Registration & Authorisation Committee
PHENYLBUTAZONE RESCHEDULED AND DECLARED A PROHIBITED SUBSTANCE!
Phenylbutazone has been rescheduled as a Schedule 7 substance (previously a Schedule 6 medicine) and consequently declared a prohibited substance, effective as from 8 May 2014, the date of publication of the Amendment to the Schedules (including Schedule 7) published in terms of section 22A of Act 101 of 1965 in Government Gazette Number 37622 under Notice Number R352. The amendments, including the rescheduling, came into operation on the date of publication of the Government Gazette.
The amendment notice (attached) must be read in conjunction with Section 22A(8) & (9) of Act 101 of 1965. An extract of the relevant subclauses of Section 22 is attached and the relevant parts highlighted. The meaning of both documents read in conjunction, in short means that NO PERSON may acquire, use, possess, manufacture or supply any Schedule 7 substance (substances listed in Schedule 7), unless issued with a permit (valid for a period for 12 months, subject to certain prescribed conditions and on prescribed grounds), for such acquisition, use, possession, manufacture or supply to the permitholder (specifically a medical practitioner, analyst, researcher or veterinarian), only if such permit application is approved by the Director-General: Health.
The following inserts relate to practical arrangements to deal with phenylbutazone stock. Please read it carefully!
Virbac informed as follows on 9 May 2014:
“Subject: RESCHEDULING OF FENYLBUTAZONE 20% PHENIX 100ML INJECTION
Please be informed that all phenylbutazone containing products were re-scheduled from S6 to S7 , published in the Government Gazette on Thursday 8th May.
Unfortunately , Virbac received no prior notification from the MCC , which is regrettable.
As you are aware, S7 products may only be in your possession if a permit has been issued by the Director- General (refer Act101/1965 - section 22A points 8 & 9)
This product will no longer be available with immediate effect.
We will accept returns for credit until 30th May, 2014, provided the product is unopened and credit requests are accompanied by the original invoice number.
We apologise for any inconvenience caused”.
The Medicines Control Authority informed as follows on 9 May 2014 as to how to deal with phenylbutazone stock on hand:
“They need to make a request to Jerry Molokwane (DD of Names & Scheduling Unit) and Joey Gouws and request for an extension to get rid of their stock. They normally need to submit how much stock they have and approximately how much time they need to clear it.” (sic)
Questions and answers received (Practical aspects):
1.Q: I have a box of Equipalazone is worth at least R2175.00. May that still be dispensed?
A: No, you may not. If you would like to dispense until your stock is used up, make a request (apply for a permit) to Jerry Molokwane (DD of Names & Scheduling Unit) and Joey Gouws (Head of Law Enforcement and Inspectorate) and request for an extension to get rid of stock. You'll need to submit how much stock you have and approximately how much time you need to clear it.
2.Q: Then who carries the loss for stock currently in my possession? Does the practitioner/ wholesaler now repossess the stock?
A: Losses are yours to carry. The MCC is not responsible as they will grant permission to sell if you approach them for a permit. If the permit is not granted, the stock must be destroyed.
3.Q: If the practitioner is now prohibited from selling, what does he do with the unused medicine? – is there a destruction system in place and at whose cost?
A: The unused medicine need to be destroyed in the same manner as any S6 expired medication. It is recommended that you return it to the supplier for incineration. If the destruction takes place at the practice the SAP need to be present.
4.Q: If I just ordered from the wholesaler, do I have to pay – whose loss will it be?
A: If you've not received stock as yet, they can’t sell it to you, so they have to refund you should you have paid in advance.
5.Q: If I do get a permit, do I need one to have the medicine in the clinic, and then dispense carefully?
A: Once the permit is granted, you can use the medicine subject to the same conditions as a S6 product.
6.Q: Do I need to apply for a permit for every animal I see, in which case how do I get it before I leave the farm?
A: No. Apply for a permit to Jerry Molokwane (DD of Names & Scheduling Unit) and Joey Gouws (Head of Law Enforcement and Inspectorate) and request for an extension to get rid of stock. You'll need to submit how much stock you have and approximately how much time you need to clear it. A reasonable period will probably be a period of three to six months. The conditions of the permit will be apparent from the permit.
As this will be continuously updated as and when new information regarding the above becomes available, please regularly visit our website for the latest. update!