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Besides ensuring first-in, first-out, what other key compliance requirements apply to medicine inventory management?

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

Q359 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
Effective inventory management is central to ensuring medicine quality and safety. In addition to strictly applying the “first-expired-first-out” (FEFO) principle (that is, dispatching items with the earliest expiry date first, which is more accurate than FIFO), the following key compliance points apply: 1. Clear zoning: the warehouse must have clearly designated areas for quarantined goods pending examination, released goods, non-conforming goods, returned goods and recalled goods, with clear signs to distinguish them and prevent mix-ups and cross-contamination. 2. Environmental monitoring: medicines with specific temperature and humidity requirements must be monitored and recorded continuously, 24 hours a day, using calibrated equipment. There must be an emergency plan for environmental excursions, and actions taken must be documented. 3. Regular stocktakes: stock must be counted regularly, and physical inventory reconciled against stock records. Any discrepancies must be investigated and documented. 4. Expiry-date management: establish an expiry-date alert system and closely monitor medicines approaching their expiry date to prevent expired medicines from being dispatched accidentally. 5. Security: take appropriate security measures to prevent unauthorised access to storage areas and prevent medicines from being stolen or tampered with.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers sets out detailed requirements for the storage, stock control and distribution of medicines, requiring licensees to take all necessary measures to maintain medicine quality throughout the supply chain.

📗 Drew Tang's recommendations

We recommend that clients treat stock management as a dynamic process. An electronic inventory system using barcodes or RFID can greatly improve the accuracy of FEFO implementation, stocktaking efficiency and medicines tracking. For high-value or controlled medicines, consider higher-level security measures, such as a separate locked storage area and video surveillance. Regular inventory analysis can also help optimise procurement planning and reduce tied-up capital and losses from expired products.

📕 Risk notice

Disorganised inventory management creates conditions in which medicine quality problems can arise. Accidentally supplying non-conforming or expired goods to customers can lead not only to complaints and commercial losses, but also to medicine safety incidents, regulatory penalties and legal liability. Medicines deteriorating because of improper storage conditions is likewise a serious breach.

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