DHSC consultation on pharmacist flexibilities excludes generic and therapeutic substitution
The Department of Health and Social Care (DHSC) has launched a consultation on proposals to amend the Human Medicines Regulations 2012, SI 2012/1916 (HMRs 2012), to allow pharmacists in community settings to supply a different strength or formulation of the same prescription-only medicine (POM) in specific circumstances, where the prescribed medicine is unavailable, there is an urgent clinical or practical need, and the alternative enables the same dose, dosage regimen and treatment cycle. The consultation does not cover generic substitution (supplying a different brand or generic version), therapeutic substitution (supplying a different medicine), unlicensed medicines, off-label dispensing, or secondary care settings such as hospitals. Responses are sought by 11 December 2025.