Compounding Medicine for Pets: FAQ for Pet Owners
Q: What is compounding medicine?
A: In a simple answer, compounding medicine is the manipulation of a drug beyond the described label on the drug. This may include mixing, diluting, concentrating, flavoring, or changing a drug’s dosage form. Examples of this can include mixing two injectable drugs, preparing a paste or suspension from crushed tablets, or even adding flavoring to a drug.
Q: When is compounding necessary?
A: This medical option becomes necessary when an animal is suffering from a condition and there is not an FDA-approved human or veterinary product available. An example of this could be a dog that needs a medication that is only available in a pill form. If the dog is unable to consume the medication for dietary or biological reasons, the veterinarian might have a drug compounded into a flavored liquid that the dog will then take.
Q: How is compounding medication regulated?
A: It’s regulated by the Food and Drug Administration and state governments. On the federal level, the FDA regulates compounding for animal patients as a subpart of it’s Extralabel Drug Use (ELDU) Rules. The FDA also has a Compliance Policy Guide (CPG) which describes more about how it regulates compounding for animals and what items get deferred to the state. The state boards pharmacy oversee the practice of veterinary medicine, including prescribing. Before using a pharmacy, veterinarians should also consider whether the pharmacy is complaint with the United States Pharmacopeial Conventions (USP) standards.
Q: Are compounded drugs the same as generic drugs? How can I tell the difference?
A: They are not the same. A generic drug is a non-proprietary name version of a drug. In general, buying a non-proprietary drug with the same ingredients and same strength as the brand name is equivalent to buying the brand name version. It is a known fact, however, that there are individuals who seem to respond better to either the brand name or generic version of a drug- so there can be some variation involved. Generic drugs you can obtain from your veterinarian or a pharmacy are approved by the FDA. They have been shown to be safe and effective from previous studies. The manufacturer is also required to continually ensure the shelf life and stability of the product. Non-proprietary (generic) animal drugs have an Abbreviated New Animal Drug Application (ANADA) number given to them by the FDA, which you can often find on the package or label.
When a drug is compounded, the new form may not perform in the same manner that it was intended to by the FDA, yet it still has the same ingredients. Although this may be true, you cannot expect the drug to be identical in every way. Therefor, the government considers compounded preparations to be drugs that they have not reviewed or approved.