Mr. WARNACK. I think it should be left to the discretion of the physician if he chooses to exercise it. In the absence of exercising that discretion, this law would plug up the loopholes; or, if he forgot to do so, in the case of a dangerous drug, it would require the pharmacist to obtain authorization for refilling. Mr. WOLVERTON. In your long practice as a pharmacist, would you say whether or not there would be any considerable number of doctors who would require a refill prescription in order to require the patient to come back to them to get a new prescription? Mr. WARNACK. Do I think the doctor's motive in placing that on the prescription would be for the purpose of requiring the patient to come back? Mr. WOLVERTON. Yes. Mr. WARNACK. You are asking me a tough question there, to try to determine the motive of the doctor. Mr. WOLVERTON. All I am trying to do is to look at it from the standpoint of the patient. Mr. WARNACK. I would answer that, in my opinion, that would not be the motivating influence on the part of the doctor. Mr. WOLVERTON. The reason I ask is that somebody-I do not know who-mentioned to me that situation might exist, and I have no knowledge of it, of course. The doctors I do have knowledge of are reputable men. On the other hand, in every profession we recognize there are individuals who do not maintain the highest standards that are possible, and I am just wondering, from the standpoint of the patient in this case, whether this bill increases that situation or decreases it. Does it increase or decrease that possibility? Mr. WARNACK. You mean from the economic standpoint of the patient and the patient's position? Mr. WOLVERTON. Yes. Mr. WARNACK. I do not think so. I think, from the standpoint of the patient, the patient gets a better break under this bill than he does under the existing situation. Under the existing situation, we cannot take by phone or refill any prescription. Under the provisions of this bill, we can take a prescription by phone or refill it without authorization unless it contains a drug, for instance, that is classified as a dangerous one. I think for the safety of the public that is a very wise provision. Then we should call the doctor for authorization to refill, unless the doctor himself has indicated it might be refilled. Mr. WOLVERTON. In your experience, have you found a physician to any great extent prescribes medicines that could be just as easily purchased over the counter by a trade name? Mr. WARNACK. I think in many cases they do, because those products are good but are not generally known to the public because of the fact that they are not advertised to the public but only to the physician. I might add that from the standpoint of the economics of the situation it is a fairly general practice among stores in dispensing that type of preparation, especially if it is dispensed in the complete or original form, that the patient pays just about what he would pay for it if he came in and asked for it. That is a fairly general practice. Mr. WOLVERTON. I have in mind that a prescription written in terms of technical names and given to the patient would sell for a whole lot more than if he merely said to buy some particular kind of cough medicine. Mr. WARNACK. I repeat the statement that if the doctor orders a thing that might be purchased and sold to the patient in the original form, most stores have a practice of charging for that what it would be sold for if the patient asked for it, unless it is unpacked and broken and only part used. Then there is an additional charge. Mr. WOLVERTON. Suppose you took some common form of cough sirup that is well recognized and in most instances it has the different component parts stated on the label and the proportion of each and suppose the physician, instead of saying "Get a bottle of John Jones' cough sirup," would write out all of those different elements that go into that cough sirup and give the requested amount. Would that be sold to the patient for the same price you would sell him the cough sirup in the original bottle? Mr. WARNACK. I would say this, that it is very unusual that the doctor would write out the identical quantities of things that would appear in the preparation. I will give you an illustration. Take a common thing used every day as a cough sirup, elixir of terpin hydrate with codeine. I think uniformly doctors will not take time to write out the complete formula and give the patient the same specific amounts. They will write "elixir of terpin hydrate with codeine," and the patient comes into the store and gets it filled. If he comes into the store and asks for a 4-ounce bottle of elixir of terpin hydrate with codeine, which is an exempt narcotic and can be sold, I have him sign the exempt narcotic register and sell it to him for $1.25, and that is about what I would charge if he brought in a prescription for a 4ounce bottle. But I think he would get more out of it if the doctor gave it to him in a prescription, both psychologically and otherwise, than if he bought it himself. · Mr. WOLVERTON. Maybe this may seem facetious to you, but if you got a prescription that called for a particularly well known labeled cough sirup, would you, in filling that prescription, sell the bottle of cough sirup as it was packaged for sale over the counter, or would you put it into prescription form and sell it? Mr. WARNACK. If it called for the original container Mr. WOLVERTON. No; it would not call for the original container. You could sell the same thing in the original container, but I am assuming the physician wrote out a prescription which contained the component parts, which was identically the same and you knew it to be the same. Would you, in filling that prescription, give the patient one of your labeled bottles that you sell over the counter, or would you fix up his prescription either by doing it yourself or taking it out of a labeled bottle and sell it to him as a prescription rather than as the labeled article? Mr. WARNACK. I repeat what I said before. It would be almost impossible to have a case where the doctor would write out the formula for the identical preparation which you might have on your shelf, and you would be obligated, if the doctor wrote down the quantities, to see that you just put in the quantities as he said it. You cannot take a chance on doing a thing like that. Mr. WOLVERTON. I have had it brought to my attention that very simple remedies which you could have bought over the counter have been written out in language that the layman could not understand, and he would come out with a prescription that would be very much. higher in price than if he had gone in and asked for the remedy he was getting. That is the only reason for my questions. I have had that experience. Mr. WILLIAMS. Mr. Warnack, perhaps I might be a little biased in my consideration of this legislation, because I have a little personal or selfish interest in it, being the son of an old-time druggist. In regard to what the gentleman from Minnesota (Mr. O'Hara) asked you a few minutes ago about the 72-hour provision on taking prescriptions over the telephone from doctors, I think possibly you might clear that up for him if you would tell him that the fraudulency of a prescription given over the telephone would be immediately suspected by the druggist, would it not, because of the very make-up of the drugs which would be ordered? In other words, if a person was going to order a prescription fraudulently, he would include some narcotic, such as a barbiturate or something like that, normally in his request, would he not, whereas, if it was just for a harmless tonic there would be no reason why the druggist should not fill it? Mr. WARNACK. That is true. I do not think there is any reason why the druggist should not fill any request of the physician if he uses the proper care and consideration in accepting it and translating it in the proper terms. The druggist knows the doctor's language, and it would be very difficult for a person to attempt to speak fraudulently in that language without the druggist's being able to detect it if there is something fishy or something wrong about it. Mr. WILLIAMS. As for getting a confirmation in writing from the doctor, I think you will agree with me when I say that is virtually impossible nowadays. Mr. WARNACK. It is quite difficult to do. As I said before, I cannot see how it serves any useful or practical purpose. Mr. CARLISLE. Mr. Warnack, in your testimony a few minutes ago you referred to shifting the responsibility. Whom did you have in mind when you spoke of shifting the responsibility? Mr. WARNACK. I had in mind the manufacturer who hides behind the permissive privilege granted in the law to use the legend which can be placed on there, thereby passing on the responsibility, because when he places the legend on there, even though it is a harmless drug, he precludes the sale of it other than as indicated. Mr. CARLYLE. Do you mean shifting for the purpose of avoiding responsibility? Mr. WARNACK. Yes. Mr. CARLYLE. In case of injury? Mr. WARNACK. That is right. In case of injury, his responsibility ceases and is shifted to the pharmacist when he puts that legend on there. Mr. CARLYLE. Then, if a drug is not properly labeled, it would not be a complete shift of responsibility; would it? Mr. WARNACK. The drug is properly labeled; that is, it is labeled, but it is not properly labeled. It is labeled because he has chosen to hide behind the permissive rights granted in the regulation to use that legend. Mr. CARLYLE. Have you carefully studied this bill? Mr. WARNACK. I have carefully studied this bill. Mr. CARLYLE. Let us turn to page 2, line 14, where it refers to drugs being "unsafe or ineffective for use." Do you think the two words "or ineffective" add to this bill? Mr. WARNACK. I know the purpose of those words being put in there is to say whether a drug is safe or ineffective without professional supervision. But I would say that the Food and Drug Administration, which believes that is a necessary provision in this bill, will testify later, and in defense of that provision I would have you direct your questions later to them. The only statement I would make is that, so far as we are concerned, we are satisfied with that provision in the bill. Mr. CARLYLE. Do you think those words would be to some extent confusing in the interpretation of the bill? Mr. WARNACK. I do not think they would be. Mr. O'HARA. If the gentleman will yield at that point, in connection with that, Mr. Warnack, this last winter a friend of mine suffered a severe heart attack. He was put in the hospital, and some very strong medicine, which I know nothing about, was prescribed. Somewhere along the line the dosage or the time of dosage was mistakenly given and instead of once or twice a week it was given more often, and as a result the man suffered a very, very bad relapse from the medicine. Would you say that medicine was "unsafe" or "ineffective?" Mr. WARNACK. It would be unsafe and ineffective for use other than by the supervision of a doctor. If the doctor directed the space between doses, it would be safe, but if a layman directed it, certainly it would be unsafe and ineffective, because he would not have the proper knowledge. Mr. O'HARA. A medicine which might be safe if used in proper form and might be effective if used at the proper time might be very ineffective and very harmful to the patient otherwise. What does the word "ineffective" mean? Does it mean it does not do anything at all, or does too much? That is what we would like to know. Mr. WARNACK. My opinion would be that it could refer either to an inert or useless drug or one which required professional supervision. I again suggest to the gentleman that the Food and Drug Administration can better speak on that provision in the bill than I can, because it is their desire to have it in the bill. Mr. STANLEY. I would like to ask one question. On the first page of your statement, you say the law as it is now contains six provisions that are obstructive to the efforts of the druggists to provide the medicinals available for the treatment of diseases. I believe you stated just a moment ago that you are in accord with the bill as now written. You made that statement in response to a question from Mr. Rogers-that you are in accord with the bill as now written without amendment. Is that right? Mr. WARNACK. May I have permission just to modify that statement in one respect? That is in respect to the appeal provision in the bill to which objection was made yesterday. I would say so far as the professional pharmacist is concerned, that appeal provision is of no particular interest to us. We are willing to go along with the present act, under the General Administrative Procedures Act. We feel we have sufficient redress so far as the present act is concerned and, with the exception of that appeal provision, the rest of the act I am in complete accord with. Mr. STANLEY. You list six provisions here, Mr. Warnack, and the third one is that allow a manufacturer to confine a medicine he makes to a prescription though it be nothing more than charcoal or molasses. Is that objection removed in this bill and, if so, in what section and at what place? Mr. WARNACK. It is removed in the section that provides for the classification of drugs into two classes. Mr. STANLEY. Where would that be found in the bill? Mr. WARNACK. Sections 1, 2, and 3 on page 2. Mr. STANLEY. Habit-forming drugs? Mr. WARNACK. Habit-forming drugs is a habit-forming drug subject to the regulations prescribed under section 502 (d)— or has been found by the Administrator, after investigation and opportunity for public hearing, to be unsafe or ineffective for use without the professional diagnosis or supervision of a practitioner licensed by law. Mr. STANLEY. Thank you, sir. I have nothing else, Mr. Chairman. Mr. HELLER. Mr. Warnack, would you please exhibit again the precipitated chalk? Mr. WARNACK. The two packages of precipitated chalk? Mr. HELLER. Yes. The package in your right hand—is that the chalk? Mr. WARNACK. Yes. Mr. HELLER. And the package in the left hand is the antacid? Mr. WARNACK. It is the same thing. They both have the same label on them. Mr. HELLER. What is the one in your right hand marked? Mr. WARNACK. Calcium carbonate, precipitated. Mr. HELLER. What is the other package marked? Mr. WARNACK. Precipitated chalk with "calcium carbonate" in parentheses below. Mr. HELLER. They have the same contents? Mr. WARNACK. They have the exact same label and exact same contents. Mr. HELLER. And either one of them can be used as a tooth powder; is that correct? Mr. WARNACK. That is correct. Mr. HELLER. For which one of those is a prescription required? Mr. WARNACK. This bottle [exhibiting]. Mr. HELLER. And is this more expensive than the precipitated chalk so far as a refill is concerned? Mr. WARNACK. No. I think they are comparable in cost. I think the cost would be comparable if you took into consideration the size of the quantity. Mr. HELLER. But you think for one of those packages we would need a prescription to get it from the pharmacist; is that correct? Mr. WARNACK. That is correct. Mr. HELLER. For the one for which a prescription is necessary, would the charge to the consumer be greater; would that sell for a higher price to the consumer? |