Compounded Joint Products

Great Lakes Equine Wellness Center will no longer be carrying compounded joint products such as Acetyl-D-Glucosamine and compounded sodium hyaluronate (HA).

Over the years, these products have commonly, but erroneously, been referred to as generic Adequan and generic Legend by veterinarians, trainers, and clients. Understanding the differences in the terminology used in describing these drugs is paramount to understanding what products can be legally used in a given situation. Our goals are to clarify the definitions of generic, compounded, and FDA pioneer drugs and to explain the many important legal and ethical considerations of using compounded drugs.

FDA Pioneer Drug*: A drug that has undergone the scrutiny of blinded controlled studies to demonstrate safety and efficacy in accordance with federally mandated Good Laboratory Procedures (GLP). The active ingredient and product were manufactured under federally mandated Good Manufacturing Practices (GMP) in federally inspected plants. Therapeutic consistency, product quality, accurate drug shelf life and scientifically substantiated labeling are all federally mandated on these products.

Generic Drug*: A generic drug is bioequivalent to a brand-name drug in dosage form, efficacy, safety, strength, route of administration, quality and intended use. Generic drug labels display an ANADA# or ANDA# signifying FDA approval of a generic animal drug or human drug, respectively. Generic drugs and their active ingredients also must be manufactured under GMP in federally inspected plants.

Compounded Drug*: A compounded drug is made by a pharmacist in any given pharmacy. FDA regards traditional compounding as the extemporaneous combining, mixing, or altering of ingredients by a pharmacist in response to a physician's prescription to create a medication tailored to the specialized needs of an individual patient. Traditional compounding typically is used to prepare medications that are not available commercially, such as a drug for a patient who is allergic to an ingredient in a mass-produced product, or diluted dosages for children.

Both Legend IV™ and Adequan IM™ are FDA-approved joint products. There are no generic drugs for these products. Adequan IM is a Polysulfated Glycosaminoglycan (PSGAG). Acetyl-D-glucosamine (which is an aminomonosaccharide with a molecular weight of <1000kDa) is a compounded product marketed to be used in the same treatment regimen as Adequan IM™. This product is not chemically identical, has not been approved by the FDA as a generic version of PSGAG, and there is no efficacy or safety data in equine joint disease reported. The product is not manufactured or monitored according to the FDA’s Good Manufacturing Practices, and so purity and potency are not assured. The same goes for compounded Sodium Hyaluronate (HA) which has been used in place of Legend IV™. What this means is that we cannot be sure that these products work, or that they are safe.

As veterinarians, if we choose to prescribe these products and experience adverse side effects – we are legally liable for the effects. The professional liability insurance we carry would not stand behind the decision to use a compounded product if there is an FDA-approved drug for that purpose. It is also important to us to ensure that the products we prescribe are proven to work. There is extensive research proving the efficacy of the FDA approved joint products.

There are situations that exist in which compounding medications is legal, and useful. Veterinarians sometimes have patients that require a drug not approved for the specific intended use. In that case, veterinarians can use compounded drugs to meet the unique needs in specific patients and for those animals for which no other method or route of drug delivery is practical. Veterinarians must realize that the use of bulk compounded medications is (under strict interpretation of the Federal Food Drug and Cosmetic Act) illegal because it results in the production of an unapproved new animal drug. Preparation, sale, distribution, and use of unapproved new animal drugs is in violation of the Act. The bottom line is that as veterinarians, we must comply with the law and provide the best care for our patients. We feel that continuing to use compounded joint products for our clients horses falls below the “Standard of Care” (one acts below the standard of care when he/she fails to exercise the level of care, skill, diligence and treatment that is recognized as the standard of acceptable and prevailing veterinary medicine).

We at Great Lakes Equine Wellness Center would like to continue to provide the most state-of-the-art care for your equine companion. We strive to provide your horse with the most advanced diagnostics and medical therapies available in veterinary medicine. We will continue to prioritize the welfare of our patients as we continue to practice veterinary medicine.

If you have further questions regarding the use of joint therapies for your horse or compounded medications, please feel free to contact Dr. Ehrmentraut, Dr. Blohowiak, and Dr. Zarda at 920-886-2929.

*Definitions reprinted from the AAEP Equine Veterinary Compounding Guidelines