Directive & Clarification on Supply of Pseudoephedrine-containing Products

Directive & Clarification on Supply of Pseudoephedrine-containing Products

A Directive has been issued by the Pharmaceutical Services Division to all licensed manufacturers, importers and wholesalers who are authorised supplier of products containing Pseudoephedrine to the private clinics and pharmacies that

1. prohibits the supply of Pseudoephedrine-containing products free of charge as an incentive in a bonus scheme

2. are only allowed to sell or supply of Pseudoephedrine-containing products to a maximum of 480 grammes a month for each premise, and to limit to a maximum of 480 grammes Pseudoephedrine Hydrochloride or Sulphate per month

Supplier who wished to have additional quantities are to write in to BPF for authorisation.

This Directive will take effect from 1st Sep 2010.

It was furthur clarified that:

a. the maximum of 480 grammes per month would cover all registered products, ie tablets, capsules, caplet, syrups etc.

b. the maximum of 480 grammes per month is for all preparations of each licensec holder for each clinic and pharmacy.

Pseudoephedrine (PSE) is a primary precursor that has been misused to produce Amphetamine Type Stimulant (ATS) like syabu and ‘ice’. As such this chemical has been designated as a precursor under the UN convention against illicit traffic in Narcotic Drugs and Psychotrophic Substances 1988.

Following the difficulty to obtain the raw material PSE in the market, various other methods were tried to produce ATS using raw materials from pharmaceutical products that contain the stated material.

Audits that have been carried out on buyers (including clinics and pharmacies) of pharmaceuticals containing PSE show that these buyers cannot provide explanation on the high quantities that were purchased. It is suspected that these stocks are diverted to clandestine ATS factories either within or outside the country. Action is being taken on these buyers.

One of the measures to be taken to stamp out the diversion of PSE (either as a single entity or in combination with other actives), by the Division is to issue a Directive to ensure that the PSE stock in the market is for legitimate use only.

It is the responsibility of the wholesaler to adhere to the Directive and the Division would no hesitate to take action against anyone who contravene with this Directive.