Pennsylvania Statutes Title 35 P.S. Health and Safety § 780-107. Adulteration

(2) If it purports to be or is represented as a drug or device, the name of which is recognized in an official compendium and its strength differs from or its quality or purity falls below the standards set forth in such compendium.  Such determination as to strength, quality or purity, shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay those prescribed under the authority of the Federal act.  No drug or device defined in an official compendium shall be deemed to be adulterated under this subsection because it differs from the standard of strength, quality or purity therefor set forth in such compendium, if its difference in strength, quality or purity from such standard is plainly stated on its label.

(3) If it is a color additive and is to be used or is recommended for use as a hair dye and it is not exempt under section 9 unless its label bears the following legend conspicuously displayed thereon:  “Caution.  This product contains ingredients which may cause skin irritation on certain individuals 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 bears adequate directions for such preliminary testing.  For the purpose of this paragraph, the term “hair dye” shall not include eyelash dyes or eyebrow dyes.

(4) If it is not subject to the provisions of clause (2) of this section and its strength differs from or its purity or quality falls below that which it purports or is represented to possess.

(5) If it is a drug or device and any substance has been (i) mixed or packed therewith so as to reduce its quality or strength, or (ii) substituted wholly or in part therefor.