What is a compounded medication?

There are several categories of medication used in our pets: nationally approved (FDA/Health Canada), brand-name animal medications; nationally approved, brand-name human medications; nationally approved generic animal medications; nationally approved generic human medications; and compounded medications.

A compounded medication is one that has been mixed or altered in a way that is different from any recommendations on the drug label. This can include mixing with other medications or suspensions, adding flavoring, or changing the concentration (strength) of the drug. Compounded medications are prepared to meet a specific need that can’t be met by the available nationally approved medications.

By law, a compounded medication is not allowed to be the same as any approved medication.

Examples of compounded medications include 

• flavored liquid made from an unflavored tablet,
• gel that allows a medication to be absorbed through the skin rather given orally, and
• a combination of medications that can be applied to the skin or ear for treatment of specific infections or disease.

Why do we use compounded medications in pets?

Compounded medications are acceptable to use in veterinary medicine only when there is no approved veterinary or human product available to treat a specific condition. They are most commonly used in small patients for which an approved medication is too strong for a veterinarian to be able to provide an accurate dose.

Another common reason for using compounded medications is to make the medication easier for pets to accept. For example, many pets can be resistant to taking pills. In these cases, pills may be able to be formulated into a liquid or transdermal gel (to be absorbed through the skin).

Lastly, there are not enough approved medications to meet the needs of every patient and problem, so compounded medications containing more than one active ingredient can provide more specific treatment of a condition, such as an ear infection with multiple bacteria.

Why is an approved drug preferred over compounded?

Medications approved by regulatory agencies like the FDA (Food and Drug Administration) and Health Canada have undergone rigorous testing prior to approval. These agencies ensure that the product is safe, effective, stable (won’t degrade before its expiry date), and that the product matches the label concentration (potency).

Compounded medications don’t go through the same testing, so there is no guarantee that they will work the same or that they meet the same safety standards as approved medications.

Most compounded medications are made from medications approved by these national agencies; however, they are not considered approved for use because they have been altered, and the process of altering them can affect their safety, efficacy and/or stability.

There are some rare instances that require the use of compounded medications made from unapproved medications. It is important that these compounded medications are used legally, when there is no alternative to ensure a pet’s health. Examples of these medications include antidotes for certain poisons or a medication used to induce vomiting in ingested poison cases.

What are the risks of using compounded medication?

There is no assurance that compounded medications will be effective at treating a pet’s condition or that they are safe. There is also the risk that any substance used in the formulation of a compounded medication could be toxic or cause an allergic reaction. For example, xylitol is a common sweetener used in human medications and other products, but it is toxic to dogs, causing severe hypoglycemia and liver failure.

It is always safer to use approved medications and to only use compounded medications if your veterinarian has determined these are the only choice available for ensuring your pet’s health.

Are compounded medications safe? Are they effective?

Unfortunately, there is no guarantee that a compounded medication will be safe or effective. Notify your veterinarian right away of any changes in your pet while they are using a compounded medication. If you see any change in the appearance, consistency, or odor of the medication, do not administer it and contact your veterinarian.

A compounding pharmacy can demonstrate excellent standards of practice by following the United States Pharmacopeial (USP) compounding standards and being accredited by the Pharmacy Compounding Accreditation Board (PCAB); however, this does not mean the product is safe or effective. It means only that the product was prepared following appropriate procedures to increase the likelihood that it will be the correct potency and remain stable. The pharmacy cannot guarantee safety or efficacy because the compounded medications have not gone through the strict trials required by the FDA or Health Canada, and are not subjected to the same quality testing used for manufactured products. Ask your veterinarian what compounding pharmacies they trust.

Are compounded medications less expensive?

Sometimes, at first glance, compounded medications appear less expensive; however, if the medication does not work, or if your pet develops severe side effects, the total cost to you and your pet becomes much higher. Cost of medication is not a valid reason to use a compounded medication.