Pharmacy and poisons board of hong kong endorses regulation of medical gases as pharmaceutical products under ordinance, effective june 14, 2026
The Department of Health (DH) today (June 17) said that the Pharmacy and Poisons Board of Hong Kong (the Board) has endorsed the regulation of medical gases as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138) (the Ordinance) with effect from June 14, 2026.
In September 2023, the Board agreed that medical gases should be regulated as pharmaceutical products under the Ordinance after taking into account the regulatory control of medical gases in other jurisdictions and the current situation in Hong Kong. In this connection, a public consultation had been conducted by the DH in November last year for collecting views and comments from the public and relevant stakeholders.
Noting that the overall responses were in support of the regulatory control of medical gases, the Board has decided at its meeting on June 14, 2024, to regulate medical gases as pharmaceutical products under the Ordinance by giving two years' preparatory time (i.e. from June 14, 2024, to June 13, 2026) for the trade to apply for relevant licences and registration of their products. The Board has also promulgated relevant Guidance Notes and details are available at the Board's website (www.ppbhk.org.hk/eng/index.html).
The DH has started issuing letters to inform relevant traders and stakeholders about the aforesaid regulation. When the new regulatory control takes effect, the medical gases, as pharmaceutical products, have to be registered with the Board before they can be legally sold or supplied in Hong Kong. In addition, traders of the pharmaceutical products must obtain relevant licence(s) from the Board before conducting manufacture, wholesale (including import and export) of pharmaceutical products and retail sales of pharmaceutical products containing poisons. According to the Ordinance, illegal possession or sale of unregistered pharmaceutical products or prescription drugs, and manufacture, wholesale of pharmaceutical products and retail sales of pharmaceutical products containing poisons without relevant licences are criminal offences. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment upon conviction.
For relevant information on the Regulation of Medical Gases, please visit the website of the Drug Office of the DH (www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/medical_gases_regulation.html).
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CFS steps up surveillance of lead content in powdered infant and follow-up formula
The Centre for Food Safety (CFS) of the Food and Environmental Hygiene Department (FEHD) announced today (July 29) that the CFS continues to actively follow up on a case announced earlier by the Macao authority, concerning a batch of powdered infant formula found with lead exceeding its permissible levels.
A spokesman for the CFS said, "Upon learning of the incident earlier, the CFS immediately stepped up the surveillance of powdered infant and follow-up formula. Over the past four days (from July 25 to July 28), the CFS collected over 50 samples of powdered infant and follow-up formula products in the market for lead content testing, including 11 batches of Frisolac Prestige Stage 1 Infant Formula (800g) (see Annex for details). No case exceeding Hong Kong's statutory standard was found, i.e. lead content not exceeding 0.01 milligram per kilogram."
The spokesperson added that the CFS will continue to collect powdered infant and follow-up formula samples in the market for testing, and will closely monitor the development of the incident to fully safeguard food safety.
The spokesperson supplemented that long term excessive exposure to lead in children can lead to neurological impairment and affect brain development. Regarding the individual batch previously recalled (Product name: Frisolac Prestige Stage 1 Infant Formula (800g); Best-before date: September 30, 2027; Batch number: 1W07KPJ), the CFS has deployed officers to inspect various retail outlets to ensure that the affected batch of the product has been removed from shelves to safeguard food safety.
The CFS urged again members of the public not to let infants and young children consume the affected batch of product, and to seek medical treatment if infants or young children who feel unwell after consuming the product concerned. Apart from contacting the Macao authority and informing the trade and relevant departments, the CFS took the initiative earlier to meet with the importer concerned, urging them to properly handle the product recall issue. The importer concerned is currently recalling the affected batch of powdered infant formula. Members of the public can call the importer's hotline at 2280 4731 during office hours for enquiries about the recall. The trade should also immediately stop using or selling the affected batch of products.
The CFS has been collecting powdered infant and follow-up formula samples from local retail outlets for testing under its routine Food Surveillance Programme to safeguard the food safety of infants and young children. From 2023 to July 2026, the CFS has collected over 2 200 powdered infant and follow-up formula samples from the market for chemical and microbiological testing, including lead content tests. No unsatisfactory samples for lead content were found.
The CFS has established a designated webpage (www.cfs.gov.hk/english/whatsnew/powdered_formula_lead/index.html) to facilitate public access to more information.
CFS steps up surveillance of lead content in powdered infant and follow-up formula Source: HKSAR Government Press Releases
CFS steps up surveillance of lead content in powdered infant and follow-up formula Source: HKSAR Government Press Releases
