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Ephedrine
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16-06-2014 8:50pm#1
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This is quite complex, so pay attention...
Ephedrine is a substance that is listed in the First Schedule of the Medicinal Products (Prescription and Control of Supply) Regulations, 2003.
This means it is a prescription only medicine.
The same schedule also include the circumstances under which it is exempt from prescription control - namely; when it is for external use, not including its topical application to the eyes.
What does this mean?
It means that any company can apply to the IMB for a Product Authorisation to manufacture and supply a medicinal product containing Ephedrine. The default legal status* of such a product will be prescription only, unless it's intended for external use other than in the eyes. As long as the application satisfies all of the requirements of the IMB (such as including convincing evidence that the product is both safe and effective for its intended use, and evidence that the manufacturing facility is capable of guaranteeing the consistency and quality of the product), the application will be granted.
At this time, there is no such product authorised by the IMB.
Now, the above should not be taken to mean that just anyone can supply, say, a cream for the skin containing Ephedrine, even though I said above that it would not be prescription only. That exemption would only apply to an authorised product.
In the absence of an authorised product, does that mean you cannot get it? Not really. A doctor is entitled to write a prescription for anything he likes. Even products that are authorised in another country but not this one. So if your doc writes it, and if your pharmacist can locate it, and if you're willing to pay for it, then you can get it.
* : You might be wondering why I said "default legal status": The above-mentioned regulations were amended in (I think) 2008, and since then the IMB can supercede the legal status of a medicine if it deems it appropriate to do so. For example, in the above regulations the antihistamine Cetirizine is prescription only, unless it is in packets of 10 tablets or less. However, in the last few years a couple of companies put in applications for authorisations to sell it in packs of 30. The applications were successful, and now you can buy 30-packs of products called Cetirilief and Cetriz. However, the makers of Zirtek (who were the original inventors of the drug) have not put in an application to amend the terms of their original authorisation, and therefore Zirtek - which has the exact same active ingredient - is currently only available in packets of 7 without a prescription. The 30-pack remains on prescription only.
This means that Ephedrine could be available without a prescription if the hypothetical application I mentioned above asked for - and if the IMB agreed that it was safe for - it to be so.Labarbapostiza wrote: »How does the IMB licencing work?
If they don't licence ephedrine, is it an omission, or they effectively ban the substance.
I was told in a Chinese shop they can't sell Ma Huang tea anymore. That's made from the ephedra plant.
Pseudoephedrine is not in fact a pseudo or false ephedrine. It's just one of the enantiomers of ephedrine, so it is ephedrine. I think the tea made from the plant contains all the different enantiomers, and I think what's sold as ephedrine contains a mix too - so a quarter to a half might be pseudoephedrine.
To the best of my knowledge, only the left spinning enantiomers are effective as medicines.1 -
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locum-motion wrote: »This is quite complex, so pay attention...
Ephedrine is a substance that is listed in the First Schedule of the Medicinal Products (Prescription and Control of Supply) Regulations, 2003.
This means it is a prescription only medicine.
The same schedule also include the circumstances under which it is exempt from prescription control - namely; when it is for external use, not including its topical application to the eyes.
What does this mean?
It means that any company can apply to the IMB for a Product Authorisation to manufacture and supply a medicinal product containing Ephedrine. The default legal status* of such a product will be prescription only, unless it's intended for external use other than in the eyes. As long as the application satisfies all of the requirements of the IMB (such as including convincing evidence that the product is both safe and effective for its intended use, and evidence that the manufacturing facility is capable of guaranteeing the consistency and quality of the product), the application will be granted.
At this time, there is no such product authorised by the IMB.
Now, the above should not be taken to mean that just anyone can supply, say, a cream for the skin containing Ephedrine, even though I said above that it would not be prescription only. That exemption would only apply to an authorised product.
In the absence of an authorised product, does that mean you cannot get it? Not really. A doctor is entitled to write a prescription for anything he likes. Even products that are authorised in another country but not this one. So if your doc writes it, and if your pharmacist can locate it, and if you're willing to pay for it, then you can get it.
* : You might be wondering why I said "default legal status": The above-mentioned regulations were amended in (I think) 2008, and since then the IMB can supercede the legal status of a medicine if it deems it appropriate to do so. For example, in the above regulations the antihistamine Cetirizine is prescription only, unless it is in packets of 10 tablets or less. However, in the last few years a couple of companies put in applications for authorisations to sell it in packs of 30. The applications were successful, and now you can buy 30-packs of products called Cetirilief and Cetriz. However, the makers of Zirtek (who were the original inventors of the drug) have not put in an application to amend the terms of their original authorisation, and therefore Zirtek - which has the exact same active ingredient - is currently only available in packets of 7 without a prescription. The 30-pack remains on prescription only.
This means that Ephedrine could be available without a prescription if the hypothetical application I mentioned above asked for - and if the IMB agreed that it was safe for - it to be so.
Ah sure we will be ok with OTC then depending on the Pharmacist :-; the only difference sometimes in OTC (over the counter) and Prescription drugs is the size of the pack.??(limited)0 -
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locum-motion wrote: »This is quite complex, so pay attention....
Span my attention.
How does this effect the status of the substance itself? Does it limit who can be in possession of say, a kilo of ephedrine hcl?Ephedrine is a substance that is listed in the First Schedule of the Medicinal Products (Prescription and Control of Supply) Regulations, 2003.
This means it is a prescription only medicine.
Does it effect the possession or importation of the ephedra plant?
Is this where all the "bath salts" stuff arises?The same schedule also include the circumstances under which it is exempt
from prescription control - namely; when it is for external use, not including
its topical application to the eyes.
What does this mean?
So, if I apply with my label for a UK manufactured product, that's on sale in the UK, then the IMB will grant me a licence? I can't really see an objection, unless the IMB use their discretion on a whim. The UK isn't a dodgy third world country, where anything goes. It's the same manufacturers as supply many other drugs used in Ireland.It means that any company can apply to the IMB for a Product Authorisation to manufacture and supply a medicinal product containing Ephedrine. The default legal status* of such a product will be prescription only, unless it's intended for external use other than in the eyes. As long as the application satisfies all of the requirements of the IMB (such as including convincing evidence that the product is both safe and effective for its intended use, and evidence that the manufacturing facility is capable of guaranteeing the consistency and quality of the product), the application will be granted.
"effective for its' intended use" is interesting. Could I complain to the IMB as regards to over the counter preparations that are long time scams? Cod liver oil is a cod, and Andrews liver salts does nothing for your liver. If I went the whole hog, I could probably clear the shelves of more than half the OTCs.
Ephedrine has a bad name for its' long history. Manufacturers have tried to dissociate themselves for it by switching it with something else. But some of the things they've switched it with can have far worse, even fatal consequences. I don't know if phentermine is available in Ireland, but it is available elsewhere. It's known to have horrific consequences, I think it's completely outlawed in the US. The things they're substituting ephedrine with are often not only not effective, but they could be far more dangerous. In the case of phentermine they definitely are.
Could I completely side step the requirement for authorisation - say if I was to import and prepare the ephedra plant for Chinese potpourri?At this time, there is no such product authorised by the IMB.
Now, the above should not be taken to mean that just anyone can supply, say, a cream for the skin containing Ephedrine, even though I said above that it would not be prescription only. That exemption would only apply to an authorised product.
Or for the preparation of a weed killer made from Ephedrine HCL?
I have to make a purchase through an Irish pharmacy if I have a doctors prescription? Why can't I just import it myself?In the absence of an authorised product, does that mean you cannot get it? Not really. A doctor is entitled to write a prescription for anything he likes. Even products that are authorised in another country but not this one. So if your doc writes it, and if your pharmacist can locate it, and if you're willing to pay for it, then you can get it.
As member of the public, who's had an experience of what this country is like. I've always had a little suspicion the IMB, was a much about the concern for public health, as the Vintners Association's tireless campaign against the evils of drugs, and of course, head shops.
Yes, it is amazing some of the things the "herbal" remedy websites sell. There is stuff that is really dangerous and even lethal. But I know Irish people who were hospitalised after using OTC products in Ireland. I took Zyrtec once and it gave me a day of horrible hallucinations, nausea, shortness of breath, drowsiness, but the pharmacist had sold it to me on the basis of it being a decongestant, which is the one thing it didn't do.
So, it's completely in the hands of the IMB if they accept the application to sell an OTC ephedrine preparation, that's OTC in the UK?* : You might be wondering why I said "default legal status": The above-mentioned regulations were amended in (I think) 2008, and since then the IMB can supercede the legal status of a medicine if it deems it appropriate to do so. For example, in the above regulations the antihistamine Cetirizine is prescription only, unless it is in packets of 10 tablets or less. However, in the last few years a couple of companies put in applications for authorisations to sell it in packs of 30. The applications were successful, and now you can buy 30-packs of products called Cetirilief and Cetriz. However, the makers of Zirtek (who were the original inventors of the drug) have not put in an application to amend the terms of their original authorisation, and therefore Zirtek - which has the exact same active ingredient - is currently only available in packets of 7 without a prescription. The 30-pack remains on prescription only.
This means that Ephedrine could be available without a prescription if the hypothetical application I mentioned above asked for - and if the IMB agreed that it was safe for - it to be so.
The only reason I could see the IMB determining it to be not safe, would be that they have some information regarding it, the Brits do not have.
In most states in the US it's illegal, simply because pressure was put on politicians to do something about illegal methamphetamine manufacture. What they did was ban ephedrine, but the manufacturers in some states were able to have the ban over turned. But this also meant that the Sudafed sold in one state, could be completely different to another. Sudafed would have a slight difference in the markings on their packaging. I believe there were able to sell mixed enantiomers in some states as pseudoephedrine, but in others it was just pseudoephedrine.0 -
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