Pharmaceutical Alternatives [Food and Drugs] Law & Legal Definition


Pursuant to 21 CFR 320.1 (d) [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 Alternatives means “drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in the same amount or dosage form or as the same salt or ester. Each such drug product individually meets either the identical or its own respective compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times and/or dissolution rates.”