Registration with the SAVC
Introduction: Drug compounding is an integral part of veterinary clinical practice. Veterinarians prepare veterinary medical preparations for their patients partly because no suitable registered veterinary formulations exist. Despite the advances in new drug development and availability, many unmet needs still remain
In terms of the General Regulations of the Medicines and Related Substances (Act 101 of 1965) compound means to prepare, mix, combine, package and label a medicine preparation for dispensing as result of a prescription for an individual patient or a person authorised in terms of the Act. This includes repackaging of medicines. For the purpose of this guideline compounding is defined as “the preparation of a medicament that combines legally obtainable ingredients and/or appropriate vehicles, which have not been specifically excluded from animal use” (Upson, JAVMA 205, 2, 1994). It may also include the alteration of the original medicinal dosage form for the purpose of ease of administration or because the original dosage form is unsuitable for the purpose intended. Many medicines are crossed over from one animal species to another, or are human medicines administered to animals.
Compounding should be for the purpose of rational pharmacotherapy, used to promote animal well-being, to enhance their health, and to reduce stress, pain and suffering. In principle the need for compounding should be under exceptional conditions when registered medicines are not available or are not efficacious. In general the guidelines are for patient care; are within the science and art of current veterinary practice; are responsive and responsible; are for the animal’s welfare; and are not for manufacturing.
Veterinarians and pharmacists involved in compounding must be cognisant of potential incompatibilities and procedures that may interfere with the preparation’s stability, purity, and/or potency. Some compounded medical formulations are known to present problems in safety and potency (Papich, AAPS Journal 7:2005 pp E281 – E287). Interspecies difference in pharmacokinetic and pharmacodynamics pose difficulty when compounding a drug for a different species.
The necessity for compounding in veterinary practice is recognised but overall compounded veterinary medical preparations must not harm animals, should not be associated with therapeutic failure resulting from lack of medicinal potency, and do not cause violative residues in food-producing animals. In principle compounding by veterinarians and pharmacists should not be performed in an effort to circumvent the usual medicine approval and registration process.
Liability: Although rational pharmacotherapy is the veterinarian’s privilege and responsibility, it must be borne in mind that the veterinarian prescribing or using a compounded veterinary medical preparations takes full responsibility and liability for its use.
I. Compounded drugs
a) Must be used only by, or on prescription of a veterinarian registered with the SAVC;
b) Must be used only if a valid veterinarian/client/patient relationship exists and follow the code of conduct, chapter 7, on the responsibilities arising from the use of veterinary medicinal products (http://www.savc.co.za/cocap.htm#_Toc145304065);
c) May be used or dispensed only for the treatment or prevention of disease or to improve the health and/or welfare of the animal(s) and not as a management tool to improve production;
d) Needs to be linked to a specific patient for a specific condition;
e) May be used only when a need has been established and when registered veterinary medicines or stock remedies are not available in a suitable or requested specific formulation or where no alternative registered medication exists; and.
II. Compounded drugs may not be utilised for animals in food production except for the treatment of individual diseased animals.
III. The veterinarian must apply his/her professional judgement consistent with currently acceptable veterinary clinical practice in ensuring the safety and efficacy of the veterinary medical preparation.
IV. The veterinarian must use professional judgement consistent with proper pharmaceutical and pharmacologic principals when compounding a veterinary medical preparation or when prescribing such a compounded preparation. The following points should be considered:
a) The stability of the active ingredients.
b) The physical and chemical compatibility of the active ingredients.
c) The pharmacodynamic compatibility of the active ingredients.
d) The active ingredients and diluents must be of known composition and not contaminated with harmful substances or agents.
V. The compounded veterinary medical preparation must be properly labelled before being dispensed. It must be dispensed according to the veterinarian’s prescription, must have a complete, indelible, legible label attached. A complete label requires the following:
- Name and address of the attending veterinarian;
- Date dispensed;
- Active ingredients;
- Identity of animal(s) to be treated (i.e., species, class, group, or individual animal(s);
- Directions for use;
- Cautionary statements, if needed;
Additional information that may be included on a label: Disease conditions to be treated; Expiry date.
VI. Compounded veterinary medical preparations must not be advertised or displayed to the public.
VII. A compounded veterinary preparation for food producing animals must either be compounded by the veterinarian for his/her own use or compounded by a registered pharmacist on prescription of a veterinary professional and, where applicable, only registered medicines or active pharmaceutical ingredients from the Medicine Control Council, European Union or Federal Drug Administration may be used to compound the compounded veterinary preparation.
Note: Food producing animals include wildlife harvested for human consumption.