distributor, or in such other conditions, if any there be, for which such drug or device is commonly and effectively used;

(2) Quantity of dose (including quantities for persons of different ages and different physical conditions);

(3) Frequency of administration or application;

(4) Duration of administration or application;

(5) Time of administration or application (in relation to time of meals, time of onset of symptoms, or other time factor);

(6) Route or method of administration or application; or

(7) Preparation for use (shaking, dilution, adjustment of temperature, or other manipulation or process).

(b) Except as otherwise provided by paragraphs (h) and (i) of this section, a shipment or other delivery of a drug or device shall be exempt from the requirements of section 502 (f) (1) of the Act if it complies with all of the following conditions:

(1) Such drug or device, because of its toxicity or other potentiality for harmful effect or the method of its use or the collateral measures 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.

(2) Such shipment or delivery is to be:

(i) Dispensed by physicians, dentists, or veterinarians in their professional practice;

(ii) Dispensed upon prescriptions issued by physicians, dentists, or veterinarians in their professional practice and under labeling bearing the directions for use specified in such prescriptions;

'or

(iii) Compounded with other substances in filling such prescriptions;

(iv) Used in the manufacture of another drug or device.

(3) Information adequate for the use of such drug or device by physicians, dentists, or veterinarians, as the case may be, is readily available.

(4) The label of such drug or device (other than surgical instruments and other devices to be used exclusively by physicians, dentists, or veterinarians in their professional practice) bears the statement "Caution: To be dispensed only by or on the prescription of a ", or "Caution: To be dispensed only by or on the prescription of a or otherwise used only for manufacturing purposes", the blank being filled in with one or more of the words "physician","dentist", and "veterinarian", as the case may be.

(5) No representation with respect to the conditions for which a drug or device is to be used, or how it is to be used, appears in its labeling except representations:

(i) In printed matter supplied to a physician, dentist, or veterinarian separately from such drug or device;

(ii) Specified in a prescription, which was issued by a physician, dentist, or veterinarian in his professional practice, upon which such drug or device was dispensed; or

(iii) Required by an official compendium.

(6) In the case of a drug which is not designated solely by a name recognized in an official compendium and which is fabricated from two or more ingredients, its label also bears a statement of the quantity or proportion of each active ingredient.

(c) Except as otherwise provided by paragraphs (h) and (i) of this section, a shipment or other delivery of a drug which cannot be exempted under paragraph (b) of this regulation because of the provisions of subparagraph (1) thereof also shall be exempt from the requirements of section 502 (f) (1) of the Act if it complies with all of the conditions set forth in paragraph (b) (4) and (5) of this section and with all of the following additional conditions:

(1) Such drug is not a liquid solution, emulsion, or suspension and is not in tablet, capsule, or other unit form.

(2) The name whereby such drug is designated in its label is recognized in an official compendium.

(3) Such drug is ordinarily compounded with other substances before it is dispensed.

(4) Such shipment or delivery is to be:

(i) Compounded with other substances in filling prescriptions issued by physicians, dentists, or veterinarians in their professional practice; or (ii) Used in the manufacture of another drug.

(d) Except as otherwise provided by paragraphs (h) and (i) of this section, a. shipment or other delivery of a drug which cannot be exempted under paragraph (b) of this section because of the provisions of subparagraph (1) thereof also shall be exempt from the requirements of section 502 (f) (1) of the Act if it is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, of other drugs.

(e) Except as otherwise provided by paragraphs (h) and (i) of this section, a shipment or other delivery of a drug or device also shall be exempt from the requirements of section 502 (f) (1) of the Act if it complies with all the conditions set forth in paragraphs (b) (3) and (6) of this section and if such shipment or delivery is made to a physician, dentist, veterinarian, hospital, or clinic to be dispensed by or under the direction of physicians, dentists, or veterinarians in their professional practice.

(f) A shipment or other delivery of a drug or device also shall be exempt from the requirements of section 502 (f) (1) of the Act if it is made to a dealer or manufacturer to be used in the manufacture of another drug or device and its label bears the statement "For manufacturing use only."

(g) A shipment or other delivery of a drug or device also shall be exempt from the requirements of section 502 (f) (1) of the Act with respect to common uses, adequate directions for which are known by the ordinary individual.

(h) No shipment or other delivery of any drug shall be exempt under any provision of this section from any requirement of section 502 (f) (1) of the Act unless its labeling bears the information concerning its use which is contained in the labeling upon the basis of which an application under section 505 of the Act is effective with respect to such drug.

(i) No exemption under any provisions of this regulation shall apply to any shipment or other delivery of:

(1) A drug if its advertising disseminated or sponsored by or on behalf of its manufacturer, packer, or other person responsible for making such shipment or delivery, contains any representation not borne by its labeling and which, if so borne, would make it a new drug;

(2) A drug intended for administration by iontophoresis or by injection into or through the skin or mucous membrane; or

(3) A drug or device if such shipment or delivery is made in the course of the conduct of a business of dispensing drugs or devices pursuant to diagnosis by mail.

(j) If a shipment or other delivery, or any part thereof, of a drug or device which is exempt under paragraph (b), (c), (e), or (f) of this section is disposed of for any purpose other than those specified in such paragraph, such exemption shall expire, with respect to such shipment or delivery or part thereof which is so disposed of, at the beginning of the act of such disposal. The causing of an exemption so to expire shall be considered to be an act which results in such drug or device being misbranded unless, prior to such disposal, it is relabeled to comply with the requirements of section 502 (f) (1) of the Act, or it is disposed of for use otherwise than as a drug or device.

(k) For the purposes of this section:

(1) The term "manufacture" does not include the use of a drug as an ingredient in compounding any prescription issued by a physician, dentist, or veterinarian in his professional practice.

(2) The terms "physician," "dentist," and "veterinarian,' as used in relation to the exemption of any drug or device, include only those physicians, dentists, and veterinarians who are licensed by law to administer or apply such drug or device.

Mr. EWING. The existing law requires that the labeling of drugs bear adequate directions for use. This requirement, however, may be relaxed by regulations as to any drug when such labeling is found by the Federal Security Administrator to be unnecessary for the protection of the public health. As to the class of drugs which involve the application of diagnostic and treating techniques that are beyond the knowledge and competence of laymen, I have found that the re-quirement is not necessary when these drugs are sold on prescription. When such a drug is received by the pharmacist it bears a label stating "Caution-To be dispensed only by or on prescription of a physician." It comes to the druggist that way from the manufacturer.

If the pharmacist sells the drug without prescription, the exemption does not apply, and the drug is misbranded because it does not bear adequate directions for use. If the pharmacist undertakes to write labeling giving adequate directions for use, we believe that the drug becomes misbranded under other sections of the act. It would violate section 502 (a) because of the false implication that it can be safely used by a layman and section 502 (j) because it is dangerous to health when used without professional guidance.

The practical effect of the existing regulation is to limit a number of drugs to the prescription departments of retail pharmacies. My belief is that the legislation could much more clearly tell the pharmacist exactly what his obligations are. That belief, however, cannot relieve me of the statutory duty to promulgate regulations under the present law. But I earnestly hope that this committee will act upon the bill and thereby will more clearly define the scope of action required of the Administration.

I have other reasons, also, for that hope. The present provisions of the statute, amplified to the full extent of our regulatory authority, are in our judgment inadequate either, on the one hand, to give full protection to the consuming public or, on the other, to relieve the honest and lawabiding pharmacist of all the red tape that can safely be dispensed with.

I will not take your time to discuss the grave dangers to health which can result from misuse of many of our most beneficient drugs. This committee, which handles both food and drug and public health legislation, is well aware of the basic problem, and I feel sure that other witnesses will bring to you all of the detailed information which you may wish.

The problem as I see it—and it is the same problem that we face framing regulations-is to strike the best balance we can between the need for maximum protection of consumers from abusive practices and the need to minimize the impediments to the legitimate distribution and sale of useful drugs.

First, let me point out ways in which the bill would strengthen our hands in the prevention of abuses. The present statute does not in so many words authorize us either to differentiate between "prescription drugs" on one hand, and "over-the-counter drugs" on the other, or to forbid the sale of prescription drugs without a prescription. On both these points our present methods of control are partially adequate. We were sustained in the Sullivan case on part of this problem. But on both points I think we ought to have clear and unequivocal authority. The bill before you would confer such authority in both these respects, and I believe that these changes in law are of very great importance in strengthening the protection of the public.

To accomplish the former objective—that is, to distinguish between prescription and over-the-counter drugs-the bill authorizes the Federal Security Administrator to list, by name, the drugs that are to be limited to prescription sale. I am aware that this proposal is vigorously opposed by some. I cannot but believe, however, that it is the only practical solution of an extremely difficult problem. The first essential of any program to regulate prescription drugs, I think, must be some method of determining and of stating in plain and unmistakable terms what drugs are prescription drugs. Several States

list by statute or regulation the drugs requiring that they be sold on prescription. Canada does so by regulation.

Our best efforts to devise, in our existing regulations, a general definition of prescription drugs leaves a broad twilight zone in which no one can know with certainty into which classification a given drug will fall.

That is because we have got to use general terms, and then the matter of whether the drug comes within those terms or outside of them is a matter of judgment which the pharmacist must exercise first; and then if that is challenged by the law-enforcing authorities, a court might have to make a decision.

That twilight zone makes it very unsatisfactory for both the pharmacist and for any enforcing agency and therefore this provision in Mr. Durham's bill to authorize the Administrator specifically to determine whether a specific drug should be dispensed only on prescription or not seems to us perhaps the best way out of this difficult situation.

This uncertainty cannot fail to be as disturbing to manufacturers and sellers of drugs as it is to those engaged in enforcing the law. To obviate this uncertainty the bill would provide that prescription drugs should be listed from time to time by regulation. With the protection afforded by public hearing and judicial review, I believe that this is the most practical method any one has yet devised to deal with this problem and at the same time to safeguard all the interests concerned.

On the second point, the prohibition of sale of prescription drugs without prescription, the bill would write clearly into law conclusions which we believe can be drawn from a number of clauses of the present statute, but which are at this moment pending before a circuit court of appeals in the first serious test of the pharmacist's ability to evade the prohibition by adding what he claims are adequate directions for If your committee agrees with us that many drugs are too dangerous for use without professional supervision, and that many others, while not toxic in themselves, require professional supervision for their effective use, then I would urge that Congress impose explicit prohibitions and not leave the matter to judicial interpretation of an ambiguous statute.

use.

Let me turn now to the other side of the problem, the protection of legitimate trade in drugs against unnecessary interferences. Here the bill would also make two changes, and I think them of importance equal to the strengthening of consumer protection.

First, the bill would relieve the pharmacist, when he fills a prescription, from the necessity of meeting certain of the labeling requirements of the statute from which, under existing law, we are unable to relieve him.

That is section 502 (f) which says that a drug or device shall be deemed to be misbranded:

Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users.

The Administrator has no authority to exempt from the provisions of clause (2) of this subsection and technically the warnings there required should be on a bottle, even though it is dispensed under

a doctor's prescription. We think that that is unnecessary when there is a doctor's prescription on which the drug is given out.

These have to do chiefly with warnings against misuse which the statute requires in certain cases. These warnings we believe are quite unnecessary when the drug is used in accordance with the doctor's orders; that is, when the doctor takes the responsibility that the drug will be properly used. I see no question that in such cases the pharmacist ought to be relieved of this burden.

The other change to facilitate legitimate dealing would be the express authorization of telephoned prescriptions. As medical practice is carried on today, the use of the telephone is plainly essential. While there is inevitably some risk in the use of the telephone-risk of misunderstanding the name of a drug, for example-this is a point on which the gain from relaxing present requirements seems to me clearly and heavily to outweigh the risks involved. To minimize the risks the bill provides that the pharmacist must make and keep a written record of the telephone order. I should like to suggest that it also provide, as did last year's bill, that the doctor must agree to confirm the prescription in writing within 72 hours. Without imposing any unreasonable burden, this would help to guard against certain possible abuses.

In the case of prescription drugs, the troublesome question of refilling prescriptions would be dealt with by the bill in similar fashion. Here again, the doctor's orders would be controlling, whether they were given at the time of the original prescription or when a refill is desired; but in either case they could be given by telephone.

In the case of over-the-counter drugs, on the other hand, the doctor's approval would not be necessary for a refill. Since these are drugs that can properly be sold in the first place without prescription, I see no harm, in most cases, in permitting prescriptions for them to be freely refilled.

I ought to tell the committee that we have been strongly urged to amend the existing regulations to permit telephoned prescriptions, and that if the matter is left to the Federal Security Agency to deal with by regulation, I intend to publish a proposed regulation that would have this effect, insofar as our authority to make exemptions extends. But here again, I think the subject is more appropriate for legislation than for regulation.

A question has been raised about permitting telephoned prescriptions for barbiturates, or "sleeping pills," and I am sure your committee will wish to give special attention to this issue.

In the case of narcotic drugs, of course, amendment of the Federal Food, Drug and Cosmetic Act would not affect the requirement of a written prescription contained in the Harrison Narcotic Act. In the case of barbiturates, however, no other Federal law is applicable.

As I am sure the gentlemen are aware, a subcommittee of the Ways and Means Committee has recently held hearings on the problem of barbiturate control, and has asked the Treasury Department, the Department of Justice, and the Federal Security Agency to frame a plan. for strengthening the present legislation in this field.

The Food and Drug Administration believes that it would be unduly dangerous to permit telephoned prescriptions for barbiturates without limit. On the other hand, we do not want the chance of abuse by barbiturate addicts to cause us to place unreasonable burdens