Enhance Regulatory Control of Skin Antiseptic Products
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The Pharmacy and Poisons Board of Hong Kong (the Board) has made a decision on enhancing the control of skin antiseptic products containing benzalkonium salts, benzethonium salts, cetrimide, hydrogen peroxide and iodine/povidone iodine will come into effect on 11 Jun 2022.
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In response to the incidents of bacterial contamination of chlorhexidine containing skin antiseptics in 2019, the Board enhanced the regulatory control of skin antiseptic products containing chlorhexidine which came into effect on 8 July 2020.
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To safeguard public health in the safe and proper use of all skin antiseptic products containing substances other than chlorhexidine, the Board decided that under the current regulatory control of pharmaceutical products with antiseptic ingredients, the sales control of skin antiseptic products containing benzalkonium salts, benzethonium salts, cetrimide, hydrogen peroxide and iodine/povidone iodine should be tightened as well after reviewing the existing definition of pharmaceutical products and taking reference of overseas regulatory practices for antiseptic products. In this connection, the “Guidance Notes on Classification of Products as Pharmaceutical Products” (the Guidance Notes) under the Pharmacy and Poisons Ordinance (Cap. 138) related to skin antiseptic products containing the aforementioned substances have been revised as follows:-
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| (a) |
Unless otherwise stated, skin antiseptic products for human or animal use without any claims but containing well established active ingredients documented to be effective antiseptics, which include the following-
- Benzalkonium salts,
- Benzethonium salts,
- Cetrimide,
- Hydrogen peroxide, or
- Iodine / Povidone iodine,
are classified as pharmaceutical products regardless of their concentration.
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| (b) |
General toiletry or cosmetic products containing antiseptic substances as preservatives, or intended for general cleansing or sanitary use, such as hand wash, body wash, cleanser and shampoo are generally not considered as pharmaceutical products.
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From 11 Jun 2022 onwards, skin antiseptic products containing benzalkonium salts, benzethonium salts, cetrimide, hydrogen peroxide and iodine/povidone iodine that fulfil the definition of pharmaceutical product must be registered with the Board before they can be legally sold in Hong Kong.
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