TABLE 1.-Terminations of over the-counter and unauthorized refill cases as of Apr. 1, 1951-Continued

FDC
No.

28135

28134

28133

29434

29435

28122

29424

29119

28154

29128

29115

28142

28130

28121

26700

June 27, 1950. Plea: Nolo contendere by all defendants. L.
Stone fined $100 plus 1 year probation on 1 count; J. H. Stone
fined $100 plus 1 year probation on 1 count. Stone's Phar-
macy fined $100 on each of 2 counts plus 1 year probation on
each of 2 counts, sentence to run consecutively. Total
probation, 2 years; costs $41. Total fine and costs, $441.
June 27, 1950. Plea: Nolo contendere by both defendants.
Davis Drug Co. fined $100 plus costs of $39, and 1 year proba-
tion. W. S. Nelson fined $100 and placed on probation for
1 year. Total fines and costs, $239.

June 27, 1950. Plea: Nolo contendere. Fine of $100 on each
of 3 counts plus costs of $37. Total fine and costs $337. De-
fendant placed on 1 year probation on each count, the periods
of probation to be consecutive and not concurrent. Total
probation, 3 years.

Aug. 18, 1950. Plea: Guilty. Fine of $500 on count 1, and
$100 on each of 5 other counts; total fine, $1,000.

Aug. 18, 1950. Plea: Guilty. Fine of $500 on count 1 and $100
on each of 6 other counts; total fine, $1,100.

July 28, 1950. J. M. Cannon died and case dismissed against
him. Plea by Newell of nolo contendere. Fine of $100
assessed on the 4-count information. Total fine, $100.
Sept. 13, 1950. Plea: Guilty. Individual fined $25 on each of
2 counts; total fine, $50.

Aug. 17, 1950. Plea: Nolo contendere. Fine of $100 on each
of 3 counts. Total fine, $300. Defendant to stand com-
mitted until paid.

Sept. 15, 1950. Plea: Guilty. Firm fined $150; Robolt fined $25.
Total fine $175. Eamon dropped from information.

Oct. 2, 1950. Plea: Nolo contendere. Fine of $100 on each of 3
counts. Total fine, $300. Defendant to stand committed
until paid.
Oct. 2, 1950. Plea: Guilty. Fine of $1,000 on all 6 counts and
1 year probation.

Oct. 19, 1950. Plea: Nolo contendere. R. J. Evans and C. C.
Drummond fined $50 each; total fine, $100.

Sept. 25, 1950. Plea: Guilty. Fine of $75 on each of 3 counts;
total fine, $225 plus costs.

Sept. 25, 1950. Plea: Guilty. Each defendant fined $100;
total fine, $200.

Sept. 22, 1950. Plea: Guilty as to corporation. Case dismissed as to individual. Corporation fined $250 on each of 2 counts plus costs of $24. Total fine, $524,

TABLE 1.-Terminations of over-the-counter and unauthorized refill cases as of Apr. 1, 1951-Continued

29993 N. Paris, trading as Paris Drug Store, Denver, Phenobarbital.

Colo.

Benzedrine and Methylteros- Over-the-counter.
terone.

Nembutal

do.

Diethylstilbestrol, thyroid, amytal, sulfadiazine and

do.

sodium bicarbonate, sulfathi

Refill

.do.

Nembutal, sulfadiazine.

29439

J. R. Storms, trading as Belmont Pharmacy,
Houston, Tex.

Amphetamine, seconal.

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