that more precisely state the meaning, why, that would be a very desirable thing.

Mr. BECKWORTH. You people are regarded as experts in your field. If it is that difficult to do, do you feel that it might be an impossibility to label drugs accurately?

Mr. LARRICK. Do you mean by the layman? Are you talking about the committee?

Mr. BECKWORTH. The committee or anybody else. I am trying to contrast the situation that confronts experts who are having such difficulty with anybody who might not be considered an expert.

Mr. LARRICK. You see, the bill does not ask the committee to set up a list. The committee is being asked to set up a procedure by which the best experts in the country would come in and testify before us, and then we would state our opinion on the basis of all of that testimony. We would resolve all of those questions through these formal hearings.

Mr. BECKWORTH. I recognize that a hearing was to precede the classification of any particular drug.

That is all, Mr. Chairman.

Mr. HELLER. May I ask one more question that seems to be bothering me a little?

The CHAIRMAN. Certainly.

Mr. HELLER. Mr. Larrick, I believe Mr. Wolverton asked you whether, under the bill, the Administrator would be able to determine which drugs may be sold over the counter and which are to be sold on a prescription basis only. Your answer was what to that?

Mr. LARRICK. Initially all drugs are required to bear adequate directions for use. That means that they are all for sale over the counter. Now, the Administrator carves out of that group, through this regulation, the ones that must be sold only on prescription.

Mr. HELLER. Then under the bill the manufacturer could not sell restricted drugs over the counter. Is that correct?

Mr. LARRICK. That is correct.

Mr. HELLER. Can it be put as tersely as that?

Mr. LARRICK. That is exactly right.

Mr. HELLER. Is that a correct statement?

Mr. LARRICK. You have it right on the head.

Mr. HELLER. Now, under the bill the manufacturer, however, may sell over the counter drugs for resale on prescription only?

Mr. LARRICK. No, sir; not under the bill.

Mr. HELLER. Not under the bill?

That would be an offense.

He

Mr. LARRICK. Not under the bill. would have to put full and complete and adequate directions for use on that article. When it got to the retailer, he could dispense it on a prescription, but it could not move in interstate commerce unless it had labeling on it which would make it legal for the pharmacist to sell it over the counter without a prescription.

Mr. HELLER. Thank you, sir.

The CHAIRMAN. Thank you, Mr. Larrick.

Mr. LARRICK. Thank you, Mr. Chairman and gentlemen of the committee.

The CHAIRMAN. Mr. Robert P. Fischelis is our next witness.

Mr. Fischelis, will you give your name, your residence, and your representation to the reporter for the record.

PHARMACEUTICAL

STATEMENT OF ROBERT P. FISCHELIS, SECRETARY AND GENERAL MANAGER, AMERICAN ASSOCIATION, WASHINGTON, D. C.

Mr. FISCHELIS. Mr. Chairman and members of the committee, I am Robert P. Fischelis, secretary and general manager of the American Pharmaceutical Association, with offices in Washington, D. C.

I would like the privilege first, of filing for the record a statement by Dr. Hugo H. Schaefer, chairman of the committee on legislation of the American Pharmaceutical Association and dean of Brooklyn College of Pharmacy, which states some of our objections to H. R. 3298. It is possible that these objections may be met in the anticipated ruling to be issued under the present act by the Federal Security Administrator.

Dr. Schaefer points out that if a satisfactory ruling is issued, it will be unnecessary to pass H. R. 3298; and he therefore makes the request that action on this bill be postponed until the administrative ruling has been handed down.

Mr. HELLER. Is that a pending case you are talking about?

Mr. FISCHELIS. Yes. It is the ruling that Mr. Ewing referred to in his testimony on Tuesday.

Now, the bill, Dr. Schaefer points out, proposes to give the Food and Drug Administration the power to designate which drugs shall bear the prescription legend after hearings have been held. The implications inherent in this step are of tremendous significance. It would give the Food and Drug Administration control over the conduct and policies of drug manufacturers as well as retail pharmacists, vastly beyond that required for preserving public health, welfare, and safety.

As he states, there is no need for such a legislative step. He further requests that the association be given an opportunity to submit additional argument and information following the promulgation of the ruling.

That is the statement we would like to submit for the chairman of our committee on legislation.

(The statement referred to is as follows:)

STATEMENT OF HUCO H. SCHAEFER, CHAIRMAN, COMMITTEE ON LEGISLATION, AMERICAN PHARMACEUTICAL ASSOCIATION, WASHINGTON, D. C.

The American Pharmaceutical Association on August 31, 1950, filed a request with the Federal Security Administrator for a formal hearing and a resulting directive or regulation in respect to the whole matter of the condition upon which physicians' prescriptions may and may not be refilled. This request was submitted because of the need for clarification of interpretations of the present Food, Drug, and Cosmetic Act which had been issued by the Commission of Food and Drugs in speeches, magazine articles, and interviews but not in the Federal Register which is the authoritative organ of the Government for the promulgation of official rulings.

Although the Food and Drug Administration opposed the request of the American Pharmaceutical Association for an official ruling and for a public hearing, the Federal Security Administrator conducted an informal conference on the subject in his office on October 5, 1950.

On December 5, 1950, the Administrator released a statement to the press and issued a proposed ruling which was published in the Federal Register with the request that comment thereon be submitted to him within 30 days.

Comment was submitted by the American Pharmaceutical Association and others within the period prescribed, and we have been waiting patiently ever since for a final determination of this important matter.

If the final ruling to be issued on this subject meets the need of the medical and pharmaceutical professions for a practical interpretation of the present law and works no unnecessary hardship on the patients of medical practitioners and the practitioners of medicine and pharmacy themselves, the legislation proposed in H. R. 3298 would seem to be unnecessary.

If, on the other hand, the anticipated regulation does not meet the needs of the present situation it becomes very important for this committee to give careful consideration to the argument presented by the secretary of the American Pharmaceutical Association in another statement to be filed with the committee. This statement will point out the necessity for certain changes in H. R. 3298 if the legislation is to accomplish the objectives sought by practicing pharmacists and physicians in this important matter.

With respect to H. R. 3298, the American Pharmaceutical Association is therefore in the position of approving its objectives but disagreeing with the proposed method of accomplishing them because they place an unnecessary burden upon the professions and patients involved.

This bill proposes to give the Food and Drug Administration the power to designate which drugs shall bear the prescription legend after hearings have been held. The implications inherent in this step are of tremendous significance. It would give the Food and Drug Administration control over the conduct and policies of drug manufacturers as well as retail pharmacists, vastly beyond that required for preserving public health, welfare, and safety.

There is no need for such a legislative step. The present Food, Drug, and Cosmetic Act in Regulation 1.106 gives the Food and Drug Administration all the power it needs in order to protect public health and designates in detail under what conditions and for which drugs a prescription legend is required. It limits the use of the prescription legend to only such drugs as meet these conditions. This regulation definitely states that prescription legends may only be used on the labels of—

"Such drug or device, because of its toxicity or other potentiality for harmful effect or the method of its use or the collateral measure necessary to its use, is not generally recognized among experts qualified by scientific training and experience to evaluate its safety and efficacy, as safe and efficacious for use except by or under the supervision of a physician, dentist, or veterinarian."

It is true that there may be certain border-line instances in which the experts referred to in the regulations will vary in their opinions. Such instances, however, are rare and the manufacturers always have the right to seek and to ask for a determination from the Food and Drug Administration in such cases. If this paragraph were properly enforced there would be no problem whatsoever, concerning drugs bearing the prescription legend.

This provision in H. R. 3298 is impractical since it would be literally impossible for the Food and Drug Administration to hold hearings, make determinations, and publish a list of the 30,000 or more drugs which are now on the market. It would be far better to continue to allow the manufacturer to make his own determination as to the proper use of the legend but always within the scope of the regulatory provisions of the law.

As far as refilling of prescriptions is concerned H. R. 3298 presumably would allow no latitude whatsoever as to the use of a pharmacist's professional judgment. There are many instances in which sufferers from chronic conditions, well acquainted with the medication which was prescribed for them, might need emergency quantities of drugs at times when it is impossible for them or for the pharmacist to contact the physician.

The present law includes provisions sufficiently broad to take care of all abuses which might occur in the refilling of prescriptions. It is merely necessary for the Food and Drug Administration to issue regulations which would stop these abuses without, however, completely taking away the pharmacist's professional judgment and vastly adding to the cost of medical care. The American Pharmaceutical Association has asked that such regulations be issued and they are now presumably in the process of completion.

We therefore request that no action be taken on this bill until the administrative ruling on the subject covered therein is issued by the Federal Security Administrator, and we respectfully request the opportunity to submit further comment when the ruling has been issued.

Mr. FISCHELIS. I would like to preface my own statement, Mr. Chairman, with this note: Although we shall take issue with some aspects of the proposed legislation, I would like to record our high

regard for Congressman Durham, the sponsor of this bill, who has been an honorary member of the American Pharmaceutical Association for many years, and who, as a former practicing pharmacist, has the interest of pharmacists very much at heart.

I am sure that Mr. Durham would not be averse to having his bill amended in such manner as to meet some of the objections we are about to raise.

Likewise, it is a matter of some regret to us to have to differ so strongly with the Food and Drug Administration on their new concept of the regulation of the practice of medicine and pharmacy. This is the first time in our memory that we have not been on the same side of an argument with the Food and Drug Administration with respect to interpretation or amendment of the Food, Drug and Cosmetic Act.

We are mindful of and we commend highly the splendid work which the Administration has done and is doing to uphold standards of purity for drugs, but we believe that they are now embarking on an unnecessary enforcement activity which goes to the very heart of the problem of keeping the professions dealing with the public health free from unnecessary regimentation by the Government.

The American Pharmaceutical Association, of which I am secretary, and for which I speak, is the oldest and most representative national pharmaceutical association in America. Organized in 1852, nearly 100 years ago, it has been in continuous existence since then and numbers among its members the leading practitioners in every phase of the pharmaceutical profession and the drug industry. Its members. practice their profession in retail establishments, in hospitals, in manufacturing laboratories, in colleges of pharmacy, in the medical facilities of the Armed Forces, the Public Health Service, research institutions, and other places requiring professional pharmaceutical services.

The house of delegates of the association which considers and develops the policies for the profession of pharmacy is made up of representatives of every State pharmaceutical association in the United States and practically all national associations. It is a thoroughly democratic body.

I have with me, Mr. Chairman, a publication known as the Special Supplement to the Scientific Edition of the Journal of the American Pharmaceutical Association for January 1951, which gives our complete list of active members, our code of ethics, certificate of incorporation, constitution, bylaws, a brief history and summary of the activities of the association, and other data. If you would like to have copies of this publication, we have them here for distribution.

It is estimated that upward of 375,000,000 prescriptions are filled in the United States annually, and the most recent authentic prescription surveys indicate that between 35 and 40 percent of these prescriptions are refills.

About 16 percent of the prescriptions are not refillable by law, that is, they contain narcotic, hypnotic or dangerous drugs, prescriptions for which may not be refilled under existing Federal and State laws. In less than 2 percent of the prescriptions covered in the survey did the prescriber specifically indicate that the prescription was not to be refilled.

The survey on which the foregoing figures are based was made as a part of the pharmaceutical survey sponsored by the American Council

on Education and covered 38 States and the District of Columbia, and was participated in by 220 pharmacies. About 75 percent of the refill prescriptions were written less than 1 year prior to the date of refilling.

While we do not have accurate figures on the subject, we believe it to be a fair statement that the major portion of prescriptions filled in the United States today are filled by members of the American Pharmaceutical Association. This association includes in its membership practically all pharmacists functioning in hospitals of any size, and it includes in its membership all of the members of the American College of Apothecaries, the members of which organization devote their time and facilities almost exclusively to prescription practice.

One of the objectives which led to the organization of the American Pharmaceutical Association in 1852 was the improvement of the quality of drugs and the detection and prevention of drug adulteration. We advocated the passage of the Food and Drug Act of 1906 and the Food, Drug, and Cosmetic Act of 1938 which the bill before you now seeks to amend.

When we advocated the passage of the existing law, we were under the impression-and so was the medical profession that it did not and would not interfere with the dispensing of prescriptions of medical practitioners. For more than 10 years after the passage of the act, there was no interference by the Food and Drug Administration with the legitimate dispensing of such prescriptions.

Suddenly, in October of 1948, out of a clear sky, there came a pronouncement by the Commissioner of Food and Drugs that no prescription written by a medical practitioner which had once been filled was refillable by the pharmacist. It made no difference, he said, what the prescription called for it simply was not refillable. If the prescription called for bicarbonate of soda or aromatic spirits of ammonia or a simple cough sirup and the patient asked the pharmacist to refill it, the request would have to be denied unless the pharmacist wanted to risk criminal prosecution. In the same pronouncement which, incidentally, was not in the form of a ruling but consisted of an interpretation of the law given as a part of a speech to the National Association of Retail Druggists, it was stated that the pharmacist could sell the contents of any prescription in an over-the-counter container, if it was a product which could be labeled with adequate directions for self-medication. In other words, the pharmacist was prevented from refilling a physician's prescription for his patient but was encouraged to disclose to the patient what the physician had prescribed and to substitute for the physician's directions other so-called adequate directions for use, which might very well differ from those originally given by the physician.

Later, and again not in the form of a ruling, but in an article in a drug journal, the Commissioner stated that a physician's prescription is like a check on a bank. Once it has been "cashed," it cannot be "cashed" again.

The resulting confusion in the profession became so great and the requests for a definite ruling and clarification of the law so numerous, that the Commissioner was moved to state in an interview reported in another drug journal that the administration would not prosecute those who refilled prescriptions for drugs which can be purchased over the counter but that prescriptions calling for drugs labeled to be supplied only on prescription could not be renewed. The reason