Compounding is the customized preparation of a medicine that is not commercially available otherwise. The American Veterinary Medical Association (AVMA) states that compounding consistent with FDA Extra-Label Drug Use regulations is “the customized manipulation of an approved drug(s) by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient.”

Common forms of drug manipulation in veterinary compounding include

• Changing a drug’s original dosage
• Mixing two injectable drugs in the same syringe
• Adding flavoring to a drug to make it more palatable to the patient
• Creating an oral suspension from crushed tablets or an injectable solution
• Diluting or concentrating a drug
• Creating a transdermal gel for a drug typically taken through other means
• Combining two solutions to instill into the ear

The decision to use compounding is based on medical necessity. These reasons are the most common:

• When approved drugs need to be modified (flavoring, diluting, converting from tablet to suspension, etc.) to effectively treat the patient. For example, if a hyperthyroid cat needs to take methimazole but will not allow its owner to pill it, you can prescribe that the drug be compounded into liquid form for easier administration.
• When the patient is allergic to certain preservatives, dyes, or binders in available off-the shelf medications.
• The AVMA believes that compounded formulations should use FDA-approved drugs, if available. However, compounded drugs are appropriate when no approved drug exists, or if an approved drug is not commercially available.
• When a drug shortage exists. Check the FDA Drug Shortage database for more information.

To Place an order, call our toll-free number 866-236-5040 and the Professional Pharmacy Resources staff will take the order over the phone.

Or

Fax your written prescription to 866-685-7608. Our staff will review the order and contact you should additional information be needed to process the order.

The assurances that you have with an FDA-approved drug do not apply to compounded drugs. Compounded medications are similar to “off-label” use of FDA-approved drugs. When the FDA approves a drug as safe and effective, the approval only applies to the specific disease or condition for which the drug was tested, but physicians often prescribe these medications to treat other conditions when doing so is deemed to be in the best interest of the patient. If you believe that compounding will best treat a patient, ask yourself these questions:

• Is the compounded drug really necessary?
• Is the compounding pharmacy reputable and trustworthy?
• Can the pharmacist provide evidence to support the stability and effectiveness through the stated expiration date?

If you notice unexpected in drug precipitation, visible flocculant material, color change, or separation of liquid phases with a compounded preparation, the cause may be improper storage, transport, or an unexpected chemical/physical drug interaction. If you have questions about the efficacy or safety of the preparation, please contact the compounding pharmacist.

Veterinary compounding is regulated by both the federal government (Food and Drug Administration/FDA) and state governments. The FDA regulates compounding for animal patients as a subpart of its Extra-Label Drug Use (ELDU) rules, and publishes a Compliance Policy Guide (CPG) which describes how it regulates compounding for animals and which activities it defers to the state. The FDA generally defers day-to-day regulation of compounding by veterinarians and pharmacists to state authorities. The state boards of pharmacy oversee pharmacy practices within the states, while the state veterinary medical boards oversee the practice of veterinary medicine, including prescribing.

Before using a pharmacy, veterinarians should also consider whether the pharmacy is compliant with the United States Pharmacopeial Convention (USP) for nonsterile and sterile compounding.

The U.S. Food and Drug Administration (FDA) requires that compounded medications be modified versions that use only FDA-approved medications. If they use ingredients not approved by the FDA for humans or animals, the FDA considers them new drugs that require approval to be sold legally. For example, your pet may have a condition that needs to be treated with eardrops, yet the medication is only available as a tablet. Your veterinarian can request that the compounding pharmacy create an eardrop version of that tablet, so your animal can get the treatment it needs.

Compounded medications may be created outside these guidelines to relieve suffering in certain situations. Veterinarians and pharmacists consult carefully in such cases to asses compliance with state and federal law and FDA guidelines. The U.S. government continues to assess compounding to improve regulation clarity. We’re happy to answer any questions or concerns.

No, they are very different. Compounded preparations are not equivalent to FDA-approved generic drug products, which requires a demonstration of bioequivalence of safety and efficacy with the pioneer FDA-approved drug product. In contrast to generic drugs, compounded preparations lack FDA approval.

Note: Avoid any pharmacy that claims to sell compounded preparations that are identical to commercially available FDA-approved products. Legitimate compounding is prescription-driven and based on the need to customize a preparation for an individual patient’s needs.

A bulk drug substance is an active pharmaceutical ingredient (API) or pure chemical used to produce a drug. The FDA-approved version is the actual finished form containing the ingredient.

Compounding is a long-established pharmacy practice than enables veterinarians to prescribe medicines prepared by pharmacists specifically to meet a patient’s needs. Many animals have unique needs that cannot be met by off-the-shelf prescriptions, and compounding allows the safe, accurate preparation of drugs to effectively treat those needs. Usually, a compounded drug will provide a dosage, flavoring, combination, or administration form that is not available commercially. For example, a cat that refuses to allow pilling at home may be prescribed a flavored liquid that it will take. Your veterinarian can explain in detail the reasons a compound preparation may be necessary for your pet.

Understand that even though compounds may be necessary in certain medical situations, their use has both benefits and risks. Since compounded preparations do not receive FDA approval, their stability, safety, potency, and effectiveness cannot be assured. An approved drug is always preferable, but compounding plays an important role in animal health when such medications are unavailable.

No, not unless your veterinarian has specifically directed you to do so. Prescriptions for compounded medications are specifically written for individual animals; using one pet's compounded medication for another pet could harm your pet.

No. Only a veterinarian can prescribe a compounded medication for an animal.

To request a refill of an existing prescription, call our toll-free number: 866-236-5040.

Professional Pharmacy Resources staff will take the refill order over the phone. Before being processed, each refill request is verified.