Video: When are compounded drugs appropriate? Mar 7, 2013 By: Dawn Merton Boothe, DVM, MS, PhD, DACVIM, DACVCP VETERINARY MEDICINE

view video here

VETERINARY COMPOUNDING – FORMULATING THE FUTURE Dawn Merton Boothe, DM, PhD, DACVIM, DACVCP College of Veterinay Medicatine Auburn University, AL

Proceeding of 15th AAVPT Biennial Symposium – May 2007, Pacific Grove, CA
Close the current window to return to the IVIS website or go to www.ivis.org
Reprinted in the IVIS website with the permission of the AAVPT – www.ivis.org
VETERINARY COMPOUNDING – FORMULATING THE FUTURE
Dawn Merton Boothe, DVM, PhD, DACVIM, DACVCP
College of Veterinary Medicine
Auburn University, AL
 Individualized drug therapy increasingly is important to the effective delivery of health
care to both the human and veterinary patient. Accordingly, compounding has enjoyed a
resurgence of importance to drug delivery. Contributing to the recent surge in compounding are
the loss of less lucrative approved drug products as pharmaceutical companies merge, emerging
special needs populations, pharmacogenomics and improvements in the standard of veterinary
care. Among the legitimate benefits provided by veterinary compounding are the
reformulation of drugs to facilitate dosing (e.g., flavored syrups, oral rather than injectable
preparations, transdermal gels) or to reduce the risk of adverse reactions due to over dosing. This
latter service has been a mainstay of veterinary compounding because of the extensive use of
human drugs in animals, reflecting, in turn, the limited number of animal approved drugs.
 Compounding has been variably defined by different entities, but the pertinent
components of the definition include prescription driven and clinician-prescribed (or
formulated). Their importance was emphasized in 1997 by the US Supreme Court’s definition of
compounding as “a process by which a pharmacist or doctor combines, mixes, or alters
ingredients to create a medication tailored to the needs of an individual patient.” This definition
is equally applicable to veterinary and human compounding. However, in contrast to human
compounding, legal direction for veterinary compounding exists (the Animal Medicinal Drug
Use Clarification Act of 1994). Neither veterinarians nor pharmacists appear to be well
informed regarding the content or rationale for compounding rules promulgated by the FDA in
response to AMDUCA. Indeed, the pharmacy profession has objected to the Food and Drug
Administration’s perceived interpretation of AMDUCA, including the FDA’s restrictions to
compounding from bulk substances, which stem from a public health perspective. The
compounding profession has actively pursued legislation that will facilitate compounding
veterinary products. From the author’s perspective, these tactics have included a misleading
emotional appeal to the veterinary profession. “Protect the pharmacist’s right to compound”
was the opening page of the IACP website in 2004. It sought veterinary support of legislation
that would legalize compounding, including that from bulk substances, without FDA interference
(http://www.iacprx.org/site/PageServer?pagename=P2C2). Yet, the pharmacists’ right to
compound was not being challenged; indeed, AMDUCA guarantees that right for both
pharmacists and veterinarians. Rather, what was being “challenged” was the use of bulk
substances. Missing in the discussions are reasons that compounding from bulk substances might
be wisely avoided. These include the CVM’s concern regarding compounding in food animals;
this concern might be reduced but not necessarily avoided by a different set of rules for dogs,
cats or horses (for example, how might a legal definition of a food animal assure that any animal
consumed by humans in the USA would be included?). A second concern is assurance of the
quality of the bulk ingredient (see ingredient source below). A third concern is the ease with
which manufacturing may occur once compounding from bulk substances is approved. Indeed,
FDA concern regarding the distinction between compounding and manufacturing has led the
FDA to attempt to legally restrict manufacturing. The first attempt was based on restricted
advertisement (promotion) of compounding services in the Food and Drug Administration Proceeding of 15th AAVPT Biennial Symposium – May 2007, Pacific Grove, CA
Close the current window to return to the IVIS website or go to www.ivis.org
Reprinted in the IVIS website with the permission of the AAVPT – www.ivis.org
Modernization Act of 1996, which was ruled unconstitutional by a US District Court
(infringement of the right to freedom of speech). Subsequent restrictions by the FDA were based
on the regulatory responsibilities of the FDA, which has assumed that any compounded drug is a
new, yet unapproved drug. This distinction allows legal regulatory actions by the FDA.
However, in October of 2006, the Federal District Court of Texas ruled that compounded drugs
were not new drugs, precluding FDA regulatory oversight. Further, compounding from bulk
substances was ruled legal for non-food animals
(http://www.fdanews.com/dailies/drugdaily/2_425/news/59733-1.html). The IACP has declared
this a victory for consumers. In the author’s opinion, suggesting to the public that this ruling,
assured that FDA approval would be expected for each compounded product is a misleading
tactic if not accompanied by an explanation that compounded products undergo no pre-market
assessment, even when mass produced. From the author’s perspective, the intent of the FDA is
not to repress appropriate compounding but to protect the consumer from inappropriate
compounding. Indeed, would a fully informed public be as willing to accept and consume
compounded products?
 Not surprisingly, selected compounding pharmacies have extended their compounding
activities well beyond that recognized to be appropriate by the FDA, thus circumventing the
approval process. Internet pharmacies sell compounded products in bulk,
(http://www.wedgewoodpharmacy.com /animals/index.asp), promoting these professionallylabeled products on the internet and through the mail. Such compounding appears to not be

Understanding the Risk Associated with Veterinary Compounding Choices

During the Proceedings of the 56th Annual Convention of the American Association of
Equine Practitioners - AAEP -December 4-8, 2010, Scott D. Stanley, PhD, presented Understanding Risk Associated With Veterinary Compounding Choice.  His article suggest best practices for using veterinary compounds.  To read this article, click here