given for this interpretation was not that it was lawful but that the administration did not have sufficient funds to enforce the original interpretation.

The sponsors of H. R. 3298 originally sponsored a bill which Mr. Durham introduced by request in the Eightieth Congress and which repealed all reference to control over prescriptions of medical practitioners in the Food, Drug, and Cosmetic Act. Emphatic protest was registered to this legislation by the Food and Drug Administration, and its passage was not pressed.

The amendments introduced by Mr. Durham in the Eighty-first Congress and the current H. R. 3298 appear to have the blessing of the Food and Drug Administration.

We believe that the present act can and should be interpreted to meet the fundamental objection to the present official interpretation of the act, with respect to filling and refilling prescriptions.

In the meantime, as Mr. Ewing pointed out yesterday in his testimony, the American Pharmaceutical Association made a formal request for a hearing and a resulting ruling on the conditions under which physicians' prescriptions may and may not be refilled. We made this request in the hope that the Administrator would thus secure sufficient information and advice on the basis of which a ruling could be issued under the present act which would take care of the confusion that had arisen as a result of the Commissioner's speech.

I may say, Mr. Chairman, that our request for the public hearing on this subject, to which the medical profession, the pharmaceutical profession, the manufacturers, consumers, and all others interested might have been invited to air their views on this subject was opposed by the Food and Drug Administration and also by the National Association of Retail Druggists in a conference held in Mr. Ewing's office on October 5, 1950, and the hearing was later denied.

A tentative ruling was issued by the Administrator on December 5, 1950, with 30 days allowed for comment from those concerned but no final ruling has been issued. Mr. Ewing indicated last Tuesday that the anticipated ruling under the present act would probably cover the major points at issue satisfactorily, but apparently the Food and Drug Administration wants additional power in other directions: in return for a sane and common sense interpretation of the prescription refill provisions of the act.

Let me illustrate just what is at stake here. Assume that you or one of your constituents does a good deal of traveling by rail or plane. You have complained to your physician that you cannot sleep or that you are subject to motion sickness while traveling and he has prescribed an appropriate sedative or somnifacient drug for your special needs. You are to take the prescribed medicine only when you travel and according to the physician's directions on the label of the prescription, and you keep it in your travel bag. On the next trip you note at the last minute that you have only one tablet left in the vial, and so you call your pharmacist, tell him the number of the prescription and ask for its renewal. Even though he knows you personally and has filled the prescription for you at intervals with full knowledge of its purpose, the Food and Drug Administration says today that you cannot have the prescription refilled without going back to the physician and getting a new written prescription. But even if you go to the doctor and have him diagnose your case all over

again and he prescribes the same drug and telephones the prescription to your pharmacist, it is a criminal offense for the pharmacist to take that prescription over the telephone. Now does H. R. 3298 correct this situation? It does so only to the extent of permitting the physician to telephone the prescription. You would still have to locate him on the spur of the moment and get his authority for the renewal, unless the prescription calls for a drug which can be sold also without a prescription.

Let us take another example. You or one of your constituents. have an elderly member of the family who is under the care of a physician and requires a maintenance dose of a given heart tonic which is supplied to pharmacists with a label reading "to be dispensed only on the prescription of a physician." The physician calls on the patient occasionally or the patient keeps in touch with him by telephone or through an occasional office visit and the patient is told to continue with the medicine. The present law, according to the Food and Drug Administration, does not permit the prescription to be refilled and if the pharmacist should fail to obtain a new prescription each time the patient requires the medicine, he is liable to criminal prosecution. Does H. R. 3298 correct this situation? It does so only to the extent of permitting the physician to telephone the prescription in the first instance and to order its renewal by telephone. It does not permit the patient to obtain a renewal of the prescription without the physician's personal intervention, even though he has ordered the patient to continue with the medicine. Do you think your constituents want that kind of restriction placed upon themselves or upon their pharmacists? Do you think they want to put up with that kind of inconvenience? Would you personally want to be so inconvenienced?

What kind of people are we dealing with in this matter of prescription writing and dispensing? They are not uneducated, irresponsible and incompetent persons. On the contrary, the physicians and pharmacists of the United States are conscientious, highly respected, and well educated men and women who have been licensed by the several States to practice medicine or pharmacy and to meet in a highly skilled and professional manner the very problems which the Food and Drug Administration is endeavoring to solve, by imposing burdensome and totally unnecessary regulations.

The practice of the healing arts is regulated by the States under their police power and it is regulated well. It is not a function of interstate commerce. The voluntary cooperation of the medical and pharmaceutical professions has aided greatly in the splendid enforcement record of the Bureau of Narcotics and other agencies dealing with poisons and dangerous drugs.

Ours is a Nation which prides itself on its system of free enterprise. If you or I should discover or produce a drug which has valuable healing properties and we believe that, even though it is perfectly safe and harmless if used properly, its therapeutic action is such that it should be used only with proper medical advice, why should we be compelled to label it for self-medication? That is what the Food and Drug Administration is attempting to compel manufacturers to do in H. R. 3298.

Obviously, any drug offered for sale for self-medication should carry on its label adequate directions for use but when the drug is intended

for use only on the prescription of a medical practitioner, the prescription should carry the practitioner's directions to his patient. H. R. 3298 sets the Food and Drug Administration up as the judge of which drugs should be supplied only on prescription and which should be supplied freely to anyone. It takes from the producer and from the professions any authority to retain a drug in the category_of therapeutic agents to be supplied exclusively on prescriptions. We do not believe that the people want any Government agency to dictate to the professions what shall or shall not be "prescribed medicine." The present act gives the Administration unlimited power to compel manufacturers to label drugs properly without regulating the practice of medicine and pharmacy. The administration does not need the provisions of H. R. 3298 to protect the public health.

Over the years the practitioners of medicine and pharmacy have developed a procedure in the prescribing and dispensing of medicines which goes farther than any Federal or State law or regulations can go in the protection of the public.

Physicians from the time they began writing prescriptions in Latin have used the letters N. R. which stand for non repetatur (do not repeat) on their prescriptions whenever they did not want the prescription to be subject to renewal. Pharmacists from the time they began filling prescriptions have honored the directions of the physician and followed them literally. This relationship still prevails. Both professions have a code of ethics which, with few exceptions, is followed by the practitioners. Furthermore, relations between members of these professions are such as to assure complete understanding of how prescriptions are to be handled. The requirement to supplement a telephoned prescription with a written confirmation within 72 hours is completely unnecessary and would merely add an unenforceable requirement to the many regulations already in existence.

Consider the case of a pharmacist who fills 100 prescriptions per day. According to the surveys already referred to nearly 40 of these would be refills. Under the interpretation of the present act and the proposed H. R. 3298 this pharmacist might have to make as many as 40 contacts a day with prescribers to verify their authorization of refills. He would also have to develop a bookkeeping and follow-up system to assure the filing of confirmations of these prescriptions within 72 hours. This activity would probably require an additional employee and would certainly be reflected in prescription costs.

Considerable comment has been made and more will probably come from representatives of the FDA at these hearings to the effect that the refilling privilege with respect to barbiturates has been abused. The American Pharmaceutical Association has given serious study to this problem and sponsored a conference on it several years ago. We hold no brief for the promiscuous prescribing or dispensing of barbiturates but we feel that it is a problem to be handled at the State level. We joined the National Drug Trade Conference in sponsoring a uniform State barbiturate law which prohibits renewal of prescriptions for barbiturates and it has been enacted in a number of States. Our surveys show that today 45 States have separate laws to cope with this problem and in every case the renewal of prescriptions for these drugs is being banned.

It will never be possible to anticipate all possible contingencies in the enforcement of so complicated a matter as the ramifications of

interstate commerce in drugs. There is so much enforcement work of importance to be done in this field as regards production, standardizing, labeling, transporting and disposing of drugs at the manufacturing, wholesale and nonprofessional retail levels that the administration might be well advised to leave regulation of the professions and their dispensing of prescrptions to the professions themselves and to the properly constituted State authorities who are competent to deal with them. There is enough Federal law now to permit cracking down, if necessary, on deliberate flagrant violators who cannot be handled at State and local levels. To accomplish this it is unnecessary to annoy practitioners and patients alike by interfering with the established routine procedures of handling prescriptions and with the physician-pharmacist-patient relationship.

The CHAIRMAN. Are there any questions?

Mr. HESELTON. Mr. Fischelis, I rather quickly read through Mr. Schaefer's statement, and I confess that I am left a little confused about his position. He says on page 2 of his statement that the statement that you will present will point out the necessity for certain changes in H. R. 3298 if the legislation is to accomplish the objectives sought by practicing pharmacists and physicians in this important

matter.

He states further:

With respect to H. R. 3298, the American Pharmaceutical Association is therefore in the position of approving its objectives but disagreeing with the proposed method of accomplishing them because they place an unnecessary burden upon the professions and patients involved.

I have not understood from your statement that you have made any recommendations for changes. Rather I have the impression that you prefer to have this problem just left alone.

Mr. FISCHELIS. The part of H. R. 3298, which permits prescriptions to be telephoned, we favor.

Mr. HESELTON. I see.

Mr. FISCHELIS. We believe, however, that it doesn't go far enough. As cited in the illustrations in my prepared statement, there are cases which do not involve highly dangerous drugs where the actual telephoning of the prescription by the physician is unnecessary.

For example, if you are under the care of a physician and you see him and he tells you to have his previous prescription renewed, and if you go to the pharmacy and ask for a renewal of the prescription, and if the pharmacist asks you, "Are you still under the care of the physician," and you say, "Yes," that ought to be sufficient to indicate that it is an authorized renewal without having the pharmacist go to the trouble of calling the doctor up to find out if you are telling the truth or not or of having the doctor telephone the pharmacist to authorize the renewal which he has already authorized by telling the patient to have the prescription renewed.

That is the part of H. R. 3298 which we think doesn't go far enough. Now, as far as the matter of labeling of drugs is concerned, that is to set up an authority to divide them into two classes, we think that is unnecessary.

I think I can clarify some of the things that have been said on that subject by telling you that pharmacists are educated people.

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Mr. HESELTON. May I interrupt you there, please. I say this in all seriousness because I don't know. I think I know what a druggist is and what a pharmacist is, but what is the difference between them? Mr. FISCHELIS. Generally speaking, we shorten the term "registered pharmacist" to "pharmacist.' A registered pharmacist has taken the prescribed course in pharmacy which is now a course of four years leading to the degree of Bachelor of Science in Pharmacy. He has had a certain amount of practical experience required by law. He has shown the State board of pharmacy that he is a man of good moral character, that he has had the required experience and college training. Then he takes an examination and is licensed by the State to practice pharmacy.

Now, that license authorizes him to assume certain responsibilities. We have very little patience with the idea that pharmacists should not exercise these responsibilities for which they have been licensed by the State. That is what the State licenses them for-to protect the public in the dispensing of drugs and medicines. I think that the very large proportion, certainly 95 percent or more, exercise that function properly.

Mr. HESELTON. I have no doubt about that. But how does he differ from a druggist?

Mr. FISCHELIS. The term "druggist" means one who deals in drugs. We have wholesale druggists, retail druggists, and persons who are not registered pharmacists but who work under the supervision of a pharmacist. He may be a student of pharmacy or he may be a person who has never qualified fully as a pharmacist but works under the direction of a pharmacist. pharmacist. We think "pharmacist" is a term that should be applied only to those who are qualified by law to practice pharmacy.

Mr. HESELTON. When Mr. Waller testified for the National Association of Retail Druggists, I assumed that he was speaking for the pharmacists generally. Apparently I was under a misapprehension as to that.

Mr. FISCHELIS. I think what Mr. Waller said ought to be corrected. In one instance he was asked whether he spoke for all of the pharmacists of the United States. The National Association of Retail Druggists is an association of drug-store owners. The drug manufacturers associations we have three of them are associations of manufacturers. The American Pharmaceutical Association is the only association of a national character in which every pharmacist, regardless of where he practices, whether he owns a pharmacy or drug store or is an employed pharmacist or the manager of a drug store, or whether he functions in the laboratory of a manufacturer, or whether he is teaching, rgardless of what pharmaceutical function he fulfills, is eligible for membership. It is like the American Medical Association for the general practitioners of medicine or like the American Bar Association for the lawyers. That is the distinction between our professional association and the trade associations in the industry.

Mr. HESELTON. Just one point on that. I would still like to get this clear: Does not the National Association of Retail Druggists contain a great many pharmacists?

Mr. FISCHELIS. Oh, yes.

Mr. HESELTON. Then there is a difference of opinion between pharmacists as to the merits of this legislation?