suggestion with respect to quinidine because of the similarity of its action.

I might go on at great length in calling to your attention the use and misuse of the prescription legend on drugs and the conditions arising therefrom in the every day practice in the drug store. Because I have been a student of the drug laws, both in my own State and the Federal laws, I may have a more acute awareness of what is and what is not lawful to sell than the average practicing pharmacist. I know, however, in talking to scores of them in my own State and druggists from other States, that their problems are no different than mine. They find the conditions existing intolerable and will certainly welcome any change that will clarify their position as pharmacists in performing the services required of them.

Some of these products are simple drugs with which the general public is quite familiar. Most of them have been used for decades with safety and without the need for professional supervision in their use. Some of them are official drugs and would qualify for over-thecounter sale if designated by name only and such sales would not cause them to be misbranded (Regulation 1.106 (c) (2) (g)). Yet the manufacturer chooses to arbitrarily limit their sale to manufacturing or prescription use by placing the legend on them. He can do it for no other purpose than to absolve himself from any responsibility with respect to the drugs.

Obviously if the situation did not present a serious and provoking trade problem it would be funny. Many manufacturers of advertised proprietary products ship us their preparations, the labels of which comply with all provisions of the Food, Drug and Cosmetic Act. Yet the same drugs alone or in combinations come to us from other manufacturers carrying the prescription legend.

A pharmacist might order a certain drug from his wholesaler without specifying the maker and receive the drug with the prescription legend on the label. A call from a customer for the drug would have to be met with a refusal to sell and yet the customer might walk into a store across the street and obtain the identical item with labeling that would permit its sale.

As a practicing pharmacist I have for years had a serious problem to face; trying to serve the public and at the same time comply with a law and regulations which permit the unfair and unworkable conditions outlined in this statement.

Having an intimate and working knowledge of the situation I do not believe there is any solution to the problem except through amendment to section 503 (b) of the Food, Drug, and Cosmetic Act as offered in H. R. 3298.

H. R. 3298 will make it possible for the druggists to provide the pharmaceutical service which is vital in the treatment of disease. I am confident that after you have studied the arguments in support of the bill you will issue a favorable report on the proposed amendment of section 503 (b) of the Food, Drug, and Cosmetic Act.

I thank you, gentlemen, for the attention you have given me and the interest you have displayed toward what I had to say in support of H. R. 3298.

Mr. O'HARA. Mr. Warnack, with respect to the complaint which you make as to the labeling of so-called similar drugs, such as a salt

solution or the salt in the container you referred to, does not the Food and Drug Administration have the right to compel the proper and somewhat uniform labeling of drugs under the present law?

Mr. WARNACK. I would say that right is conferred expressly on the Food and Drug Administration, but it is practically left to the manufacturer to place his own label on there if it does not, per se, violate the provisions of the act. In other words, if he wishes to hide behind the provision of using a legend, he can do so without interference from the Department.

Mr. O'HARA. Of course, under the present law, improper labeling or failure to label a drug would be subject to prosecution by the Food and Drug Administration; would it not?

Mr. WARNACK. That is correct. But it is not improper labeling if he hides behind the legend and chooses to use it. They will not force him to amend his labeling to supply a label that would indicate the usage of the product.

Mr. O'HARA. Do I gather from your statement that what precipitated this legislation was a speech by Dr. Dunbar made at Atlantic City a couple of years ago on the matter of refill?

Mr. WARNACK. That was primarily it. The original purpose was to amend the right to fill and refill prescriptions or to state the conditions under which they might be filled or refilled.

Mr. O'HARA. As a matter of practice, in your long years of practice, if a physician in your neighborhood writes out a prescription of some rather dangerous drug-I am speaking not only of barbiturates but of other forms of drugs which might be harmful to the patient-is it not a matter of practice that the physician usually puts on there "Not for refill"?

Mr. WARNACK. That is a manner in which the problem could be largely solved, but I am sorry to say doctors are very remiss in connection with instructions on prescriptions. A few. of them do. But also today, in practice, it is a custom for pharmacists to ask for authorization of refills if the drug is in the dangerous classification. In fact, many State laws preclude refilling without authorization, including my own State.

Mr. O'HARA. Does that apply to all forms of prescriptions, whether they are dangerous or not?

Mr. WARNACK. No; only to those which would be dangerous.
Mr. O'HARA. Only to those which might be of danger?

Mr. WARNACK. That is right. It has been customary to refill prescriptions, without authorization, of simple drugs; it has also been the custom, ever since we have had telephones, to accept any prescription by phone.

Mr. O'HARA. With reference to the suggestion that has been made. that the doctor, within 72 hours, confirm the telephone prescription, what are your comments on that? Is that too long a time, or what is your thought on that?

Mr. WARNACK. My comment on that is that it is too long a time; that any requirement for a written confirmation is unnecessary and serves no useful purpose. As a matter of fact, if the prescription is bona fide, and there is every reason to belive it would be, confirmation would serve no useful purpose. If there was fraud, 24 hours, 48 hours, or 72 hours would be too late to do any good, and, if there was any possibility of fraud, you could not get confirmation.

As to care in taking prescriptions over the phone, druggists are trained to be careful. I do not think you would find very much incidence of fraud there, and it is impossible to legislate to prevent fraud. And in respect to narcotics, no prescription for narcotics can be filled until a written prescription is received. Yet, there is fraud there by forgery. You might have that on occasion, but I can see no useful purpose that would be served in requiring confirmation. It is of no value whatsoever.

This is not a new problem; permitting this thing under Federal statute would be no new problem. It has been done for 50 years, and we would have a vast experience behind it to show it is a safe and sound enough practice.

Mr. O'HARA. As a matter of practice, Mr. Warnack, you would not take a telephone prescription from some doctor whose voice you did not recognize over the telephone; is not that a matter of practice?

Mr. WARNACK. That is a matter of practice. The most prescriptions you get are from physicians you know or for patients you know And there are so many things that bring about a factual situation, where you realize the thing is going to be an authentic prescription, that you do not have too much trouble in that respect. And as far as carefulness in transcribing it is concerned, you take the prescription and write it down and double check in that respect.

Mr. O'HARA. If there is going to be any time limit, I would think it should be a 24-hour limit rather than a 72-hour limit; would not you?

Mr. WARNACK. Yes. But that would be almost a physical impossibility, because you would either have to go 2 or 3 or 5 miles to get the prescription or ask the doctor to send it to you, and they are rather loath to do that. I cannot see any practical value whatsoever for a confirmation factor in the thing.

Mr. PRIEST. Referring again to Dr. Dunbar's speech, do you feel the Food and Drug Administration actually goes beyond the provisions of the present law with reference to prescriptions, particularly with reference to refilling?

Mr. WARNACK. I would answer that by saying "No," both from a careful study of the provisions of the present act and the advice of our counsel. He has gone over the thing quite thoroughly, and he is in agreement that the Food Administrator has no other choice than to issue such a proclamation or pronouncement.

Mr. BECKWORTH. Mr. Warnack, I was interested in your comment in regard to calcium carbonate, of which you have some packages there. To what do you attribute the great difference in handling by the two manufacturers of that identical drug?

Mr. WARNACK. The reason behind it?

Mr. BECKWORTH. Yes.

Mr. WARNACK. I think I stated that or attempted to state that as plainly as I could. It seems to me it is just a desire to assume no responsibility themselves and give it to the pharmacist who should not have to bear the responsibility of the manufacturer of the product. I could take this product with the legend on it, because I know it is perfectly safe to sell and lawfully safe to sell, and I could tear this label off and put my own label on there "Warnack Pharmacy" and sell it, but I am assuming the responsibility. And we do have a record, both from your recollection and mine, where some manu

facturers have put wrong things in packages and have caused death and lawsuits. If I did that and the manufacturer made a mistake, I am the guy who gets the blame and not the man who manufactures it. So why should not the manufacturer assume responsibility if I should sell his package?

Mr. BECKWORTH. Why would the manufacturer who made that particular product put what he did on that package?

Mr. WARNACK. I do not know that I can describe or explain the motive of the manufacturer except to say it is one of avoiding liability. Mr. BECKWORTH. Why would the manufacturer put what was on the other package there? Is there any gain, or does it place one manufacturer in a more favorable position than the other?

Mr. WARNACK. I think his motive in labeling it properly and in a manner to make it salable is that he wants the druggist to sell it.

Mr. BECKWORTH. It is not clear to me exactly why one manufacturer would handle one product one way and another in an entirely different way, as you pointed out. There must be some gain or harm from the two types of handling.

Mr. WARNACK. I have explained my position in the best way I can by saying I think the manufacturer is trying to avoid responsibility. If he has another story to tell, when he becomes a witness perhaps you can get that information from him.

Mr. BECKWORTH. Does what you describe here happen in many, many instances?

Mr. WARNACK. There are hundreds of cases. I have a whole table full of things here, and I understand the other witnesses have a trunk full of things. We have not attempted in any sense to bring all we could here, because the train would not be big enough to enable us to bring them all.

Mr. BECKWORTH. Is there any financial gain in handling it in one way that is far more lucrative than handling it the other way?

Mr. WARNACK. The economics that result from that situation I would hesitate to answer.

Mr. BECKWORTH. You do not think the economic problem has much to do with it?

Mr. WARNACK. It may; yes. Undoubtedly it does. But I still am unable to understand why one manufacturer would put a legend on his product when he could place a lawful label on it and make it possible to sell it.

Mr. BECKWORTH. You do think, though, economics have a lot to do with it?

Mr. WARNACK. It definitely would.

Mr. ROGERS. How long do you think the life of a prescription should be before it should be prohibited from being refilled? I believe you take the position that every prescription should be refilled without authorization. How long would you say the life of the prescription ought to last before it could not be refilled?

Mr. WARNACK. My opinion is, so far as a drug that would be safe for lay use and one that might be sold without a prescription is concerned, that I would not put any limitation on the life of the prescription; for a simple cough remedy or an external salve or something of that kind, I should say no limitation should be placed on that. But with respect to a drug that might be harmful and which is classified as a dangerous drug, the limitation on that under this act would

not extend beyond the original filling, and any further supply of that medication would require authorization.

Mr. ROGERS. Might not conditions change so that within a year's time or 2 years' time a prescription which would be good at one time. would not be good at another time?

Mr. WARNACK. That would be true in the case of any remedy, even a very simple thing. Again I go back to a simple thing like a cough remedy containing white pine compound or some simple thing. That would be as efficacious and safe to take at any time as it would be at the time of its original prescribing.

Mr. WOLVERTON. Mr. Warnack, do you favor the bill as is, without any amendment?

Mr. WARNACK. I do. I think the bill represents a lot of thought and study, after a matter of about 3 years' work to iron out and change, and I favor the bill in its present form.

Mr. WOLVERTON. With reference to the matter about which Mr. Beckworth was examining you, as to why some manufacturers put a certain legend on a package and others do not, in those instances where the legend is put on "for manufacturing purposes only" or "by prescription only," where the character of the drug is such that, in your opinion, it is not necessary to have it on that package and it is probably put on there merely to avoid responsibility by the manufacturer, does that same manufacturer carry through that idea or principle pretty generally with respect to all of his products, and the other one does not do so?

You see, what I am trying to get at is whether it is a practice of some, not only on the articles you have brought here with you but, as you stated, on many other articles, to follow through on that, or do they draw a distinction as to where they shall put that restrictive legend?

Mr. WARNACK. I will answer that by saying they do not follow through. Take this particular product I referred to, precipitated chalk, and the calcium lactate product I referred to: this particular manufacturer does not follow through. He has many products which carry the legend which would be safe for sale; on the other hand, he manufactures and distributes many products which, in my opinion, would be far more dangerous than this on which he does place directions for use. So he does not have a uniform or standard policy of carrying through with the legend or without the legend.

Mr. WOLVERTON. That is what I was trying to determine whether there was a uniform standard label that some manufacturers adopt and others do not. You say that does not seem to you to be the case? Mr. WARNACK. That is not the case.

Mr. WOLVERTON. Do you think there should be any recommendation or restriction on the prescription by the physician that it should not be refilled?

Mr. WARNACK. We would like very much to have the physicians exercise that right, lawful right, which they have to do that, by stating the prescription may not be repeated by placing a nonrep on there, or, if they desire the patient to have a refill, to place on there the number of times it can be refilled.

Mr. WOLVERTON. Do you think that should be left to the discretion of the physician?