Is your compounding pharmacy pursuing best practices?

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Facing the challenges of daily veterinary practice is exciting and complicated. You are a physician, surgeon, counselor, business owner, trainer, teacher, problem solver, and caregiver, navigating a constantly changing landscape, including compounded medications. Compounding opens wonderful possibilities, allowing you to customize treatment for your patients when a commercially available medication does not fit exactly what they need, such as a different strength, flavor or dosage formulation, avoiding drug allergies/sensitivities, creating a new form of a discontinued medication, and even combining 2 medications together for easier administration for certain patients.

As you consider calling in or writing a prescription for compounded medication for your patient, you may wonder...is the medication truly what it states it is on the label? Can you trust that it is safe, effective, and high-quality?

Find out if your compounding pharmacy is going above what is required and implementing the best practices by calling them and speaking to a pharmacist. This can help determine if they are familiar with the latest industry standards, and if they are taking proactive steps to meet and exceed them.

At a minimum, every compounding pharmacy must be compliant with the quality standards set by the United States Pharmacopeia (USP), the 200-year-old scientific organization that provides the most comprehensive source of legally recognized medication quality and purity standards in the world. Your pharmacy must also be licensed to dispense or ship to your state and compliant with state and federal regulations.

Here is a list of questions you should ask your potential compounding pharmacy partner about what really happens behind the scenes.

The product

Professionals need peace of mind that the pharmacy starts with the best quality ingredients. To maintain the highest quality medications, does your compounding pharmacy:

• Purchase their raw ingredients from reputable manufacturers registered with the FDA.
• Purchase ingredients that meet USP quality standards. For an ingredient to be labeled USP grade means that the results of analytical testing have met or exceeded the strict standards set by USP for that ingredient.
• Require the manufacturers to provide a valid Certificate of Analysis
• Schedule routine audits of manufacturers to assess their facilities and processes.
• Perform their own testing on raw ingredients prior to using them for compounding.

The people

To find out more about who is compounding your patients’ medications, consider asking:

• Are compounding technicians nationally certified?
• Do pharmacists and compounding technicians complete a hands-on training program prior to compounding?
• Is each pharmacist and compounding technician required to pass an analytical test on each dosage form (such capsules, chews, tablets, oral suspensions, or transdermals) before they compound them to be dispensed for a patient?
• Are they assessed on their knowledge of policy, processes, and procedures at least annually?

The process

To determine that the compounding facility and its equipment meet safety and quality standards, ask about accreditation. Accreditation is the process by which a compounding pharmacy's quality is measured and determines that a pharmacy exceeds minimum standards in their quality and operations. This demonstrates their commitment to compliance, safety, and continuous improvement.

The gold standard of accreditation for compounding pharmacies is known as Pharmacy Compounding Accreditation Board (PCAB) accreditation. Top compounding pharmacies voluntarily choose to undergo this expensive and involved process.

PCAB accreditation shows that a pharmacy is dedicated to meeting the highest standards of quality and safety. Consider asking:

• Is your compounding pharmacy PCAB accredited?
• Does a pharmacist check every batch of medication at each phase of the compounding process every time?
• How often are compounded medications analyzed by a third party to ensure that they accurately match the labeled strength before dispensing it to a patient?
• Have new medications and dosage forms undergone research, development, and analysis? Be mindful of compounding pharmacies that offer significantly greater varieties of medications than similar pharmacies. Compounded medications that are less potent may not absorb as well as the approved commercial product, and medications that should never be compounded for transdermal use, such as antibiotics or medications may harm the skin or gastrointestinal tract.
• How is a compounded medication’s beyond-use date (BUD) established? Does the pharmacy perform advanced testing to extend BUDs (e.g. stability studies)?
• If the medication is a sterile compound (eye drops or injectable medication), does the pharmacy require a confirmed sterility report before dispensing the medication?
• Is the laboratory environment continuously monitored and rigorously cleaned and sanitized to maintain safety and integrity?
• Is the equipment and the facility up to date and third-party certified?

How do you start looking for a compounding pharmacy?

The best way to start is to look for PCAB-accredited pharmacies listed on the Accreditation Commission for Health Care website, choose “PCAB Compounding Pharmacy” under “Select Your Program,” and give them a call. A great compounding pharmacist will be quick to answer your questions, explain their process, and make sure you feel confident about the medication they prepare for your patient.

When FDA-approved medications are not an option in certain circumstances, you need a compounding pharmacy partner to help deliver the best possible outcome for your patient. Reasonable prices, fast and reliable delivery, and excellent customer service are always important, but ultimately you need the medication that you can trust.

The best compounding pharmacies hold themselves to a higher standard. They make sure each medication is safe and effective for your patients.

Molly Price, DVM, is a veterinarian at Chewy who has practiced small animal medicine for over 20 years and is a graduate of Texas A&M College of Veterinary Medicine. She enjoys preventative medicine, wellness care, dermatology, internal medicine, and palliative care. Her favorite veterinary experiences include working with Sheltie Rescue and Golden Retriever Rescue. In her personal time, Price enjoys outdoor activities and supporting the fine arts.

Kory Muto, PharmD, is a graduate of the Philadelphia College of Pharmacy where he earned his Doctor of Pharmacy degree in 2014. He currently serves as the Associate Director of Quality Assurance for Chewy Pharmacy and has spent his career focused on compounding. His primary specialties are veterinary compounding, quality assurance, and pharmacy compliance. Muto enjoys hiking, cooking, and exploring new cities.