Section 780-108 - MisbrandingA controlled substance, other drug or device or cosmetic shall be deemed to be misbranded:
(1) If its labeling is false or misleading in any particular.(2) If in package form unless it bears a label containing (i) the name and place of business of the manufacturer, packer or distributor, and (ii) an accurate statement of the quantity of the contents in terms of weight measure or numerical count: Provided, That under subclause (ii) of this clause, reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations.(3) If any word, statement or other information required by or under authority of this act to appear on the label, or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs or devices in the labeling), and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.(4) If it is for use by man and is a controlled substance designated by Federal law as habit-forming, unless its label bears the statement "Warning. May Be Habit-Forming."(5) If it is a drug and is not designated solely by a name recognized in an official compendium, unless its label bears (i) the common or usual name of the drug, if such there be, and (ii) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient including the kind and quantity or proportion of any alcohol and also including whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, thyroid or any derivative or preparation of any such substances contained therein: Provided, That to the extent that compliance with the requirements of subclause (ii) of this clause is impracticable, exemptions shall be established by regulations.(6) Unless its labeling bears (i) adequate directions for use, and (ii) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of users: Provided, That where any requirement of subclause (i) of this clause as applied to any drug, device or cosmetic is not necessary for the protection of the public health, regulations shall be promulgated exempting such drug, device or cosmetic from such requirements.(7) If it purports to be a drug or device the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein: Provided, That the method of packaging may be modified with a consent of the secretary.(8) If it has been found by the secretary to be a drug, device or cosmetic liable to deterioration unless it is packaged in such form and manner and its label bears a statement specifying such precautions against deterioration as the secretary shall by regulation require as necessary for the protection of public health.(9) If it is offered for sale or sold under the name of another drug, device or cosmetic or brand of drug, device or cosmetic, or if it is manufactured, packaged, labeled or sold in such manner as to give rise to a reasonable probability that the purchaser will be led to believe he is purchasing such drug, device or cosmetic as another drug, device or cosmetic or as the product of another manufacturer.(10) If it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended or suggested in the labeling thereof.(11) If it is a drug, device or cosmetic and its container is so made, formed or filled as to be misleading.(12) If it is a controlled substance its commercial container must bear a label containing an identifying symbol for such substance in accordance with Federal regulations.1972, April 14, P.L. 233, No. 64, § 8, eff. 6/14/1972.