Tuesday, April 30, 2013

Statement on Veterinary Compounding from the Veterinary Council in New Zealand

Statement on Compounding Veterinary Medicines
This statement should be read in conjunction with:
• Paragraph 6 of the Veterinary Medicines section of the VCNZ Code of
Professional Conduct and related explanatory notes
• MAF Guidance on Developing a Documented System to meet conditions of
exemption from registration for Compounded Veterinary Preparations under the
ACVM (Exemption) Regulations 2011
Compounding means to combine ingredients (for example, generic chemicals or
biological compounds or trade name products) to prepare a medication to be
dispensed to a person to treat an animal. To prepare means not only the process of
combining ingredients in an appropriate manner for the intended purpose but also
placing the medication into appropriate packaging with appropriate labelling to allow
it to be dispensed to and used by a person other than the veterinarian who
compounded it.
Practices that are also included but do not strictly fit the above definition of
compounding are:
• decanting and breaking down trade name products into smaller quantities when
there is no change in the product itself
• reconstituting trade name products, and
• preparing medications to be used immediately by the veterinarian who prepares
the medication.
Prescribing in this document means to make a decision about the choice of a
particular veterinary medicine as the most appropriate under the circumstances and
to convey that decision to the person requesting the advice. It is not used in the
context of authorising the use of veterinary medicines that have conditions of
registration that restrict who can sell or use the products. To convey the latter
meaning the word ‘authorisation’ would be used.
Dispensing means to supply or sell a veterinary medicine.
General requirements for Compounding
Compounded veterinary medicines are either compounded by a veterinarian or by a
manufacturer or compounding pharmacist on behalf of that veterinarian. The practice
of compounding and dispensing compounded veterinary medicines is authorised via
an exemption from registration in Schedule 2 of the ACVM (Exemption) Regulations
2011. The exemption only applies to veterinarians. Veterinarians must comply with all
of the conditions of exemption from registration (refer to Regulations 7, 10, 12 and
If the compounding is to be carried under a veterinarian’s direction, the compounding
order (equivalent to the manufacturing specifications, such as formulation, packaging
and labelling) must be the instructions of the veterinarian to the person who will
compound the veterinary medicine.
Compounded veterinary medicines are not assessed by MAF, so there is no external
review of information to supports their use as veterinary medicines. Nevertheless,
they may be used as such when a veterinarian accepts full responsibility for their use
and takes due care to manage risks. Apart from any other risks, the ones relevant to
the ACVM Act are:
• trade in primary produce
• agricultural security
• animal welfare and
• public health not related to those managed under the HSNO Act.
Veterinarians must have a documented system in place for compounded veterinary
preparations and must implement this in accordance with Regulations 7, 10, 12 and
14. Under these Regulations veterinarians must provide adequate labelling and, if
the compounded product is to be used on a food-producing animal, must provide
sufficient advice to avoid residues that do not comply with New Zealand food residue
Prohibition on promotion and advertising
Compounded veterinary medicines must not be advertised or promoted as veterinary
medicine trade name products.
They must not be displayed for sale to the general public.
Compounded veterinary medicines must be sold only in the context of a veterinarian
providing professional services associated with an adequate consultation for
particular animals under his/her care. They must not be offered for sale as trade
name products.
Compounded veterinary medicines must be prescribed only after a veterinary
consultation and only for animals under the care of the prescribing veterinarian. The
veterinarian must conclude that there is no alternative product that has already been
authorised under the ACVM Act (ie registered or specifically exempt from
Veterinarians must be competent in all aspects of formulation and manufacturing
commensurate with the type, complexity and potential hazards of the preparations
they are compounding. In the first instance, it is up to the compounding veterinarian’s
judgement as to whether or not he/she is competent to compound a particular
medication. However, the veterinarian must be able to defend that judgement
successfully in light of common practice of the veterinarian’s peers.
Veterinarians must have a documented system in place governing their
Veterinarians must not use or specify an ingredient that is prohibited from use as an
agricultural compound or specify an ingredient or use that is inconsistent with
limitations on a similar veterinary medicine trade name product. The most current list
of prohibited/restricted substances can be obtained from MAF.
Because prescribing a compounded veterinary medicine must be restricted to those
cases in which there is no suitable alternative, the veterinarian should not compound
any more of the preparation than would be needed to meet his/her short-term
requirements. The prescribing veterinarian must take full responsibility for the
product, its preparation, packaging and labelling.
The veterinarian should not store quantities of compounded veterinary medicines in
anticipation of future needs beyond the short term. The veterinarian must be satisfied
that, if the veterinary medicine is stored at all, it will continue to meet the
compounding specifications.
Third parties compounding preparations under a compounding order
When a prescribing veterinarian contracts the compounding to a third party, the
veterinarian retains full responsibility for the medication. The veterinarian must
ensure that the third party is competent and reliable to carry out the preparation. The
veterinarian must issue a compounding order specifying the product, quantity
required, packaging and labelling.
It is recognised that specialist compounding pharmacists may have more detailed
and current information than veterinarians regarding formulation specifications,
manufacture and quality control. It is acceptable practice for veterinarians and
specialist compounding pharmacists to collaborate in the specification and
manufacture of preparations. It is also acceptable practice to include human
medicines approved for sale in New Zealand or a veterinary medicine trade name
product that has been registered under the ACVM Act without specifying its full
formulation. However, there must be sufficient information to judge that, even without
the full formulation information, the medicine or veterinary medicine can safely be
considered fit for the purpose, and can be mixed with the other ingredients with no
adverse consequences.
Proprietary ingredients of the compounding pharmacist that have not been registered
or approved for sale in New Zealand and for which the pharmacist refuses to disclose
the formulation should not be acceptable to the veterinarian issuing the compounding
The quantity of the compounded veterinary medicine should be only what is
necessary and sufficient to meet the prescribing veterinarian’s short-term
requirements. If the veterinarian intends to do the packaging and/or labelling
personally, the compounding order must specify this. The veterinarian must consider
how long the preparation could be kept, depending on the stability of the preparation
and the need by the current cases being treated.
The third party compounding a veterinary medicine in accordance with a
compounding order should follow the instructions of the veterinarian and prepare no
more than was specified in the compounding order. However, the veterinarian will be
held responsible for any adverse consequences.
Where the specification of the formulation has been a collaborative effort, the
acceptance by the veterinarian of any lack of disclosure must be apparent. The
acceptability of a lack of disclosure must be based on the professional judgement of
the veterinarian issuing the compounding order. However, the veterinarian must be
able to defend that judgement successfully in light of common practice of the
veterinarian’s peers.
The veterinarian must ensure that the compounding order is clear and complete in its
instructions and limits the quantity to the amount that meets the short-term
requirements. The third party is expected to keep records of compounding orders
and be able to relate their preparations to specific compounding orders. It is also
expected that the full quantity prepared is given to the veterinarian (or his or her
agent) who issued the compounding order. The third party must not retain or hold
any part of the order. However, if they do and they offer the preparation to another
party or offer it for sale themselves, the exemption from registration will be nullified
and the action is likely to be illegal. The original veterinarian will not be held
responsible for the action, if the veterinarian took no part in the action.
Importation prohibited
Compounded veterinary medicines must not be imported without approval from MAF.
Decanting and breaking down trade name products
At times, a client may not be able to use all the product in the smallest pack size
available. A veterinarian may, under the exemption from registration for
compounding, decant off a portion of a liquid trade name product or break down a
non-liquid/gas trade name product into smaller quantities. The veterinarian must
ensure that:
• the product Is not altered in any material way other than to change from the
original packaging and labelling
• no additional hazards are introduced through careless or inappropriate
procedures during decanting or breaking down
• the choice of alternative packaging does not jeopardise the quality of the product
• all the crucial information about the product is provided to the client, as well as
the veterinarians contact information and additional instructions.
Having breached the integrity of the trade name product, the veterinarian must take
full responsibility for any adverse consequences.
Reconstituting trade name products
Trade name products must be reconstituted in accordance with the instruction for
each product, using only appropriate diluents and careful procedures to avoid
introducing additional hazards.
Preparing medication to be used immediately by the veterinarian who
prepares the medication
At times, a veterinarian may have to compound a preparation for immediate use. The
preparation will not be stored or dispensed to another person, so the requirements
for packaging and labelling are irrelevant. However, the requirements for careful
formulation and preparation still apply. The veterinarian must ensure that the
resulting medication is fit for purpose and take full responsibility for any adverse

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