Current through Register Vol. 54, No. 24, June 15, 2024
Section 25.101 - Standards(a) No drug, device, or cosmetic shall be deemed misbranded under the act if such drug, device, or cosmetic would-if introduced into interstate commerce-comply with 21 U.S.C.A. § 352 and the rules, regulations, and interpretations adopted thereunder relating to misbranding, except where the act or this chapter provides otherwise.(b) Any drug in a solid dosage form other than a nonproprietary drug that contains any quantity of caffeine, phenylpropanolamine, or pseudoephedrine or any of their salts or that contains any quantity of ingredients which have a stimulant or depressant effect on humans will be deemed misbranded-with all attendant criminal penalties found in the act-regardless of its label, labeling, or packaging if its size, shape, and color or its imprinted symbols, numbers, or letters are substantially identical in appearance to a controlled substance as displayed in the color product identification section of the current edition of the Physician's Desk Reference.(c) Any solid dosage form which contains markings which bear a distinctive trademark, trade name, brand name, or manufacturer's name so as not to appear substantially identical to a controlled substance will not be in violation of this section.The provisions of this § 25.101 amended February 5, 1982, effective 3/8/1982, 12 Pa.B. 522.The provisions of this § 25.101 issued under sections 2102(g) and 2108 of The Administrative Code of 1929 (71 P. S. §§ 532(g) and 538).
This section cited in 28 Pa. Code § 551.3 (relating to definitions).