Potential for misuse in the illicit production of methylamphetamine (crystal meth) which is a class A Controlled Drug
Legal restrictions on the quantities that can be sold or supplied without prescription - It is unlawful to supply a product or combination
of products at any one time, without a prescription, that contain:
more than 720mg of pseudoephedrine
180mg of ephedrine
Law 3: Legal Aspects of Providing Pharmaceutical Services - 29.11 1
, Consider the signs of misuse? PJ article - https://www.pharmaceutical-journal.com/cpd-and-learning/learning-article/deal-with-over-
the-counter-requests-for-pseudoephedrine-with-confidence/11041158.article
EHC OTC:
What are the options? - oral levonelle/ullipristal
https://www.rpharms.com/resources/quick-reference-guides/oral-emergency-contraceptives-as-pharmacy-medicines. Covers
professional and legal considerations.
Analgesics - aspirin and paracetamol.
Legal restriction Additional note
Not more than 100 non effervescent* tablets or capsules can There are no legal limits on the quantity of over-the-counter
be sold to a person at any one time. Since most OTC pack effervescent* tablets, powders, granules or liquids that can be sold to a
Paracetamol
sizes are for 16 or 32 dose units, this means that, in practice, person at any one time. Use professional judgement to decide the
96 is the maximum number that can be sold. appropriate quantity to supply and what limits to impose.
Not more than 100 non-effervescent* tablets or capsules can There are no legal limits on the quantities of over-the-counter
be sold to a person at any one time. Since most OTC pack effervescent* tablets or powders that can be sold to a person at any one
Aspirin
sizes are for 16 or 32 dose units, this means that, in practice, time. Use professional judgement to decide the appropriate quantity to
96 is the maximum number that can be sold. supply and what limits to impose.
NB: The definition of effervescent for the purposes of the restrictions above is provided by medicines legislation. Soluble or dispersible
formulations
as defined by the British Pharmacopoeia may not meet the definition of effervescent in medicines legislation. Where in doubt, quantities
of soluble
or dispersible formulations sold should be restricted as non-effervescent preparations.
Codeine & dihydrocodeine:
Solid dose OTC products are now restricted to
the short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone. All other previous
indications, including cold, flu, cough, sore throats and minor pain have been removed.
Any pack containing more than 32 dose units (including effervescent formulations) is a POM.
There are tighter controls and warnings on packaging of OTC solid dose medicines to minimise the risk of overuse and addiction.
On PIL & labels - The warning ‘Can cause addiction. For three days use only’ must be positioned in a prominent clear position on the
front of the pack. In addition, both the PIL and packaging must state the indication and that the medicine can cause addiction or
headache if used continuously for more than three days. The PIL must also contain information about the warning signs of addiction.
Recommend that only one pack should be sold, if appropriate, as sale of >1 pack would undermine the reduction in pack size and POM
restriction on packs containing more than 32 dose units.
Coughs and cold meds for children (< 6 years/ 6-12 years)
POM to P re-classification
Amorolfine nail lacquer
Chloramphenicol eye drops and eye ointment
Omeprazole and pantoprazole (see proton pump inhibitors as pharmacy medicines)
Orlistat
Sumatriptan
Tamsulosin
Tranexamic acid
Can read more on Reclassification Guide https://www.rpharms.com/resources/pharmacy-guides/reclassification-guide
CDs – who can possess/supply?
CD 1:
Law 3: Legal Aspects of Providing Pharmaceutical Services - 29.11 2
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