Now, the question is: Will they follow it? I maintain, as you have said, that most of them are legitimate, and that they will follow it. Those that are illegitimate, those that are fly by night, you may never catch up with no matter what law you pass.

So I say to you that here is a way out of the whole thing without the need of having a lot of controversy, with the hope that they will place a halo around themselves so that we will not have to come to you in a few years from now.

Senator HUMPHREY. I am only directing these rather pointed questions to you-and I hope they are not caustic questions, because that is not the purpose-to clarify what kind of bargain is being made.

Now, of course, this does not control any members of this committee at all. We are very interested in whatever proposals you ad

vance.

You see, you have made a very persuasive case thus far. We have only heard the proponents of the bill. It is always persuasive up to that point where some of the evils that now exist and some of the inadequacies of the present law are explained.

Now, you point up very appropriately a matter which, I think, is common knowledge, namely, that the area of controversy in this bill is with reference to the authority to list prescription or legend drugs. That has been attacked as bureaucratic interference with the free practice of the manufacturers. It means ultimately, it is at least allegedl, Government supervision and control of the whole drug-manufacturing industry.

Now, that is the fight. That is the arena.

Now, we have also had a good deal of testimony that there are a number of safeguards provided in S. 1186 and in the original House bill that would prevent any capricious or discriminatory action. In fact, we have incorporated in this bill the Administrative Procedure Act procedures, plus review in the courts of appeal, to give a quick, judicial determination.

You feel that the House proposal will give you a standard at least by incorporating into proposed statutory law the definition of a prescription drug?

Mr. WALLER. That is right.

Senator HUMPHREY. We will talk about the refill business after a while. There does not seem to be very much controversy as between the opponents and the proponents and maybe the committee on that item.

Mr. WALLER. That is right.

Senator HUMPHREY. Now, what you propose is to remove the villain, so to speak, namely, the Administrator's problem to list prescription legend drugs.

Mr. WALLER. Senator, it not only gives us the standard that we must follow, but it also provides, in section 4, what the legend ought to be. If it is not the kind of drug that ought to have the legend, it is misbranded if it does not contain proper directions.

Senator HUMPHREY. And therefore the manufacturer is subject to the penalty of misbranding?

Mr. WALLER. That is correct, sir. Because of that, I say that we have accomplished a lot on behalf of the public and on behalf of those who serve the public in this respect.

If we can avoid a controversy which might possibly stymie the whole thing, we would like to offer this suggestion, after much deliberation. It is not just an overnight affair. We would like to offer it for your consideration.

Senator HUMPHREY. I think it is well that you have gone into this. Mr. WALLER. We have studied every word and every comma and everything else, and we think we ought to have it for the good of the public.

Senator HUMPHREY. In other words, it is your feeling if I may just state this in layman's language, that what was done at the House hearings and what you will undoubtedly do in these hearings is to have sort of an exposé of the sins of the profession and the inadequacies of existing law. After we have done that and have found out just where the blame lies or rests, we are to end up with a nice spiritual admonition to the culprits and say, "Now, we are going to put an admonition in the law, and we are also going to put certain standards into the law." Of course, we are not going to have any policemen to enforce those standards, so to speak, but we are going to rely now upon the good nature and the reconstructed individual, the man reborn, to live the good life.

Is that what you are saying?

Mr. WALLER. Not exactly that.

Senator HUMPHREY. Well, maybe not exactly.

Mr. WALLER. Not exactly. I say this to you: You have clarified the provisions of the present law so that you have avoided much confusion. Because of that, you have made it possible for people who are subject to it to comply with it. It need not be necessarily that you have to have policemen in the back of every door or at the front of every door. Now, if you don't follow, the Administrator will go after you on it.

Of course, we have brought up a condition and they will come to realize that condition, and I think they are going to remedy that condition. If they do not, Senator, we may have to come back to you again.

Senator HUMPHREY. I appreciate this constructive effort that has been made. I am just dubious as to its quality; that is all.

Now, you are in a very ticklish area when you get into this matter of Government regulation of prescription legend drugs. I recognize that. My own feeling is this I am not saying that this is my final considered judgment, but just for the purposes of discussion-maybe this listing provision ought to be held in abeyance until we have time to examine it thoroughly on its merits.

What I have often worried about is that when we take conciliatory steps, take what is justly termed a compromised arrangement, we often find out that we have only muddied up the waters more than they were before.

Now, I am not saying that your proposal does that. I have no reason to make that statement nor do I want to be so interpreted. I just want to be sure that if a proposal comes forth from the proponents of the bill for a conciliatory amendment that we do make progress. I recognize that you do not gain the millenium overnight. You do not even get the kind of solid advance that you would like to make in most areas.

But does this, in your mind, make a sizable advance in terms of clarifying the responsibilities of the druggist and does it make an advance in terms of encouraging uniformity of labeling, placing the responsibility on the manufacturers? Finally, does it vest in the Administrator the authority properly to enforce this for the protection of the public?

Mr. WALLER. In my opinion, it does that, Senator.

Senator HUMPREY. All right.

Mr. WALLER. At this time I want to introduce another statement. Senator HUMPHREY. May I interrupt to ask you this: The House bill left out of the definition of so-called dangerous-prescriptiondrugs the word "efficacious" which I think was in the definition proposed by the House committee.

Mr. WALLER. That is right, sir.

Senator HUMPHREY. I have had some talks with the Food and Drug people about that.

What is your opinion? Do you think such a test ought to be in the bill?

Mr. WALLER. We believe that it ought to be, but then, again, it would bring about a long controversy which I believe will not accomplish much. We would rather have it in, because it gives the Administrator greater area in which to control the miscellaneous labeling of products.

Senator HUMPHREY. Well, now, for example, I recall that at the prescription counter we used to have sugar and milk pills for the hypochondriac who figured that he ought to have a prescription every day. It was safe but it was not very efficacious.

Do you not think the word "efficacious" has something to do with proper labeling?

Mr. WALLER. It does have, Senator. We have that in the original bill, and we discussed the effect of it pro and con. Few drugs will be in that particular zone. Also the word "unsafe" means efficacious

to this extent that if it is unsafe it does no good and, therefore, if it does no good it is already unsafe.

Senator HUMPHREY. That is a reverse gear approach to it.
Mr. WALLER. That is right.

Senator HUMPHREY. That is very persuasive.

Mr. WALLER. That is a problem for the committee to consider. We have no recommendation to make for or against it.

Senator HUMPHREY. I want to say, Mr. Waller, that I appreciate your desire to remove all controversy from this bill.

It is very difficult to get any bill as to which there is a lack of controversy, particularly in these days.

Mr. WALLER. I believe that probably the Administrator's representative could tell you more about that word and how it affects them in their endorsement. The word "efficacious" will have to do with enforcement of the act. They could tell you more about it, except that, as I said a little while ago, if we can get a bill which would give the public as much as we think this gives them, I think we ought to have it.

Senator HUMPHREY. Now, you also propose striking out the following language

Mr. WALLER. Yes, sir.

Senator HUMPHREY. I want to get your thought on this. The language is as follows:

or any other statement which represents or implies that the dispensing of the drug without the prescription of a licensed practitioner is prohibited.

Mr. WALLER. I am of the opinion that that statement at the end of section 4 merely strengthens the previous language but, in effect, it need not be there because if it is a legend drug it will have to have this legend statement. If it is not, it has to have the directions for use. That is on page 3, I believe.

Senator HUMPHREY. Yes.

The reason I have brought that up is this: I have thought about this particular bottle that we have here, this bottle of quinidine sulfate. There is no prescription legend on this bottle, but there is likewise no dosage on the bottle. It says that it is to be used for the treatment of cardiac disorders or malaria, just mild cardiac disorders or malaria.

Under the treatment it says―

Important. If its use causes deafness, skin rash, gastrointestinal disturbances, a physician should be consulted immediately.

Mr. WALLER. That is right.

Senator HUMPHREY. While that is not a prescription legend, I do not think that a man would start to sell pills out of that bottle without thinking that he ought to have a prescription.

Mr. WALLER. That would be left up to the professional knowledge and ethics of the pharmacist. It has to be left up to him. It is not intended for this bill to take away the right of the pharmacist to use his knowledge.

Senator HUMPHREY. I would like to read the admonition that you have here. It states:

Paragraph 1 of this subsection shall not apply and a drug shall not be deemed to be misbranded

now this would be a drug to which paragraph 1 does not apply because it is not a drug containing a prescription legend

if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence or any other statement which represents or implies that the dispensing of the drug without the prescription of a licensed practitioner is prohibited.

Mr. WALLER. That is right, sir. What it says is no more than that if it is a legend drug it must have a legend, and if it is not a legend drug it must have adequate directions. That follows, Senator, as a matter of course.

Senator HUMPHREY. This does not have a legend and it does not have the directions.

Mr. WALLER. All right, sir. If it is a drug that must have a legend, it is misbranded.

Senator HUMPHREY. But if it is a drug that does not meet the legend standards, is it misbranded?

Mr. WALLER. No, sir; because adequate directions can be had on it. Senator HUMPHREY. I am talking now about this particular commodity as it is now. There are no directions upon it.

Mr. WALLER. Under the definition of this proviso, it would be misbranded. It is misbranded because it does not have a legend because it

should have a legend. If it does not have adequate directions, it is misbranded anyhow.

Senator HUMPHREY. I see.

Mr. WALLER. So it is misbranded, whichever way you look at it. Senator HUMPHREY. I want to question the Food and Drug people about this.

Mr. WALLER. That might be desirable, sir.

Senator HUMPHREY. I am not saying that the statement in question needs to be in the bill, but apparently it has real purpose.

Mr. WALLER. It has the purpose of accomplishing more certainty, but we believe that it may have a further complicating effect on the labeling with which I am not familiar.

Senator HUMPHREY. If, as proposed in your joint statement, we are going to take away the authority of the Administrator to list the drugs, we ought to get language in the bill that will give real power and protection.

Mr. WALLER. I am in agreement with that, sir.

Senator HUMPHREY. I am somewhat worried by the fact that under your proposal, in eliminating this listing function and power of the Administrator, you are also weakening the law by taking out a few other things. I do not think we should try to do that.

Mr. WALLER. That is for your consideration, sir.

Senator HUMPHREY. I would want to look into that pretty critically.

I think that will be all unless you have something further.
(Mr. Waller's detailed statement filed for the record follows:)

STATEMENT OF HERMAN S. WALLER, LEGAL COUNSEL FOR THE NATIONAL ASSOCIATION

OF RETAIL DRUGGISTS

Mr. Chairman and gentlemen of the Senate Committee on Labor and Public Welfare, my name is Herman S. Waller, of the law firm of Waller & Waller. I am a registered pharmacist and a member of the Illinois and Florida bars, with offices at 32 West Randolph Street, Chicago, Ill. I represent the National Association of Retail Druggists, the proponents of S. 1186, to which association I shall hereafter refer to as the NARD.

The NARD represents the Nation's retail drug-store owners exclusively, with an active membership of some 35,000 of the 50,000 independent retail drugstore owners, and by affiliation with State and city pharmaceutical associations, embraces a representation of almost every drug-store owner in the United States. In their behalf, I respectfully desire to direct your attention first to the difficulties and the problems the retail druggists encounter in serving the public with medicaments under the present provisions of the Federal Food, Drug, and Cosmetic Act, and the regulations thereunder; and secondly why and how S. 1186, introduced by Senator Hubert H. Humphrey of Minnesota, with a similar measure introduced by Representative Carl T. Durham of North Carolina, H. R. 3298, now commonly known as the Durham-Humphrey bill, seeks to amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act in an effort to obviate certain existing problems and thereby enable the country's retail druggists to serve the public with medicaments, more conveniently, more efficiently, and more economically.

Section 503 (b) of the act presently provides certain specific exemptions from the labeling requirements of section 502, when the sale of a drug or device is made upon the authority of a written prescription of a physician, dentist, or veterinarian and is in words and figures as follows:

"A drug dispensed on a written prescription signed by a physician, dentist, or veterinarian, ** * * shall if

"(1) Such physician, dentist, or veterinarian is licensed by law to administer such drug, and

"(2) Such drug bears a label containing the name and place of the dispenser, the serial number and date of such prescription, and the name of