Pharmaceutical Equivalents [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 320.1 (c) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter D Drugs for Human Use; Part 320 Bioavailability and Bioequivalence Requirements; Subpart A General Provisions], Pharmaceutical Equivalents means “drug products in identical dosage forms that contain identical amounts of the identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, or, in the case of modified release dosage forms that require a reservoir or overage or such forms as prefilled syringes where residual volume may vary, that deliver identical amounts of the active drug ingredient over the identical dosing period; do not necessarily contain the same inactive ingredients; and meet the identical compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times, and/or dissolution rates.”