Mr. LARRICK. The way we have handled that, frankly, Congressman, has been on a common-sense basis. If a steamship line has a freighter with a crew of 13 men, they will have 1 man on board who is generally the captain or the mate who is designated to be custodian of certain drugs which are only used in great emergency. They have arrangements made whereby, if a crew member gets quite sick, they are in radio communication with a boat that has a doctor on it.

We have just used common sense and have not considered that to be in violation of the law. We have had the same problems with respect to airplanes. Where they have provided the best type of medical supervision they can have under the circumstances in which they find themselves, we have just thought we would use common sense and regard that as complying with the law.

Mr. HESELTON. But you don't have the same feeling about developments now that make it desirable to encourage prompt treatment with as little red tape or delay as possible?

Mr. LARRICK. On board ship you mean, sir?

Mr. HESELTON. No. I refer to conditions on land.

Mr. LARRICK. We think we ought to have as prompt treatment and with as little delay as possible, and we think this bill provides that.

Mr. HESELTON. You don't see in that requirement for written confirmation some complications?

Mr. LARRICK. That comes later. I am an enforcement officer. My interest and my drive is to try to do a good job of enforcement. Now, if a coroner at Cincinnati, Ohio, tells us that a man died some time ago of barbiturate poisoning, we run that down, and we may wind up with the purchase of the barbiturate in a certain drug store. We find that the pharmacist had recorded a prescription under this bill. Then we go back to the doctor and say, "Did or did you not authorize this pharmacist on March 1, nineteen so-and-so, to fill that prescription?"

Well, if the doctor says, "I don't know, I don't remember, I didn't make any record of it," that would be a problem for us.

Now, we are a little prejudiced on that side of the thing. I would rather the committee would weigh it, and if they think that the bother and the trouble to the doctor and to the pharmacist and to the patient would outweigh the advantage to us in helping our enforcement, we will be quite content to go along with your decision on it.

Mr. HESELTON. Of course, we have taken testimony from druggists on that point.

Mr. LARRICK. That is right. I was here at the time.

Mr. HESELTON. As I understand from Mr. Stanley's questions and those of the chairman, we are not likely to receive any direct comment or recommendation by the medical societies. Do you have any idea, in connection with your work, whether the medical profession is at all concerned one way or another with the requirement of confirmation? Mr. LARRICK. I think they would prefer not to confirm the telephone prescriptions. They would prefer to be relieved of all of the paper work possible.

Mr. HESELTON. Even though, as you have just suggested, it might be useful in terms of refreshing their recollection should the occasion arise as to the kind of prescription they actually made?

Mr. LARRICK. What they would do as an organized body, I just don't know on that point; but I have talked to enough individual doctors to know that some of them would enthusiastically be willing to do it. As a matter of fact, you will recall this letter that I read, which was sent out by a chain drug store which provided that when an oral prescription arrived at the drug store, the pharmacist was to fill it out in triplicate, with two carbon copies. He was to put one carbon copy in a stamped envelope and mail it to the doctor asking him to sign it. Well now, they sent that letter to 500 and some doctors in an area around Akron, Canton, Youngstown, and so forth, in Ohio. They got back 81 replies, which is a pretty good return, and none of them objected to it. Now, I don't know whether that is enough of a survey to give you the picture or not.

Mr. HESELTON. One other point occurred to me during the hearings. There was testimony about some kind of a drug that was sold in bulk as against the same drug sold in small packages. I don't know whether we are going to have any evidence on this, but I would like to be enlightened as to whether all of the pharmaceutical manufacturers use this method of large, bulk sale as a means of disposing of their goods, or whether only a portion of them do so.

Mr. LARRICK. Only a portion.

Mr. HESELTON. That raises the question in my mind as to whether there is any economic competitive advantage in doing that so far as the manufacturers are concerned beyond the possibility that it might relieve them of some liability.

Mr. LARRICK. That may well be. We have a view on that that perhaps might be worth expressing. There are many firms in this country who are largely drug chemical manufacturers. Their business is predominantly to make drugs in bulk which they sell in large quantities to the other manufacturers who carry them further along toward the finished goods.

That is where their main business lies. One big chemical house will sell to 50 or to 100 pharmaceutical manufacturers who remanufacture the products.

Now, as a minor incident to their business, they also supply small bulk packages which are predominantly used in retail drugstores as ingredients in prescriptions. We provide in our regulation that, for example, if I am a drug manufacturer, and I am shipping from my plant to another manufacturing plant, I don't have to put on all of this labeling. That would be wasteful. They can just state "For manufacturing purposes only."

If a drug is, in fact, exclusively used in a retail drugstore to manufacture prescriptions, there is no point in putting it on there because it will all be used in prescriptions.

The other day a witness testified that pound packages of chalk were used pretty largely to fill prescriptions. We know Mr. Warnick very well, and talked to him after the hearing. He told us that in his locality people buy that product by the pound, and they use it to brush their teeth and to correct sour stomach.

Well, that package ought to have the full directions for use on it. I don't think that it is as important for us to put our enforcement money into that as it is to go after these very dangerous situations. But, nevertheless, that drug, if it is sold in pound packages ought to

have directions for its use on it; and the seller shouldn't have to make them up himself in his retail drugstore.

Mr. HESELTON. Does it actually have the effect of relieving the manufacturer of liability?

Mr. LARRICK. Well, I wouldn't think that in the case of chalk there is much liability; but it would certainly put the responsibility on the pharmacist of being liable to us if the claims are wrong. Certainly it would transfer the liability there.

The retail pharmacist is not as well equipped to know precisely what labeling should go on all of the drugs in his store as is the large manufacturer with a competent staff dealing with the relatively fewer items they make.

Mr. HESELTON. I don't know whether anybody asked this question, but have you considered the bill in the light of the additional duties and additional expenses involved?

Mr. LARRICK. Yes; we have considered that. We now get 31⁄2 cents per person per year to enforce the law, and we will work it out with the Appropriations Committee to get as much money as they are willing to give us. The better the law, the better job we can do with whatever amount of money they give us.

Mr. HESELTON. I might warn you that you will probably have to deal with more than the Appropriations Committee.

Mr. DOLLIVER. There is one thing I want to clear up in my mind, a matter that is contained in your statement. I was called out, and perhaps this subject has been already covered. You mentioned the fact that there are some beauty parlors using X-ray machines. Mr. LARRICK. That is right.

Mr. DOLLIVER. Do you have authority to control that now?

Mr. LARRICK. Yes, sir. You gave us that authority in 1938 when you defined therapeutic devices. The same requirements generally with respect to use and safety apply to therapeutic devices as to drugs.

We didn't have that until this committee put that into the bill in 1938.

Mr. HELLER. I don't know whether Congressman Wolverton asked this question. I had to leave to use the telephone. Do you think the medical profession should be invited to testify on this bill?

Mr. LARRICK. I certainly do, but we don't want to see the bill delayed any longer than necessary.

Mr. WOLVERTON. So that there will be no question about it, I would suggest that the chairman communicate with them and indicate the desire of the committee so that they will either say "Yes" or "No" and give their reasons.

I have one further question, one that has bothered me considerably because I can see two sides to it. That is the right to telephone prescriptions. I have heard the arguments in favor of it such that it is necessary in rural areas where distances enter into it and where emergencies arise which make it necessary that they call quickly.

On the other side, there has been the feeling within myself as to whether we can pin down the responsibility in a case where it works out disastrously as to just what the prescription was, whether it was actually given or not.

Now, suppose a prescription comes over the telephone and that subsequently, within 24 hours or 48 hours or 72 hours, whatever the

committee decides on, that doctor says, "No, I didn't send such a prescription to you," or "I didn't give it to you just that way."

How could you fix the responsibility in a case of disaster? Do you have any such cases that come to your attention?

Mr. LARRICK. We have had some.

Mr. WOLVERTON. The case I mentioned the other day as an illus-tration was a written prescription, but the writing was not distinct. As I have noticed doctors' prescriptions, I have a great deal of respect for the druggists' ability to read them sometimes. In this case the ending of a word made all the difference between life and deathand it this case it meant death. I am just wondering about this: In that case, if the prescription had been given over the telephone and death had resulted, certainly the doctor wouldn't come in and say that he had prescribed it because it evidently would have been a mistake on somebody's part.

Whether it would have been the mistake of the doctor in not wording it, in not telling it correctly, or whether it would have been the mistake of the individual druggist in not reading it correctly would remain to be seen. It would be either one case or the other, at any rate.

Now, how would we hold down to some degree the responsibility of the doctor in the prescription that he gives if it is given to the druggist over the telephone?

Mr. LARRICK. Of course, the committee has the power, I presume, to require the doctor to keep a copy of the prescription in his own office. Whether that would be a practical thing to do or not and whether it would defeat the bill or not, I don't know.

Our own personal judgment is this: We have given a great deal of thought to this matter. In dealing with the harm that does flow from prescriptions, we find that rarely has a paramacist had a misunderstanding with the doctor about what the prescription is. They teach them in the pharmacy schools, and when the pharmacist takes this prescription over the telephone, he writes it down. Then when the doctor has finished, the pharmacist reads it back to him, as a witness testified the other day.

Now, the great bulk of the pharmacists are honest and conscientious, and they are going to do it without danger. There is going to be an occasional accident; but, in our opinion, the greater good is to let them have telephone prescriptions for ordinary drugs so that, for example, when a child is sick in the middle of the night and the doctor has seen the child in the daytime and knows something about what the condition is, and the mother calls up, the doctor can call the drug store in the vicinity and have the medicine there in very brief time.

There are just hundreds of similar illustrations where the public good is in that direction.

Our reservations, the reservations of the Food and Drug Administration, go more particularly to the type of drug that people have a craving for, the sleeping pills, and things like that. We are afraid of oral prescriptions unconfirmed. We would like to see written prescriptions for those drugs. But perhaps that would put too much of a burden on the ordinary patient.

We are willing to go along with the oral prescription knowing that the House Ways and Means Committee is very seriously considering the barbiturate problem, hoping that they will be able to either make special provisions for the barbiturates or will decide that they cannot

do it or do not want to do it under the tax construction and send it back here for consideration.

With that one reservation, we think the public good will be best served by allowing telephone prescriptions. I can assure you that, if we find that our judgment is wrong and that public harm from it outweighs the good, we will be back up here trying to get further changes.

Mr. WOLVERTON. I fully appreciate the necessity that exists for some practice of that kind to be pursued; but, on the other hand, I would like to see some kind of provisions adopted which would give greater assurance after it has been done that they have both understood each other. I do not know just what kind of provision you could write into the bill in that respect. I do not think the provision permitting them to send in confirmations within 72 hours would meet the situation because in the case that I had in mind death had resulted by that time, and it was not a case of confirmation.

We could decide for ourselves just what the evidence might be on either side.

Mr. LARRICK. That is right. Your judgement is just as good as

ours.

Mr. BECKWORTH. Mr. Chairman.

The CHAIRMAN. Mr. Beckworth.

Mr. BECKWORTH. Suppose a manufacturer was making a given product, such as sulfur ointment compound.

Mr. LARRICK. I did not get that.

Mr. BECKWORTH. I said, suppose a manufacturer was making a given product such as sulfur ointment compound, which was the subject of one of the exhibits yesterday, and that the manufacturer labeled one part of that, going to a certain area of the country, as being subject to prescription use only and then sent another amount to another section and didn't put such a requirement on it

Mr. LARRICK. One of those would be illegal.

Mr. BECKWORTH. Have you found much of that occurring?

Mr. LARRICK. No; I don't think that very often happens for the simple reason, as I say, that usually a firm's business drive is toward the proprietary field or the drive is toward the doctor's field.

Mr. BECKWORTH. But if that did occur, one of them definitely would be in violation of the law?

Mr. LARRICK. Yes. Our problem is that we just don't have facilities to make so many cases all at one time.

Mr. BECKWORTH. To what extent do you feel that the law now defines what drugs must be labeled for prescription sale only and those which do not have to be? I have not been clear on that.

Mr. LARRICK. The regulations refer to that, Mr. Beckworth, only in general terms. It says that a drug is entitled to bear the prescription legend if it cannot safely and efficaciously be used by a layman without medical supervision. It defines it in general terms. That leaves it in a situation where one firm may reach one conclusion and another firm may reach another conclusion.

Mr. Dunn this morning seemed to find a difference in the wording that we had used in our regulation as contrasted with the wording that is in this bill. In our thinking, the two sets of words mean exactly the same thing. If anyone thinks differently and can choose words