What is Compounding?
Millions of patients have unique health needs that off-the-shelf, manufactured medications cannot meet. For these patients, personalized medication solutions – prescribed by licensed practitioners and prepared by trained, licensed pharmacists – are the only way to better health.
Working with a physician, a compounding pharmacist can meet individual needs of children, adults and animals. Whether it’s an allergy to a dye or ingredient, a need for a different strength, or a preference for a different dosage form, compounding pharmacists provide patients with solutions to their medication needs.
- When needed medication are discontinued by or generally unavailable form pharmaceutical companies, often because the medications are no longer profitable to manufacture;
- When the patient is allergic to certain preservatives, dyes or binders in available off-the-shelf medications;
- When treatment requires tailored dosage strengths for patients with unique needs (for example, an infant);
- When a pharmacist can combine several medications a patient is taking to increase compliance;
- When a patient cannot ingest the medication in its commercially available form and a pharmacist can prepare the medication in cream, liquid or other form that the patient can easily take; and
- When medications require flavor additives to make them more palatable for some patients, most often, children.
How is it Regulated?
All pharmacies and pharmacists are licensed and strictly regulated by State Boards of Pharmacy. Compounding is a core component of pharmacy and has always been subject to the oversight and monitoring of these agencies and the state legislatures who decide upon the way pharmacy compounding should be regulated within their borders. Additionally, the Food & Drug Administration has authority over some aspects of compounded prescriptions at the federal level under the direction of Congress. Standards set by the United States Pharmacopeia (USP) are integrated into the day-to-day practice of pharmacy compounding and are mandated by law in most states. Even greater oversight comes through accreditation from a variety of non-profit agencies that establish and survey on guidelines designed to improve quality in the compounding process.
Compounding – The Numbers
- The compounding industry now makes up an estimated 1 to 3 percent of the U.S. prescription market, which is $300 billion overall.
- A national survey of independent pharmacists showed that 76 percent compound medications for patients.
- Virtually 100 percent of hospitals compound medications.
- Virtually all home health specialty pharmacies compound
- All nuclear pharmacies compound.