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Pharmacy compounding is the customized preparation of a medicine that is not otherwise commercially available. These medications are prescribed by a physician, veterinarian, or other prescribing practitioner, and compounded by a state-licensed pharmacist. A growing number of people and animals have unique health needs that off-the-shelf, one-size-fits-all prescription medicines cannot meet. For them, customized medications are the only way to better health.
Pharmacy compounding is a centuries-old, well-regulated and common practice within the pharmacy profession. Over the past 30 years, compounding has evolved into a specialty practice requiring pharmacists and technicians to pursue additional training and continual education to stay current on the latest information and techniques within the practice.
Compounded medications are similar to the so-called “off-label” use of FDA-approved drugs. When the FDA approves a specific drug as safe and effective, this determination applies only to the specific disease or condition for which the drug was tested; however, physicians and veterinarians often prescribe medications for treatments for which they have not been specifically approved. Medical professionals do this because, in their judgment, the treatment is in the best interest of the individual patient. Similarly, medical professionals often prescribe compounded medications because they believe it is the best medical option for their patients. It is estimated that one fifth of all prescriptions written for FDA-approved drugs are for uses for which they were not specifically approved.
Some valuable medications are available only by compounding. Restricting a doctor’s access to compounded medications would be a serious mistake. Moreover, because of the economics of pharmaceutical manufacturing, FDA-approved drugs that serve a limited population are often discontinued by manufacturers. In most of these cases, the only option left for doctors and their patients is to have a compounding pharmacist make the discontinued drug from scratch using pharmaceutical grade ingredients.
Just like big pharmaceutical manufacturing companies, compounding pharmacies get their ingredients for medications from suppliers that are registered and inspected by the FDA.
All pharmacies and pharmacists are licensed and regulated by State Boards of Pharmacy. Compounding is a core component of pharmacy and is 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 under the direction of Congress. Standards set by the United States Pharmacopeial Convention (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.
The FDA is legally tasked with regulating drug manufacturers and appropriately holds such operations to cGMPs, or current Good Manufacturing Practices, which are more far-reaching than USP <795> and USP <797>. Additionally, the FDA may inspect any pharmacy at any time to assure that the medications they have available for patients are being stored correctly.
- The U.S. Congress passed the Drug Quality and Security Act (DQSA), and President Obama signed it into law in November 2013.
- The DQSA created a new “outsourcing facilities” category for those facilities that produce large quantities of sterile medication that are not patient-specific prescriptions. Registration with the FDA is voluntary.