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For medicines that require light-protected storage, besides keeping them in opaque containers, what design requirements apply to the premises?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q162 · Category D: Premises and Storage Requirements (Q151-Q200)
For light-sensitive medicines, opaque original packaging or containers alone are not sufficient; the entire storage environment should take light protection into account. First, the storage area should be kept as far as possible from direct natural light. Windows should be fitted with blackout curtains or blinds, or covered with UV-blocking film. If windows cannot be fully avoided, medicine shelves should be positioned away from them. Second, lighting that does not emit significant amounts of ultraviolet radiation should be used. Traditional fluorescent tubes emit some ultraviolet radiation, which may affect medicine stability over prolonged exposure. LED lighting or other low-UV light sources are recommended. Finally, the relevant Standard Operating Procedures (SOPs) should clearly specify how light-sensitive medicines are to be handled. For example, during picking and packing, their exposure to strong light should be kept as short as possible.

📘 Regulatory basis

Medicine labels commonly state “Store protected from light”. Good Distribution Practice (GDP) requires licence holders to follow the storage conditions specified by the manufacturer. Failure to provide suitable protection from light breaches this basic requirement.

📗 Drew Tang's recommendations

We recommend that clients establish a dedicated “light-protected storage area”, which may have no windows or may have specially treated windows. Store all light-sensitive medicines in this area for centralised management and control. Adding a requirement to the SOP for staff to close the door behind them when entering the area is also a simple and effective control measure.

📕 Risk notice

Do not underestimate the effect of light on medicine stability. Prolonged exposure to unsuitable light may cause active ingredients to degrade and produce toxic by-products. If, during a Drug Office inspection, medicines clearly labelled “Protect from light” are found stored beside a window in direct sunlight, this will be regarded as a serious breach and will directly affect the licence application outcome.

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