Medicines Control Council notice

The Minister of Health has in terms of Section 22A(2) and Section 37A of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) on recommendation of the Medicines Control Council amended the schedules of the substances pseudoephedrine, d-nor-pseudoephedrine and ephedrine and has limited the maximum pack size of these products due to:

The rapid increase in the illicit manufacture of methamphetamine where individuals are diverting ephedrine, d-nor-pseudoephedrine and pseudoephedrine, the key precursors for methamphetamine, obtained from licit distribution channels, to methamphetamine.

The International Narcotics Control Board recommendation that the controls of ephedrine and pseudoephedrine substances should be expanded to pharmaceutical preparations containing these substances.

In light of the concerns regarding the increasing widespread misuse of pseudoephedrine, d-nor-pseudoephedrine and ephedrine, these substances have been scheduled as per the 25 April 2008 Government Gazette publication and the corresponding Schedules have been amended accordingly by the insertion of the expressions in the correct alphabetical order.

Applicants to note: Where an alternative schedule(s) is included in natural parentheses at any point of an inscription, this is provided for information only and shall not be used in the interpretation of the inscription.

The intention of the limit of one pack per customer for combination products containing ephedra alkaloids, ephedrine, pseudoephedrine or d-nor-pseudoephedrine intended for the symptomatic relief of colds and flu is to control distribution of large quantities of these substances, but to allow for a Schedule 2 status at retail pharmacy level for the sale of a single pack to the customer, which could be the patient or the caregiver.

Larger amounts are now Schedule 6. This does not preclude manufacturers and wholesalers from supplying retail outlets with more than one pack.

The amendment to the Schedules came into operation on 25 April 2008 which corresponds to the date of publication in the Government Gazette.

The Medicines Control Council has considered and agreed to a phase out period of existing printed packaging components of six months from the date of publication in the Government Gazette.

In light of the concern about the possibility of increasing widespread misuse of pseudoephedrine, the Medicines Control Council advised that the pharmacy profession be aware of the potential for misuse and that pharmacists are to supervise the sale/supply of pseudoephedrine-containing preparations.

http://www.pharmcouncil.co.za/news.asp?NewsId=110
http://www.pharmcouncil.co.za/documents/31010.pdf