Q: What exactly is compounding? 

Compounding is a scientific process to customize a medication beyond what is described on its drug label. Compounding drugs are created as per the patient’s unique needs. For veterinary drug compounding, a prescription from a licensed veterinarian should be obtained.

Q: Is compounding pharmacy regulated by the federal or state governments?

The federal government regulates the compounding pharmacy industry under the Food and Drug Administration. It is also regulated at the state level.

Q: Do pharmacists go through special training to create compounding medications for animals?

A pharmacist will typically acquire specialized knowledge and training in the area of veterinary compounding through continuing education. Compounding for animals should be performed only by pharmacists with specialized professional skills.

Q: Are compounding drugs different from generic drugs?

Yes, generic and compounding medications are quite different. Generic drugs basically refer to the non-brand-name version of a branded drug. However, with compounding medications, the drug itself acquires a changed form, and cannot be called identical to the approved drug.

Q: When does compounding become necessary for veterinary medicine?

When it is difficult to administer approved veterinary drugs to a pet or another non-food animal, the alternative of compounding drugs may be used to ensure compliance. Compounding may involve diluting, flavoring, using different delivery mechanism or adjusting the ingredients to achieve compliance. In some cases, the non-availability of an approved drug may also make it necessary to use compounding medication.

Q: How to comply with the legal requirements in compounding?

The compounding pharmacy must diligently follow both federal and state regulations in order to ensure legal compliance. Licensure of the compounding pharmacist can be verified through the state board of pharmacy. Furthermore, compounding must be performed only an individual patient basis, and any use of commercial scale equipment would make compounding illegal.

Q: What are the regulations in case of compounding for food producing animals?

The regulation regime is more stringent when it comes to food animals. In this category, the use of compounding drugs should be allowed only when all other options to treat the animal are exhausted. Secondly, the safe use of animal for food purposes should be predictable when the drug is discontinued.

Q: How to define mimic drugs?

When compounding of a medication is carried out with the sole aim of copying an FDA approved drug with the intent to avoid the drug approval process, it is called a mimic drug. The motive here is economic, and not medical. Mimic drugs are both dangerous and illegal.

Q: Should compounding medications be prescribed just because of the economic factors?

It is unethical to choose a compounding medication in place of a readily available approved drug just because of the potential economic advantage that compounding may offer in a particular situation.

Q: How to ensure the reliability and effectiveness of compounding drugs?

To begin with, the veterinarian should ascertain the absolute necessity of compounding medications. Once this is established, they should identify a recognized and certified compounding pharmacy for prescribing medications. They should also seek evidence to ensure the stability and the assigned date of expiration of the medication from the pharmacist.

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