6487. Various drugs.    (Inj. No. 376.)
COMPLAINT FOR INJUNCTION FILED : 3-21-60, N. Dist. N.Y., against Rand Phar-
maceutical Co., Inc., Rensselaer, N.T.
CHARGE: The complaint alleged that the defendant was in the business of
preparing, selling, and introducing and causing to be introduced and deliver-
ing and causing to be delivered for introduction into interstate commerce,
drugs which were adulterated and misbranded as follows: 501(b)-the articles
purported to be drugs, the names of which were recognized in an official
compendium, namely, the United States Pharmacopeia, and their strength
differed from the standards set forth in such compendium; 501(c)-they were
not subject to the provisions of 501(b) and their strength differed from, and
their quality feel below, that which they purported and were represented to
possess; 502(a)-the labeling of the articles contained false and misleading
statements with respect to the nature and quantity of the ingredients contained
in the articles.
The complaint alleged also that the adulterated and misbranded condition of
the drugs resulted from deficiencies in their ingredients which were due to
inadequate manufacturing facilities, lack of identification control, lack of ade-
quate analysis and formulas, or lack of other precautions essential to the
preparation of drugs.
DISPOSITION : On 3-21-60, a consent decree of permanent injunction was filed.
The injunction enjoined and restrained the defendants from directly or
indirectly introducing or causing to be introduced, or delivering or causing to
be delivered for introduction into interstate commerce, any articles of drug
that are adulterated:
(a)?In that their strength differs from, or their quality or purity falls below,
the standard set forth in an official compendium; or
(b)?In that their strength differs from, or their quality falls below, that
which they purport and are represented to possess; and that are misbranded:
(a) Because of false and misleading statements in their labeling with
respect to the nature and quantity of the ingredients contained therein.
The injunction further enjoined the defendant from directly or -indirectly
introducing or causing to be introduced or delivering or causing to be delivered
for introduction into interstate commerce, any drug manufactured, prepared,
relabeled or repacked by them unless and until:
(a)?Sufficient qualified and experienced personnel, including supervisory
personnel are employed in the defendant's plant to properly operate it;
(b)?A properly qualified pharmaceutical chemist is employed to make
sufficient analyses of each batch of finished drug to insure that it conforms
to the labeling under which it is to be shipped and to the requirements of the
National Formulary or United States Pharmacopeia or other standard which
may be applicable. Lacking this, a representative sample of each finished
batch of drugs is submitted to a reliable established outside laboratory for
examination and the results of such examination are received prior to
shipment;
(c)?A system of properly identifying and storing raw materials as they
are received at the plant is instituted;
(d)?Batches of drugs in preparation are not manipulated in an improper
manner resulting in unwarranted shortages or averages in the final yield;
(e)?Sampling of finished tablets, and all other finished products is done in
a representative manner to insure the taking of a representative, adequate
sample;
(f)?Capsules are assayed in finished form rather than in earlier stages of
manufacture;
(g)?Finished batches of drugs are analyzed prior to shipment;
(h) Effective new drug applications are obtained for new drugs prior to
their distribution;
(i) At least one qualified person in the plant has sufficient information
concerning the new drugs shipped from the plant to eliminate confusion and
violations;
(j) Adequate samples of incoming raw materials are taken and appro-
priate analyses of these samples made;
(k) Preparation of manufacturing records and forms is done with such
clarity, care and completeness so that each lot or batch of drugs manufactured,
prepared, relabeled, or repacked is so identified that the complete manufactur-
ing, packing, and labeling history and control examination reports are readily
available and so as to eliminate mistakes and confusion;
(1) Each batch or lot of drugs manufactured, prepared, relabeled or
repacked is properly identified at all times and during all stages of said
manufacturing, preparation, relabeling or repacking;
(m) Operations involving the weighing out of raw materials and the
preparation of formulas and application of labeling are checked by another
qualified party in addition to the employee originally performing such duties;
(n) Returned goods are recorded, handled, stored, and again disposed of
in a manner which will eliminate uncertainty, confusion and the possibility of
mistakes;
(o) Samples of each lot of raw materials and each batch or lot of drugs
manufactured, prepared, relabeled or repacked by them are taken and re-
tained for the time reasonably necessary for the distribution and use of drugs
distributed;
(p) Representatives of the Food and Drug Administration of the Depart-
ment of Health, Education, and Welfare are given free access to all records
and controls pertaining to (1) the receipt of all raw materials or lots of drugs
for manufacturing, preparing, repacking or relabeling; (2) the manufacturing,
preparing, repacking or relabeling of all lots or batches of drugs; and (3) the
distribution of all batches or lots of drugs whether interstate or intrastate,
including, but not limited to, the records necessary to establish that adequate
control systems have been installed embodying all of the herein listed safe-
guards for interstate commerce considered necessary to good pharmaceutical
manufacturing practice.