Sometimes you may require medication dosages that aren't readily available, or a delivery formulation that is easier to administer. If you're new to the benefits of compounding, or you simply want to know more about it, then you may find the answers you're looking for in this list of frequently asked questions.
Veterinary compounding is a process by which a drug is manipulated in a way that
changes it from what is described on the drug's label so it is more accessible for
treating animals. Common forms of drug manipulation in a veterinary compounding
• Changing a drug's original dosage
• Adding flavoring to a drug to make it more palatable to the patient
• Diluting or concentrating a drug
• Mixing multiple drugs into a single-dose application
When an FDA-approved drug is available for veterinary use, it is almost always
recommended to prescribe that medication, because it has been tested for effectiveness and safety. But when an animal patient requires treatment and there is no FDA-approved human or veterinary product available, or the needs fall under the list above, then the veterinarian can use veterinary compounding in order to treat the patient.
In most cases, the decision to use veterinary compounding is one that's based on medical necessity, and it's one that's made within the confines of a veterinarian-client-patient-relationship.
Yes. Veterinary compounding is regulated by both the Food and Drug Administration
(FDA), and by state governments. At the federal level, the FDA regulates veterinary
compounding as a subpart of its Extralabel Drug Use (ELDU) Rules, and via its
Compliance Policy Guide (CPG). In most cases, however, the day-to-day regulation of
compounding by veterinarians and pharmacists is deferred to the state authorities
where the compounding pharmacy operates.
In addition to federal and state guidelines, a reputable compounding pharmacy will also be compliant with the standards set by the United States Pharmacopeial Convention (USP).
No. Veterinary pharmacotherapy is not always included in the curricula of a pharmacy
school. Pharmacists who work in the veterinary compounding field have undergone
independent veterinary-specific pharmacy training (including compounding) beyond
what is provided in the traditional pharmacy program.
However, veterinarians should never assume that a pharmacist working in the compounding field has specialized training or credentials in veterinary compounding. They should always ask beforehand, and inquire about state licensure form the relevant state boards of pharmacy prior to using a pharmacy. Veterinarians should only seek the compounding services of pharmacists who have veterinary compounding training and experience.
No. When the patient is a food-producing animal, veterinary compounding is only
reserved for situations where there is absolutely no other choice for treating that
animal's medical condition. However, according to general industry guidelines,
compounding for food producing animals is not allowed.
If the animal is to continue to be used for human food purposes after the treatment is finished, then the use of the drug also has to be predictably safe for the future use of the animal. Veterinarians can learn more by referring to the FDA's Compliance Policy Guide.
Yes. But veterinarians should be aware that beyond-use dates and expiration dates are not the same. Expiration dates for the chemical and physical stability of compounded drugs are determined via rigorous analytical and performance testing. As a result, a product's expiration date is specific for that particular formulation, in the container it is in, and at stated exposure conditions.
There is no way to tell whether or not a compounded drug is bioavailable. Therefore, veterinarians should refer to studies that demonstrate the efficacy and safety of a particular drug compound in the species of animal to be treated. The results of the study should be a primary consideration in the benefit-risk analysis of deciding whether or not to use the compounded drug to treat the patient.
Refills of compounded medications are no different than refills of conventional medications. But because of the time it takes to produce compounded drugs, you may need to order the refill earlier than you would for a conventional drug.
Yes. But the process not only needs to follow the FDA's and the state's rules, it will also
have to follow the rules of the Drug Enforcement Administration (DEA). Therefore, you
have to maintain a "closed distribution system", in which the product is directly
dispensed to the patient's owner or caretaker.
Keep in mind, if the compounding pharmacy delivers the controlled substance product to your clinic for the client to pick up, you will be required to include the delivery into your controlled substance records to keep in accordance with federal laws regarding controlled substances.
A mimic drug is a drug that is intentionally compounded to "mimic" an FDA-approved human or animal drug. But by having the drug compounded, it avoids the drug approval process. This is most commonly done for economic reasons rather than for reasons that are medically necessary. This is something that is not ethical in veterinary compounding. In fact, the production and prescribing of compounded mimic drugs is illegal.
No. Generic drugs are non-brand versions of brand-name drugs. They are made from
the exact same ingredients and consist of the exact same dosages, with the exception
being that the generic version is usually somewhat less expensive for the consumer.
Compounded drugs, on the other hand, are sometimes very different from their brand-name counterparts. For example, a compounded drug may be formulated into a product that isn't available on the market. Sometimes, this can cause the drug to perform differently than its brand-name version.
Only drugs that have been tested and approved by the FDA can be expected to deliver results within a reasonable capacity. Since compounded drugs are not tested or reviewed by the FDA, there is no assurance that a compounded product will work as intended. This is why a veterinarian should always use an FDA-approved product whenever possible, and only prescribe compounded medications when it is determined medically necessary for the patient's health.
Yes. Veterinary compounding is legal when federal and state rules are followed, and when it is performed using an FDA-approved and in-line with the FDA's Extralabel Drug Use Rules. Veterinary compounding from FDA-approved drugs is permitted in cases where a veterinarian believes there is definitive need to alter a medication in order to adequately treat a non-food animal suffering from a diagnosed medical condition. An established Veterinarian-Client-Patient Relationship (VCPR) is also needed.
Since veterinary compounding is regulated on both federal and state government levels, claims involving compounded drugs tend to be complex. In addition, not every insurance carrier offers the same level of protection. Therefore, to better understand your full liability in such a case, you should contact your liability insurance carrier. In addition, you can call your compounding pharmacy to request proof of product liability insurance, as well as compounding pharmacists' professional liability.