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USP-NF Monograph

Meaning

A detailed, legally recognized document published in the United States Pharmacopeia–National Formulary (USP–NF) that establishes the official public standards for the identity, strength, quality, purity, packaging, and labeling of a specific drug substance or pharmaceutical preparation. Compliance with a USP-NF monograph is mandatory for prescription and non-prescription drugs sold in the U.S. and serves as a crucial benchmark for the quality assurance of active pharmaceutical ingredients, including those used in compounded hormonal therapies.