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be done by adding at the end of the language dealing with refilling of prescriptions the following clause: or if the drug is commonly sold or dispensed without the necessity of a prescription. The problems in the refilling of prescriptions affecting the physician or dentist and pharmacist and patient could be further simplified by the use by the physician or dentist at the time of writing the prescription of a prescription blank which would bear upon it the following:
Renew O 2 * or in lieu thereof, the following:
Do Not Renew o Renew
Renew 30 Section 503 (b): Insofar as it establishes a procedure for enabling an interested person to file with the Administrator a petition proposing the addition to, or deletion from, the list of drugs promulgated by the Administrator in accordance with clause 2, obtain a hearing and appeal from the decision of the Administrator, the proposed legislation presents a cumbersome and expensive means of relief, desirable only in the event that clause 2 is enacted.
The CHAIRMAN. If there are no questions we will recess at this time. We thank you very much for your statement and the committee will stand adjourned until 10 o'clock tomorrow morning.
Before adjourning, however, we will insert in the record at this point the statement of Mr. Horace Walker, the executive secretary of the District of Columbia Pharmaceutical Association, and also the statement of Abbott Laboratories.
(The statements referred to follow:)
STATEMENT OF HORACE WALKER, EXECUTIVE SECRETARY, DISTRICT OF
COLUMBIA PHARMACEUTICAL ASSOCIATION My name is Horace Walker and I am the executive secretary of the District of Columbia Pharmaceutical Association in whose behalf I appear here today.
The District of Columbia Pharmaceutical Association represents pharmacy and the drug industry throughout metropolitan Washington, both the independent retailer and chain stores, similar in scope to State associations throughout the country.
I should like to point out that we enjoy an enviable record throughout the United States in the field of pharmacy as revealed in the latest United States Census Bureau figures. These figures indicate that druggists in the District of Columbia topped the entire Nation with a per store average of $171,769—this in contrast to the second largest State-per-store average of $130,000 per store in Nevada.
Furthermore, the District of Columbia jumped ahead of 31 States in total drugstore-dollar volume. It is interesting to note, at this point, that figures just released indicate that the average family income in the District of Columbia also topped the Nation for 1950 with an all-time high of $4,130 per family—25 percent higher than the national average.
It is the consensus of opinion among pharmacists in this area that relief from the present state of confusion regarding the handling of prescriptions can best be accomplished through the enactment of H. R. 3298 or S. 1186—the DurhamHumphrey bill.
Our legislative committee, the executive committee and officers of the District of Columbia Pharmaceutical Association, have given this bill considerable study and hereby wish to go on record as thoroughly endorsing this bill; furthermore, we recommend passage of the bill at the earliest possible date. It is believed that the provisions of the new bill relative to:
(1) The sanctioning of telephone prescriptions without subsequent confirmation in writing by the prescriber;
(2) Proposed new regulations clarifying the procedure in refilling prescriptions, and;
(3) The provision whereby the Food and Drug Administration will make the decisions as to whether a given drug or preparation is to be sold only on prescription or over-the-counter without prescription. At present, this
determination is made capriciously often by the manufacturer. are in the interest of better pharmaceutical practice and service to the public, we therefore, heartily endorse H. R. 3298, and once more, wish to go on record as favoring its early passage.
STATEMENT OF PAUL GERDEN, GENERAL ATTORNEY AND AssisTANT SECRETARY,
ABBOTT LABORATORIES, CHICAGO, ILL. Abbott Laboratories has always been desirous of cooperating in any revision of the Federal Food, Drug, and Cosmetic Act which enables the Food and Drug Administration to protect the public health more adequately. The revision under consideration, H. R. 3298, merits scrutiny in order to determine whether its objective and subsequent operation will so benefit the public. This amendment to section 503 (b) of the Federal Food, Drug, and Cosmetic Act in general modifies the existing law by, first, making specific provisions relative to refilling of prescriptions, and second, by vesting in the Federal Security Administrator authority to determine which drugs may be sold without a prescription and which drugs may be sold only on a prescription basis.
The problem relating to refilling of prescriptions is of primary interest to physicians and pharmacists, and comments on these provisions should come from members of these professions. However, the provision which empowers the Federal Security Administrator to determine the items which may be sold solely on a prescription basis is of direct interest to drug manufacturers as well as the public and the medical profession. To this provision we, as drug manufacturers, are unalterably opposed. The following sets forth the reasons for our opposition to this provision of H. R. 3298.
I First, it has not been demonstrated to our satisfaction that there is any need for such a revision of the procedure for determining which drugs are to carry the prescription legend.' We have heard it alleged by the proponents of this amendment that (1) the drug manufacturers are presently using the prescription legend indiscriminately, (2) that this present type of labeling is creating confusion among the druggists, and (3) that “thousands of items” will, as a result of this amendment, be available for sale “over the counter" which are now sold only on a prescription basis.
Under the present law the drug manufacturer is charged with the primary responsibility for adequate labeling of its products. The Federal Security Administrator has provided by regulation that drugs which may not be used safely and efficaciously without medical supervision must carry the following prescription legend: "Caution: To be dispensed only by or on the prescription of a physician.' The manufacturer, in discharging its responsibility for proper labeling, consults with competent pharmacologists, qualified medical advisers, and, in many cases, the American Medical Association Council on Pharmacy and Chemistry, and the Food and Drug Administration in order to determine whether the product should carry the prescription legend or whether it may be sold without restriction. under the present law, the Food and Drug Administration comes to the conclusion that the label of a given drug does not indicate the appropriate mode of dispensing, the act provides the Administrator with ample authority to correct such a situation.
We are not surprised that exhibits can be presented showing instances of variations in labeling between different manufacturers of the same drug. However, the variation is no greater or more frequent than the difference in honest medical and pharmacological opinion, or legal opinion as to the meaning of the regulations. When it is considered that the problem of proper labeling involves the concentrated effort of many experts, minor variations may occur.
Nor are we inclined to accept the view that the present type of labeling is creating confusion among the druggists. Every druggist is, or should be, familiar with the requirement that if a drug carries the exact prescription legend provided for in the regulation it may then be sold only upon the written prescription of the physician. If a drug does not carry this exact prescription legend it may then be sold without a prescription. If the druggist makes a sale of a product that does not carry the exact prescription legend and the drug is sold as packaged and labeled by the manufacturer, any resulting charges of misbranding rest, under the present act, with the manufacturer rather than the druggist.
It is further reasoned by the proponents of this measure that if this provision is enacted “thousands of items' will be added to the list of drugs which may be freely sold without the necessity of a prescription. By what process this is to be accomplished without endangering the public health has not been disclosed. As previously indicated, the drugs which now carry the prescription legend do so because the manufacturer deems it necessary in the interest of public health thus to restrict their distribution.
Our second basic objection to this provision is that the proposed bill does not meet the problems which have been advanced as necessitaiing its enactment. As far as we can see, H. R. 3298 contains no provision which would enable the Administrator to bring about the elimination of any of the alleged cases of confusing label statements with greater ease than is already possible under the provisions of the present act. the Administrator now believes that certain drugs are labeled in a manner which produces confusion to the pharmacist and thereby endangers the public, he has ample authority under the present act either to issue clarifying regulations or to correct the situation through court action.
Our third objection is that this provision is basically unsound and appears to constitute a substantial step toward the Government control of medical practice. This provision reverses the philosophy of the present law in that it transfers the primary responsibility of determining which drugs are to be available for selfmedication and which drugs are to be used under medical supervision from the medical profession and the drug manufacturer to the Government. The determination as to the availability of drugs for self-medication should be continued as in the past, for by what reasoning can it be said thai the decision of an administrative body as to the availability of self-medication should be substituted for the determination of this factor by the medical profession? Certainly such administrative decisions would border on the control of the practice of medicine and this very fact was recognized by the Food and Drug Administration in its Trade Correspondence No. 356 which stated: The
act, however, is not intended to regulate the practice of medicine.
You must, therefore, reach a decision for yourself as to whether or not you will recommend the sale of these items and preparations of them for prescription use.
It is also provided in this proposed amendment that appeals from determinations and orders of the Federal Security Administrator are to be made to the circuit court of appeals and such appeals shall be in the nature of a trial de novo. This requires the members of an appellate tribunal to make factual determinations on the technical aspects of safety and efficacy of drugs. The Federal Food, Drug, and Cosmetic Act, and regulations issued thereunder should continue to provide objective standards to which the manufacturer and other persons must conform and under which performance is susceptible of judicial appraisement.
Our final objection is directed toward the implications of the phraseology of this provision, as it unduly extends without a corresponding public need the authority of the Federal Security Administrator. As an example, we mention the logical interpretation which must be given to subsections (b) (2) and (b) (3) when considered in connection with section 505 of the present act. Section 505, the new drug provision, now requires the Administrator to review and pass upon the data presented in reference to the safety of a new drug. Considering subsections (b) (2) and (b) (3) of the proposed amendment concomitantly with section 505, efficacy of use must be given equal consideration with safety of use whenever a new drug application under section 505 is presented to the Administration.
We, therefore, reiterate our opposition to this provision in the proposed amendment to the Federal Food, Drug, and Cosmetic Act. If, in the intereso of public health, this commiiiee deems iö necessary to make revisions in the presenü law relating to che refilling of prescripcions, and subject to the approval of ühe inierested professions, we have the termiiy to suggest that section 503 (b) be amended as indicated in the proposal which we have furnished to ühe clerk of this commiuiee.
In conclusion, we wish to indicate chat ühe Food and Drug Administration, less than 3 years ago, recognized ühe impracöical nature of such a provision as is now proposed, for in response io che requesů "Please send us a list of drugs which may be legally sold on prescription,” Mr. A. C. Murray of that agency soated:
“Obviously, no list of drugs falling inčo the category in quesóion is feasible; and if ic were atempted the list would need amendment daily. Fortunačely, ühe retail pharmacist, by reason of his craining, is in a posicion to reach an intelligent conclusion with respeco to any particular item; and manufacturers of drugs very generally are guiding him by supplying direcüions for use in the labelings of the medicines he sells over ühe counöer, or are conspicuously marking the packages with the legend 'Caution: To be dispensed only by or upon the prescripcion of a physician'" (3 FDC Law Quarterly 194, 203). A BILL To amend section 503 (b) of the Food, Drug, and Cosmetic Act of June 25, 1938, as amended
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That subsection (b) of section 503 of the Federal Food, Drug, and Cosmetic Aci, as amended, be amended to read as follows:
"SEC. 503. (b) A drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 502, except paragraphs (a), (i) (2) and (3), (k), and (1), and the packaging requirements of paragraphs (g) and (h), if the drug bears a label containing the name and address of the dispenser, the serial number and date of che prescription, or of its filling, ühe name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in ühe course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or otherwise without examination of the patient. If the drug is intended for use by man and, for ühe purposes of this Act, bears on its label, a statement that it is to be dispensed only by or on the prescription of a physician or dentist; such exemption shall apply only if such drug is dispensed upon a written prescription of a practitioner licensed by law to administer such drug or upon an oral prescription of such practitioner which is reduced to writing and filed by che pharmacist, or is dispensed by refilling a prescription if such refilling is authorized by the prescriber in the original prescription or by oral order and such order is reduced to writing and filed by the pharmacist.
"The act of dispensing a drug contrary to the provisions of this subsection shall be deemed to be an act which results in the drug's being misbranded while held for sale."
(Thereupon an adjournment was taken until 10 a. m., Saturday, May 5, 1951.)
FEDERAL FOOD, DRUG, AND COSMETIC ACT
SATURDAY, MAY 5, 1951
HOUSE OF REPRESENTATIVES,
Washington, D. C. The committee met at 10 a. m., Hon. Robert Crosser (chairman) presiding
The CHAIRMAN. The committee will come to order.
First, I would like to put into the record a statement by Mr. James G. Flanagan, counsel and legislative chairman of the drug, chemical, and allied trades section of the New York Board of Trade.
(The statement referred to is as follows:) STATEMENT OF JAMES G. FLANAGAN, COUNSEL AND LEGISLATIVE CHAIRMAN OF
THE DRUG, CHEMICAL, AND ALLIED TRADES SECTION OF THE NEW YORK BOARD OF TRADE
My name is James G. Flanagan. I am counsel for and chairman of the legislative committee of the drug, chemical, and allied trades section of the New York Board of Trade. I am also vice president and general counsel of S. B. Penick & Co. of New York, manufacturers of bulk drug and chemical products.
The drug, chemical, and allied trades section is composed of over 700 drug and chemical manufacturers throughout the country representing a cross section of these industries. I might add that I am not paid for my work as counsel for the section or for representing it.
It is appreciated that the complex Federal Food, Drug, and Cosmetic Act and regulations promulgated thereunder have created problems for all concerned with the supplying of drugs and medicines and that all regulation required in the public interest is to be and is wholeheartedly supported by the drug and chemical section and the manufacturers and distributors of these products which comprise its membership
The objective of the bill under consideration is primarily to relieve the confusion which the retail pharmacists claim to have encountered as the result of the official interpretation of the act in respect to the refilling of prescriptions and the lack of uniformity on the part of drug manufacturers in distributing the same or similar drug products either on a prescription basis or over the counter with directions for use.
Our section does not believe that H. R. 3298 would accomplish the objective and hence does not support the bill for the following reasons:
As the result of the Sullivan case (332 U. S. 689) it is unlawful for a pharmacist to dispense drugs received by him after interstate shipment, labeled by the manufacturer to be sold on prescription only, except on the written prescription of a doctor, dentist, or veterinarian.
At present, under the law and regulations, the manufacturer has the responsibility of determining whether the individual drugs which he manufactures are to be prescription drugs or not but, generally speaking, the toxic and potent drugs are required by the regulations promulgated by the Food and Drug Administration to be sold on prescription only.
The Food and Drug Administration has taken the position that once a prescription for a drug has been filled, it is illegal under the present law for the druggist to refill such a prescription even though the prescribed drug may be one which may be freely sold over the counter under the directions for use with which it was labeled by the manufacturer.