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Tuesday, 8 April 2014

Question 1f) - The Schedule 2 exemption regulation

The question is what is the classification of a cream containing diphenhydramine 1%, calamine 3% and camphor 0.1%.

This is clearly a cream for allergic skin rash, at a guess something which can be bought from your local chemist which would make it a P1 or P2. The restricting ingredient is probably diphenhydramine, so I would look up diphenhydramine in the PSHK list.

Annoyingly enough diphenhydramine is not listed under 'D', it is under A for antihistamine (pg. 7). Antihistamine classification in HK is kind of interesting. It is a P1 drug, (pharmacy drug) BUT it also says 'Preparations intended for external use only and eye/nose drop preps containing not more than 1% antihistamine' have schedule 2 status.

What is schedule 2?? you might ask.

Schedule 2 drugs have legally been exempted from all legislation requirements, and are effectively like non-poisons. Presumably this means they can even be sold by your Aunt Betty who could be a hairdresser and I find it odd they have this kind of exemption regulation. OK, maybe for antihistamine creams, but oral contraceptives are also included on this list. I can understand them wanted to make OCs more freely available, but I'd have thought at least make them P1 or P2 right?

The schedule 2 regulation is here (Regulation 8 is here)

In short the answer to this question is 'NP', which stands for Non-Poison, but the exam question puts it as meaning 'none of the above' which is more technically accurate.

Some of you purists might be asking but what about calamine and camphor? You're welcome to go try to find these ingredients on the lists. I don't think they're there though

I wanted to try and find out what product contains these specific components but I couldn't find any, so either they made it up or this product is no longer made. Or maybe it's too generic?


The exam paper I am going through is here

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