3167. Misbranding of sulfadiazine tablets, Seconal Sodium capsules, Dexedrine
Sulfate tablets, and Ergoapiol with Savin capsules. U. S. v. Leroy M.
Clayton (Jack Clayton Drug Store), and Paul E. Calmes. Pleas of guilty.
File of $200 against defendant Clayton and $25 against defendant Calmes.
(F. D. C No. 29117.    Sample Nos. 55801-K to 55808-K, incl.)
INFORMATION FILED : June 5, 1950, Western District of Oklahoma, against
Leroy M. Clayton, trading as the Jack Clayton Drug Store, Clinton, Okla., and
against Paul E. Calmes, pharmacist.
INTERSTATE SHIPMENT: From the States of Indiana, New York, and Pennsyl-
vania, into the State of Oklahoma, of quantities of sulfadiazine tablets,
Seconal Sodium capsules, Ergoapiol uoith Savin capsules, and Dexedrine Sulfate
tablets.
NATURE OF CHARGE: While a number of the Erffoapiol with Savin capsules
were being held for sale at the Jack Clayton Drug Store after shipment in
interstate commerce, Leroy M. Clayton, on or about September 30, 1949,
and Paul B. Calmes and Leroy M. Clayton, on or about October 3, 1949,
caused the capsules to be sold and disposed of to two different purchasers
in the original bottles in which the capsules had been shipped in interstate
commerce, without requiring a prescription of a physician. When received
by the defendant, the label of the capsules bore the statement "Caution??To
?be dispensed only by or on the prescription of a physician," and as a result
?the capsules were not required to comply with Section 502 (f) (1), which
?requires that adequate directions for use appear in the labeling. However,
?by selling the capsules without a prescription, the defendants caused the
?exemption to expire, resulting in the misbranding of the capsules, in violation
?of Section 502 (f) (1), since the bottles bore no labeling containing directions
?for use
In addition to the above sales, defendant Clayton, on or about September
27 and 28 and October 3 and 4, 1949, caused various quantities of sulfadiazine
tablets, Seconal Sodium capsules, and Dexedrine Sulfate tablets to be repack-
aged and sold without a prescription while they were being held for sale at
the Jack Clayton Drug Store after shipment in interstate commerce, which
acts resulted in the repackaged drugs being misbranded as follows: Sections
502 (b) (1) and (2), the repackaged drugs failed to bear labels containing
the name and place of business of the manufacturer, packer, or distributor,
and statements setting forth the quantity of the contents.
Further misbranding, Section 502 (d), the repackaged Seconal Sodium cap-
sules contained a derivative of barbituric acid, which derivative has been
?designated by regulations as habit forming; and when repackaged, the capsules
bore no labeling containing the name, and quantity or proportion of such
derivative and in juxtaposition therewith the statement "Warning??May be
?habit forming.
Further misbranding, Section 502 (f) (1), the repackaged drugs bore no
labeling containing directions for use; and, Section 502 (f) (2)., the repack-
aged sulfadiazine tablets and Dexedrine Sulfate tablets bore no labeling
containing warnings against use in those pathological conditions where their
use may be dangerous to health, and against unsafe dosage and methods and
duration of administration.
IDISPOSITION : June 12, 1950. Pleas of guilty having been entered on behalf of
the defendants, the court imposed a fine of $200 against defendant Clayton
and $25 against defendant Calmes..
?3168. Misbranding of sulfadiazine tablets and apiol and ergotin compound cap-
sules. U. S. v. Stone's Pharmacy, Joseph H. Stone, and Leon Stone.
Pleas of nolo contendere. Fine of $200 against pharmacy and $100 against
each individual; in addition, pharmacy placed on probation for 2 years