№ files_lp_4_process_3_097582
Legislative instrument explaining the declaration of serious scarcity for certain labetalol medicines and specifying the conditions under which pharmacists may dispense substitutable medicines to ensure continued patient access.
Year: 2026
Region / Country: Australia
Subject: Medicine shortage and substitution
Document Type: Legislative instrument / explanatory statement
Governing Body: Australian Government Department of Health, Therapeutic Goods Administration
Affected Medicines: PRESOLOL 200 mg and PRESOLOL 100 mg labetalol hydrochloride tablets
Purpose: Declaration of serious scarcity and permitted pharmacist substitution
Legal Basis: Therapeutic Goods Act 1989, Section 30EK
Duration of Effect: Until supply of scarce medicine returns to normal (expected May 2026)
Background: Ongoing manufacturing issues and previous shortages
Substitution Rules: Specifies alternative registered medicines with labetalol 100 mg or 200 mg tablets
Price: 8 / 10 USD
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