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An Urban Experience
medicines can only contain active substances which have been approved for the purposes of this exemption by the Secretary of State.” ( exemption-from-authorisation-for-medicines-for-small- pet-animals). This is also known as the VMR Schedule 6 and from a veterinary perspective Schedule 6 contains little to get excited about although it did prevent removal from the market of some essential, if older, products which would have harmed  sh welfare.
In the USA legislation stems from the Federal Food, Drug and Cosmetic Act 1938 (as amended) and is overseen by the Food and Drug Administration’s Centre for Veterinary Medicine. Of interest is the Minor Use Minor Species Act (MUMS) ( DevelopmentApprovalProcess/MinorUseMinorSpecies) which provides for three possible advantages;
Conditional Approval which can be granted before all data is collected,
Designation which provides incentives such as grants for research and extended exclusive marketing rights, and Indexing which is intended for minor species drugs “intended for uses that cannot reasonably go through the standard drug approval process.”, and “indexing provides a faster and less expensive process to obtain legal marketing status for eligible products”.
Of further importance is AMDUCA already mentioned above which provides for Extralabel Use and there
are two further interesting innovations. The  rst is Investigational New Animal Drug (INAD) which is aimed to generate publicly available data through research studies. This has provided for the licencing of several aquaculture drugs in the USA as the generated data is available to the public including pharmaceutical companies. The Aquatic Animal Drug Approval Partnership Program ( sheries/aadap/home.htm) indicates on
its website some 17 available INADs. The second is
the Food Animal Residue Avoidance Databank (www. which aims to provide open access to comprehensive, up to date information and data for food animal drugs. In theory anyone can ask the question, “I want to use X drug what might be the adverse effect”.
Does it Work?
The regulatory authorities were clearly aware that there was a problem with providing safe, ef cacious and quality medicines to minor species and took many of the steps outlined above well over a decade ago. Certainly, for ornamental  sh this does not appear to have led to a golden age of licenced medicines. Perhaps the issue is market failure or simply there is not a market out there, rather than problems with the legislation?
On the face of it the US legislation and supportive programs should address all the issues from the cost of obtaining a marketing authorisation to veterinarians
having access to information that can help them defend themselves against any claim. Browsing through the FARAD database shows some excellent information
but not much on  sh. Anyone can submit a question and expect an answer within 72 hours which seems reasonable. Presumably if a question is submitted, and an answer provided, then the resulting literature search would become available for future reference? If that is the case then it suggests not many  sh questions have been submitted. Does that indicate poor awareness
by veterinarians of FARAD? Or does it imply a lack of interest?
Does it work? Currently the answer is no and there needs to be a rethink.
Any Changes?
In considering current legislation and the availability of medicines for ornamental  sh then the immediate answer is that we need to look again, possibly fusing some of the better ideas and concepts from around the world.
As said the US system seems to address many of the issues but does not appear to be engaging those with most to gain from it. One cannot help concluding that maybe instead of the profession spending time and energy striving for improvement, maybe we just need
to get on with working under current legislation and accepting the shortfalls. Since much pharmaceutical usage in ornamental  sh is based on colleague interaction then perhaps a signi cant and useful change would be to build international databases of expert peer reviewed information and experience on pharmaceuticals that could provide data for medicine authorisation applications and references for veterinarians considering using different pharmaceuticals. Of course, this is similar to FARAD and may raise the same problems. At the
very least these issues should be discussed looking
for a way forward so we as veterinarians can treat the animals under our care with safe, ef cacious and quality products.

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