01
The legitimate role
Compounding exists to meet clinical needs that approved products cannot — an allergy to an excipient, a required non-standard formulation, or a paediatric dose form. It is a pharmacy practice, not a parallel drug approval pathway.
Fig. 02 / Molecular pathway02
Where peptides raised concern
Regulators have evaluated a number of peptide bulk substances and placed several in categories reflecting significant safety concerns, citing issues such as immunogenicity risk, insufficient characterisation, and lack of safe-use data.
Shortage-driven compounding of approved peptide medicines has also prompted repeated agency communications about unapproved and counterfeit supply, incorrect dosing, and adverse events.
Editorial 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.