The practice of prescribing or using a drug or a vaccine outside the scope of the drug's official approved label as designated by a regulatory agency concerning the treatment of a particular disease or condition
Drug Labeling -- legislation & jurisprudence : Safe and effective medicines for children : studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act / Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA), Institute of Medicine of the National Academies ; edited by Marilyn J. Field and Thomas F. Boat
