Is azelaic acid banned in Malaysia?
No. Azelaic acid is not banned as a medicine in Malaysia. It is a scheduled poison, which is the legal name for a substance whose supply the Poisons Act 1952 controls. The word "poison" here is a legal class, and it does not mean the substance is toxic when used as directed. The Poisons List sets out who may supply it, and the groups below explain what that means for a buyer.
The position for cosmetics is different. The cosmetic rules that the National Pharmaceutical Regulatory Agency (NPRA) applies list azelaic acid among the substances that must not form part of a cosmetic product. So a serum sold as a skincare product should not contain it, and one sold as a medicine should carry a registration number. Both rules are set out below, as read in the official files on 2 November 2026.
What does the Poisons List say about azelaic acid?
The Poisons List is the First Schedule of the Poisons Act 1952. The copy on the Ministry of Health's pharmacy website is marked as updated in line with P.U.(A) 460/2025. Its entry for azelaic acid reads:
- Group A: no entry.
- Group B: "All medicinal preparations unless in Group C".
- Group C: "Medicinal preparations for external use".
- Group D: "All preparations unless in Group B or Group C".
In plain words, a medicine with azelaic acid that goes on the skin, such as a cream or gel, is in Group C. A medicine with azelaic acid in any other form is in Group B. Any other preparation containing it falls in Group D. The Act decides who may supply each group.
What do Groups B, C and D mean when you buy it?
Sections 18 to 24 of the Poisons Act set the rules. For retail supply, a poison of these groups may be supplied only by a registered pharmacist at a licensed pharmacy, or by a doctor, dentist or vet to their own patient. Within that:
- Group B (section 21): supplied by a doctor to a patient, or by a registered pharmacist as a dispensed medicine on a doctor's prescription.
- Group C (section 22): supplied in the same ways as Group B, or as a dispensed medicine. The Act defines a dispensed medicine as a medicine supplied by a doctor, or by a registered pharmacist at a licensed pharmacy, for the treatment of one particular person. When a pharmacist dispenses without a prescription, section 24 requires the pharmacist to record the person's name and address.
- Group D (section 23): supplied by a registered pharmacist to a person the pharmacist knows personally, or who is introduced by someone the pharmacist knows, with an entry in a poisons book.
So a medicinal azelaic acid cream is a doctor-or-pharmacist product, handed to a person for their own treatment, which is different from picking a tube off an open shelf. A prescription is the route for Group B, and a Group C cream can also be dispensed by a pharmacist. Which pharmacies stock a particular cream, and at what strength, is not something the Poisons List says, and this article did not check any product's availability. The article on melasma creams in Malaysia sets out the same groups for hydroquinone and tretinoin, and the article on what Malaysian law lets you buy in retinoids explains what a Group C entry means in a shop.
Can a cosmetic contain azelaic acid in Malaysia?
Cosmetics in Malaysia are notified to NPRA rather than approved. NPRA's Guidelines for Control of Cosmetic Products in Malaysia, second edition, say in section 3.3 that marketing a cosmetic containing a substance on the Poisons List (unless exempted) is prohibited, and so is marketing one containing a substance in Annex II. Annex II is the ASEAN list of substances that must not form part of a cosmetic product.
NPRA's Annex II release of 10 June 2026 lists azelaic acid, CAS number 123-99-9, reference A1141, with no limit or condition beside it. The guidelines allow traces of an Annex II substance only where the presence is technically unavoidable in good manufacturing practice and meets safety requirements. NPRA's circular 2/2026, issued in July 2026, changed other entries in the annexes and does not list azelaic acid among its changes.
What about names that sound similar, such as potassium azeloyl diglycinate?
Skincare labels also carry ingredient names that sound close to azelaic acid. Potassium azeloyl diglycinate is one. NPRA's Annex II and Annex III of 10 June 2026 list azelaic acid and have no entry under the name potassium azeloyl diglycinate, and the Poisons List has no entry under that name either. None of the official files read for this article says how that ingredient is treated, so this article does not say whether it is allowed. A pharmacist, or NPRA through its public enquiry service, is the one to ask about a named ingredient.
Has NPRA cancelled a cosmetic because it contained azelaic acid?
Yes. NPRA's page of cancelled cosmetic notifications names azelaic acid (asid azelaik) as the scheduled poison found in products cancelled in 2011, 2013, 2016 and 2023. The latest entry cites a Ministry of Health press statement dated 24 October 2023, which lists a serum among five cosmetics found to contain scheduled poisons. It says the notifications were cancelled by the Senior Director of Pharmaceutical Services and the products may no longer be sold in Malaysia.
The same statement says products containing azelaic acid, hydroquinone, tretinoin or betamethasone 17-valerate must be registered with the Drug Control Authority and used only on the advice of a health professional. It lists the effects of azelaic acid used without supervision on the face as burning, itching, redness, peeling and a change in skin colour. This article names no product. A product's status is whatever the NPRA search shows on the day it is checked, and a cosmetic that is notified today can be cancelled later, as the steroid example in the article on steroid cream on the face and hidden steroids also shows.
How do I check a serum labelled azelaic?
Work out first what the product claims to be, because the register to search depends on it. The KKM check for creams, injections and slimming pens explains each step. In short:
- A medicine carries a MAL number: the letters MAL, eight digits and a category letter (A for a medicine containing a controlled poison, X for one without), together with a hologram label. Search the number on NPRA's QUEST3+ product search under pharmaceutical products. The search can also be run by active ingredient.
- A cosmetic carries a notification number that starts with NOT, then digits, then K. Search it under cosmetic on the same page, then check that the product is not on NPRA's list of cancelled notifications. A notification lasts two years, so the check is worth repeating.
- Neither number means there is nothing to check, and that is a reason to leave the product alone.
- The ingredient list helps for a cosmetic. Azelaic acid is on NPRA's Annex II list, so finding it on a cosmetic label is a reason to check the notification status before use.
An online listing, a review or a claim of approval is not the register. NPRA's 2023 statement also points to its Product Status app for checking a notification, and a pharmacist can check a hologram label.
What is azelaic acid used for, and what are the side effects?
Azelaic acid is a medicine for the skin. The UK product information for a 20 per cent azelaic acid cream lists acne as its use, applied twice daily, with a distinct improvement usually after about four weeks and the best results from continuous use over several months. DermNet NZ lists mild to moderate acne, and says azelaic acid helps reduce pigmentation, which is useful for post-inflammatory marks and melasma, particularly in darker skin. A US label for a 15 per cent foam lists the inflammatory papules and pustules of mild to moderate rosacea. DermNet says rosacea may take up to 12 weeks to improve. The strengths named in these sources are 20 per cent for creams and 15 per cent for gels and foams. Which strengths are registered in Malaysia was not checked for this article.
The most frequent side effects in the UK information are burning, itching and redness where the cream goes on, and it says local irritation generally eases as treatment continues. The US label lists application-site pain as the most frequent reaction, a term that includes burning and stinging. DermNet adds that lightening of the skin is more noticeable in darker skin tones, and the UK information lists a worsening of asthma as rare. The melasma creams article reports where azelaic acid stands in the trial reviews for dark patches.
On pregnancy, the UK information says there are no adequate and well-controlled studies of azelaic acid applied to the skin of pregnant women, that animal studies indicate potential effects on pregnancy, although the doses without observed effects were 3 to 32 times the maximum human dose, and that caution should be exercised when prescribing it. It also advises caution when breastfeeding and says infants must not touch treated skin or breast. Whether to use it during pregnancy, or when planning one, is a decision to make with a doctor.
What does The Retreat Clinic offer here?
The Retreat Clinic is a doctor-led aesthetic clinic in Setia Alam, Shah Alam. It is not a pharmacy and not a dermatology service, and this article is about the law and about checking a product, not advice about a particular tube or bottle. Dr Ong can examine the skin and say whether spots, redness or dark patches look like acne, rosacea or melasma, which is the question that comes before any choice of cream. The article on what a doctor checks first in adult acne and the article on rosacea and the eye explain what that examination covers.
Whichever route is used, a doctor or a licensed pharmacist is the legal source for a medicine, and the number on the box is the first thing to check.
