration of the period of acceptance, each preparation is reexamined and retained only if the claims made for it and the present day knowledge of its value permit this action.

Since manufacturers give information only in regard to their own products, New and Non­official Remedies groups together articles of a similar character, and includes in each case a general discussion of the group for the purpose of comparison, not only with each other, but also with the established or pharmacopeial drugs which members of the group are intended to supplant.

In brief, New and Non­official Remedies is a book in which are described preparations that have been accepted by the Council. The description includes facts that the physician should have. It is a book that should be in the hands of every physician who prescribes medicines, and who wishes to know the facts regarding the newest remedies. It is the only book in which he can find information relative to proprietary medicines that are worthy of his patronage. It will protect the physician who makes use of it against the wiles of the promoters of products not worthy of his patronage. It would certainly be of use to the physician when the detail man calls on him, for if he were being importuned to prescribe or use samples of something which he had not heretofore used and which he was unable to find in N. N. R., he might ask the detail man why. In the nature of things few physicians are sufficiently expert in chemistry and allied sciences to be able unerringly to discriminate between the true and the false as regards many preparations that he is asked to prescribe.

2. The Reports of the Council on Pharmacy and Chemistry.—A medicament may be inadmissible to New and Non­official Remedies for various reasons; it may be worthless or irrational, its composition may be secret or indefinite, or it may be exploited under exaggerated or unwarranted claims or in a way otherwise detrimental to the public health and scientific medicine. Of these various reasons which make an article unacceptable, the manufacturer obviously may remove all except the first, viz., worthlessness or irrationality. Consequently, a preparation which has been presented for admission is not definitely rejected until after its proprietor has been informed of the objections to his product and has failed to bring the preparation in conformity with the Council’s rules. When a preparation is found definitely inadmissible to New and Non­official Remedies, that is, when the proprietor cannot or will not make it acceptable, the Council prepares a report for publication. These reports are sent for publication to The Journal of the American Medical Association, and later published in the annual “Reports of the Council on Pharmacy and Chemistry.” The more important of these are also published in the book, “The Propaganda for Reform in Proprietary Medicines.”

3. Useful Drugs.—Since the domination of proprietary medicines, which was retarding medical advance and threatening therapeutic chaos, had been made possible only by the insufficient and inefficient instruction given in medical schools in subjects having to do with drugs, the Council appointed a Committee on Medical Teaching to secure the cooperation of teachers in materia medica, pharmacology and related branches. This committee has endeavored to effect an improvement in these courses of instruction. One of the results of this work was the selection of a list of drugs to serve as a basis of materia medica instruction and thus insure that medical students shall be better informed with regard to the therapeutic worth of a few well established drugs, rather than, as in the past, leaving school with a smattering of knowledge about many drugs. The outcome of these efforts is the publication of “Useful Drugs,” a concise but thorough and up-to-date discussion of the actions, uses and dosage of the more important drugs. The list of drugs presented in this book is now the basis of instruction in many schools; and many state examining boards are confining their materia medica questions to the drugs in the list.

4. Epitome of the U. S. P. and N. F.—To encourage the use of official drugs and to make available an estimate of their therapeutic value, a committee of the Council prepared an abstract of the U. S. Pharmacopeia and the National Formulary. This booklet, the “Epitome of the U. S. Pharmacopeia and National Formulary,” presents those portions of these books which are of interest to physicians, and in addition, gives a concise statement of the therapeutic usefulness of the drugs and preparations described in them.

5. Patent Law Reform.—Some of the worst abuses connected with the exploitation of proprietary medicines have been made possible by our patent and trademark laws and the method of their interpretation and enforcement. The Council, therefore, appointed a committee to study these laws and the various propositions advanced for their improvement. This committee has published, from time to time, reports on various phases of our patent and trademark laws and recently summarized these reports in an address[5] sent to the commissioner of patents and the interested congressional committees. It is hoped that by means of these reports physicians will be enabled to give intelligent support to a revision of the patent and trademark laws when legislation is proposed.

6. Therapeutic Research.—Through its Committee on Therapeutic Research, and with the aid of funds provided by the Board of Trustees of the American Medical Association, the Council has encouraged the investigations of questions which might lead to a better understanding of the action of drugs. These investigations are brought together in the annual reports of the Committee on Therapeutic Research, and are an important addition to our knowledge of drug action.

In the past, the Council has in particular encouraged the investigation of the action and therapeutic value of widely used drugs regarding which our knowledge is still unsatisfactory. These investigations have included a study of the action of strychnin in cardiac disease, a comparison of the action of absorption and excretion of iodid preparations, a study of the pharmacology of the opium alkaloids, etc. Appreciating that the available knowledge of proprietary drugs is one sided in that it comes from investigations made by interested pharmaceutical concerns or from investigations made at the instigation of these firms, the Council is planning a comprehensive study of many of the synthetic drugs that have gained some vogue during recent years.

THE FUTURE

Medical research, and efficient instruction in therapeutics and related subjects, spell a diminishing influence of commercial medicine over rational therapeutics. The fact that the present shortage of German synthetics has not handicapped seriously the practice of medicine should be a lesson to American physicians for many years to come.

On the other hand, it must be remembered that the publicity given to the reports of the Council and to other contributions toward rational therapeutics by The Journal of the American Medical Association, the journals of the state organizations, and a few personally owned publications, is as nothing when compared with the persistent and wide publicity given to the propaganda of the proprietary houses. While a report setting forth the objections to a proprietary is published but once, the firm’s laudatory pronouncement goes forth again and again until the Council’s report is completely overwhelmed and forgotten. Manufacturers of proprietaries not only keep in close touch with the practicing physician by means of house organs, special “literature,” or by traveling representatives, but many of the firms, through the meritorious lines of pills, tablets, tinctures, etc., which they put out, also obtain and hold the good will and confidence of a large proportion of the medical profession.

Furthermore, some of these firms may gain the confidence of the medical profession through these high grade pharmaceuticals, and certain of their proprietaries may be of distinct therapeutic value but may fail to be acceptable for New and Non­official Remedies, because they do not conform to the reasonable rules of the Council. These firms do not find it profitable to force the sale of their regular nonproprietary pharmaceuticals by unwarranted claims or objectionable methods, yet they may consider it good business to market certain proprietary products by means of claims which are extravagant and without warrant, and which will lead to indiscriminate use by the profession and the public. In a word, where there is one dollar spent on behalf of rational medicine, thousands are spent for the purpose of increasing the sale of preparations which directly or indirectly are a detriment to the public health, to medicine, and to the pocketbook.

That the day of the secret nostrum of the pseudo-chemical company is not yet past is well illustrated by the recent introduction of an asserted arsphenamin preparation called “Syphilodol.” The A. M. A. Chemical Laboratory proved one form of this asserted French discovery to be essentially a pill of mercurous iodid. Another form of Syphilodol (for intravenous administration) had all the characteristics of water, and appeared devoid of any potent ingredient. Though the advertising sent out by the promoters in regard to its composition was suspiciously evasive, the Illinois Medical Journal published an advertisement of “Syphilodol,” which, possibly by a coincidence, appeared above an appeal to “Our Readers” to use wares advertised in that journal.

While such rank deceptions as “Syphilodol” are not common, there are more subtle deceptions that are even more dangerous. Types of widely exploited remedies of today comprise so-called ethical specialties composed of well known and established drugs (with “jokers” hidden away somewhere) or preparations which have a plausibly fascinating pseudo-scientific background of radiant energy, colloidal chemistry, nonspecific protein reaction, or something of the sort. The latter class of preparations in particular appeal to physicians who are striving hard to keep pace with modern science. Exposure of their fallacies requires most careful consideration on the part of the Council.

Progress toward a rational and scientific drug therapy must continue, and, therefore, it is important that the Council on Pharmacy and Chemistry should continue to make the investigation of proprietary medicines its chief work. Investigation of a proprietary medicine, however, and a report of such investigation are of value in direct ratio only to the number of physicians who read the report, endorse it and act in accordance with its conclusions. In order that you may determine to what extent those preparations which are admitted to New and Non­official Remedies deserve your interest and confidence, it will be worth while briefly to outline the rules which govern the Council in the admission of articles to New and Non­official Remedies.

RULES GOVERNING THE ACCEPTANCE OF ARTICLES FOR N. N. R.

Composition.—Rules 1 and 2, and in a measure 5, 7, and 9, deal with the composition of articles. Rule 1 requires that the quantitative composition of an article be furnished the Council for publication. Rule 2 requires that the manufacturer furnish methods whereby the composition of products that are definite chemicals or the potent constituents of mixtures may be determined. The Council does not require that the process of manufacture of an article be declared unless this becomes necessary in order to judge its composition. Rule 5 requires that statements with regard to the origin and source of an article shall be truthful. Rule 7 requires that for the guidance of the dispenser, the amounts of poisonous ingredients of a preparation be placed on the label. Rule 9 requires that if patent rights are claimed for a product, the Council be informed on this point.

That it is not only the right but also the duty of the physician to know the composition of what he prescribes for his patients is so generally admitted that few have attempted to market preparations of avowedly secret composition. When the Council first began its work, it was common to see chemical formulas or statements of composition published which a chemist or a pharmacist was able to pronounce at a glance as impossible.[6] It was not unusual to find that the promoter published “a formula” for his preparation, rather than “the formula.”[7] Today, however, a more prudent, if not more honest, course is pursued. This gives a “formula” which is correct so far as it goes, but which fails to divulge the actual composition of a preparation. When it is considered that many physicians are not any too conversant with the chemistry and pharmacy of drugs, it is not surprising that some administered the proprietary “Venarsen,” regarding the composition of which they had only the vague statement that it was “... a comparatively nontoxic organic arsenic compound, 0.6 gm. representing 247 mg. (33⁄4 grains) of metallic arsenic in chemical combination ...” in the belief that a preparation similar to that first introduced as salvarsan was being used. That “Venarsen” contained its arsenic as sodium cacodylate—a notoriously inactive state of combination—does not justify the intravenous administration of a drug of unknown composition.

While for the present it probably is not feasible to require, on the part of those who manufacture medicinal preparations, such professional training as is required of those who prescribe and those who dispense them, it certainly is not too much to require, as does Rule 2, that a manufacturer shall be able to demonstrate that his preparation has the composition claimed for it. Nor is it sufficient for him to know that the ingredients claimed as constituents were used in the manufacture. The fallacy of his method of reasoning was furnished by the physician who reported that he had personally added the required amount of mercuric iodid for a batch of “Mercol” which, nevertheless, was devoid of mercury.[8] Acceptance of this rule by manufacturers will permit physicians to have a more accurate knowledge of the composition of preparations such as “Taka-Diastase”[9] and “Iodeol”.[10]

A requirement similar to that of Rule 5 is contained in the Federal Food and Drugs Act and so no objection has been made to this rule which requires a truthful statement of the origin and source of articles. An illustration for the need of the rule was furnished by the one time popular “Vin Mariani”[11] which, though very French in its makeup, was found to be largely of the “made in the United States” variety of tipple.

The issuance of a patent for a medicinal product does not prove that such a product presents a discovery or that its owner is entitled to a temporary monopoly, yet it is only fair to physicians and to other manufacturers that notice of such patent claims be given. Hence, the Council publishes in New and Non­official Remedies the information bearing on this point.

Lay Advertising.—Rules 3 and 4 provide against the recognition of articles that are advertised to the public directly or indirectly, exempting from this requirement preparations which the Council believes are safe to be so advertised.

It has been held with some justice that certain shotgun proprietaries are purchased by the public with as much circumspection as they are ordered by those physicians who are addicted to the prescribing of them; but even the exploiters of these mixtures have not denied that the use of medicines by the public on its own initiative is surrounded with many objections. Hence the practice of self medication should not be encouraged by prescribing or using those preparations advertised for public use.

The only objection to the rule has come from a firm which markets a brand of liquid petrolatum, the Standard Oil Company of Indiana. The Council has considered the question of exempting simple laxatives from the restrictions of Rules 3 and 4 as it has exempted antiseptics and nonmedicinal foods. The conclusion was, however, that the excessive use of a simple laxative like a liquid petrolatum, when prompted by newspaper exploitation, is likely to be detrimental to health by overuse as well as by misuse.

The indirect advertisement to the public, which Rule 4 provides against, has been the means of inducing the extensive lay use of “Antikamnia,” “Bromidia” and “Fellows’ Syrup.” Naturally Rule 4 has been bitterly opposed by most proprietary firms. Arguing that many physicians dispense their own drugs, pharmaceutical firms have insisted that every medicinal preparation should bear on its label, not only the dose of the preparation, but also a statement of the diseases in which the article is indicated. Whether manufacturers anticipated the profession’s resentment toward the claim that physicians determine the treatment and perhaps the diagnosis by means of the statements on labels, or because the Shirley amendment to the Food and Drugs Act makes the proprietor responsible for therapeutic claims on the label of a medicine, it is a fact that fewer preparations than formerly need to be refused on account of infringement on this rule. In fact, some thoroughly objectionable proprietaries make a show of being “ethical” by omitting all therapeutic discussion from the labels of their preparations.

Therapeutic Claims.—Rule 6 makes ineligible for New and Non­official Remedies any articles regarding which the manufacturer or his agents make unwarranted, exaggerated or misleading statements as to the therapeutic value. Recognizing the long established custom of therapeutic exaggeration, it has been most difficult to determine the degree of conservatism which might with fairness be required of a manufacturer. In view of the common acceptance of individual impressions as dependable evidence, it is often almost embarrassing to declare as incompetent the statement of some well meaning and all-too-kind-hearted doctor. However, as the pitfalls of haphazard clinical trials become better known and the physician’s mistrust of glowing accounts of marvelous cures more outspoken, the manufacturers’ claims will be more moderate.

Nomenclature.—Were it possible to enact and enforce a law which would oblige manufacturers to sell their medicinal products under properly descriptive names and which would make it illegal for a physician to prescribe it unless he understood the meaning of such properly descriptive titles, then the Council might safely disband. In that case, physicians would discontinue the use of most proprietary preparations in favor of established drugs, and successful newcomers might each year be counted on the fingers of one hand. Such a rational nomenclature is not to be thought of, at least in our generation. Rule 8 requires that the name of an article shall not be misleading, that it shall not be thera­peutically suggestive, and that established drugs shall not be disguised by fanciful titles. It recognizes the right of discoverers of new drugs to name their discoveries, and interposes no objection to arbitrary names for such products so long as such names are not misleading or do not suggest the therapeutic uses of the products. As the rule provides against the recognition of coined names for established nonproprietary drugs, so it requires that mixtures of drugs shall bear names descriptive of their composition. It would be a long step forward if physicians would recognize more fully the objections to the many proprietaries which have, as their only point of originality, a non-descriptive name for an old drug or a mixture of well known drugs. It is an encouraging sign that the Federal Trade Commission, when issuing licenses for the manufacture of synthetic drugs introduced under German patents, stipulated that all manufacturers authorized to make a given drug shall use the same name for it.

Irrational Articles.—Rule 10 provides against the recognition of an article which, because of its composition, is useless or inimical to the best interests of the public and medical profession. This rule excludes medicaments which (1) are unessential modifications of established articles, or (2) are of no therapeutic value or (3) are irrational. With regard to the recognition of mixtures or compounds containing two or more active ingredients, the Council requires that the manufacturer establish the rationality of its combination. The rule has prevented the recognition of many unnecessary so-called ethical specialties. Though a mass of testimonials was often to be had for them, these contained no evidence that the mixture was superior to its potent ingredient, or that its therapeutic effect had been determined. That there is a healthy tendency to use single drugs for their definite action and to discard combinations (be they shotgun proprietaries or “mixed” vaccines) is perhaps best illustrated by the fact that at the last revision of the U. S. Pharmacopeia a considerable number of complex antiquities were omitted from that book.

Feeling confident that this meets with the endorsement of the profession, the Council is examining more critically the evidence for the value of pharmaceutical mixtures.—(From The Journal A. M. A., May 10, 1919.)