What is Veterinary Compounding, and is it Safe?

Veterinary compounding refers to the preparation of customized medications by licensed pharmacists to meet the unique needs of animal patients. Compounding allows vets to prescribe tailored medications when an appropriate drug is not commercially available or to create alternate dosage forms or strengths when needed. While compounding provides important benefits for veterinary medicine, there have been concerns in recent years regarding the safety and quality control of some compounded preparations. 

Below is an overview of veterinary compounding. Read on as we explain how it can help treat animal patients, discuss its safety considerations, and explore whether veterinary compounding is adequately regulated.

What is Veterinary Compounding? 

Veterinary compounding involves making customized medications for animal patients by combining, mixing, or altering ingredients. Compounding allows a pharmacist to change a drug’s flavor, dosage form (e.g. from tablet to liquid), and strength or create a medication for species-specific needs that is not otherwise available. For example, a smaller dosage of medication may be needed for a Chihuahua versus a Great Dane. Compounding can also allow for the removal of ingredients that an animal may be allergic or sensitive to. The pharmacist works closely with the veterinarian to create a compound medication that meets the animal’s treatment needs.

How Can Compounding Help Animal Patients?

There are several key benefits of veterinary compounding. Some of these include:

Palatability:

Getting pets to happily take their medication is a challenge for many owners. A specialized pet apothecary can have the expertise in adding flavor enhancements like meat, cheese, bacon, or fish flavoring to make medications more enticing. Pets are more likely to readily consume their medication when disguised by a tasty treat formulation. 

Compounding also allows the production of dosage forms like gels that can be rubbed into the animal’s ear or gelatin capsules that pets perceive as a treat. These palatable options can greatly ease administration, as trying to force an animal to swallow a pill is no easy task. They help ensure pets receive medications as prescribed.

Accurate dosing:

Getting the dose right is extremely important to providing effective treatment while avoiding toxicity. Compounding allows the strength of a medication to be customized to the exact body weight of the animal patient. For a Chihuahua, the dose may need to be in micrograms versus multiple milligrams for a larger breed of dog. Compounding allows precision in dosing to get the concentration adjusted appropriately for the animal’s size. This helps prevent under or overdosing that could lead to treatment failure or adverse effects.

Pharmacists work together with veterinarians to ensure each compounded medication is the ideal dose for that particular patient’s needs. Those needs are approximated based on factors like the animal’s species, breed, age, and weight. This level of customization is not possible with commercially available medications that only come in fixed strengths and dosage forms.

Allergy avoidance:

Some animals may have allergies or intolerances to certain inactive ingredients found in commercial medications, like dyes, preservatives, or binders. This could result in side effects or outright refusal to take the medication. Through compounding, pharmacists can formulate customized medications using ingredients tailored for that patient, avoiding problematic compounds that trigger allergies or reactions.

For example, a pet may experience gastrointestinal issues every time it is given a medication containing lactose as an inactive filler. A pharmacist can compound that medication using a different suitable filler that does not cause any sensitivity issues for that animal. That would allow the pet to comfortably receive the medication and benefit from its therapeutic effects.

Discontinued medications:

Sometimes, medications that have been safely used for many years in veterinary medicine are discontinued by manufacturers for business reasons. However, these tried-and-true drugs may still be the best option for certain patients. Compounding allows these discontinued medications to still be available when prescribed by a veterinarian for an animal that could benefit from it.

For example, a heart medication may have been discontinued and replaced by a newer drug. But for some animal patients, that older heart drug may be better tolerated and more effective. Compounding pharmacies generally have access to manufacturing facilities that let them produce these drugs on a smaller scale or may have connections to manufacturing plants that can legally make and sell them.

Treatment of multiple conditions:

It is common for animals to face multiple health conditions as they age, like thyroid disease and arthritis. Taking many different medications can be difficult in these cases. Compounding enables multiple drugs to be combined into one easier-to-give dosage form.

For instance, a pharmacist can compound a single flavored chewable tablet containing medications for both hypothyroidism and joint pain, simplifying the medication regimen.

One customized, compounded formulation eliminates the need for an owner to give their pet separate pills or treatments for different conditions. This makes it more convenient for the owner and more agreeable for the animal.

Regulation of Veterinary Compounding

While compounding provides advantages, there have been concerns about inadequate regulation and oversight leading to serious errors or quality issues with some compounded veterinary preparations. Compounding falls into a gray area between traditional pharmacy and drug manufacturing. 

The FDA maintains that compounded drugs are unapproved new animal drugs and are subject to FDA enforcement. However, the agency has traditionally focused oversight on compounding for humans. States regulate the practice of pharmacy, but there is variability in the regulation of compounding practices across states. 

To address this regulatory gap, the Animal Health Institute issued voluntary Good Compounding Practices for state boards of pharmacy regarding veterinary compounding. The FDA has also issued Compliance Policy Guides outlining conditions under which they intend to exercise enforcement regarding compounded animal medications. However, critics argue this does not adequately address the inconsistent patchwork of state and federal oversight.

Is Veterinary Compounding Adequately Regulated?

While policies and guidelines exist, some feel the current regulatory framework does not go far enough in ensuring safety and quality control. There are concerns about compounding pharmacies operating more like manufacturers without being subject to the same FDA oversight as commercial drug manufacturers. 

However, supporters of compounding argue that imposing overly rigid restrictions could limit access to beneficial customized medications for veterinary patients. They believe existing voluntary quality standards are sufficient if properly enforced at the state level.

The debate continues regarding how to best balance providing access to customized compounded veterinary preparations while also ensuring appropriate regulatory safeguards. Striking the right balance is important to allow veterinarians to prescribe compounded medications when medically warranted while also adequately protecting animal health.

Conclusion

Veterinary compounding provides a means to create customized medications meeting the clinical needs of animal patients. While it is an important tool in veterinary medicine, there are legitimate concerns about variability in quality control and safety standards at some compounding pharmacies. It is important to ensure veterinary patients receive compounded preparations meeting high standards for quality and safety through appropriate regulation and oversight. Veterinarians should verify that any pharmacy providing compounded preparations follows best practices and quality standards. With the right balance of access and oversight, veterinary compounding can continue providing safe, customized treatment options for our animal companions and patients.