Macao, China Special Administrative Region has issued a public warning against the use of a topical product adulterated with Western medicine ingredients, specifically lidocaine, tetracaine, and prilocaine, due to health risks associated with these local anesthetics.
Macao Warns of Adulterated ‘Dermasa’ Cream
A topical product was found with hidden prescription anesthetics.
What changed
Public alert issued for ‘Dermasa’ cream adulterated with lidocaine, tetracaine, and prilocaine.
Import and distribution not approved for ‘Dermasa’ in Macao.
Product contains hidden anesthetics that can cause skin allergies.
Who it affects
Residents using ‘Dermasa’ must stop use immediately due to health risks.
Importers and distributors are barred from bringing ‘Dermasa’ into Macao.
What to do
Stop using the ‘Dermasa’ product immediately.
Return the product to the Macao Drug Supervision Bureau for safe disposal.
Compliance Analysis: Prohibition of Adulterated Topical Product in Macao SAR
Direct Answer
The Macao Pharmaceutical Administration Bureau (药物监督管理局, hereinafter "the Bureau") has issued a public warning prohibiting the use, purchase, or distribution of the topical product "Dermasa", which is adulterated with the prescription local anesthetics lidocaine, tetracaine, and prilocaine1, 2. The product is unapproved for import or sale in Macao SAR, and its use poses health risks, including skin allergic reactions.
Regulation Analysis
1. Legal Status of the Product
- The product "Dermasa" is not approved for import or market distribution in Macao SAR. The Bureau has no record of its registration1, 2.
- The adulterants (lidocaine, tetracaine, prilocaine) are classified as prescription-only drugs under Macao regulations when used in topical formulations2.
2. Public Health Risks
- The adulterants are local anesthetics used to relieve pain but may cause skin allergic reactions1, 2.
- Unregulated use of prescription drugs in unapproved products violates Macao’s pharmaceutical safety laws, which mandate prior approval for all medicinal ingredients in topical products2.
3. Compliance Obligations
| Regulation | Key Requirement | Authority |
|---|---|---|
| Prohibition of Adulterated Products | Residents must not purchase or use "Dermasa"1, 2. | Pharmaceutical Administration Bureau |
| Disposal of Unapproved Products | Users must immediately cease use and surrender the product to the Bureau1, 2. | Pharmaceutical Administration Bureau |
| Prescription Drug Control | Topical products containing lidocaine/tetracaine/prilocaine require prescription and Bureau approval2. | Pharmaceutical Administration Bureau |
4. Enforcement Actions
- The Bureau will monitor the product’s circulation in Macao SAR and take enforcement measures against unauthorized sales1, 2.
- Residents may report suspected violations or seek guidance by contacting the Bureau’s Monitoring Division at +8598 3233 during office hours1, 2.
Summary Answer
The Macao Pharmaceutical Administration Bureau has banned the use, purchase, and distribution of the topical product "Dermasa" due to its adulteration with lidocaine, tetracaine, and prilocaine, which are prescription-only local anesthetics1, 2. The product lacks approval for import or sale in Macao SAR, and its use may cause skin allergic reactions2. Residents must discontinue use immediately and surrender the product to the Bureau for disposal1, 2. For further inquiries, contact the Bureau’s Monitoring Division at +8598 32331, 2.
Sources
- ↩ isaf.gov.mo — post / 26234 https://www.isaf.gov.mo/cn/post/26234
- ↩ gov.mo — news / 927069 https://www.gov.mo/zh-hans/news/927069/