What’s the difference between a compounding pharmacy and a drug manufacturer?
A compounding pharmacy makes customized prescription medications. A drug manufacturer makes FDA-approved prescription drugs for mass markets in predetermined set strengths and dosage forms.
Do you compound commercially available medications because you can provide them cheaper than the manufactured drugs?
There are two parts to your question. Let me clarify an incorrect assumption: We do not compound commercially available medications. We compound medications that are not commercially available in a particular dosage form, dose, flavor or combination. When drugs are removed from the market or are on back order, we can compound medications using the same active ingredients of commercial drugs that aren’t available. Lower cost should never be a reason to prescribe a compounded preparation rather than an FDA-approved drug.
How do I know that my compounded medications are safe? How do I know that the compounded medications I’m getting from you are safe for my patients?
The best way to know that your compounded medications are safe is to talk with your compounding pharmacist. Ask them about their quality procedure. Ask questions about their testing protocols and if you can see their test results. Know who is compounding your medications and make sure that you feel comfortable with them. Should I ask my clinic or doctor if they are using compounded prescriptions and if they are safe? If you do not know if a medication you are taking is an FDA-approved manufactured drug or a compounded drug, by all means ask your prescriber for more information, including the name of the compounding pharmacy that compounds your prescription
Does the FDA have the expertise and federal power to regulate compounding pharmacies? Why shouldn’t compound medications, especially the most commonly used combinations, have to go through the FDA’s established drug approval process?
The medical profession, including the practice of pharmacy, has always been regulated by the states. State boards of pharmacy are in the best position to inspect pharmacy operations, develop appropriate regulations and respond to problems or violations. The FDA does have an important role to play in making sure that ingredients used in compounding are safe and are manufactured by FDA-registered and inspected facilities, but there is no such thing as an “FDA-approved” pharmacy. The FDA’s drug approval process takes years and can cost hundreds of millions of dollars. Requiring this for individually personalized medications that fulfill an individual doctor’s prescription is both impractical and contrary to the best interests of patients requiring immediate treatment.
Should I ask my clinic or doctor if they are using compounded prescriptions and if they are safe?
If you do not know if a medication you are taking is an FDA-approved manufactured drug or a compounded drug, by all means, ask your prescriber for more information, including the name of the compounding pharmacy that compounds your prescription