01
Core terms
These definitions are deliberately narrow. Loose use of these words is the main mechanism by which unapproved products acquire the appearance of legitimacy.
- New Drug Application: the submission seeking marketing authorisation for a new medicine.
- Investigational New Drug: the authorisation permitting human study of an unapproved compound.
- Off-label use: prescribing an approved medicine outside its authorised indication.
- Bulk drug substance: an active ingredient used in compounding, subject to specific evaluation.
- Import alert: a measure allowing detention of products at the border.
- Adulterated / misbranded: statutory findings about product composition or labelling.
Fig. 02 / Molecular pathwayEditorial disclaimer
This site is educational and does not provide medical advice, dosing protocols, or treatment recommendations. Regulatory status and evidence strength differ sharply between compounds. A “research use only” label does not indicate that a product is appropriate for human use. Decisions about medicines belong with a qualified clinician.