United States Pharmacopeia

“ The historical expansion of the statute's definition, furthermore, clearly points out Congress' intention of going beyond the medical usage. The 1906 Food and Drug Act, for instance, defined 'drug' in a rather limited way to include 'all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals.' 34 Stat. ”

“ In the Latin countries the result of such a method would probably be bad; in the Anglo-Saxon lands with the habit of submission of the individual to the majority, the present method has been successful, and probably more successful than direct governmental rule would have been. The United States Pharmacopœia scientifically and practically ranks with any in the world, and obedience to its mandates in pharmacy and in medicine is universal. ”

“ There is one great advantage in specifying U. S. P. drugs and preparations: Physicians who do so invoke legal standards of purity and identity. The only way to be sure of obtaining substances of therapeutic efficiency, however, is to exercise discrimination. The Pharmacopeia is no guide. Being prepared mainly by pharmacists to meet the needs of pharmacists, the Pharmacopeia of course contains much matter of little interest to physicians and entirely foreign to scientific medicine.— (Editorial from The Journal A. M. A., Sept. 2, 1916.) ”

“ But we are all the more convinced that we must give effect to congressional intent in view of the well-accepted principle that remedial legislation such as the Food, Drug, and Cosmetic Act is to be given a liberal construction consistent with the Act's overriding purpose to protect the public health, and specifically, § 507's purpose to ensure that antibiotic products marketed serve the public with 'efficacy' and 'safety.' Cf. ”

“ Respondent's primary contention here is that the sensitivity discs are not subject to any of the provisions of the Act because Congress did not intend it to cover articles used so indirectly in the 'cure, mitigation, (and) treatment' of disease. Respondent uses the same two-step analysis relied on by the courts below: (1) Congress did not intend to write the drug definition more broadly than does the medical profession, and (2) the medical concept of drug is limited to articles that are administered to man either internally or externally. ”

“ The druggist has been permitted to import and manufacture as freely as he pleased, and to sell under restrictions which were insufficient to prevent promotion of drug habits; the physician has never been required to make accounting for prescription of or the administration of these dangerous substances, and his medical training, both in college and in hospital, has left him in the dark concerning the danger point in their administration.
“This proposed New York State legislation has been drawn with careful eye to the establishment, here in the Empire State, of a model law for other States. ”

“ It is much to be regretted that perfect conformity throughout the United States, with our National Pharmacopœia should not prevail, so that our citizens, traveling or removing with prescriptions, or copies of them, might not be subjected to inconvenient, and even in some cases to dangerous alterations, impairing confidence in the medicine relied upon, or involving the safety of the patient in using it. ”

“ For many drugs and chemicals not in the Pharmacopoeia there is no standard of purity that can be used under the Adulteration of Food and Drugs Act, and for these, as well as for the commercial quality of those drugs and essential oils which are also in the Pharmacopoeia, a legal standard of commercial purity is much needed. ”

“ In the United States, wherever statutes do not otherwise direct, apothecaries and druggists are put upon the common law footing of provision vendors, and may sell in any quantities articles in which they deal.
A druggist is held to a strict accountability in law for any mistake he may make in compounding medicine or selling his drugs. By the statute law of England it is declared to be the duty of every person using or exercising the art or mystery of an apothecary to prepare with exactness, and to dispense, such medicines as may be directed for the sick by any physician (465) . ”

“ Manifestly the phrases 'to a patient' and 'in the course of his professional practice only' are intended to confine the immunity of a registered physician, in dispensing the narcoticdrugs mentioned in the act, strictly within the appropriate bounds of a physician's professional practice, and not to extend it to include a sale to a dealer or a distribution intended to cater to the appetite or satisfy the craving of one addicted to the use of the drug. ”

“ Probably more dependence is to be placed on careful selection of the drug, and skill in its preparation and preservation by the retail pharmacist, who should be personally responsible for the quality and purity of the preparations he sells. Although the attempt to form an international pharmacopoeia has failed, a project for an imperial pharmacopoeia which should be adapted to the general and local requirements of all parts of the British Empire has met with better success. ”

“ But I want the American people to know: The federal government is aggressively fighting the opioid epidemic on all fronts. We’re working with doctors and medical professionals to implement best practices for safe opioid prescribing, and we will do something very, very special. ”

“ Part I of the volume contains formulas, good, bad and indifferent, including the equivalents of a large number of shotgun proprietaries. Part II contains descriptions of drugs. This is a new feature. The purpose is to provide standards for those drugs not described in the Pharmacopeia but used in N. F. preparations. Many of these drugs were described in the U. S. Pharmacopeia VIII, but have not been included in the ninth revision. Practically all are either worthless or superfluous. ”

“ Despite Senator Copeland's proffered explanation, there was continued criticism during the Senate debates (79 Cong.Rec. 4905 4920, 5215-5234) [10] of the definition on the ground that it would lead to the incongruous result of calling the following items 'drugs': shoulder braces (id., at 4841) , radium belts (ibid.) , electrical devices (id., at 4842) , bathroom weight scales (ibid.) , and hospital air conditioning apparatus (id., at 5231) . [11] The opposition finally settled on 'crutches' (id., at 4913) [12] to signify the ultimate absurdity of the drug definition's broad coverage. ”

“ In England the task of elaborating 11 new Pharmacopoeia is entrusted to a body of a purely medical character, and legally the pharmacist has not, as in other countries, a voice in the matter, notwithstanding the fact that, although the medical practitioner is naturally the best judge of the drug or preparations that will afford the best therapeutic result, he is not so competent as the pharmacist to say how that preparation can be produced in the most effective and satisfactory manner, nor how the purity of drugs can be tested. ”

“ It is enacted by legislation, and thus becomes binding on all who prepare drugs or sell them for medication.” By soliciting the help of various American consuls and Navy officers abroad, about 16 such official pharmacopoeias were collected, making an almost complete international representation of all available, official, drug standards. With these sources of information, Dr. Flint compiled and arranged an international list of materia medica specimens, indicating the authorized preparations of each. ”

“ I am urging all Americans to help fight this opioid epidemic and the broader issue of drug addiction by participating in the National Prescription Drug Take-Back Day this Saturday. When you can safely turn in these dangerous and horrible drugs for disposal, that will be a wonderful, wonderful period of time for you. ”

“ We do not hesitate to enact laws to prohibit druggists and others from selling other well-known poisons to people without the prescription of a physician, for fear they may possibly be used by the purchasers to harm either themselves or others ”

“ The nerves are unsettled; they are habituated to a morbid craving, and, at a later period, that craving is liable to return in a changed manifestation.”
“But a drug-store can’t sell opium or morphine except on prescription, can it?” asked Mr. Clyde.
“It can in a patent medicine,” replied the doctor. “That’s one of the ugly phases of the drug business. Yet it’s possible to find honest people who believe in these dopes and even give testimonials to them.” ”

“ Morphine, opium, and heroin appear in many cough-mixtures in habit-forming quantities and are offered for sale everywhere save in New York State, where recent legislation somewhat restricts the traffic. Indeed, in every [Pg 225] State except New York there are few druggists who do not make up and sell preparations of their own containing codeine, morphine, heroin, or some of the derivatives of opium.
No druggist has a right to prescribe any of these powerful drugs. The American public has fallen into the bad habit of trusting the druggist when it should go to the physician. ”

“ The numerous preparations used by druggists are mostly prepared in factories under competent and careful supervision, and the standards laid down in the British Pharmacopoeia are, broadly speaking, carefully adhered to. ”

“ As one historian has reminded us, "few fields of history have been more intensively cultivated by successive generations of historians; few offer less reward in the shape of fresh facts or theories" than does the American Revolutionary War. [1] This is true to some extent even in the medical history of the Revolution. The details of the feud within the medical department of the army have been told and retold. [2] Even accounts of the drugs employed and pharmaceutical services have been presented, primarily in the form of biographies and as reviews of the Lititz Pharmacopoeia of 1778. ”

“ Again, it is not only Physicians and Apothecary Men who deal out the poisonous drugs for disease, but the people use them repeatedly and continually while they enjoy comparative good health. Even the conscientious and Christian man and woman indulge in teas, coffees, catsups, peppers, tobaccos and the thousand and one, poisonous drugs, which have no business in the houses' of an enlightened and Christian community. ”

“ Q No, the President is committed to fighting the war on drugs. The President thinks it's very important to address the terrible problem this country has of drug abuse. There are 5 million hardcore drug abusers in America today. Ten percent of people who use drugs represent 80 percent of all drug use in America. And it's a hardcore addiction that the President wants to tackle. Of those 5 million, some 2 million are already in treatment. There are 3 million people who do not have treatment. And the President recognizes the problem of one of both supply and demand. ”

“ The price of the drugs and the tariff for dispensing prescriptions is fixed by government authority. In Russia a prescription containing any of the poisons indicated in the schedules A and B in the Russian pharmacopoeia may not be repeated, except by order of the doctor. The use of pharmacopoeia preparations made by manufacturers is allowed, but the seller is held responsible for their purity and strength. The prices charged for dispensing are lower in countries where the number of pharmacies is limited by law, the larger returns enabling the profit to be lessened. ”

“ 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. ”

“ With this attitude on the part of the men supposed to be serving the public and the medical profession by the practice of pharmacy, is it any wonder that it is difficult to induce the medical profession to prescribe official preparations or combinations of official drugs in place of ready-made commercial substitutes largely drawn from among the proprietaries or specialties? ”

“ The pharmacopœia exists for the purpose of requiring the apothecary to give in the first place pure brick-dust or pure witch-hazel when asked for; and in the second place uniform preparations of these remedies.
Every European country has its own pharmacopœia, prepared by governmental officials; or, in the case of England, by a board especially authorized by the government. One of the peculiarities of Anglo-Saxon civilization is the performance by volunteer bodies under sanction of law of functions which are really governmental. ”

“ Realizing this responsibility, the American Medical Association some years ago established its Council on Pharmacy and Chemistry. This Council is strictly an educational agency—it collects and disseminates knowledge about drugs, especially those drugs that are advertised to physicians and that are not described in the legal pharmacopeias. Physicians are thus put in a position to discriminate. Many have done so; others will, a few may never see the light on this earth. ”

“ Consider the quantity of proprietary medicines taken in this country, some of them harmless, some of them good in some cases, some of them injurious, but generally taken without advice and in absolute ignorance of the nature of the disease or the specific action of the remedy. The drug-shops are full of them, especially in country towns; and in the far West and on the Pacific coast I have been astonished at the quantity and variety displayed. They are found in almost every house ”