Compounding Pharmacy in Animal Health
Compounding pharmacy is the science and art of making unique medications for patients for whom mass-manufactured drugs are not appropriate. Compounding is vitally important to veterinary medical practice. Because the practices of animal-health and human-health medicine are so different, veterinarians’ ability to stock, prescribe, administer, and dispense compounded preparations are fundamental and critical to patient care.
Veterinarians are licensed professionals who prescribe compounded medications that meet the needs of their patients that otherwise would not be served given the wide number and variety of species, breeds, and physical differences of the animals in their care. While veterinarians use manufactured drugs 95.7% of the time, many studies have confirmed that virtually every veterinarian in the United States also depends on compounded medications.
The market for animal drugs is different from the market for human drugs. There are virtually no third-party payors such as insurance companies, Medicare, or Medicaid that will pay the high prices necessary to ensure the profitability of specialty markets for drugs. Therefore, drug manufacturers appropriately concentrate on medications for which demand is sufficient to meet their need for a reasonable profit. Compounding pharmacies fill the gap. Veterinarians work with compounding pharmacies to order and prescribe customized medications that are used for needs that would otherwise be unmet or poorly served.
Some Myths About Compounding Pharmacy
Perhaps no aspect of veterinary medicine is as misunderstood as compounding pharmacy. These statements are all true:
- Compounding for animal health, whether from manufactured drugs or bulk ingredients, is legal. Because of the nature of compounding, which addresses individual patients’ needs, compounding from bulk ingredients is a scientifically, pharmaceutically, and legally sound way to prepare these medications.
- Compounded drugs are not prepared based on FDA standards for drug manufacturing. They are prepared based on a different set of standards, established by the U.S. Pharmacopeia (USP). One standard is not more rigorous than the other; they’re just different standards. Compounding pharmacies use ingredients from FDA-registered re-packagers of chemicals. The historic safety of compounded medications is well known to veterinarians, who have used them to treat patients during their entire careers or have been instructed to use them by mentors when starting new careers. A few headline-grabbing incidents highlighted by critics of compounding, while tragic, do not represent the state of an entire profession.
- Office administration and dispensing of compounded medications by veterinarians are critical to the practice of veterinary medicine. This is the standard of care in veterinary medicine. Mandates that eliminate or restrict veterinarians’ right to order compounded medications for administration in or dispensing from their practices—so-called “office use”—prevent them from having medication available in their practices to treat the urgent needs of varied species. Veterinary compounding pharmacies often are highly specialized, with access to the 800 or more APIs typically used in compounding for animal-health, and with the expertise and facilities to compound complex dosage-forms and sterile preparations.
Why Veterinarians Depend on Office Stock of Compounded Medications
Veterinarians must be able to administer and to dispense compounded medication in their offices to reduce pain and suffering, disease transmission, and in many cases, death.
Office use of compounded medications is ubiquitous and vital to animal health. There are fewer commercial drugs available for animal health than for human health. Because animal patients vary so widely, there are unique needs that cannot be met by manufactured drugs. Compliance with medication regimens is especially critical and difficult in veterinary medicine; compounded medications with unique dosage forms, such as transdermal gels and flavored suspensions, and uniquely calibrated dosage amounts are often the only route to compliance.
A Recent Development in Compounding for Animal Health
FDA’s recent Guidance for Industry GFI #256, “Compounding Animal Drugs from Bulk Drug Substances,” is a Guidance document issued by the FDA. It gives recommendations about compounding animal drugs from bulk drug substances (BDS), which are the pharmaceutical ingredients uses to compound. It indicates which bulk substances are appropriate for office use and which should be prescribed, in FDA’s opinion. The Guidance will be enforced by the FDA beginning April 1, 2023.
GFI #256, like all Guidance, is not a regulation. It is not a law. It represents FDA’s “current thinking” about using bulk substances for compounding medications for animals. (Virtually everything we and other compounding pharmacies offer is prepared from bulk drug substances.) However, FDA bases its enforcement of pharmacies and veterinarians who compound for animals on this Guidance. So, as a practical matter, to maintain a stable and predictable regulatory environment, Wedgewood Pharmacy will be complying with this Guidance.
GFI #256 creates lists that define which preparations will be available from Wedgewood Pharmacy for office use and which will be available by prescription:
- Medications on FDA’s list of office stock drugs and medications under review may be ordered for office use and prescriptions.
- Medications that have been reviewed and not listed may be prescribed but are not available for office use.
FDA has made it very clear that it wants to hear from veterinarians, in whose sole discretion the decision to administer or prescribe compounded medications rests. While GFI #256 places the majority of the compliance burden on compounding pharmacies—which have taken the lead in nominating BDS for use in compounding for animal health—FDA reasonably could see arguments from compounders as being self-interested. That’s why, if this is important to you and your patients, it is extremely important that veterinarians share their perspectives with FDA. The agency wants to hear your unique professional viewpoints on why specific compounded medications are needed for immediate use or dispensing from your practice, and why the compounded medication you want to order is a clinically different and preferred alternative.
To comment on any BDS under review or not approved for office-use compounding, go directly to the FDA’s GFI #256 commenting docket and provide specific use cases and examples of why you need to have a certain medication available on hand for office use and why you sometimes have patients with unique needs that cannot be met by the alternative. If you want some simple tips for writing your comments, visit this site.