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 March 8, 1982, 12 Pa.B. 522. Immediately preceding text appears at serial page (37618).

Notation

Authority

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).

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions).