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physician, dentist, or veterinarian, be exempt from the requirements of section 502 (b) and (e), and (in case such prescription is marked by the writer thereof as not refillable, or its refilling is prohibited by law) of section 502 (d).

Under this section of the act, the Food and Drug Commissioner, some 3 years ago, announced that under the law as it is now written, the exemption from the labeling requirements as it may apply to the sale of any type of drug upon a prescription, applies only to written prescriptions, and to such prescription refills which were specifically authorized in the original prescription, or unless the refill of such a prescription was again authorized in writing by the physician; so that an unauthorized refill of a prescription is in fact and in logic, a sale of the drug or drugs over the counter and constitutes a misbranding under the act, unless the druggist has fully complied with all of the labeling requirements of the act, as is provided in section 502, subsections A to L, both inclusive.

In everyday practice-in the drug store-here is what this provision of the act, and the Commissioner's announced policy thereunder means: When a doctor desires to prescribe, let's say, aspirin-sodium salicylate-sirup of white pine tar, or for that matter any other drug, no matter how simple or how potent, he must write a prescription for it, and the refill of such a prescription, unless it is also in writing, will constitute a violation of the present law subjecting the druggist to a possible penalty of a $1,000 fine or a year in jail, or both, unless he has fully complied with all the labeling requirements as outlined by section 502, subsections A to L.

To demonstrate to you further the practical implications of the present provisions of the law and the regulations thereunder, as far as they relate to the compounding of prescriptions-suppose a situation which is a frequent occurrence where a doctor is called to a house where the mother is alone with a sick child. The doctor's prescription for whatever type of drug, and no matter how urgent, must be in writing before the druggist may fill or refill it. In other words a druggist, under the present law, may not fill an oral prescription phoned in by the physician for immediate delivery-leaving the sick in need-to wait until the mother can get someone to go with the written prescription to the drug store.

Without enumerating more of analogous situations which experience has proven to result in a great hardship to the sick, plus added costs and inconvenience and probable prolonged affliction, suffice it to be said that no one to my knowledge has, or I believe will, object to that part of H. R. 3298 which provides that an oral prescription or a refill thereof may be had-and if the prescription calls for a drug which is restricted to sale upon prescription only as is provided in the bill, such sale must be authorized by a licensed practitioner, and if the prescription, or its refill, is given orally, the pharmacist must reduce it to writing and file it, as is provided by practically every State law. In other words, in this respect H. R. 3298 will permit a doctor to prescribe and the druggist to dispense any drug, except a narcotic, whether the prescription is in writing or is phoned in to the druggist by the doctor. If the drug is a restricted drug, a prescription therefor may be refilled only upon the physician's written or oral authority. If the authority is oral, the druggist must reduce the authority to writing, and preserve it as is provided by State law.

I repeat that so far no one has nor could conscientiously object to the practical need for so modifying the present provision of the act as would permit the medical and pharmaceutical professions to more effectively and more economically serve the sick.

The controversial part of H. R. 3298 seems to lie in that part thereof which provides for a listing of drugs under three categories therein named. A list of drugs when so chosen may not be dispensed promiscuously without the authorization of a licensed practitioner in the manner provided.

The three categories of drugs provided by the bill are to be:

(1) Those which are habit-forming and are already subject to regulations as listed in section 502 (d);

(2) Those drugs which have been found by the Administrator, after investigation and opportunity for public hearing, to be unsafe or ineffective for use without professional diagnosis or supervision of a practitioner licensed by law; and

(3) New drugs under section 505 of the act, in an effective application therefor, are limited in their use to the professional supervision of a practitioner licensed by law.

I believe that none of the opponents to the bill will or conscientiously can maintain that the drugs covered by categories (1) and (3), already listed and provided for in the present act, ought not, in the face of experience, be controlled and limited to sale, upon a physician's prescription in the manner provided by H. R. 3298.

While the opponents to the bill object to any type of a list of restricted drugs other than those which they themselves restrict promiscuously and inconsistently under the present prescription legend label regulation, their chief objection seems to be directed to the listing of drugs under category (2), namely, those drugs which the Administrator after investigation and a public hearing has declared to be unsafe and ineffective when used without medical supervision.

Gentlemen, you may now justifiably ask, why and who opposes the enactment of H. R. 3298. The opponents are the manufacturers of drugs, and for this reason. Under the present act by a regulation under section 502 (f) it is provided that a shipment or other delivery of a drug or device in interstate commerce by a manufacturer or distributor of such drug or device shall be exempt from the requirements of adequate labeling, such as directions for use or adequate warnings against use, if the label bears the so-called prescription legend, which in words and figures reads as follows:

Caution: To be dispensed only by or on the prescription of a physician, dentist, or veterinarian, or otherwise used only for manufacturing purposes.

In effect and in practice here is what this prescription legend regulation brought about. Manufacturers large and small, distributing any kind of a drug, no matter how simple or how potent, for any reason or no reason at all, promiscuously labeled their products with the prescription legend, thereby relieving themselves from the liability of proper and adequate labeling as is required by the act-passing on this liability and burden to the retail druggist. By this process of uncontrolled and promiscuous use of the prescription legend label, many simple drugs were thereby restricted to sale upon a physician's prescription only with the consequent result of increased costs of medical care, much confusion among the retail druggists because the

same product coming from different manufacturers may or may not carry the prescription legend restriction; no one has really known when or which drug is or is not a legally and scientifically restricted drug properly limited to the sale upon a physician's prescription only. This varied and confusing practice of labeling not only resulted in a growing unfair competition problem among the retail druggists but it also brought about an undeserving disrepute upon the pharmaceutical profession in that pharmacists were and could, under the law as now interpreted and the confusing labeling practices of the manufacturers, be branded criminals if they broke an inconsistent and unreasonable restrictive prescription legend label and sold such a drug, no matter how simple or how potent, without first complying in every respect with the labeling requirements of the act. Moreover, this uncontrolled, promiscuous and unjustifiable restrictive method of labeling confused, inconvenienced, and harassed the public as well as impeding the medical and pharmaceutical professions in serving them more effectively and more economically.

So that you may better visualize our problem, permit me to more practically illustrate to you our difficulties in this respect by directing your attention to but a few actual exhibits of promiscuous, unreasonable, and confusing labeling practices, which were made possible under the present prescription legend labeling regulation.

Mr. Chairman, I have some 23 exhibits. I shall not burden you with reading all of them, because 20 of them are described in my remarks. I shall, however, direct your attention to but a few. I direct your attention first to exhibit 1.

Exhibit 1, consisting of two labels of different manufacturers covers the labeling of a sulfur ointment compound. One of the two labels contains the prescription legend, thereby restricting the sale of the product upon a physician's prescription only. The other label, although the product contains a larger percentage of sulfur, does not have the prescription legend, thereby permitting its sale over the counter without a physician's prescription.

Exhibit 2, consisting of four labels of different manufacturers covers the labeling of paregoric. Two labels of the group give directions for use, with proper warnings against use and contain no prescription legend restriction, permitting the sale of this common household remedy, without a physician's prescription. However, one of the four labels in the group covering the same product, while it contains directions for use and proper warnings against use is further specifically restricted by the prescription legend to sale only by or on the prescription of a physician, while the fourth label in this group covering the same product restricts its sale to professional and manufacturing use only.

Exhibit 3, consisting of two labels of different manufacturers, covers the labeling of sodium solicylate, a common and frequently used drug for various types of pain. One of the labels has the prescription legend, while the other has not. A druggist stocking this product of one manufacturer, who labels it without the prescription legend, could sell it without a physician's prescription; while another druggist, or even the same druggist having the product of the manufacturer, which labeled it with the prescription legend could not sell it without a physician's prescription.

Exhibit 4, consisting of four labels of different manufacturers, covers the labeling of elixir of iron, quinine, and strychnine, N. F., and old and frequently used remedy as a general tonic. Three of the labels in the group contain directions for use and certain cautions against use, while the fourth label omits the directions and cautions, but restricts its sale, by the prescription legend, to, by, or on the prescription of a physician or veterinarian.

Exhibit 5, consisting of four labels of different manufacturers covers the labeling of elixir terpin hydrate with codeine, N. F., an exempt narcotic preparation commonly known and frequently used for the relief of a cough. Two labels of the group prescribe directions for use and warnings against use, thus permitting the sale of this product without a physician's prescription. One label in the series while it furnishes directions and warnings, nevertheless also restricts its sale. upon a physician's prescription only. The fourth label in the group limits the sale of this product "to professional and manufacturing use only."

Exhibits 6 and 7, consisting of four labels of different manufacturers, covers the labeling of elixir of three bromides, N. F., a compound frequently used as a sedative. Two labels in the group provide directions for use and warnings against use permitting the sale of this product without a prescription. The other two labels contain the prescription legend, thereby limiting the same product to sale upon a prescription only.

Exhibit 8, consisting of three labels of different manufacturers covers the labeling of tincture of belladonna, U. S. P., frequently used by sufferers of colitis. Two labels in the group, although providing directions and warnings, also contain the prescription-legend restriction, while the third label, with directions and warnings, limits the distribution of this product for professional and manufacturing use only.

Exhibit 9, consisting of two labels of different manufacturers covers the labeling of sulfadiazine tablets, both the same strength, a drug generally considered as dangerous when used promiscuously without the professional diagnosis or supervision of a practitioner licensed by law, yet one label properly restricts its sale by or upon the prescription of a physician, while the other label does not.

Exhibit 10, consisting of three labels of different manufacturers, covers the labeling of elixir phenobarbitol U. S. P., a compound generally regarded, and by section 502 (d) of the act specifically listed, as a habit-forming product. Two of the labels in the group provide the caution contained in the act, and properly further provide the legend restriction, while the third label restricts the sale of this product to professional and manufacturing use only.

Exhibit 11, consisting of two labels of different manufacturers, covers the labeling of lead and opium wash H. F., a preparation frequently used externally as an astringent. One label has directions for use and warnings against use; the other label likewise has some directions for use, but it limits its sale, by the prescription legend, to a physician's prescription.

Exhibit 12, consisting of three labels of different manufacturers, covers the labeling of a preparation commonly known as cocillana compound, frequently used for a cough. Two labels in the group give directions for use, but restrict the sale by the prescription legend. The

third label furnishes directions and warnings without the prescription legend.

Exhibit 13, consisting of two labels of different manufacturers, covers the labeling of different products; the formula of each contains a drug specifically listed in section 502 (d). Both labels contain directions for use, the required warnings, yet both labels also contain the prescription-legend restriction.

Exhibit 14, consisting of two labels of different manufacturers, covers the labeling of digitoxin tablets, both the same strength. One label contains the prescription-legend restriction, while the other gives directions and warnings, permitting it to be sold without a physician's prescription.

Exhibits 15, 16, and 17, consisting of three labels of different manufacturers covers the labeling of so-called male hormone tablets, the chief ingredient of which is methyl-testosterone. The labels of these products give directions for use and are said to be sold exclusively by mail; yet the sale of the same drug in drug stores is properly restricted by the prescription legend to sales upon a physician's prescription only. Exhibit 18, consists of a label which covers the labeling of calcium carbonate U. S. P. commonly known as chalk, yet it contains the prescription legend as well as the further restriction that it be used also only for manufacturing purposes.

Exhibit 19, consisting of seven labels of different manufacturers covers the labeling of various products showing particularly the indiscriminate and confusing use of the prescription-legend restriction. One label in the group limits the sale of soda-mint tablets, a commonly known antiacid consisting of baking soda and oil of peppermint, to the directions of a physician.

Exhibit 20, consisting of four labels of different manufacturers, covers the labeling of zinc oxide, charcoal, magnesium oxide, and elixir peptenzyme. Each of the labels has the prescription-legend restriction, which unnecessarily and without reason limits the sale of these simple and commonly known drugs upon the prescription of a physician only. The label which covers the product of elixir peptenzyme is of particular interest. The product is described to be a delightfully aromatized preparation, valuable for disguising the taste of unpleasant drugs, yet has the caution, "To be dispensed only by or on the prescription of a physician.

I want to direct your attention to exhibit 21, which is not described here, but of which I have a photostatic copy and will ask leave to introduce in the record for the committee's attention.

Exhibit 21 covers three labels. It covers the label of acid acetylsalicylic, U. S. P., which is commonly known as aspirin; another label reads alumen and potassium sulfate, which is ordinary alum powder; and another label calls for calomine powder. Each of these labels has the prescription legend.

In other words, if this were the only aspirin I had in the drugstore and you came in to refill a prescription I filled once before, I could not do it unless I had another prescription from a physician.

Yesterday I heard one of the members of this committee talk about strychnine. I went out and bought two packages. On one package, the label reads strychnine sulfate, one-sixtieth of a grain. The other reads the same, strychnine sulfate, one-sixtieth of a grain. One has the prescription legend-this one in particular. This one I have here

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