If the drug has a caution legend on it, the druggist knows he may not lawfully sell it without a prescription. So far, 112 druggists have been convicted because they willfully violated the law and sold prescription drugs across the counter.

Now, that really is a tribute to the druggists rather than a condemnation of them; when you consider there are 50,000 druggists in the country, and only 112 of them have been violating the law or been convicted of it, that is a pretty small number. You are not going to have perfect compliance with the law at any time, and of that we are all very much aware.

Far from being confusing, the situation is crystal clear. What is confused is not what drugs can be sold without prescription, but what prescription can be refilled without first getting the physician's approval. The examples shown this committee do not bear upon this problem at all. If H. R. 3298 is adopted, with the revisions we propose, it will clarify the doubt as to refillability of prescriptions.

Some witnesses, in particular Mr. Warnack and Mr. Waller, stated flatly that caution-legend items are on some relatively harmless drugs because the manufacturer is trying to escape his responsibility by making such statements. They are talking about the law and the regulations as they were prior to the change in the regulations in 1946. From 1939 to 1946, the regulations of the Food, Drug, and Cosmetic Act allowed a manufacturer to choose, without any rules other than his own choice, whether he wished to sell his drugs across the counter or whether he wished to put a prescription legend on them and confine them to a physician's use. In 1946 the regulations were changed. From that time to date there are only two classes of drugs. Under the law, if adequate regulations can be written for a drug for lay use, the law says that they must be written, and it it misbranded if you don't write them. If, on the other hand, its toxic potentialities are such that it can only safely and efficaciously be administered under a physician's supervision, then it must bear the caution legend and it must be sold only on prescription; and under the standard we propose here, that type of prescription would require the physician's authorization before it could be refilled.

The exhibits that were brought in had a number of drugs that are slightly confusing unless you understand how the chemical manufacturer operates. These are preparations, two of them put out by Merck & Co. and two put out by Mallinckrodt. Both are large chemical manufacturers. They make raw materials. They sell them mostly to manufacturers of pharmaceuticals and to druggists; and in the case of the sales to the druggist they are for the purpose of use in compounding prescriptions. It is much like going out and buying the material for a suit. You buy the goods, but you don't expect to have the buttons sewn onto it and the buttonholes worked into it. If you want a suit, you buy a suit, but if you buy the materials you buy the materials.

These are raw materials. However, any druggist that wants to sell those across the counter, like calcium carbonate, can buy, and they do buy, from so-called label houses, prepared labels. These come in a roll, and they have a rack of these prepared labels, in the prescription pharmacy. The pharmacist just tears off a label and puts it on the 2-ounce package and sells it. It has the directions on it.

There is nothing in the law that prevents the sale of a harmless preparation like this across the counter, if it has adequate directions. The law doesn't care who puts those directions on, whether the original manufacturer or the pharmacist. But, essentially, these are raw materials for preparing prescriptions in the drugstore, and they are not designed for over-the-counter sale.

Some of the labels that were brought in are stale labels. By that I mean that they are products that were manufactured prior to the 1946 change. That is bound to be true in any drugstore we go in. The labels are changing constantly. It is almost impossible to have entirely fresh labels in your drugstore all of the time.

Here is a very good example that has been brought in. It is Heptuna, brought out by Roerig. It is exactly the same product, put out by the same manufacturer. It may seem very strange that one of them has a caution legend and the other has adequate directions. The explanation for it is, it is a preparation containing folic acid, and the one under the caution legend was manufactured and distributed at a time when the Food and Drug Administration did not have, nor did the manufacturers have, enough experience with folic acid to say that it was safe for use except under a caution legend and under a physician's guidance. The other is put out after the evidence accumulated and it no longer needed to be so restricted and could be sold across the counter.

Now, those are not in contradistinction to each other. They show the progress in drug development that is going on all of the time. That is another reason why a list is a poor approach to this division, because the list is going to be constantly out of date. The label on the package that is put out day by day is the only up-to-date guide that you can possibly get.

There are and maybe always will be some very honest and legitimate differences of opinion among medical, pharmacological and legal experts, as to whether a drug should be limited to prescription. These differences will become increasingly lessened, however, when the Food and Drug becomes more active in this field. For example, if I may speak for a moment on behalf of the Upjohn Co., alone, Commissioner Larrick has one product of the Upjohn Co. in his list of exhibits. It is dehydrocholic acid. Mr. Larrick thinks it should have a prescription limitation. The Upjohn medical staff felt that under the mandate of law, directions could be written for overcounter sales. This is definitely a border case. As is our customary practice in such cases, we will yield to the views of Food and Drug and change. We will even go further. We will change as often as their opinion may change. And without any reflection at all on the Food and Drug Administration, but just to illustrate the way these things do change, we have numerous examples, as has every manufacturer and as has the Food and Drug Administration, of changes back and forth across the counter as to opinions when a drug should be sold under a caution. legend and when it should not.

For many years the Food and Drug Administration required that all parenteral preparations under this law should be sold only under a caution legend, and you couldn't put any directions on the package. Well, that caused so much trouble in medical circles where they needed the guidance of these inserts and detailed discussions of the drug, its indications and use, that they changed the regulations and

now you are prohibited from putting a caution legend on a parenteral preparation, and you must include adequate directions. That is perfectly logical, but it shows the change. You can't keep drugs static, because science marches on and things keep changing all of the time.

Again, in closing, we urge that a legislative standard be created to classify the drugs that may be refilled without limit. Such a standard earnestly enforced will clear up this problem.

H. R. 3298 presents but one question of major importance. That question is: What prescriptions may the druggist refill without further authority from the physician. There is a collateral problem concerning oral or written prescriptions, and we think it would be appropriate for the manufacturers not to comment on this. It is a problem which the pharmacist is qualified to discuss, and it has been discussed at great length. It isn't a problem that would affect us and we would prefer not to talk about that.

There are just one or two remarks, if I may have the permission of the Chairman, in regard to Mr. Larrick's testimony, that I would like to try to tie into our proposal. Mr. Larrick in his testimony used as illustrative of the attitude of the Food and Drug Administration a series of dangerous drugs, and they are all dangerous drugs; and he said, and Administrator Ewing ahead of him said, that this was the real concern of the Food and Drug Administration. It is the real concern of the pharmaceutical manufacturer. But those drugs are all on the "caution" legend now. You don't need any list. to get them there. All you need is this law, properly amended to allow the druggist to refill all prescriptions for products that don't bear the caution legend, without the authority of the doctor.

Now, the one area in which we have some dispute with the Food and Drug Administration, an honest difference of opinion, is in this word "efficacy." We have proposed the word "efficacy" in adopting the language of the present regulations, but we are frank to say that we are very nervous and apprehensive about its ultimate effect. If it is included in the draft as we propose it, we think that the committee report, in the interest of keeping the thing straight, should include the statement of Mr. Larrick on page 7 where he said:

Opposition has been expressed to this bill on the ground that the Government is empowered to determine whether or not a drug is efficacious for its intended use. The language of the bill does not justify this conclusion.

The bill does not authorize the Administrator to determine the efficacy of a drug. It authorizes him to hold a hearing where the evidence of the best informed experts in the country would be received. On the basis of this testimony he would then determine not whether the drug is efficacious, but whether or not a layman can use the drug effectively without the diagnosis or supervision of a physician.

When Mr. Larrick said that the principal reason that they wanted a list was because of the disagreement with some of the drug-industry lawyers, he wasn't talking about the dangerous and toxic drugs, because there isn't any substantial difference or any difference at all in opinion between the lawyers of the industry and the Administration in this regard. There certainly is no difference of opinion in the actions of the industry and that is the real standard: What does the industry do, and how do they label the products; not what their lawyers may think is the standard. Lawyers are always talking up and down both sides of the street.

I am a lawyer, and therefore I can criticize my own profession. It is our business. But it is what the industry is doing that counts and the industry has all of these drugs labeled with the caution legend.

Now, in this field of efficaciousness, and whether a harmless drug should be kept from being available to the public at large on the theory that, since they don't know what is wrong with them, they can't possibly administer it to themselves efficaciously, you are getting into a very speculative field. It is just as dangerous to the public one way as it is the other. Because you may deny the public some very proper medication on the theory that they don't know what is wrong with them. And yet, I will have to admit that I am very much nonplused and perplexed as to what a doctor's prescription does to make, let us say, aluminum hydroxide jell effective. The drug is exactly the same, and it will counteract acidity in the stomach when you take it, and it probably will do just as much counteracting without the doctor's prescription as it will with it.

However, if you are talking about a drug that is dangerous, that may injure the patient, there isn't any difference of opinion at all. If there is any question of safety, we would rather lean over backward and say don't let him have it without the doctor's permission. But where it is not toxic, and you are talking about the theoretical possibility of masking symptoms, for example, you are getting out to the limits where you may put everything on a doctor's prescription and have nothing available for sale over the counter.

I think, in closing, that we would like to summarize by saying that it seems to us that this calls for a proper compromise. That is what we are trying to propose here. We are giving up something that we are a little doubtful about, in fact quite doubtful, and that is that word "efficacy," hoping we could propose something that would be acceptable to this committee and would satisfy pharmacy at large and would serve the public, because really, it is not what we want or what the retail pharmacists want; it is what the public should have that should guide this bill. In those interests we think we should give up on the word "efficacy," here, and we think that the National Association of Retail Druggists should give up on their idea of a list. It is going to work out the same way, anyway. There are a lot of objections to the list from an administrative standpoint; but we think both parties should give up something, because the public has got to be protected, and they have got to be able to buy these drugs on proper refills and not have to keep going back to the physician. He doesn't want to be bothered. He doesn't want people calling him up, druggists or patients, all times of the day and night to get permission to refill a prescription that could have been bought across the counter in the first instance.

Thank you.

(The list of members of the American Drug Manufacturers Association follows:)

MEMBERS OF THE AMERICAN DRUG MANUFACTURERS ASSOCIATION

Abbott Laboratories, North Chicago, Ill.

The Armour Laboratories, Armour & Co., Chicago, Ill.

J. T. Baker Chemical Co., Phillipsburg, N. J.

Bauer & Black, division, The Kendall Co., Chicago, Ill.
E. Bilhuber, Inc., Orange, N. J.

Bristol Laboratories, Inc., New York, N. Y.

Buffington's, Inc., Worcester, Mass.

Burroughs Wellcome & Co. (U. S. A.), Inc., Tuckahoe, N. Y.

W. J. Bush & Co., Inc., New York, N. Y.

Calco Chemical Division, American Cyanamid Co., Bound Brook, N. J.

G. W. Carnrick Co., Newark, N. J.

Chilcott Laboratories, division, The Maltine Co., Morris Plains, N. J.

Ciba Pharmaceutical Products, Inc., Summit, N. J.

Citro Chemical Co. of America, Maywood, N. J.

Cole Chemical Co., St. Louis, Mo.

Commercial Solvents Corp., Terre Haute, Ind.
Cutter Laboratories, Berkeley, Calif.

Davies, Rose & Co., Ltd., Boston 18, Mass.

Difco Laboratories, Inc., Detroit 1, Mich.

Distillation Products Industries, Division, Eastman Kodak Co., Rochester 3, N. Y.

The Dow Chemical Co., Midland, Mich.

Fritzsche Bros., Inc., New York 11, N. Y.

Gelatin Products Division, R. P. Scherer Corp., Detroit 13, Mich.

Heyden Chemical Corp., New York 1, N. Y.

Hoffmann-La Roche, Inc., Nutley 10, N. J.
Hyland Laboratories, Los Angeles 27, Calif.

Hynson, Westcott & Dunning, Inc., Baltimore, 1, Md.

Mead Johnson & Co., Evansville 21, Ind.

Johnson & Johnson, New Brunswick, N. J.

Lakeside Laboratories, Inc., Milwaukee 1, Wis.

Lederle Laboratories Division, American Cyanamid Co., New York 20, N. Y. Eli Lilly & Co., Indianapolis 6, Ind.

Lloyd Brothers, Pharmacists, Inc., Cincinnati 3, Ohio.

Lloyd & Dabney Co., Inc., Cincinnati 2, Ohio.

Magnus, Mabee & Reynard, Inc., New York 13, N. Y.

Mallinckrodt Chemical Works, St. Louis 7, Mo.
Maltbie Laboratories, Newark 2, N. J.
Maywood Chemical Works, Maywood, N. J.
McNeil Laboratories, Inc., Philadelphia 32, Pa.
Merck & Co., Inc., Rahway, N. J.

The Wm. S. Merrell Co., Cincinnati 15, Ohio.
Monsanto Chemical Co., St. Louis 4, Mo.

The National Drug Co., Philadelphia 44, Pa.

The New York Quinine & Chemical Works, Inc., Brooklyn 11, N. Y.
The Norwich Pharmacal Co., Norwich, N. Y.

Parke, Davis & Co., Detroit 32, Mich.

The E. L. Patch Co., Stoneham 80, Mass.

S. B. Penick & Co., New York 7, N. Y.

Chas. Pfizer & Co., Inc., Brooklyn 6, N. Y.

Pitman-Moore Co., Division, Allied Laboratories, Inc., Indianapolis 6, Ind.
Reed & Carnrick, Jersey City, N. J.

G. D. Searle & Co., Chicago 80, Ill.

Sharp & Dohme, Inc., Philadelphia 1, Pa.

Sherman Laboratories, Detroit 15, Mich.

Smith, Kline and French Laboratories, Philadelphia 1, Pa.

Carroll Dunham Smith Pharmacal Co., New Brunswick, N. J.

E. R. Squibb & Sons, New York 22, N. Y.

R. J. Strasenburgh Co., Rochester 4, N. Y.

Tailby-Nason Co., Cambridge 42, Mass.
The Upjohn Co., Kalamazoo 99, Mich.

Valentine Co., Inc., Richmond 9, Va.

Henry K. Wampole & Co., Inc., Philadelphia 23, Pa.

Warner-Hudnut, Inc., New York 11, N. Y.

White Laboratories, Inc., Newark 7, N. J.

The Wilson Laboratories, Division, Wilson & Co., Inc., Chicago 9, Ill.
Winthrop-Stearns, Inc., New York 18, N. Y.

The Zemmer Co., Inc., Pittsburgh 13, WM

Mr. BENNETT. I merely would like to ask permission to have inserted in the record, following the testimony of the present witness, a copy of a telegram which I received this morning, addressed to the