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Mr. DOLLIVER. In that way you differ from the National Retail Druggists Association, I take it?'

Mr. FISCHELIS. They are all drug-store owners.
Mr. DOLLIVER. In that association?
Mr. FISCHELIS. Yes,
Mr. DOLLIVER. But not in yours?
Mr. FISCHELIS. No.

Mr. DOLLIVER. Your membership covers all branches of the trade from the manufacturing to the final distribution to consumers?

Mr. FISCHELIS. That is correct. About 75 percent of the membership is made up of practicing pharmacists in retail pharmacies and hospitals: 1.6 percent are Government pharmacists; 3.2 percent are teachers; 1.2 percent are wholesalers; 3.4 percent are manufacturers; 4 percent are research or control chemists. Then there are about 12 percent who are in miscellaneous activities. That is to say, they may be drug-store owners or practicing pharmacists and also secretaries of State pharmaceutical associations or something of the sort. They have mixed employment. Then in addition to the active members, which number about 15,000, we have about 10,000 associate student members who are in the colleges of pharmacy today. That is more than half of the student population in pharmacy colleges. They are located in 66 colleges of pharmacy throughout the United States.

Mr. DOLLIVER. Well, now, does your membership include those pharmacy practitioners or experts who deal in veterinary medicines and veterinary products?

Mr. FISCHELIS. To some extent.
Mr. DOLLIVER. I suppose that is a rather small minority, is it not?
Mr. Fischelis. Yes. There are relatively few firms that specialize

FISCHELIS in veterinary remedies. Most of the larger manufacturing houses also make remedies for veterinary use.

Mr. DOLLIVER. Would your membership include the people who deal or manufacture serums as distinguished from pharmaceuticals?

Mr. FISCHELIS. Yes; it does.
Mr. DOLLIVER. I yield.
Mr. HESELTON. I would like to make one request.

I notice from Mr. Schaefer's statement that the association submitted certain comments on the proposed ruling. Would those comments be available so that we can have them?

Mr. Fischelis. Yes; we will be glad to have that entered.
Mr. HESELTON. Then you will supply us with that?
Mr. FISCHELIS. I will be glad to supply that.
Mr. HESELTON. I was referring to this pronouncement.
Mr. Fischelis. Yes; I understand.
(The following information was later supplied:)

ARNOLD, FORTAS AND PORTER,

Washington, D. C., August 31, 1950. Hon. Oscar R. EWING, Administrator, Federal Security Agency,

Washington, D. C. DEAR MR. Ewing: We, the undersigned, as attorneys for the American Pharmaceutical Association, respectfully ask 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 is made in the name of the association, of its 13,000 active and 10,000 associate members, and of the public whose health it is the very purpose of the Food, Drug, and Cosmetic Act to safeguard; and we feel sure that, after reading the reasons which

prompt this demand-as set forth in the paragraphs below-you will agree that such a hearing is imperative. It should be held at the earliest date consistent with due notice and the kind of preparation essential to a probing inquiry. The best time seems to be sometime between the 1st and the 15th of October.

1. This request for a hearing is put forward, not in a hostile, but in a friendly spirit. The American Pharmaceutical Association is a professional, not a trade or industrial, association. Pharmacy, going back to the apothecary of old, ranks among the most ancient of our professions. Its exact training and its demand for competence on the part of its practitioners goes back to the Middle Ages. Its code of ethics since time immemorial has made the profession of pharmacy an instrument of the public health. In medical practice the pharmacist's office is second only to that of the physician; in fact the success of the physician's ministrations depends upon the complete integrity with which the pharmacist does his work. There is no need here to remind you of the support which the association and its members have given to the Food, Drug, and Cosmetic Act, and of their cooperation at all times with the officials in charge in an endeavor to make the administration of that act a success. This, their first formal protest, is

prompted by a genuine conviction that, in respect to the refill of prescriptions, the Food and Drug Administration is usurping a power not given to it by the act; that it seems to be giving effect to a policy which it has not formulated into a directive or a regulation; and that, as matters now stand, there is no authoritative statement to guide pharmacists in the practice of their profession. Let us be specific.

2. The Food, Drug, and Cosmetic Act.—which we shall hereafter refer to as the Act—is a code of law applicable within the domain of commerce among the the several States which, in the dispensing of drugs and medicines, aims to protect the public health. Section 502 of the act, especially subsections (b), (c), and (e), contains provisions designed to secure the accurate labeling of all dispensed drugs. Section 503 (b) is concerned with prescriptions issued by licensed physicians and sets down the conditions upon which such medicines, dispensed at the prescription counter, shall be exempt from the requirement of section 502 in respect to labeling. In plain and unmistakable language it recites that labels stating ingredients, amounts, and like information are not required if the physicians issuing the prescriptions are properly licensed to administer such drugs and if the drugs dispensed bear labels containing the name and place of business of the dispenser, the serial number and date of such prescription, and the name of the prescribing physician. Such is the exemption from the requirements of section 502 (b) and (e). If, however, the drug belongs within a class which falls under the prohibitions of section 502 (d), the exception applies only to the original filling of the prescription; it does not apply "in case such prescription is marked by the writer thereof as not refillable or its refilling is prohibited by law.” The Congress, in enacting section 503 (b) had in mind the custom which prevails in the medical professions in respect to refilling; the Congress is presumed to intend the plain meaning of its words. In respect to prescriptions marked "not to be refilled” or those where refilling is prohibited by law, the Congress formally withdrew from the refill the exemption privilege. In respect to ordinary prescriptions, not containing

proscribed drugs, the Congress made no such withdrawal of the exemption. The meaning of the statutory language is beyond peradventure.

3. Yet, in disregard of the accepted principles of statutory interpretation, the Food and Drug Administration has formulated—and has moved to put into effect -an “interpretation” by which the exemption from labeling granted by section 503 (b) is withdrawn from all refill prescriptions. Thus, in a widely circulated address before the National Association of Retail Druggists, Commissioner Paul B. Dunbar insisted that no prescription should be refilled except by the will and purpose of the prescribing physician, which must be attested in writing. In supplement thereof, Mr. Edgar A. Reed, an official of the Food and Drug Administration, in an article entitled “Refilled Prescription Cases,” reiterates that a prescription is a single order and is not to be refilled. Even as mere expressions of personal views, such utterances from high officials have something of a mandatory quality with pharmacists in general and are taken for something more than unofficial interpretation of the law. But in a number of ways and by diverse means—for which there is no space_here but which the association is prepared to present at a formal hearing—the Food and Drug Administration has caused it to be generally known that the statements of Dr. Dunbar and Mr. Reed represent its official view.

4. It is true that as yet these views have found expression in no official directive or regulation. It is also true that as yet no proceeding has been instituted against a pharmacist for the refill of an ordinary prescription. In fact, evidence gathered

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by the association indicates that the Food and Drug Administration is attempting to secure conformity of the profession to the unofficial views of Dr. Dunbar and Mr. Reed without recourse to a formal mandate. Evidence of a gradual trespass upon territory which the law has given it no authority to enter is the appearance in the list of violations of a new classification, namely, “barbiturates sold and original prescriptions refilled without physicians' orders.” The grouping together of the two unlike things—the doing of an unlawful thing and the doing of an act innocent in the eyes of the law-is eloquent testimony to the attempt of the Administration to usurp power, indirectly.

As a result of this trespass, a state of confusion has been created in the profession. The pharmacist knows that the views of Dr. Dunbar and Mr. Reed are not a correct interpretation of the law. He knows that they run directly contrary to the usages of the profession from time immemorial. He is no lawyer; yet he knows that, in the discharge of his public office, he is entitled to a clear-cut statement of his rights and responsibilities. He knows he is not getting it; and, in its absence, he is disposed to play safe. So an enormous amount of mischief is resulting from a policy, which bears the appearance of being official, yet has never been put into the form of a mandate. Patients are being denied refills of ordinary and harmless prescriptions; physicians are being disturbed by useless visits and telephone calls. The ancient liberties of the profession of pharmacy are being abridged without resort to anything even approaching due process of law. The pharmacist, under hazard of prosecution, must live up to what officials-who will not put their interpretation into the form of an order or directive--insist is the meaning of the law.

5. We are persuaded that the interpretation of section 503 (b) now rapidly becoming official is not the law. We are persuaded that the views of Dr. Dunbar and Mr. Reed derive no sanction or support from the act. We are persuaded that their logic is wrong, their analysis faulty, their reasons not valid. But this letter is not the place to argue these matters. These differences can be resolved, and the issues here presented clarified, only in a hearing open to all parties in interest and only through a searching inquiry. It hardly needs arguing that the Administrator of the Federal Security Agency has the authority to call such a hearing, at which he himself or his designated deputy will preside. He is endowed with all the power necessary and proper to the administration of his supervisory office. Hearings are habitually held in respect to matters of less consequence to the interests involved and to the public. Nor is it necessary to argue the right of an ancient profession, whose liberties are being irresponsibly invaded, to a hearing and to a definition of the rights and obligations of its members. The vital interest of the public in the refill of ordinary prescriptions, which contain no drugs which fall under the prohibition of the law, does not need to be pointed out.

6. Here is no mere routine administrative matter. For the Food and Drug Administration to overrule the will of the Congress, and to outlaw the refilling of prescriptions which contain no outlawed drug, is a serious matter. Even if the Administration had the power to issue such a mandate, it should act only after careful inquiry and in the light of the probable consequences of its act-a matter which has been little explored. This is no place to resolve prescriptions into their secret clauses and to determine the effect of such a mandate upon each. But, to cite obvious examples, why should the refill of a prescription designed to compensate for a constant deficiency be denied? Or why should the relation of doctor and patient be disturbed when a medicine is to be taken upon the recurrence of a contingency under instructions which are perfectly clear? In fact, the great mass of ordinary prescriptions can do little, if any, harm. To forbid refills is to vex doctors with unnecessary phone calls, to force upon the high cost of medical care the extra expense for unneeded visits to doctors. It will for a certainty lead to a substantial shift from physicians' prescriptions to over-the-counter sales. These and a series of like consequences need to be explored in detail before any mandate is issued-and officials should not state “the law” in advance of—or in the absence of-its definition.

7. The hearing may, or may not, be called to take testimony in respect to a proposed order, directive, or interpretation. It may be advisable to call the hearing for the purpose of objectively and thoroughly inquiring into the whole issue of refills. Such a call would be the best of evidence that the Administration is approaching the issue with an open mind. In case it is deemed a necessary formality, we enclose a copy of a proposed interpretation which should serve as a basis for discussion. It is written in simple language easily understood by persons not versed in the law. It does little more than translate into easier language what is already plainly written in section 503 (b).

We need hardly add that the American Pharmaceutical Association is as much concerned as any member of your official family in suppressing all unauthorized sales of drugs which carry a threat to the public health. Here it will in the future, as it has done in the past, give full support to every effort, of the Food and Drug Administration to stop such traffic and to have the penalties of the law visited upon those who transgress its commands.

A word in conclusion. The rights for which we here contend rest upon a foundation far more ancient, and are secured by a document far more authoritative, than the Food, Drug and Cosmetic Act itself. If your procedure requires it, we will be glad to convert this rather informal demand for a hearing into a formal motion. But we much prefer that you, as the Administrator, issue the call for the hearing on your own initiative. Such a move is more in keeping with the close and informal relationship which for many years has existed between your Agency and the American Pharmaceutical Association. With all good wishes, believe us to be Sincerely yours,

THURMAN ARNOLD

WALTON HAMILTON. (Docket No.

-) Re the Refill of Physicians' Prescriptions. ORDER, INTERPRETING SECTION 503 (B) OF THE FOOD, DRUG, AND COSMETIC Act

By virtue of the authority vested in the Federal Security Administration by the provisions of the Food, Drug, and Cosmetic Act, and upon the basis of substantial evidence received at the hearing duly held pursuant to the notice published in the Federal Register on September —, 1950 (F. R. —), and upon consideration of all the matters submitted at that hearing, it is ordered:

I. That section 503 (b) of the Food, Drug, and Cosmetic Act, is to be interpreted as follows: 1. No prescription can lawfully be refilled

(a) if it is marked by the issuing physician, dentist, or veterinarian as not to be refilled; or

(b) if it contains a drug or drugs which fall under the prohibition of section 502 (d) of the Food, Drug, and Cosmetic Act, unless the drug is "a preparation of limited narcotic content,” as defined in section 2551 of title 26, United States Code (the Harrison Anti-Narcotic Act) or the amount of the drug or drugs in a preparation thereof is insufficient to class it as habit-forming, as

determined by the Administrator. 2. Any other prescription of a physician can lawfully be refilled

(a) if the issuing physician, dentist, or veterinarian is authorized by law to administer such a drug, and

(b) if such a prescription when refilled bears a label containing the name and place of business of the dispenser, the serial number and date of such prescription, and the name of such physician, dentist, or veterinarian. II. This interpretation is in strict accord with the intent of the Congress, the plain and unmistakable meaning of section 503 (b) of the statute in question, and the ancient usages of the medical and pharmaceutical professions.

FEDERAL SECURITY AGENCY,

Washington, December 4, 1950. THURMAN ARNOLD, Esq., WALTON HAMILTON, Esq., Attorneys for thé A. Ph. A.

Ring Building, Washington, D. C. GENTLEMEN: After consideration of the arguments and data submitted at the meeting in my office on October 5, 1950, I have concluded that section 503 (b) of the Federal Food, Drug, and Cosmetic Act provides no basis for a regulation such as you proposed to exempt all prescription refills, except for habit-forming drugs and refills made though the prescription was marked not refillable, from all of the labeling requirements of section 502.

I am convinced, however, that there is confusion as to when a prescription may be refilled. Refillings can be exempted from the requirement that their labeling bear adequate directions for use (Section 502 (f) (1)) upon a finding that directions are not necessary for the protection of the public health.

I am proposing to make such a finding with respect to the refilling of prescriptions for over-the-counter drugs. No such finding can be made as to refilling of prescriptions for drugs in the class covered by 21 CFR 1.106 (b). The latter class includes drugs which, because of toxicity or other potentiality for harmful effect or the method of use or the collateral measures necessary to use, are not generally recognized among qualified experts as safe and efficacious for use without professional supervision. To that end, I have signed and forwarded for publication in the Federal Register a notice of proposed rule making. All interested persons are invited to submit written comments within 30 days after publication. In view of these considerations, I am denying your request for a hearing. Sincerely yours,

/s/ OSCAR R. EWING, Administrator.

[From the Federal Register, Wednesday, December 6, 1950)

PROPOSED RULE MAKING

FEDERAL SECURITY AGENCY

FOOD AND DRUG ADMINISTRATION

(21 CFR, Part 1) DRUGS AND DEVICES: DIRECTIONS FOR USE

NOTICE OF PROPOSED RULE MAKING

use.

By virtue of the authority vested in the Federal Security Administrator by the provisions of sections 502 (f) and 701 (a) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1051, 1055; 21 U. S. C. 352 (f) and 371 (a)), it is proposed that Sec. 1.106 be revoked and a new Sec. 1.106 be added to read as follows: Sec. 1.106 Drugs and devices; directions for use--(a) Adequate directions for

This phrase means directions under which the ordinary individual can use a drug or device intelligently, safely, and effectively. Directions for use may be inadequate because (among other reasons) of omission, in whole or in part, or incorrect specification of:

(1) Statements of all conditions, purposes, or uses for which such drug or device is intended, including conditions or purposes for which it is prescribed, recommended, or suggested in its advertising sponsored by its manufacturer, packer, distributor, or seller or conditions or purposes for which the drug or device is commonly 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) Exemption for prescription drugs and devices. A drug or device which, because of 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 qualified experts as safe and efficacious for use otherwise than by or under the supervision of a physician, dentist, or veterinarian shall be exempt from section 502 (f) (1) if all of the following conditions are met:

(1) The drug or device is to be dispensed by physicians, dentists, or veterinarians in their professional practice, or upon written prescriptions issued in their professional practice with labeling bearing the directions specified in such presscriptions;

(2) Information as to the safe and effective use of the drug or device by physicians, dentists, or veterinarians is available to them in widely disseminated scientific literature or in brochures supplied to them;

(3) The label of the drug or device (other than surgical instruments and other devices used exclusively in the professional practice of physicians, dentists, or veterinarians) bears the statement:

“Caution: To be dispensed only by or on the prescription of a the blank being filled with one or more of the words "Physician", "dentist”, or "veterinarian”.

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