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administer the drug; and (4) it must bear a label containing the name and address of the dispenser, the serial number and date of the prescription, and the name of the prescriber. Within these limitations such a drug is exempted from the label requirements of section 502 (b), (d), and (e), except as indicated. Section 502 (b) provides that the label of a packaged drug shall contain the name and address of its seller and a statement of its net weight, measure, or numerical count. Section 502 (d) provides that the label of a human drug containing a named narcotic or hypnotic substance, or any chemical derivative thereof administratively designated as habit forming, shall bear its name and quantity or proportion and the statement “Warning—May be habit forming." But a prescription drug is only exempted from such label requirements of section 502 (d), if the prescription is marked by its author as not refillable or where its refilling is prohibited by law. I pause here to note that this is the only reference in the above law to the refilling of a prescription; that it is directed to prevent the unauthorized refilling of a prescription for a dangerous drug; and that consequently the Food, Drug and Cosmetic Act so enters the field of prescription refilling, to protect public health. As to section 502 (e), it provides that the label of an unofficial drug shall bear its name and, if it is a mixture, the name of each active ingredient (etc.).

It follows that a prescription drug, dispensed by the pharmacist, is thus left subject to all the composition requirements of the Food, Drug, and Cosmetic Act against drug adulteration; and to all other label, labeling, packaging and additional requirements of that act against drug misbranding. Of the latter requirements the major

. negative one is that of section 502 (a), which prohibits the false or misleading labeling of a drug; and the major affirmative one (from the standpoint of this discussion) is that of section 502 (f) which requires the labeling of a drug to bear adequate directions for its use and also adequate warnings against its dangerous or unsafe use. But this adequate-directions requirement is qualified by a proviso that where such requirement is not necessary for the protection of public health in the case of any drug, the act’s administrator shall promulgate regulations exempting it therefrom. The Administrator has promulgated such regulations and they contain one relating to a prescription drug. It exempts this drug (except as provided) from the above adequate-directions requirements, (a) where it is safe and efficacious for use only by or under the supervision of a physician, dentist, or veterinarian; (b) if its label bears the statement: "Caution: To be dispensed only by or on the prescription of a physician” (or dentist or veterinarian); and (c) provided it is dispensed by the pharmacist upon a prescription issued by a physician, dentist, or veterinarian in his professional practice and under labeling bearing the directions for use specified in the prescription (etc.). The regulation goes on to provide in effect that this exemption expires, if and when the pharmacist does not dispense such a prescription-restricted drug on that prescription basis, and that he must then label it in full compliance with the adequate-directions requirement of section 502 (f). This last provision has the significance that the pharmacist is administratively deemed unable to comply with such requirement, in the situation thus presented.

This regulation practically divides drugs into two classes, under the Food, Drug, and Cosmetic Act. They are, first, prescription drugs which the pharmacist should dispense on a prescription basis; and, secondly, nonprescription drugs which he may freely dispense over the counter. Furthermore, it vests in the manufacturer of a drug the original responsibility of determining the class in which it belongs. This statement has the significance that it is the basic theory of the act to make the producer of a subject article initially responsible for general compliance with it, subject to the rules defined in or under it.

The bill, H. R. 3298, revises the prescription-drug law in section 503 (b) of the Food, Drug and Cosmetic Act, by dividing it into two parts as follows: The first part continues the exemption plan of this law, in another form, for it provides that a drug dispensed by filling or refilling a written or oral prescription of a physician, dentists, or veterinarian, licensed by law to administer it, shall be excempt from the label, labeling, packaging, and other requirements of section 502, except paragraphs (a), (i) (2) and (3), (d) and (1), and the packaging requirements of paragraphs (9) and (h), if it bears a label containing the name and address of the dispenser, the serial number and date of the prescription or its refilling, the name of the prescriber, and, if stated in the prescription, the name of the patient with the directions for use and cautionary statements thus specified by the prescriber. Therefore, this exemption similarly leaves the dispensing of a prescription drug subject to all the requirements of the act against drug adulteration, and also to all the other requirements of the act against drug misbranding; but it is permitted only on the condition that such drug is not dispensed pursuant to diagnosis by mail or otherwise without examination of the patient. Hence in its first part this prescription-drug law has been revised, on the one hand, to strengthen it by broadening its application for an express inclusion of prescription refilling and by tightening its exemption requirements as indicated; and, on the other hand, to liberalize its policy by sanctioning an oral prescription. This revised law is equally directed to prohibit the pharmacist from dispensing a prescription-restricted drug, on a nonprescription basis; and it is equally designed to prevent the pharmacist from dispensing such a drug on that basis, where this is dangerous to the public health. Consequently, we must conclude that in its first part the revised law is significantly better than the existing one; but that comment is made without prejudice to a further appraisal of its details.

The second part of this revised prescription-drug law is new. For it classifies the drugs which the pharmacist should dispense on a prescription basis thereunder; it provides that they shall only be dispensed by him on that basis thereunder; and it instructs him how to dispense them thereunder, where he either fills or refills the prescription. These drugs are confined to those intended for use by men; consequently they do not include drugs used for the treatment of animals; and that distinction makes the second part of this law inconsistent with its first part, which has a comprehensive product application. Such drugs are (1) habit-forming drugs subject to the regulations under section 502 (e), but any of them may be administratively removed from this entire revised law when its requirements are not necessary to protect the public health; (2) drugs found by the

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act's administrator, after investigation and opportunity for public hearing, to be either unsafe or ineffective for use without the professional diagnosis or supervision of a physician or dentist; and (3) "new drugs” which must be used only under the professional supervision of a physician or dentist, by virtue of section 505. As to each of these drugs it is then provided that such a drug shall come within the prescription-drug exemption made in the first part of this revised law only (a) if it is dispensed upon a written prescription of a physician or dentist, licensed by law to administer it, or upon his oral prescription which he agrees to confirm in writing within 72 hours; or (b) if it is dispensed by refilling a prescription where this is authorized by the prescriber in the original prescription or by his oral order and agreement to confirm such order within 72 hours. It is also provided that the label of each such drug shall bear the following statement: "Caution: Federal law prohibits sale or dispensing without prescription." In comment on this provision it may be said that, first, such caution statement may be shortened by omitting the unnecessary reference to a sale; and, secondly, the requirement of this statement will practically reach the manufacturer of a drug, which he markets under a prescription-restricted label, for dispensing by the pharmacist in its original container. It is further provided that the pharmacist's dispensing of a drug contrary to any requirement of this entire revised law shall be deemed an act which results in its being misbranded while held for sale, for the purposes of enforcing the FCD Act.

Therefore in its second part this revised prescription-drug law corrects two important defects in the existing law of section 503 (b). They are, first, its failure generally to regulate the refilling-in addition to the filling of a prescription; and, secondly, its unreasonable application against the refilling of a harmless-drug prescription. The revised law also improves the existing one by classifying the prescription-restricted drugs subject to it and by defining the rules governing their dispensing by the pharmacist, whether he fills or refills a prescription.

The witnesses who follow me will probably be able better to explain all the details than I. We have here practicing pharmacists who see these things in operation and can point out to you the handicaps and the difficulties that we face in carrying on under the present rules.

Thank you, Mr. Chairman and gentlemen.

Mr. WOLVERTON. In order that we may have before the committee the attitude of the various parties interested, may I ask what is the attitude of the physicians toward this bill?

Mr. DURHAM. I am not in the position to answer that. Witnesses following me, I think, will be in a position to answer that question.

Mr. WOLVERTON. Do you know what is the attitude of the drugmanufacturing concerns?

Mr. DURHAM. No; I understand they have asked to be heard, and I assume they will express their opinion in regard to the measure.

Mr. WOLVERTON. Are you familiar with the Federal Security Agency's opinion on this bill?

Mr. DURHAM. No. Mr. Ewing is here this morning and he will speak for the Agency and, I understand, they have another witness who will also appear.

Mr. WOLVERTON. Thank you.

Mr. CARLYLE. Mr. Chairman, my friend and colleague, Congressman Durham, has been a little modest this morning. He said that he has been practicing as a druggist in North Carolina for about 30 years. I have known the Congressman to be a very efficient and one of the most popular druggists in North Carolina for more than 30 years.

That is all I care to say. The CHAIRMAN. If there are no further questions, thank you, Mr. Durham.

Mr. DURHAM. Thank you very much, Mr. Chairman; I appreciate your courtesy.

The CHAIRMAN. Our next witness is Mr. Ewing, the Federal Security Administrator.



Mr. EWING. Mr. Chairman, before I present my prepared statement, I think it might be helpful in understanding some of the points in that statement if I make a little preliminary explanation.

The CHAIRMAN. Very well.

Mr. Ewing. Under the present law, the Food and Drug Administration, as Mr. Durham has said, has taken the position that a prescription could not be refilled, that it was specifically an order for, say, 30 pills, or some other quantity of drugs, and, once it had been filled, that was the end of it.

That position was not accepted entirely by one of the interested associations, the American Pharmaceutical Association, so that last fall they filed a petition with the Administrator asking him for an inquiry which would go into all details of the problem; and they particularly asked him to make a new regulation which would waive all of the labeling requirements of the Food, Drug, and Cosmetics Act.

That request, we were sure, asked us to do certain things that were beyond any authority that the act gave the Administrator. On the other hand, the act did give him authority to make regulations that would exempt drugs under section 502 (f) (1) and that was the very provision which the Food and Drug Administration had used to justify its position that they could not permit refills of prescriptions. It did seem to me that our regulations under that provision needed clarification.

At the time that we discussed the matter with the interested parties, a bill similar to the one we are now discussing was pending in Congress, and it was felt that, if the Administration got out new regulations at that time, then it might have some unintended effect on the action on the bill then before the Congress.

Frankly I feel very strongly that this matter of refilling prescriptions is a question that should be dealt with by legislation rather than by regulation of the Administrator. I feel that for two reasons. In the first place, I am sure that under the law the Administrator cannot do some of the things that ought to be done; and, secondly, I think this is so far-reaching that it is important that it be done by legislation and not by regulation of the Administrator.

It is also true that some of the things we are authorized to do could, I think, be done better by legislation. Nevertheless, I am in a situation as Administrator where, when the parties insist on my

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dealing with this matter, I am compelled to act, although I should much prefer to see Congress do it.

As a result of all these considerations, we did get out a proposed new amendment which would permit the refilling of prescriptions for nondangerous drugs, what we call over-the-counter drugs, but would not permit the refilling of a prescription for other drugs which are generally described as those which can be safely dispensed only on the prescription or under the direction of a physician.

The proposed regulation would not have permitted the refilling of prescriptions unless the doctor himself said that it could be refilled. In that proposed regulation there was nothing said about telephoned prescriptions and we received, as to that, a number of suggestions and objections. We considered them and we are working on a revision of that point. But I say that whatever we do in the way of new regulations will, I hope, have no effect on your judgment, because I certainly am not trying to anticipate what the committee or the Congress will do. I would much rather that you dealt with it, and, to the extent that I do deal with it, it will be simply because I feel that, under the law, I am compelled to act, since Congress has given me the authority and there is one party insisting that I act.

But my whole philosophy, gentlemen, is this, that, in a field of this kind, the Government should only act where it is necessary. not in the least interested in taking any action unless it is compelled; that is, unless there is some condition that really compels action by the Federal Government. I feel action should go no further than is necessary to take care of the actual situation that exists. With that general explanation, I should like to proceed with my statement.

The CHAIRMAN. You may proceed.

Mr. Ewing. The bill which is before you, H. R. 3298, deals with the retail sale of drugs that have previously moved in interstate commerce and are thus subject to Federal regulation. This is a subject which has lately been very much on our minds in the Federal Security Agency and I welcome this opportunity to talk with your committee about it.

Let me say at the outset that the subject is of such importance and of such complexity that in my judgment it ought to be dealt with, in a comprehensive way, by legislation rather than by administrative regulation. I earnestly hope that your committee will share this view and will report out this bill, modified in such fashion as, to the committee, may seem wise.

The Federal Security Agency has in fact dealt with this subject, or at least with a large part of it, in an extensive and elaborate regulation, and we are now engaged in considering whether that regulation should be amended in important respects. While some lawyers have disagreed, I believe that authority for our present regulation and for its proposed revision is found in the present statute—though it is contained in one four-line proviso. At least in its general pattern, the regulation was held valid by the Supreme Court of the United States in United States v. Sullivan (332 U. S. 689 (1948)).

(The regulation referred to follows:) Regulations. (8 1.106] (a) Directions for use may be inadequate by reason (among other reasons) of omission, in whole or in part, or incorrect specification of:

(1) Directions for use in all conditions for which such drug or device is prescribed, recommended, or suggested in its labeling, or in its advertising disseminated or sponsored by or on behalf of its manufacturer, packer, or

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