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urge the enactment of H. R. 3298 in order to correct these provisions through amendment of section 503 (b) of the Food, Drug, and Cosmetic Act.
I wish to comment further on various major points.
The restriction on the oral prescription and the usual refill is unrealistic in that it runs counter to modern times and contrary to the needs of public health.
Let me illustrate.
I will take you through the magic of imagination to the prescription department of a drug store. The telephone rings. The pharmacist hastens to answer it. The caller is a physician and he orders a sunburn preparation for a patient. I may sell an identical trade-marked product over the counter and yet it is against the law for me to dispense it on a prescription which a doctor communicates to me on the telephone. It is unethical for me to suggest to the patient that the sunburn preparation is available as a proprietary medicine. Substitutions of that kind will soon give a pharmacist a ruinous reputation.
The telephone rings again. The physician on the line tells me to rush penicillin to a patient. It is a violation of a Federal statute to comply. I think of the patient and the drug is sent to him at once. I doubt that there is one of you gentlemen of the mind to argue it is wrong for me to cooperate with the doctor in such cases. It is unwise indeed to continue in force a law that must be ignored for the sake of public health. Also it is unfair to compel the pharmacist to assume the jeopardy of prosecution every time he supplies a drug for an emergency in response to instructions by way of the telephone from a physician. The fact that enforcement of the restriction on the oral prescription has been considerate is beside the point.
It has long been the custom in the profession of pharmacy to recognize the oral prescription from a physician. Moreover the doctor of today would find it extremely difficult to practice unless he could depend on the pharmacist to take prescriptions over the telephone and then deliver them to his patients.
The physician may call the pharmacist from his office or the home of an ill person for an urgently needed drug. Quite often the time saved is a major factor in the rapidity of the recovery of a patient. It could even be the difference between life and death. Many people are alive today because druggists responded with speed to instructions which doctors communicated via the telephone. I could cite numerous cases of heart attack, for instance, or heat fever, or serious injuries.
You may question the safety of the oral prescription. There is no evidence that the incidence of abuse or of error is greater than with the written prescription. The pharmacist is trained to exercise the utmost care and he takes every precaution to avoid mistakes. Interpretation of an oral prescription or detection of fraud in a prescription which comes over the telephone is just as easy as with the written prescription.
The Food, Drug, and Cosmetic Act was enacted in 1938. Nevertheless the pharmacist has since then, as he did before, had to accept oral prescriptions for the reason that the welfare of the public made it necessary. Yet section 503 (b) refers specifically to certain exemptions from the labeling requirements with respect to the written prescription.
Of course the Administrator of the Federal Security Agency could not do otherwise than recognize the plain language of the law and accordingly he had to hold that only a written prescription is legal and that it was a violation of the Federal statute for à pharmacist to accept an oral prescription. However, there was no real problem until the Food and Drug Commissioner, Dr. Paul Dunbar, in an address before the convention of the National Association of Retail Druggists, held in Atlantic City in 1948, announced that a further interpretation of section 503 (b) held the filled written prescription to be a complete and final transaction like a canceled check. This meant that refills of a prescription were against the law regardless of the nature of the ingredients specified in the prescription, whether they were for lemon juice and ordinary sugar or for the more dangerous sulfa drugs.
The druggists were now confronted with an official restriction against both oral prescriptions and refills of every kind on request of the patient.
The Atlantic City address by Dr. Dunbar brought a widespread demand for an amendment to the Food, Drug, and Cosmetic Act to clarify the position of the pharmacist. The druggists insisted on the right to recognize an oral prescription. Also they sought to be certain to what extent a prescription could lawfully be refilled on request of a patient.
The demands of the druggists are easy enough to understand, for an established procedure that was recognized generally and that had not seriously been interfered with before Dr. Dunbar's Atlantic City address suddenly became a declared unlawful practice.
The pharmacists believed that instead of challenging interpretation of the Administrator, which he would undoubtedly defend through the courts, relief and clarification were a proper matter for legislative consideration. The druggists expressed the conviction that it never was intended to have the Food, Drug, and Cosmetic Act molest the traditional relationship of the physician, the pharmacist, and the patient.
Now I wish to speak on the “Prescription legend.”
The "prescription legend" appears on many products. This legend reads as follows: "Caution: to be dispensed only by or on the prescription of a
or otherwise used only for manufacturing purposes," the blank being filled in with one or more of the words physician," "dentist," or "veterinarian," as the case may be.
This legend and its application to the retail druggist in the conduct of his profession and his business of retailing drugs presents many difficulties. It creates a serious situation in the practice of pharmacy, since it appears needlessly and without reason on many products which the public should be able to buy on request without the requirement that they have a prescription. Many useful drugs that are perfectly safe for lay use carry the legend and because of that fact, if sold without a prescription, are misbranded and the seller is in violation of the law.
Section 502 of the Food, Drug, and Cosmetic Act is the section that covers misbranding. It consists of some 10 paragraphs which define misbranding and its provisions must be followed by all who manufacture, distribute, and sell drugs. In a business as extensive and diversified as the manufacture and distribution of drugs it is understandable that many points of misunderstanding or misinterpretation would arise with respect to the meaning of the different clauses in the section. As a result the Administrator of the Federal Security Agency, who is empowered by law to do so, has issued numerous regulations to cover these misbranding clauses. intended to serve as a guide to the drug industry.
Regulation (1.106) was issued pursuant to section 502 (f) and among other reasons exempts a drug from the labeling requirements of section 502 (f) if it complies with certain conditions set forth, one of which is that the product or drug bears the statement, "Caution: To be dispensed only by or on the prescription of a physician, dentist, or veterinarian, as the case may be." The only instance where the manufacturer may not of his own choice use the legend is under the prohibition of paragraphs (h) and (i) where an effective application with respect to a new drug would apply. Even then, for all practical purposes, he controls the situation. If he has in his application supplied the Administrator of the Federal Security Agency with the required information and the copy of the label he will use, if that copy bears the legend, approval means that the legend will subsequently appear on all of the distributed drug.
It is with respect to the hundreds of cases where the manufacturers under the permissive privilege granted in the regulations use the legend as an evasive instrument to pass responsibility and liability to the druggist that we object. The responsibility for proper labeling lies with the manufacturer. He should not be permitted to avoid or dodge it. He makes the drug and unless it is per se a dangerous or habit-forming drug, he should be required by law and regulation to label it in a manner wherein its sale by the druggist would not constitute an unlawful act of selling a misbranded drug.
If the drug or chemical were a bulk product the druggist could also repackage and sell small amounts as is often required and by simply designating the name of the product and copying the manufacturer's directions, fully comply with Federal labeling requirements.
When a manufacturer of a simple drug or chemical distributes his product in small containers, a pound or less, and places thereon: "For manufacturing purposes only,” he can do it for one purpose onlythat of avoiding liability and passing it on to others. He knows the druggist buys the product for resale in its original form or for sale in repackaged smaller units, and that the use of the product in manufacturing would be negligible. But his labeling precludes its sale unless the druggist assumes all liability.
A drug or chemical may be perfectly safe for lay use without professional supervision; yet if the manufacturer has used the legend and shipped his product in interstate commerce, the druggist may not lawfully sell it. If he chooses, because he knows the drug is relatively harmless, to supply it under his own label, with directions for use and such other statements as would be necessary to meet Federal labeling provisions, he must be prepared to assume any an all liabilities that might ensue from such action.
Manufacturers have been given a privilege under the regulations which they have grossly abused. They have demonstrated over the years either their inability to write labels which conform to the sions of section 502 (f) or their unwillingness to do so. From the obvious fact that they have failed to follow the purpose and spirit of the
Food, Drug, and Cosmetic Act with respect to labeling their products, it is clear to the practicing pharmacists that they need more competent counsel in their labeling department or a well-defined law that offers no loopholes for evasion of responsibility.
The pharmacist in his daily work of filling prescriptions and selling household drugs has enough responsibility of his own. He should not have to shoulder the responsibility that belongs to the manufacturer.
The bill before you provides for the segregation of drugs into two classes: Those that are unsafe for use without professional supervision, hence requiring a prescription and authorization for refilling, and those that are safe for over the counter sale. The bill provides for the method of classifying these drugs. And its provisions are clear enough for the primary producer or manufacturer and the pharmacist to follow without reams of regulations.
When a drug is classified as unsafe for lay use without professional supervision and a prescription is required before it can be dispensed, then and then only will it carry the new warning or caution, which reads: "Federal law prohibits sale or dispensing without a prescrip
The confusion with respect to labeling will cease. The pharmacist now operating in a sea of doubt will have a clear understanding of what he may sell without a prescription, and the new warning or caution will point out the products that require one.
There are countless cases of the misuse of the legend on drugs received by the druggist. I have brought here as exhibits just a few, most of which were taken from my own drug store.
I will direct your attention to some of these exhibits to demonstrate the misuse of the legend labeling, and I will leave those to which I do not call specific attention for the purpose of review by the committee, as it wishes.
It is not my purpose here to say that the manufacturers should be made to properly label a drug if it is safe for general use or that they should be granted the privilege to avoid responsibility if they so desire, thus making the retailer assume all responsibility and liability. My chief purpose is simply to say that trying to operate a drug store under this confusing situation is next to impossible.
Here is a sample or two picked at random, as I said, from the shelves of my own store. Here is a package of calcium carbonate, precipitated; certainly a harmless drug if there ever was one. Calcium carbonate, to give you the common every day name is simply precipitated chalk. It is an official USP drug, the use of which is so generally known that it could be sold as such without any further labeling than precipitated chalk USP. Yet here is a package of this simple drug with the statement “Caution: To be dispensed only by or on the prescription of a physician or otherwise used only for manufacturing purposes.”
Offsetting that, here is a package of the same drug, marked "Precipitated chalk USP," with the official name "Calcium carbonate" in parenthesis below. On this package it is marked "Antacid” and the average dose given, and the statement, in addition "May also be used as a tooth powder.” The chemical also has many other uses known to the average person. Yet one of these packages or its contents may not be sold lawfully without a prescription; while the other may be freely sold even to a child.
Now here is another situation. Here is a small container made by one of our chemical houses, containing calcium lactate. The same situation arises. This canister gives the legend, which again precludes its sale except on prescription. On the other hand, here is a bottle of tablets of calcium lactate, 10 grains, made by one of our leading pharmaceutical houses, and the package contains directions for use. Certainly calcium lactate is a drug that is harmless. The USP dose is an average 75 grains, and let me say that it takes a tablespoon, rounded, with this product to make 75 grains. Why such a drug should be permitted or why a manufacturer should desire, unless it be to avoid responsibility, to use the legend on such a preparation, I cannot understand.
Here is a preparation labeled “calcium chloride, USP, granulated.” For your information, calcium chloride is simply table salt. On this product, the manufacturer does not put any legend but simply labels it “calcium chloride, USP," which would make it permissible for sale. Yet, so far as calcium lactate is concerned, plain salt would be far more harmful, because if you took a tablespoon full of calcium lactate, it would not hurt you, but if you took calcium chloride, it would produce vomiting and make you very uncomfortable. Here we have a preparation called Ketochol. This preparation is
. one of ketocholanic acids and has a rather wide usage. It contains dosage and directions for use with a warning stating in what conditions it would not be generally safe to use. It is sold over the counter by the pharmacist upon request of a customer and does not require a prescription.
Here is a preparation called Cholanor, which is essentially the same type of product, that of ketocholanic acids and ox bile, and yet it contains the legend and may not be sold without a prescription.
Here is another case of especial interest because of the wide difference in the manufacturers' labeling. The preparation referred to is quinidine sulfate. I have here the labels of four different manufacturers. Two of these contain a legend; hence precluding the sale over the counter. The third one does not contain a legend, names the conditions for which the drug is used and contains a warning or caution which the manufacturer chooses to head by the word "Important” and then names the conditions under which the drug should not be used. But, because there are no directions for use or dosage, the item could not be sold over the counter.
Then we have the identical preparation under the label of another manufacturer where a dosage is given which states "One as directed by the physician.” But on this preparation there is no warning of any kind to indicate under what conditions the drug should not be used. The pharmacist in this case would be warranted, if the customer told him that the doctor had told him to buy it and use it, to sell it to him without the placing thereon of any further directions or warning of any nature.
If it is possible to bring to your attention any more confusing situation than exists here, I don't know how it could be done. So far as I have been able to find out, there has been no warning or caution suggested by the Administrator with reference to this drug; but they have suggested a warning or caution with respect to quinine and cinchonine and I presume the manufacturers have followed this