Prescription Compounding FAQ
What is prescription compounding?
FDA generally describes compounding as combining, mixing or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding commonly occurs in pharmacies and can serve an important medical need in appropriate circumstances.
When may compounding be considered?
A prescriber may consider compounding when a patient's medical need cannot be met by an appropriate FDA-approved drug. FDA gives examples such as a patient who needs a product without a particular dye or a patient who cannot swallow a standard tablet or capsule and needs another dosage form.
Are compounded drugs FDA-approved?
No. FDA states that compounded drugs are not FDA-approved. FDA does not review compounded drugs before marketing to verify their safety, effectiveness or quality.
Is a compounded drug the same as an FDA-approved generic?
No. FDA-approved generic drugs go through an approval process and must meet applicable requirements. A compounded drug is not an FDA-approved generic merely because it contains the same active ingredient as an approved product.
Who decides whether a compounded prescription is appropriate?
The decision begins with the patient's clinical need and the prescriber's prescription. The pharmacist then evaluates whether the prescribed preparation can be compounded appropriately within applicable requirements and the pharmacy's capabilities. The patient, prescriber and pharmacist may need to communicate when the requested formulation raises questions.
Can almost any prescription be compounded?
No. Not every medicine, ingredient combination or dosage form can automatically be compounded. Regulatory requirements, product characteristics, available ingredients, stability, route of administration and the specific prescription can all affect feasibility.
Is compounding automatically safer or more effective?
No. Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness or quality before they are marketed. Compounding may meet an important patient need, but it should not be marketed as inherently superior to an appropriate approved drug.
How much does a compounded prescription cost?
Cost depends on the specific prescription, ingredients, dosage form and preparation requirements. A fixed general price should not be assumed. Contact the pharmacy with the actual prescription for current information.
Will insurance cover a compounded prescription?
Coverage varies by plan and prescription. This page does not claim that most insurance plans reimburse compounded prescriptions. Coverage and patient cost should be checked individually.
Where can I ask about a prescription?
See Prescription Compounding for the main service page or Contact Access Care Pharmacy with a current prescription or formulation question.