AquaShield MPS Gains FDA OTC Monograph Approval
Our AquaShield multi-purpose solution has completed FDA OTC Monograph compliance review, opening the US pharmacy retail channel to Conley Carey products.
Conley Carey Biomedical is pleased to confirm that AquaShield Multi-Purpose Solution has successfully completed the FDA OTC Drug Monograph compliance process under 21 CFR Part 349.
The OTC Monograph pathway — which establishes conditions under which specific active ingredients are generally recognised as safe and effective (GRASE) — is the primary route for contact lens care products to reach US pharmacy shelves without requiring a full Pre-Market Approval.
AquaShield MPS contains PHMB 0.0001% as its preservative/disinfectant, which is listed within the FDA OTC Monograph as a GRASE ingredient at concentrations up to 0.0001% — making it eligible for OTC sale as a contact lens disinfecting solution.
The compliance confirmation covers product formulation compliance with 21 CFR 349.50, labelling compliance with OTC Drug Labelling regulations, and cGMP certification of the manufacturing facility.
"This is a significant commercial milestone," said Dr. Wei Liang, CEO. "The US contact lens care market is worth over USD 1.2 billion annually, and pharmacy chains are highly receptive to private-label opportunities. We are actively engaging with retail pharmacy buyers and private-label partners to bring Conley Carey-manufactured products to US shelves."
Importers and distributors interested in the US market opportunity should contact export@conleycarey.com.
