Eight Things Every Veterinarian Should Know About Compounded Medications

Compounded medications are an essential part of any veterinarian’s toolkit, providing options for medications that make it possible for the effective treatment of animals that can be difficult to treat otherwise.

“I prescribe compounded medications multiple times every week,” said Peter Burnett, DVM, and owner of Brevard Aid to Animals in Brevard, Florida. “We use them for formulations, especially for cats, to increase ease of application. Compounded medications are also effective in the treatment of rarer breeds, such as exotic pets when FDA-approved medications are not appropriate for that particular pet’s condition.”

While compounded medications are expected to remain a growing part of the pet care landscape, upcoming regulatory changes in the way compounded medications are prescribed and tracked may require some changes in practice management.

This sponsored article is brought to you by Chewy Health.

Here are eight factors veterinarians should take into account when considering compounded medications to help deliver the best possible outcomes for their patients.

1. The right partner is essential. Success with compounded medications begins and ends with your pharmacy partner. The right partner can help provide excellent service and high-quality medications to your patients, while the wrong one can result in disappointment and even poor clinical outcomes. When looking for the best partner, there are a number of factors to consider, including selection, prices, and delivery speed. But the most important is quality. When evaluating a new pharmacy partner, it is essential to dig into the pharmacy’s quality standards. Since compounded medications are created by individual pharmacies, there can be significant differences in the potency and quality of medications from pharmacy to pharmacy. Good questions to ask focus on quality control, analytic testing regimens (e.g., do they conduct regular quality control), the knowledge and experience of the pharmacy staff, and especially accreditation. The industry-leading accreditation is from the Pharmacy Compounding Accreditation Board (PCAB). The PCAB accreditation program is managed by the Accreditation Commission for Healthcare and represents the gold standard in pharmacy accreditation. PCAB accreditation ensures that the compounding pharmacy has committed to meeting national quality standards. We recommend scheduling an introductory call with a pharmacist to review these questions before using any new pharmacy. 
2. Consider online pharmacies. Online pharmacies like Chewy’s can offer significant advantages when it comes to price, convenience, and availability. The evaluation process for an online partner is very similar to a brick-and-mortar lab. The watchwords to look for are accreditation, quality, and training. Additionally, look at customer service and product selection. The ideal partner should offer your clients the ability to reach a real, informed person when they call seeking education. For example, Chewy’s best-in-class customer care team is available 24 hours a day, 7 days a week with agents that are specially trained to speak on Chewy Pharmacy’s wide assortment of medications for all types of pet breeds and conditions. Ease of ordering is also a critical factor in maximizing the potential of compounded medications. Through Chewy’s Practice Hub solution, veterinarians can easily create and prescribe prescriptions for thousands of compounded medications with just a few steps. There are several formulations and flavors to choose from,  with medications that are formulated from Chewy’s PCAB accredited compounding pharmacy.
3. What about recalls? Accreditation is an important factor, but it’s also a good idea to look into a compounding pharmacy’s history of recalls. Even large, nationally accredited compounding pharmacies can experience quality issues that result in recalls. The U.S. Food and Drug Administration’s website is a good place to search for recalls. A recall shouldn’t necessarily discount a pharmacy automatically, but it is a good data point, especially if the pharmacy you’re considering has multiple issues with recalls.
4. Understanding FDA GFI 256. Currently scheduled to go into effect in April 2023, both veterinarians and compounding pharmacies will have to comply with the recently released FDA Guidance for Industry 256 (GFI 256). Under the new guidance, veterinarians will have to provide more detailed, patient-specific clinical rationale for every compounded medication prescription explaining why the pet cannot be treated with an FDA-approved manufactured product. These regulations also preserve the requirement that adverse events continue to be reported to the FDA. Once again, this is where your choice of pharmacy partner matters. The larger national pharmacies have created processes to ensure their prescriptions, records, and processes remain in compliance with GFI 256. Depending on the pharmacy, there may be little or no changes in the way you order prescriptions. Chewy, for example, already requires patient-specific rationale as part of the ordering process.
5. Does GFI 256 affect when I should prescribe a compounded medication? No, the core value of compounded medications remains the same: they are the best option for pets that can’t take an FDA-approved drug or in circumstances when there is no FDA-approved medication. Pets who refuse to be pilled, dislike the taste of existing medications, or need another delivery route will remain candidates for compounded medications. The new requirement will tighten up how the patient-specific clinical rationale describes why the compounded medication is being prescribed instead of an FDA-approved drug.
6. What’s the difference between a 503A and a 503B pharmacy anyway? Broadly speaking, a 503B pharmacy is permitted by the FDA to compound medications in large batches without the need of a patient-specific prescription, while a 503A can only dispense compounded medications pursuant to a prescription. Currently, there are only a handful of 503B pharmacies in the United States that compound animal drugs in large batches without the need for a patient-specific prescription. The most common types of compounding facilities are 503A pharmacies. Within this large group, there are a wide range of compliance, quality, size, and customer service capabilities, so it’s always a good idea to carefully evaluate any new partner.
7. Can’t I just stock the compounded medications I need? Veterinarians are permitted to obtain compounded medication for “office stock” provided the compounded medication comes from a licensed 503A compounding pharmacy that uses bulk drug substances from the FDA’s List of Bulk Drug substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. There may also be state law restrictions. It is important to work with your pharmacy to understand your options.
8. How can I get my patients’ prescriptions filled faster? Even when office stock is available, speed of delivery may be an issue with urgently needed compounded medications, especially for pet parents who don’t have easy access to a local pharmacy. Between processing the prescription, compounding the medication, shipping it to the veterinarian’s office and then having the pet parent pick it up, it’s not uncommon that clients will have to wait up to 10 days for medications. The good news is that online pharmacies like Chewy are steadily improving their delivery times—in many cases, Chewy Pharmacy can now deliver compounded medications directly to pet parents within 3–5 days of receiving the prescription, making it easier and more convenient than ever to ensure the pet has the support they need.

If you have any questions about compounded medications or how Chewy Pharmacy can partner with you to provide high-quality medications with all the convenience and speed you’ve come to expect from Chewy, visit us at www.chewyhealth.com to learn more.