(4) The labeling of the drug or device contains no representation as to the condition or purpose for which, or how, it is to be used, except that this shall not proscribe representations:

(i) In brochures separately supplied to a physician, dentist, or veterinarian, or to pharmacists for use in their professional dealings with physicians, dentists, or veterinarians.

(ii) Required by an official compendium; and

(5) If it is fabricated from two or more ingredients, and is not designated solely by a name recognized in an official compendium, its label bears a statement of the quantity or proportion of each active ingredient.

(c) Retail exemption for harmless drugs prescribed by physicians, dentists, and veterinarians. A drug for which adequate directions for lay use can be written, customarily known by pharmacists as an over-the-counter item, which is prescribed by a physician, dentist, or veterinarian, shall be exempt at the time of dispensing from section 502 (f) (1) if its labeling bears the directions specified in the prescription; and this exemption shall apply to refills unless (1) a refill is made in disobedience of the physician, dentist, or veterinarian's written instructions, or (2) a refill is made under such circumstances that the dispenser reasonably should know that the refilling may be harmful to the purchaser.

(d) Exemption for drugs shipped to physicians, dentists, veterinarians, or to clinics for professional use. A drug or device shipped or delivered to a physician, dentist, veterinarian, hospital, clinic, or a public health agency to be used or dispensed under the supervision of physicians, dentists, or veterinarians in their professional practice shall be exempt from section 502 (f) (1) if it meets the conditions of paragraph (b) (2) and (5) of this section.

(e) Conditional exemption for new drugs. No exemption shall apply to any drug the labeling of which fails to bear representations as to its intended uses which would, if borne in the labeling, make it a new drug, except that a new drug may be exempted under paragraph (b) of this section, if the labeling contained in the application made effective under section 505 claimed such exemption.

(f) No exemption for drugs intended for injection or for drugs or devices dispensed pursuant to mail order diagnosis. No exemption under this regulation shall apply to (1) a drug intended for administration by iontophoresis or by injection into or through the skin or mucus membrane; or (2) a drug or device shipped or delivered in the conduct of a business of dispensing pursuant to diagnosis by mail.

(g) Exemption for drugs or devices when directions are commonly known. A drug or device shall be exempt from section 502 (f) (1) insofar as adequate directions for common uses thereof are known to the ordinary individual.

(h) Exemption for prescription components. A drug shall be exempt from section 502 (f) (1) if it is not a liquid, solution, emulsion, or suspension and not a tablet, capsule, or other dosage unit, upon the following conditions:

(1) The drug is ordinarily compounded with other substances before use and is intended for use in compounding prescriptions;

(2) The label of the drug bears the statement required by paragraph (b) (3) of this section.

(i) Exemption for inactive ingredients. A drug ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent in the preparation of other drugs, shall be exempt from section 502 (f) (1).

(j) Exemption for diagnostic reagents. A drug intended solely for use in the professional diagnosis of disease shall be exempt from section 502 (f) (1).

(k) Exemption for manufacture. A drug or device intended for use in the manufacture of another drug or device and labeled "For manufacturing use only" shall be exempt from section 502 (f) (1): Provided, however, That this shall apply to new substances which are intended to be used as the active principles of new drugs only if the shipments for manufacturing use are covered by an effective new drug application.

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

(m) Definitions. 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.

(3) The term "written prescriptions", as used in paragraph (b) of this section, means a written order signed by a physician, dentist, or veterinarian directing the dispensing of a specific quantity of a drug or device for the person named in the order; and the phrase "dispensed upon written prescriptions" does not include refilling the prescription or otherwise dispensing any quantity of the drug or device in addition to that specified in the order, unless the refilling, or other dispensing of the additional quantity, is authorized in writing by the prescriber.

Interested persons are invited to submit written comments with respect to this proposed order to the Hearing Clerk, Federal Security Agency, Room 5109, F. S. Building, Washington 25, D. C., within 30 days from the date of publication in the Federal Register.

Dated: December 1, 1950.

[SEAL]

OSCAR R. EWING, Administrator.

[F. R. Doc. 50-11159; Filed, Dec. 5, 1950; 8:56 a. m.]

Mr. DOLLIVER. I just want to make an inquiry along this line: Now, you represent your association, and that association involves every segment of this trade?

Mr. FISCHELIS. Yes, sir.

Mr. DOLLIVER. I wonder whether you would find in this type of legislation that there is an adverse position taken by various segments of it; for instance, as between the manufacturers, the wholesalers, and retailers. Would you comment on that?

Mr. FISCHELIS. There are times when there are opposing views taken on various subjects. We have a council composed of 16 members which is elected by the association. That council determines what the policy of the association shall be in the interim between our annual conventions.

Now the council consists of nine members elected for 3-year terms, and seven ex officio members who are the officers of the association. We met on the 26th and the 27th of April and considered this proposed legislation. At that time the statement which was supplied by Dr. Schaefer was approved, and I was instructed to come here and give you the kind of information I am giving you now.

Mr. DOLLIVER. So this whole matter has been considered by your association as a unit?

Mr. FISCHELIS. That is right.

Mr. DOLLIVER. Through the house of delegates; is that correct? Mr. FISCHELIS. Through the council. The house of delegates could not function on this because they are in session only during the convention. But the council is the interim body.

Mr. DOLLIVER. Then your statement has had the official approval of the interim body?

Mr. FISCHELIS. That is correct.

Mr. DOLLIVER. That is all, Mr. Chairman.

Mr. HELLER. Mr. Chairman, may I just ask one question?

The CHAIRMAN. Yes.

Mr. HELLER. Referring to the pronouncement that you have discussed on page 2, just so that I can get the record straight, I am not clear on that. Has that been reduced to any ruling as of today?

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. FISCHELIS. 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. HELLER. All right. Thank you.

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.

The CHAIRMAN. I believe that concludes our hearing for today. Mr. HALE. May I make some inquiries, Mr. Chairman?

The CHAIRMAN. Yes; I did not hear you. Go ahead.

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. And there was no dissent?

Mr. FISCHELIS. There was no dissent.

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

known to the pharmacist. The pharmacist may fill a prescription which he is told to fill, and which is a prescription which is dangerous to the individual.

Mr. FISCHELIS. I think you must have in mind such things as narcotic drugs.

Mr. HALE. Yes, sure.

Mr. FISCHELIS. In that case, there has to be a written prescription which bears the registry number of the physician.

Mr. HALE. That is true not only for narcotics but drugs containing poisons. Many drugs contain poisons in small amounts.

Mr. FISCHELIS. They do; but, of course, the pharmacist checks them to see that the dose is a safe dose. If there is any question about that, he gets in touch with the physician.

Mr. HALE. You say then that there shouldn't be any restraint on oral prescriptions?

Mr. FISCHELIS. We think that whatever restraint there should be can be handled between the professions themselves.

Mr. HALE. And you further think, as I understand you, that a prescription, once issued, unless it bears the letters "N. R." or some similar notation, should be refillable at will by the patient?

Mr. FISCHELIS. We don't think that. We think that the prescription should be authorized, but we think that the authorization need not be in writing nor does it need to be by the physician himself. If the pharmacist can satisfy himself that it is an authorized prescription, he ought to be permitted to fill it.

Mr. HALE. Well, suppose a man calls up a drug store on the telephone and says the man is completely unknown to you "I have a prescription from my doctor for such-and-such a compound or drug. Will you kindly make it up and send it around?" You do not see the doctor's prescription.

Mr. FISCHELIS. Well, we certainly would not go along with the prescription being telephoned in by a person who isn't a practitioner of medicine. The prescription would have to originate in the first instance with the practitioner. That is definite.

Mr. HALE. But if the same man brings a prescription in, then you would refill it?

Mr. FISCHELIS. We would refill it. Of course, the pharmacist would satisfy himself from the prescription blank and otherwise whether or not the writer of the prescription was an authorized practitioner.

You

Mr. HALE. Suppose a man is motoring through Ohio on his way to San Francisco and that he gives you a prescription from some place in Maine. You don't know whether the man is from there or not. don't know anything about him. It is a physician's blank that has a prescription written on it.

Mr. FISCHELIS. Well, the pharmacist would have to use his own professional judgment on that, and whatever ingenuity it takes to establish the authenticity of the prescription. If it were for some habit-forming or dangerous drug, he probably wouldn't refill it. He would take whatever precautions are necessary and would even go to the extent and I have known this to be done frequently-of telephoning to the physician even if he is out of town. Pharmacists are just naturally trained to be careful and law-abiding people.

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