An FDA-approved drug has been reviewed by the FDA for safety and effectiveness for specific uses, and its manufacturing is held to federal quality requirements. When an approved product meets a patient’s needs, it is generally the first choice.
What changes with a compounded preparation
A compounded preparation is made for one patient on a prescription. The FDA does not review it for safety, effectiveness or quality before it is dispensed. That does not make it unsafe, and it does not make it safer. It means quality depends on the pharmacy’s practices, ingredients and oversight, and on whether the preparation is appropriate for the patient.
Questions worth asking
- Is there an approved product that would work for me or my animal?
- What specific need does the compounded preparation address?
- How should it be stored, and what is its beyond-use date?
- Who do I call with questions about it?
Federal framework in brief
Human compounding by pharmacies like Cambria falls under section 503A of the Federal Food, Drug, and Cosmetic Act together with state pharmacy law. Animal drug compounding is governed separately by federal animal drug provisions, FDA policy and state law.
This article is educational and is not medical or veterinary advice. Talk with your prescriber, veterinarian or pharmacist about your own situation.