5081. (F. D. C. No. 36614.    S. Nos. 33-514 L, 58-082 L, 58-808/9 L.) 
INFORMATION  FILED:   1-19-55, N. Dist. Ill., against 2600 State Drugs, Inc., 
Chicago, Ill., Edward Kravetz  (vice president and manager of the drug 
department), Melburn vHoltzman (secretary-treasurer and apprentice phar- 
macist), and Raymond Holtzman (clerk).
CHARGE: Between 1-16-54 and 2-24-54, amphetamine sulfate tablets (counts 
1, 2, and 3) were dispensed three times and Sulfisoxazole tablets (count 4) 
were dispensed once without a prescription.
DISPOSITION: On 3-14-55, the defendants filed a motion for dismissal of the 
information on the ground that the provisions of the Act which the defendants 
were charged to have violated were unconstitutional. This motion was denied 
by the court on 5-20-55. On 6-6-55, pleas of not guilty were entered by the 
corporation to all 4 counts of the information; by Edward Kravetz to counts 
1 and 2; by Raymond Holtzman to count 3; and by Melburn Holtzman to 
count 4.
The ease came on for trial before the court without a jury on 9-21-55 and 
was concluded on 10-3-55, with a verdict of guilty and the imposition of the 
following sentences by the court: $1,000 fine, plus costs, against the corpora- 
tion ; $500 fine and imprisonment of 3 months against Edward Kravetz: and 
$250 fine and imprisonment of 3 months against Raymond Holtzman and Mel- 
burn Holtzman.
On 10-13-55, a notice of appeal to the United States Court of Appeals for 
the Seventh Circuit was filed, and on 7-11-56, this court handed down the 
following opinion:
SWAIM, Circuit Judge: "The defendant, 2600 State Drugs, Inc., and the indi- 
vidual defendants, Edward Kravetz. Melburn Holtzman and Raymond Holtz- 
man, all of whom were either officers or employees of the defendant drug cor- 
poration, were charged in a criminal information with having sold, without a 
prescription, certain drugs in violation of the Federal Food, Drug and Cosmetic 
Act, 21 U. S. C. A. Section 301, et seq. In a trial before the District Court all 
of the defendants were found guilty of violating the Act.
"The principal question presented by this appeal is whether or not those 
sections of the Federal Food and Drug Act which prohibit the sale of dan- 
gerous drags without a prescription are sufficiently definite to give reasonable 
notice to persons bounded by the proscriptions of the Act and subject to its 
penalties.
"The applicable parts of Section 331 of 21 U. S. C. A. provide:
Prohibited acts-
The following acts and the causing thereof are hereby prohibited :
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(b) The adulteration or misbranding of any * * * drug * * * 
in interstate commerce.
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(k) The adulteration, mutilation, destruction, obliteration, or removal 
of the whole or any part of the labeling of, or tJie doing of any other act 
with respect to, a food, drug, device, or cosmetic, if such act is done while 
such article is held for sale (whether or not the first sale) after shipment 
in interstate commerce and results in such article being adulterated or 
misbranded.    [Our emphasis.]
Section 353 of 21 U. S. C. A., concerning prescriptions by physicians, pre- 
scription requirements and the misbranding of drugs, provides :
(b)   (1) A drug intended for use by man which- 
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<B) Because of its toxicity or other potentiality for harmful effect, or 
the method of its use, or the collateral measures necessary to its use, is not 
safe for use except under the supervision of a practitioner licensed by 
law to administer such drug; or
(C) is limited by an effective application under section 355 of this title 
to use under the professional supervision of a practitioner licensed by law 
to administer such drug,
shall be dispensed only (i) upon a written prescription of a practitioner 
licensed by law to administer such drug * * *. The act of dispensing 
a drug contrary to the provisions of this paragraph shall be deemed to be 
an act which results in the drug being misbranded while held for sale. 
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(4) A drug which is subject to paragraph (1) 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 dispensing 
without prescription."    *    *    *
Section 355 of 21 U. S. C. A., concerning new drugs and the necessity of 
effective application, provides:
(a) No person shall introduce or deliver for introduction into interstate 
commerce any new drug, unless an application filed pursuant to subsection 
(b) is effective with respect to such drug.
(b) Any person may file with the Secretary [of Health, Education and 
Welfare] an application with respect to any drug subject to the provisions 
of
subsection (a). Such person shall submit to the Secretary as a part 
of the application (1) full reports of investigations which have been 
made to show whether or not such drug is safe for use; * * * an(j 
(6)  specimens of the labeling proposed to be used for such drug.
"At the beginning of the trial of this case the parties stipulated that the 
drugs which the defendants were accused of dispensing without a prescrip- 
tion were drugs within the meaning of 21 U. S. C. A. Section 353 (b) (1) 
(B), as amended, and which prior to January 16, 1954, were shipped in 
interstate commerce into the State of Illinois and were held in the manu- 
facturer's original labeled bottle, the label upon which included the state- 
ment, 'Caution: Federal Law Prohibits Dispensing Without Prescription.'
"In this ease the evidence in the record furnished a sufficient basis for the 
finding of the trial court that the drugs in question could be safely used only 
under the direction and supervision of a physician and that the defendants 
dispensed said drugs without prescriptions, as charged in the information.
"Although admitting that the drugs here in question had been shipped 
in interstate commerce, that the container carried a label stating that fed- 
eral law prohibited the sale of the drugs without a prescription, and that 
there was sufficient evidence to support the trial court's findings that the 
defendants had made sales of such drugs without prescriptions, the de- 
fendants insist that the language of the statute is so vague, uncertain and 
indefinite as to fall short of the constitutional requirements of due process 
of law. On this point the defendants contend that the statute here in ques- 
tion is so vague and indefinite 'that men of common intelligence must neces- 
sarily guess at its meaning and differ as to its application,' and that, there- 
fore, the statute is too vague, indefinite and ambiguous to constitute a legal 
basis for a criminal charge. We think the provisions of this Act are 
sufficiently definite to support a criminal charge for the violation of the Act.
"In Boyce Motor Lines v. United States, 342 U. S. 337, the Court was con- 
sidering the validity of a regulation promulgated by the Interstate Com- 
merce Commission which provided that drivers of motor vehicles transport- 
ing certain explosives and poisonous gases should 'avoid, so far as practi- 
cable, and where feasible, by prearrangement of routes, driving into or 
through congested thoroughfares, places where crowds are assembled, street 
' -car tracks, tunnels, viaducts, and dangerous crossings.' In its opinion in 
that ease the Court said (page 340) :
A criminal statute must be sufficiently definite to give notice of the re 
quired conduct to one who would avoid its penalties, and to guide the 
judge in its application and the lawyer in defending one charged with 
its violation. But few words possess the precision of mathematical 
symbols, most statutes must deal with untold and unforeseen varia- 
tions in factual situations, and the practical necessities of discharg- 
ing the business of government inevitably limit the specificity with which 
legislators can spell out prohibitions. Consequently, no more than a 
reasonable degree of certainty can be demanded. Nor is it unfair to 
require that one who deliberately goes perilously close to an area of 
proscribed conduct shall take the risk that he may cross the line.
"In Sproles v. Binford, 286 U. S. 374, the Court was considering a Texas 
statute which prohibited the carriage of overweight and oversize loads by 
commercial carriers but which permitted the granting by the State Highway 
Department of permits, for ninety days, for the carrying of such loads 'as 
cannot be reasonably dismantled.' The statute provided further that these 
loads were to be carried 'by the shortest practicable route.' The C-ourt 
there held (page 393) that the phrase, 'shortest practicable route,* was not 
an expression too vague to be understood.   The Court explained:
The requirement of reasonable certainty does not preclude the use of 
ordinary terms to express ideas which find adequate interpretation in 
common usage and understanding. [Citing authorities.] The use of 
common experience as a glossary is necessary to meet the practical de- 
mands of legislation. In this instance, to insist upon carriage by the 
shortest possible route, without taking the practicability of the route 
into consideration, would be but an arbitrary requirement, and the ex- 
pression of that which otherwise would necessarily be implied, in order 
to make the provision workable, does not destroy it. 286 U. S. 
at page 393.
"Another factor which we must consider in the instant case is the fact that 
the provisions of the sections of the Act here under consideration were to bind 
pharmacists and to subject them to penalties in case of violations.
"To ship these drugs in interstate commerce it was necessary for the manu- 
facturer to qualify them pursuant to the requirements of Section 355 of the 
Act. The drugs were qualified for interstate shipment on the condition that 
the container in which they were shipped bear a label which read, 'Caution: 
Federal law prohibits dispensing without prescription.' Section 331 (k) of 
the Act prohibited the removal of this label. The evidence here showed that 
when the sales of these drugs were made the label on the container was intact. 
It would seem clear that any pharmacist who sold these drugs without a pre- 
scription would necessarily know that he was violating the Food and Drug 
Act but that in order to make such sales the defendants were willing to defy 
the prohibitions of the Act.
"The defendants also insist that that part of Section 353 (b) (1) (C) of the 
Act which provides that 'The act of dispensing a drug contrary to the provi- 
sions of this paragraph [without the prescription of a physician] shall be 
deemed to be an act which results in the drug being misbranded while held 
for sale,' goes beyond the purpose of the Food and Drug Act, the sole purpose 
of which is to inform and so protect the ultimate consumer that he may be 
guarded against misrepresentation. The defendants say that the arbitrary 
extension of the meaning of the word 'misbranded' constitutes an unreasonable 
exercise of the commerce powers of Congress and violates the Fifth and Tenth 
Amendments of the Constitution of the United States.   This contention we
think is answered in United States v. Carlisle (No. 15898), 5 Cir., F. 2d-,
which was decided May 31, 1956. The court in the Carlisle case pointed out 
that the Act sets out the only way the drugs there in question could be dis- 
pensed and then goes on to say that the act of dispensing the drugs contrary 
to the provisions of the Act shall be deemed to be an act which results in the 
drug being misbranded.   The court there said (page 6 of the slip opinion) :
This established, by law in this section, there is required only resort to- 
21 U. S. C. 331 (k), which denounces the offense of misbranding, and to 
Sec. 333, which fixes the penalty for *hat offense.
The court concluded:
* * * that the sections taken together have provided as clearly as 
though it had all been written out in the same section, that one dispens- 
ing drugs of the kind dealt with here, contrary to the provisions of Sec. 
353 (b) (1) shall be guilty of, and subject to the punishment provided 
by law for, an act of misbranding.
The court there held (page 7 of the slip opinion):
* * * that the use of the word "deemed" in the Act creates an irrebut- 
table presumption, a rule of substantive law, and that the doing of the 
prohibited act, dispensing the drugs * * * without the authorization of 
the prescriber, makes refilling misbranding and subjects the dispenser 
to the penalties provided for misbranding.
"The defendants also insist that the sales of these drugs without prescrip- 
tions constituted purely intrastate transactions, that these drugs did not 
remain a part of the stream of Interstate commerce, and that the sales of 
the drugs at retail did not affect interstate commerce directly or indirectly. 
In support of this contention the defendants cite Schechter Corp v. United 
States, 295 U. S. 495, 544. But we think this contention Is answered in 
United States v. Sullivan, 332 U. S. 689. In the latter case the defendant 
Sullivan, a retail druggist in Columbus, Georgia, purchased from a wholesale 
druggist in Atlanta, Georgia, a bottle of sulfathiazole tablets which had been 
shipped In interstate commerce from Chicago, Illinois. The label on the bottle 
which the defendant received gave adequate directions for the use of the 
tablets and adequate warning to protect the ultimate consumer from dangers 
incident to their use. The defendant removed some of the tablets from the 
original labeled bottle and placed them in a pill box labeled with the name of 
the drug but without adequate directions for use or warnings of danger. 
The Court there, after pointing out that the defendant had bought the drugs 
over six months after the interstate commerce shipment to the purchaser 
in Atlanta had been completed, said (pages 696 and 697) :
But the language used by Congress broadly and unqualifiedly prohibits 
misbranding articles held for sale after shipment in interstate com- 
merce, without regard to how long after the shipment the misbranding 
occurred, how many intrastate sales had intervened, or who had received 
the articles at the end of the interstate shipment Accordingly we find 
that the conduct of the respondent falls within the literal language of 
section 301 (k) [section 331 (k) of the present Act].
* * * The words of paragraph (k) "while such article held for sale 
after shipment in interstate commerce" apparently were designed to 
fill this gap [left by paragraphs (a), (b) and (e)] and to extend the 
Act's coverage to every article that had gone through interstate com- 
merce until it finally reached the ultimate consumer.
In the Sullivan case the Court rejected the contention that its holding per- 
mitted Congress to invade the powers reserved by the Constitution to the 
states, pointing out that it had held in McDermott v. Wisconsin, 228 U. S. 
115, that the authority of Congress to make such requirements was a proper 
exercise of Its powers under the commerce clause.
"We think that the principles announced by the Court in the Sullivan and 
McDermott eases require us to hold here that Congress properly exercised its 
powers under the commerce clause by providing that drugs which have been 
transported in interstate commerce and which are dangerous to human beings 
unless their use is prescribed by a physician should not be dispensed except 
on the prescription of a physician.
"The judgment of the District Court is AFFIRMED."
A petition for a writ of certiorari was filed with the United States Supreme 
Court.    On 10-8-56, the Supreme Court denied the petition.