Frequently Asked Questions 

What is pharmacy compounding?

Some description

Pharmacy compounding is the customized preparation of a medicine that is not otherwise commercially available. These medications are prescribed by a veterinarian and compounded by a state-licensed pharmacist. A growing number of animals have unique health needs that off-the-shelf, one-size-fits-all prescription medicines cannot meet. For them, customized medications are the only way to better health. Additionally, since there is rarely significant profit within the pharmaceuticalindustry for veterinary indications, and especially compared to human medications, many companies have discontinued the manufacturing of commercial drugs for animals. Lastly, more than 300 commercial drugs were unavailable last year.  For these reasons and more, compounding pharmacies like Roadrunner have filled in these enormous gaps for essential therapy.

Who are compounding pharmacists?

All licensed pharmacists learn during pharmacy school to perform basic compounding. In addition, most pharmacies have compounding tools such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, scales for weighing solids, spatulas for mixing materials, and pill tiles on which to work. With such tools and applying their knowledge, most pharmacists routinely prepare non-sterile compounded products when requested by practitioners. Pharmacy compounding is a centuries-old, well-regulated and common practice. Though Pharmacy as a field is one of the most respected and trusted professions in the United States, compounding has evolved into a specialty practice within the pharmacy community today. New applications to meet today’s patient needs require additional education, equipment and processes that not all pharmacies possess. Roadrunner pharmacists advise and serve the veterinary community exclusively, dealing with thousands of clinics, affording them special insight into animal disease and therapeutics.

Are compounded medications safe? How does one know that the compounded medication they are taking is safe and effective?

Compounded medications are similar to the so-called “off-label” use of FDA-approved drugs. When the FDA approves a specific drug as safe and effective, this determination applies only to the specific disease or condition for which the drug was tested. But physicians and veterinarians often prescribe medications for treatments for which they have not been specifically approved. Medical professionals do this because, in their judgment, the treatment is in the best interest of the individual patient. Similarly, medical professionals often prescribe compounded medications because they believe it is the best medical option for their patients. It is estimated that one fifth of all prescriptions written for FDA-approved drugs are for uses for which they were not specifically approved. We encourage veterinarians to ask the hard questions; we pride ourselves on the highest quality of components and potency.

There are thousands of FDA-approved drugs on the market for just about any ailment. Why do we still need compounded medications?

Some valuable medications are available only by compounding. Restricting a veterinarian’s access to compounded medications would be a serious mistake. Moreover, because of the economics of pharmaceutical manufacturing, FDA-approved drugs that serve a limited population are often discontinued by manufacturers. In most of these cases, the only option left for a vet and their patients is to have a compounding pharmacist make the discontinued drug from scratch using pharmaceutical grade ingredients. Most pet owners are very interested in the animal’s health and well-being; diseases that went untreated in the past are being better diagnosed and require drugs, strengths and dosage forms that are simply not commercially available.

Does the FDA have the expertise and federal power to regulate compounding pharmacies? Why shouldn’t compounded medications, especially the most commonly used combinations, have to go through the FDA’s established drug approval process?

State boards of pharmacy are in the best position to inspect pharmacy operations, develop appropriate regulations and respond to problems or violations. To be sure, the FDA does have an important role to play in making sure that ingredients used in compounding are safe. Roadrunner strongly supports legislation towards the creation of quality standards and training. To require New Drug Applications for compounds serves no purpose. The FDA’s drug approval process takes years and can cost hundreds of millions of dollars. Requiring this for individually personalized medications that fulfill an individual doctor’s prescription is both impractical and contrary to the best interests of patients requiring immediate treatment, eliminating most compounding.

Who regulates compounding pharmacies? Do compounding pharmacies follow the same regulations as drug manufacturers?

All pharmacists and pharmacies involved in compounding are subject to oversight by both federal and state authorities. All pharmacies and pharmacists are licensed and strictly regulated at the state level. Compounding is a core component of pharmacy and has always been regulated by state boards, which are constantly updating their standards and regulations. In addition, rigid standards set by the United States Pharmacopeia (USP) are integrated into the practice of pharmacy compounding.

Why haven’t any studies been done for compounded products?

The majority of large studies are funded by drug manufacturers who are required to do so by the FDA in order to get a particular product approved for mass marketing. Some drugs (bio-identical hormones, for example) cannot be patented; therefore, there is no monetary incentive for any company to pay for an expensive drug study. Furthermore, there are published studies done for many ingredients used in compounded products. By the very definition of compounding, customization does not lend itself well to studies conducted in a large population of animals.