an abdication by Congress of its legislative powers. I happen to come from Indiana, and perhaps those people out there have an experience that certain legislative authorities and certain judicial authorities had been assumed by certain bureaus and agencies here and perhaps we do not like it out there very well. Is that correct? Mr. CLUTTER. That is correct.

Mr. BEAMER. And I think we could given some instances that do not occur particularly in the Food and Drug Act, but I am wondering if that might be a little looser assertion or a natural fear throughout the country. I am trying to get at the fact that there is something underlying this more than just the Pure Food and Drug Act, perhaps. Mr. CLUTTER. Well, the thing underlying it is that we oppose any kind of administrative determination of how we shall run our business if it isn't needed for the protection of the public, at least, and it is not needed in this case at all. We feel that it would injure the public.

Mr. BEAMER. I have had a large number, I think all of us have had a lot of telegrams and letters from other manufacturers and I have had none from Eli Lilly. I know something about the firm and I know something about the administrative officials. I think they have a very fine reputation, but regardless of that, I am wondering whether this H. R. 3298 if it were enacted into legislation as it is now written, would perhaps deny the public a certain amount of easy access to standard household remedies. Can you conceive of that? Mr. CLUTTER. We think it would.

Mr. BEAMER. Can you conceive of some simple remedies that are recognized by reputable firms such as yours and many others, that might be required to be on this list and patients would have to pay the doctor a reasonable fee?

Mr. CLUTTER. Absolutely.

Mr. BEAMER. Is that one of your fears?

Mr. CLUTTER. That is one of our fears, that this list might grow very large, and maybe not at this time, but through succeeding administrations, and it gives the Food and Drug Administration vast authority to take drugs off the over-the-counter sale.

Mr. BEAMER. In section 503, it has been pointed out before by some of the other witnesses, in the act itself, 503 (b) and two sections under that, and I am wondering why this does not permit the refilling at the present time. I am not an attorney, and I am wondering why that does not permit refilling.

Mr. CLUTTER. Is that 503 (b), even down to veterinarian and dentist?

Mr. BEAMER. Doesn't that permit a certain amount of refilling on that, going back to 502 (f)?

Mr. CLUTTER. It is our contention that it does, that this refers to a written prescription signed by a physician or dentist or veterinarian and then it provides that if a written prescription is received, drugs shall be exempt from certain requirements.

Mr. BEAMER. It has two sentences which seemed to answer the refillable clause, and I repeat again that I am not an attorney.

Mr. CLUTTER. We think that Congress had in mind, certainly when it wrote this section, the fact that drugs were refilled by pharmacists unless marked "nonrefillable."

Mr. BEAMER. You think sometimes the intent of Congress has been misinterpreted by administrators?

Mr. CLUTTER. That is right; and there is no place in the law which says that a prescription cannot be refilled, and this reference is made here to the writer marking the prescription "refillable," so that in our opinion Congress had in mind the traditional concept of the physiciandruggist in refilling a prescription, and no question was raised as to this matter until about 1947 when the Food and Drug Administration announced through speeches and articles that they considered a prescription once filled as like a cashed check, void from there on, and there still isn't any regulation on it, and it is our contention at Eli Lilly & Co. that prescriptions are still refillable.

Mr. BEAMER. Do you know by any chance the total number of drugs, as a wild guess, on the market today?

Mr. CLUTTER. The total number?

Mr. BEAMER. Does anybody know?

Mr. CLUTTER. Hundreds of thousands, but I don't know how many. Mr. BEAMER. How many of those do you think could be toxic, and could we venture another guess?

Mr. CLUTTER. No; I couldn't.

Mr. BEAMER. What I am trying to get at, how serious is this and of course, if there is one serious one, you would probably say it is worthy of careful scrutiny.

Mr. CLUTTER. I don't have any idea about how many are toxic, but I do know that under the present law the Food and Drug Administration has a right to require or enforce the law so that they are all adequately labeled.

Mr. BEAMER. And they probably have done an excellent job on that. Mr. CLUTTER. I think they have done an excellent job.

Mr. HESELTON. Before we conclude, I am going to make a request. I have read this article by Mr. Wheeler to which the witness has referred, on this problem of the prescription and refills. I think it is an excellent presentation and that it should be incorporated with the statement.

The CHAIRMAN. We will put it in the record at this point. (The matter referred to follows:)

[From the Food Drug Cosmetic Law Journal, November 1950]

PRESCRIPTION REFILLS

(By Walton M. Wheeler, Jr., secretary and general counsel, Eli Lilly & Co.) THE EDUCATIONAL RATHER THAN THE LEGISLATIVE APPROACH WILL CORRECT ABUSES IN REFILLING, STATES THE AUTHOR, WHO DECRIES THE CONTINUED DRIFT TOWARD ADMINISTRATIVE DRUG CONTROL

During the early years of the Federal Food, Drug, and Cosmetic Act, little was heard about the exemption from certain labeling requirements conferred by section 503 (b) in respect to drugs sold on prescription. This is now explained by the lack of any judicial precedent prior to 1948, recognizing the application of the act to retail transactions after the removal of the interstate label. Following the decision in the famous Sullivan case, holding that a retail druggist violated the act by removing tablets from an interstate package bearing the prescription legend and selling them over the counter in a pillbox containing no directions or warnings, the Food and Drug Administration announced through an address made by the Commissioner to the national convention of the National Associa1 American Druggist, March 1949, p. 79.

2 United States v. Sullivan, 332 U. S. 689 [CCH FOOD DRUG COSMETIC LAW REPORTS ¶ 7706].

tion of Retail Druggists in Atlantic City on October 1948 that all prescription refills violate the act unless specifically authorized by the physician. Since approximately 40 percent of all prescription business in the average pharmacy involves refilling, it is not strange that this revised interpretation of the law caused more than a ripple of consternation in the retail drug trade. The new policy in regard to refills was based upon the Administration's conception of the meaning of the word "prescription." Under that conception a prescription is the expression of the will of a physician that a particular person receive a particular quantity of a particular drug to be taken over a particular period of time. Accordingly, it is argued, when a pharmacist fills the original prescription he has discharged his responsibility. The original prescription in the files of the pharmacist is likened to a canceled check, and any refill thereof would be contrary to the will of the physician unless the physician specifically authorized it. Thus, any such unauthorized refill would be equivalent to a sale over the counter and the package would require labeling of the type necessary in connection with sales for unsupervised use. Under this theory it goes without saying that the nature of the drug is immaterial, the same rule being applicable to drugs commonly bearing the prescription legend as to those normally labeled with adequate directions for unsupervised use. In expanding upon this interpretation of the act, the Commissioner has suggested that, in respect of drugs not bearing the prescription legend, the pharmacist, if he does not desire to seek approval of a refill from the physician, may sell the drug over the counter under its interstate label or repackage it under his own label bearing equivalent information.3 In making this suggestion, the Commissioner recognizes that the new interpretation will embarrass pharmacists in their relationship with physicians.

Agreement between the Commissioner and the retail pharmacist in regard to this policy was confined to the proposition that the new policy caused embarrassment. In fact, the pharmacist was sufficiently embarrassed to take his problem to Congress and to seek a broad exemption for all products dispensed upon prescription or refills. That was the purpose of the original Durham bill and the Food and Drug Administration opposed it. After months of negotiations between the Food and Drug Administration and the National Association of Retail Druggists, the revised version of the Durham bill (H. R. 8904) was introduced on June 21, 1950.

PURPOSE OF DURHAM BILL

The Durham bill is intended to permit unlimited prescription refills of drugs which are safe for unsupervised use and to require specific authority from the prescribing physician in respect of refilling prescriptions for the following: 1. Habit-forming drugs.

2. New drugs, when the application becomes effective on condition that the drug be limited to prescription use.

3. Drugs, as designated by regulation after hearing, which can be used safely and effectively only under medical supervision.

The first question which naturally arises is whether this additional legislation is necessary. Admittedly, the present act, as interpreted by the Administration, is unsatisfactory, but some inquiry should be made into the soundness of the views of the Administration before assuming that the solution of the current problem requires additional legislation.

Before proceeding with this inquiry, it should be pointed out that neither the present section 503 (b) nor the Durham bill provides any exemption from section 502 (f) (1) which requires the labels of drugs to bear adequate directions for use. But this fact would seem to be immaterial. It is submitted that the directions specified in the prescription and copied on the prescription label are "adequate,' whether they relate to the original filling or a refilling of the prescription. They are adequate because they are specified by a physician for a particular patient. They need not be detailed. This view of the problem appears to be more realistic than the apparent view of the Administration that its regulations exempt prescription labels from the requirements of section 502 (f) (1) in respect to the original filling but not in respect to refills.

VIEW OF THE ADMINISTRATION

As previously explained in this paper, the view of the Administration is predicated upon its conception that upon the filling of a prescription the responsibility of the pharmacist is wholly discharged and the prescription itself is of no further

Drug Topics, April 11, 1949, p. 45.

4 H. R. 4203, introduced April 12, 1949.

validity except as a record of the transaction. Is the Administration correct in its contention that a prescription is an expression of the will of the physician that a particular patient receives a particular quantity of a particular drug to be taken over a particular period of time, and that a refilling of a prescription without specific approval of the physician is equivalent to a sale over the counter and is beyond the scope of the exemption conferred in section 503 (b)? The answer to this question may not be entirely free from doubt but most of the persuasive arguments appear to line up in opposition to the view of the Administration.

PRACTICE OF REFILLING RECOGNIZED BY CONGRESS

In the first place, the language of section 503 (b) shows affirmatively that Congress recognized the practice of refilling prescriptions. This is clear from the specific provision exempting prescription labels from bearing the "Warning-May be Habit Forming" statement (applicable to section 502 (d) drugs) if the prescription is marked nonrefillable or if its refilling is prohibited by law. This special provision for section 502 (d) drugs would not be necessary if the view of the Administration is correct that no prescription may be refilled without the approval of the physician. We should not assume that in writing this special rule for habit-forming drugs Congress was indulging in a futile pastime. On the contrary, we must recognize that Congress was well aware of the custom of refilling prescriptions, that it acknowledged the validity of this practice, and that it approved the refilling of prescriptions even for habit-forming drugs provided the warning statement was employed on the label. It is quite difficult, if not impossible, to understand the basis for the Administration's view in the face of the clear and plain language of section 503 (b).

PERCENTAGE OF REFILL BUSINESS

But there are other arguments. Of the total prescription business, approximately 40 percent represents refills.5 While the percentage may have been either lower or higher in 1938, when the act was passed, it was nevertheless substantial. The legislative history fails to assist in ascribing a meaning to the word "prescription" as used in the act, and Congress must therefore have intended that the word have the meaning usually and customarily ascribed to it in the appropriate professional channels. The percentage of refill business to total prescription business is adequate proof that it was customary in the pharmaceutical profession to regard prescriptions as refillable unless marked nonrefillable by the physician. This custom was apparently recognized by the Commissioner in explaining the new prescription policy."

VIEWS OF THE MEDICAL PROFESSION

From time immemorial it has been the practice of pharmacists to refill prescriptions unless otherwise directed by the physician. The medical profession has had knowledge of and, it must be assumed, has acquiesced in this custom. If this practice has resulted in the dispensing of medication not intended by the physician, it is the responsibility of the physician, not the pharmacist. The physician knows that a prescription marked "nonrefillable" will not be refilled. He is taught this in school and he is reminded of it in medical journals. Thus in the textbook Practical Therapeutics by Rehfuss, Albrecht & Price, in the section on prescription writing, the following rule appears:

"If you do not want a prescription refilled write on the prescription 'Ne Repetatur' or its abbreviation 'Ne Re' or simply in English 'Do Not Refill'. "

Again, in an article in the Journal of the American Medical Association by Dr. E. Fullerton Cook entitled "The Importance and Advantages of Prescription Writing in Medical Practice," the author savs,

"If a physician prefers that the prescription shall not be refilled except on his order. it is the common practice to add to the prescription the abbreviation Non. Rep. and this injunction will be honored by the pharmacist."

In Essentials of Prescription Writing by Cary Eggleston, M. D., Associate Professor of Clinical Medicine, Cornell University Medical College, the following language appears:

"The custom of having prescriptions refilled once or many times is very common, and it is highly advisable for the physician specifically to order that such

5 Drug Trade News. May 2, 1949, p. 20.

6 American Druggist, March 1949, p. 78.

7 Journal of the American Medical Association, Vol. 107, pp. 965, 967.

shall not be done in the case of dangerous drugs. Some physicians have such an order printed on their prescription blanks, but this is not necessary, as the writing of the words, ne repetatur, or the abbreviation, ne rep. in some conspicuous place on the prescription will prevent its being refilled."8

How can the foregoing facts and arguments be brushed aside? When the language of the present act recognizes that prescriptions are customarily refilled and when there is ample proof of an established custom recognizing this practice, how can an administrative agency reach a conclusion in complete variance with these facts? This is a question that the author cannot answer.

Perhaps an answer to the problem may be found in a study of the background and of the practical problems encountered in the routine enforcement of the act, with particular reference to enforcement at the retail level.

ENFORCEMENT OF THE ACT

Soon after the act became effective, retail pharmacists began to complain that drug manufacturers were avoiding their full labeling responsibilities by using the prescription legend on drugs having primarily, if not entirely, an over-the-counter sale. Under the regulations, retailers were forced either to decline to make the sale or to relabel the product with adequate directions for nonsupervised use. This situation led, in 1944, to the revision of the regulations under section 502 (f) of the act so as to restrict the use of the prescription legend to drugs which could not be safely or effectively used without medical supervision. The primary responsibility for selecting such drugs was left with the manufacturers, since the act conferred no authority upon the Food and Drug Administration to create classes of drugs or to specify the manner in which drugs of each class should be labeled and sold. But the implication and result of the regulations, when viewed in the light of the remaining subdivisions of section 502, presented the problem of whether a drug which, in fact, is safe and efficacious only when used under medical supervision, may be labeled for over-the-counter sale without running afoul of sections 502 (a), 502 (f), or 502 (j). It appears that the view of the Food and Drug Administration is that the act itself classifies drugs into counter items or prescription items on the basis of efficacy and safety following a factual determination on a case-by-case product-by-product basis. If this be the proper interpretation of the act, then obviously the law is basically a restrictive-sales law; that is, it controls not only the manner in which a drug is labeled but the exact manner in which it must be sold. Surely, if this be the proper interpretation of the act, no one should be more surprised than Congress. The battle for the enactment of the act is portrayed in volumes of committee hearings, committee reports, and congressional debates, and in countless early drafts of the act. All of this material seems to support the conclusion that Congress assumed and intended that a drug consumer would receive adequate protection if the label told him what he was taking, how to take it, and when to stop. This is borne out by the oft-repeated quotation from the report of the Senate committee on S. 5: "The bill is not intended to restrict in any way the availability of drugs for self-medication. On the contrary, it is intended to make self-medication safer and more effective. For this purpose provisions are included * * * requiring that labels bear adequate directions for use and warnings against probable misuse * * *

Accordingly, there is little to support the view that anything in the act or in its legislative history requires drugs to be divided into two classes, the one class for distribution over the counter directly to consumers and the other class for distribution on prescription only. Therefore the present regulation which, by implication if not directly, requires the use of the prescription legend on drugs that may be used safely and effectively only under medical supervision is of questionable validity.9

WISDOM OF ADMINISTRATIVE POLICIES

Yet, in the enforcement of the act, the Administration undoubtedly encounters daily instances in which consumers are injured as a result of the use of drugs without medical supervision. These instances probably involve true over-thecounter sales and prescription refills of so-called dangerous drugs. Possibly to combat this evil the Administration has announced its policy on prescription refills and has taken the view that drugs bearing the prescription legend cannot be

8 Essentials of Prescription Writing, pp. 106, 107.

For an excellent discussion of the validity of the regulations under Section 502 f (1) see Williams, “Exemption from the Requirement of Adequate Directions for Use in the Labeling of Drugs," 2 Food Drug Cosmetic Law quarterly 155 (1947).