TABLE 1.-Terminations of over the-counter and unauthorized refill cases as of Apr. 1, 1951-Continued M. & M. Drugs, Toledo, Ohio, M. Sherman. Matthias Prescription Pharmacy, Inc., Tucson, Taylor's Drug Store, Peoria, Ill., J. P. Taylor, B. T. Smith Co., Inc., Baltimore, Md., B. T. Oct. 24, 1950. Plea: Guilty on 1 count; 3 counts nolle prossed Nov. 10, 1950. Corporation pleaded guilty on all counts. J. Oct. 23, 1950. Plea: Nolo contendere as to counts 1, 2, 3, and 4. Oct. 23, 1950. Plea: Nolo contendere: A. G. Wilson on counts Oct. 23, 1950. Plea: Nolo contendere as to counts 1, 2, and 3. Oct. 23, 1950. Plea: Nolo contendere as to 3 counts by each Dec. 5, 1950. Plea: Nolo contendere. Fine of $25 on each of 8 Nov. 15, 1950. Plea: Guilty. Firm and individual each fined Nov. 15, 1950. Plea: Guilty. Corporation and individual Dec. 18, 1950. Plea: Nolo contendere. Charges against partner- Dec. 12, 1950. Plea: Guilty. Each defendant fined $25 plus Nov. 27, 1950. Plea: Guilty. Fined $300 on all 3 counts. Dec. 11, 1950. Plea: Nolo contendere. Fined $1,000 on count TABLE 1.-Terminations of over-the-counter and unauthorized refill cases as of Apr. 1, 1951-Continued Dec. 12, 1950. Plea: Guilty. Fined $50 on each of 4 counts, Jan. 2, 1951. Plea: Nolo contendere. Fined $100 on each of Jan. 2, 1951. Plea: Nolo contendere. Each individual finedl Jan. 2, 1951. Plea: Nolo contendere. Individuals fined $100 Plea: Nolo contendere. Fined $200. ..Jan. 11, 1951. Plea: Nolo contendere. S. P. Rottenberg fined Jan. 15, 1951. Plea: Guilty. Fined $40 on each of 5 counts; February 1951. Plea: Nolo contendere. Imposition of sen- February 1951. Plea: Nolo contendere. Imposition of sen- Plea: Guilty. Fined $100 on each of 3 counts; N. Paris, trading as Paris Drug Store, Denver, Phenobarbital. Colo. 29460 29455 Seybold Drug Co., Poplar Bluff, Mo. 29443 Mr. WOLVERTON. Mr. Chairman. I do not draw the distinctions here, maybe, as readily as I should, but for instance, in this bottle which is marked "5-A," that is illustrative of many others that are here, it says, "Adult dose, 1 or 2 tablets as directed by a physician.' Does that require a prescription? Mr. LARRICK. No. Mr. WOLVERTON. The other one that you called to our attention Mr. LARRICK. What is the number on the back of that one, Mr. Wolverton? Mr. WOLVERTON. 5-A. Now, 5-B says, "Caution: To be dispensed only by or on the prescription of a physician." 5-A says "One or two tablets as directed by a physician," and what is the difference in that respect? Mr. LARRICK. Oh, the one that says "Caution: To be dispensed only by or upon the prescription of a physician," there are no directions for use. They put that legend on and take advantage of the exemption under the statute. They put that on in lieu of directions for use. Now, so long as that drug stays in prescription channels and it is dispensed to the ultimate consumer only on prescription, the exemption is in force and it is a legal transaction; but if the pharmacist sells it to you or to me without a prescription, then the drug becomes misbranded, because it fails to bear adequate directions for use. Now, the other item that you referred to there bears some directions for use, but in the opinion of the Food and Drug Administration it likewise is not legally labeled in its entirety, because it doesn't tell you what it is for, and tell the whole story that the consumer would need to know. But that phase of the problem, Congressman, is not involved in this particular bill, and that is a matter, perhaps, for litigation as we have time with the many, many cases ahead of us. Mr. WOLVERTON. Is your answer in any way based upon the fact that one gives the dose, and the other does not? Mr. LARRICK. Yes, sir; that is right. One gives partial directions. Mr. WOLVERTON. Now, on this one, 3-A, it states "Adult dose, one tablet, as directed by a physician," and 3-B says, "To be dispensed only by or on the prescription of a physician." Now, in that instance, 3-A does state the dose. Mr. LARRICK. What would you take it for, and how would you know what to take it for? Mr. WOLVERTON. I probably would not, unless Mr. LARRICK. And I wouldn't, either. Mr. WOLVERTON. Unless I had been told about it. Mr. LARRICK. We don't think that those directions are adequate, because they don't tell the whole story, what to take it for, and how to take it, and how often, and how much. But again, that is not involved in this particular bill before you. But the second one that has the prescription legend, could not legally be sold by the pharmacist without a prescription. And the principal use of that drug is for a very serious heart disease. Mr. WOLVERTON. Well, for what purpose did you give us all of these exhibits? Mr. LARRICK. To show that under the present law and the regulations, there are so many of them that have this confusing balance |