Marvin Mandel, Governor                       1287

(3) To any drug which is subject to Section 189B [(a) (1)] of
this subheading.

190A.
A cosmetic shall be deemed to be adulterated:

(a) If it bears or contains any poisonous or deleterious substance
which would reasonably be expected to render it injurious to users
under the conditions of use prescribed in the labeling or advertise-
ment thereof, or under conditions of use which are customary or
usual; provided, however, that this provision shall not apply to
coal tar hair dye, the label of which bears; the following legend con-
spicuously displayed thereon [;]: "Caution—This product con-
tains ingredients which may cause skin irritation on certain indi-
viduals and a preliminary test according to accompanying directions
should first be made. This product must not be used for dyeing
the eyelashes or eyebrows; to do so may cause blindness," and
the labeling of which bears adequate directions for such preliminary
testing. For the purpose of the subsection and subsection (e) the
term "hair dye" shall not include eyelash dyes or eyebrow dyes.

191C.

(a) For purposes of enforcement of this subheading, the Secre-
tary or any of his authorized agents, are authorized upon present-
ing appropriate credentials to the owner, operator or agent in
charge to enter at reasonable times any factory, warehouse or
establishment in which food, drugs, devices or cosmetics are manu-
factured, processed, packed or held for introduction into commerce
or after such introduction or to enter any vehicle being used to
transport or hold the food, drugs, devices or cosmetics in com-
merce; and to inspect at reasonable times and within reasonable
limits and in a reasonable manner the factory, warehouse, estab-
lishment or vehicle and all pertinent equipment, finished and unfin-
ished materials, containers and labeling therein, and to obtain
samples necessary to the enforcement of this subheading. In the
case of any factory, warehouse, establishment or consulting labora-
tory in which prescription drugs are manufactured, processed,
packed or held, the inspection shall extend to all things therein
(including records, files, papers, processes, controls, and facilities)
bearing on whether prescription drugs which are adulterated or mis-
branded within the meaning of this subheading or which are pro-
hibited from being manufactured, introduced into commerce or
sold or offered for sale by reason of any provision of this sub-
heading, have been or are being manufactured, processed, packed,
transported or held in any such place or otherwise bearing on
violation of this subheading. No inspection authorized for prescrip-
tion drugs by the preceding sentence shall extend to (i) financial
data, (ii) sales data other than shipment data, (iii) pricing data,
(iv) personnel data (other than data as to the qualifications of
technical and professional personnel performing functions subject
to this subheading), and (v) research data (other than data, relat-
ing to new drugs and antibiotic drugs, subject to reporting and
inspection under regulations lawfully issued pursuant to Section
355 (i) or (j) or Section 357 (d) or (g) of the federal act, and
data, relating to other drugs, which in the case of a new drug
would be subject to reporting or inspection under lawful regula-