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The CHAIRMAN. I believe that concludes our hearing for today.
Mr. HALE. Was this legislation approved unanimously by your council?
Mr. FISCHELIS. Do you mean the bill? Mr. HALE. Yes; H. R. 3298. Mr. Fischelis. It has been approved with the modifications that I have offered here.
Mr. Hale. I know that; but was the council of the American Pharmaceutical Association unanimous in its recommendations?
Mr. FISHELIS. Yes, sir.
Mr. HALE. Is it not true that there are a great many drug stores in the country that don't have any prescription departments at all?
Mr. FISCHELIS. I would not say that there are a great many, Mr. Hale. There may be a few, but the vast majority of the approximately 54,000 have prescription departments. Some of them do not fill very many prescriptions, but practically all have prescription departments. There are a few that have done away with their prescription departments. But in most States they wouldn't be able to get a license for their establishments under such conditions.
Mr. Hale. The people who fill the prescriptions are supposed to be and they are, in fact, are they not, highly trained men?
Mr. FISCHELIS. Exactly.
Mr. HALE. Who have to work to receive their license, the same as a doctor or a dentist?
Mr. FISCHELIS. That is right.
Mr. Hale. You say that as far as the prescriptions are concerned, there should be no limitation at all in the law on the oral giving of prescriptions?
Mr. FISCHELIS. We think that should be left entirely to the pharmacist and the physician ordering the prescription. If a pharmacist gets a request for a renewal of a prescription, and he is not satisfied with what the patient says, that is, that the prescription is authorized by the physician, he should verify the authorization.
Mr. Hale. I am not talking about renewals. I am talking, now about the prescription in the first instance.
Mr. Fischelis. Well prescriptions, in the first instance, of course, are presented by the patient, and the pharmacist, of course, has to assume that they are bona fide unless there is something wrong that is readily discerned.
Mr. Hale. Suppose that Dr. X calls the pharmacist and says, “Will you kindly send around to John Jones, residence No. so-and-so Smith Street, a compound containing such-and-such ingredients.” Does the pharmacist in that case make sure that the man who purports to be the doctor is the doctor? Of course, there are all kinds of elements of chance in that transaction.
Mr. FISCHELIS. If he has any doubt about it, he will verify the call immediately after the call has been made. That is a common practice with careful pharmacists.
Mr. HALE. But suppose the doctor is unprincipled. There are such things as unprincipled physicians. The physician may not be
Mr. FISCHELIS. Are you referring to page 2 of my statement or to page 2 of Dr. Schaefer's statement?
Mr. HELLER. Your statement. On that page you talk about the pronouncement that no prescription written by a medical practitioner, once filled, was to be refillable by the pharmacists.
Mr. Fischelis. That is the interpretation that was given by the Commissioner and, as far as the pharmacists are concerned, it is supposed to have the force of law.
Mr. HELLER. Has that been reduced to a ruling, and does it appear in the Register as of today?
Mr. FISCHEIIS. It has never been reduced to a ruling, and it has never appeared in the Federal Register. That is the reason the American Pharmaceutical Association asked for an official ruling to cover this interpretation.
Mr. HELLER. And you are awaiting that, as I understand it, according to the statement of Dr. Schaefer?
Mr. FISCHELIS. That is right.
Mr. HELLER. Now do not all physicians' prescriptions contain the letters “N. R."'?
Mr. FISCHELIS. No, sir. They contain those letters only when the practitioner specifically wants to direct a pharmacist not to renew the prescription.
Mr. HELLER. Well, my recollection is that every prescription blank has that printed right on it.
Mr. FISCHELIS. No, sir.
Mr. FISCHELIS. There are physicians who occasionally have a statement like that printed on their prescription blanks, but they are very, very few.
Now I might also say that at present there is no official prescription blank, the matter of printing certain directions to pharmacists on the prescription blank with "boxes” in which the physician can check how often he wants a prescription to be renewed has been suggested but expecting the physician to use this system just does not work out any more than the furnishing of a copy after 72 hours does. Physicians just will not do that. They have confidence in their pharmacists, and they usually have an understanding with them as to how renewals are to be handled.
If I may make one additional remark, Mr. Chairman, you have to bear in mind that all prescriptions do not call for ready-made products. There are many prescriptions—at least 30 to 40 percent of the prescriptions that are received by pharmacists-which require compounding by the pharmacist. It should also be noted that in many cases, physicians have direct telephone lines to the prescription departments of pharmacies, and the telephoning of prescriptions is a continuous process, and the dictation of the prescription over the telephone is always repeated to avoid errors.
Every pharmacist that I know of, who receives prescriptions over the telephone for dangerous drugs, and who has any doubt about the authenticity of the voice at the other end of the telephone, always makes sure to call back the doctor to check as to whether or not he just telephoned such prescription. That is a common practice with the careful pharmacists.
Mr. HALE. Then really your answer to the whole thing is that pharmacists are a pretty good lot. I hope you are right. As far as my experience goes, I have always found them so. It still does worry me a little, I will say.
Mr. HESELTON. I have one final question. In line with what Mr. Hale asked you earlier, do you have any knowledge of whether there is any amount of double membership—that is, cases where members of your association are also members of the Retail Druggists Association?
Mr. FISCHELIS. Oh, yes; there are many.
Mr. HESELTON. So that we have a confused situation as to which recommendations really constitute the recommendations of the pharmacists?
Mr. FISCHELIS. I don't think you will find us very far apart on this. We all have the same objective. We want to have the opportunity to fill prescriptions that are given orally. We may differ as to what extent labeling ought to indicate to a pharmacist what he ought to do. Some of us feel that our professional judgment, based on our education, is sufficient so that we can determine that.
Mr. WOLVERTON. Up to the time that the witness said they were not very apart, I confess that I thought I was on some sort of a merrygo-round. I have heard opinions on this bill by pharmacists, and I have heard the pharmacists differ with drugstore owners or at least their national organization, patients, and consumers. We have heard from the Food and Drug Administration, the manufacturers of drugs for over-the-counter use, and the manufacturers of drugs for prescription purposes. The only horse on the merry-go-round that seems to be vacant at the present time is that which would ordinarily be occupied by the doctors.
As the different witnesses have come before this committee, each giving their views, it seems to me the merry-go-round has gone faster all the time. It may be a good place to stop and recess when this witness says that we are not very far apart.
The CHAIRMAN. The hearing will be recessed until tomorrow morning at 10 o'clock.
(Whereupon, at 4:40 p. m., the hearing was recessed until Friday, May 4, 1951, at 10 a. m.)
FEDERAL FOOD, DRUG, AND COSMETIC ACT
FRIDAY, MAY 4, 1951
HOUSE OF REPRESENTATIVES,
Washington, D. C. The committee met, pursuant to recess, at 10 a. m., in room 1334, New House Office Building, Hon. Robert Crosser (chairman) presiding.
The CHAIRMAN. The committee will come to order.
STATEMENT OF LESLIE D. HARROP, GENERAL COUNSEL, AMERI
CAN DRUG MANUFACTURERS ASSOCIATION
Mr. HARROP. Mr. Chairman and members of the committee, my name is Leslie D. Harrop. I am the general counsel for the American Drug Manufacturers Association and the Upjohn Co.
The American Drug Manufacturers Association is composed of 66 manufacturers of pharmaceuticals, chemicals, biologicals, and allied products. The membership includes such well-known firms as ParkeDavis, Lilly, Squibb, Lederle, Sharp & Dohme, Winthrop-Stearns, Abbott, Upjohn, Penick, Merck, Pfizer, and Johnson & Johnson. A complete list of the membership is attached to this statement.
H. R. 3298 was introduced to try to clear up the confusion that has resulted from a statement made 2 years ago by the Commissioner of Food and Drugs. Commissioner Dunbar then stated that in the opinion of the Food and Drug Administration no prescription could be refilled. Since traditionally then, and at the time the Food, Drug, and Cosmetic Act was enacted in 1938, some 30 or 40 percent of all prescriptions in a drug store were refills of old prescriptions, it is understandable that Commissioner Dunbar's statement caused consternation in retail
The purpose of H. R. 3298 is to define what prescriptions a druggist may refill at will and those for which the further authority of the physician must be secured. With that avowed purpose, we have no objection. We heartily endorse the principle of clearly outlining the situations in which a pharmacist may refill prescriptions without further authorization from the physician.
At the same time we are entirely in accord with the statement that dangerous drugs should only be dispensed originally on prescription and that such prescriptions should only be refilled if and when and as the physician may direct.
We wish to propose three changes in this bill. With these changes we give such an amended bill our full support. (The proposed amended bill follows:)
[H. R. 3298, 82d.Cong., 1st sess.] A BILL To amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act 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 Act, as amended, is amended to read as follows:
“(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 the prescription, or of its filling, the 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 the 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
"(1) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not generally recognized among experts qualified by scientific training and experience to evaluate its safety, as safe and efficacious for use except by or under the supervision of a practitioner licensed by law;
“(2) if an effective application under section 505 limits it to use under the professional supervision of a practitioner licensed by law, 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 the 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 Administrator may by regulation remove drugs subject to section 505. from the provision of this subsection when such requirements are not necessary for the protection of the public health.
“A drug which is subject to clause (1) or (2) of this subsection shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement 'Caution: Federal law prohibits sale or dispensing without prescription'.
"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.
“The provisions of this section of the Act shall not be applicable to drugs now included or which may hereafter be included within the classifications stated in section 3220 of the Internal Revenue Code (26 U. S. C. 3220), or to marijuana as defined in section 3238 (b) of the Internal Revenue Code (26 U. S. C. 328 (b))."
Mr. HARROP. I believe the clerk has copies of the modified bill amended as we suggest, for the members of the committee.
No. 1 is to delete section (b) (1), lines 10 and 11, on page 2.
The necessity for deletion of this section is to be certain that the exempt narcotics are not inadvertently placed under a prescription limitation. As the Federal Security Administrator has pointed out, exempt narcotics preparations are those containing such a small quantity of these drugs that they are harmless and thus freely available over the counter.
Mr. Larrick testified yesterday that it was not the intention of the Food and Drug Administration to affect exempt narcotics at all, and all of the other substances of section 502 (d) of the Food, Drug, and Cosmetic Act are already controlled under the provisions of the following section (b) (2).
The last paragraph on page 4 is believed to have been included for the purpose of eliminating these preparations from the operation of this bill but it would be clearer if section (b) (1) was stricken.
2. Delete section (b) (2), lines 12 through 16, on page 2, and substitute in lieu thereof the following: