Breaking News Drug Topics: Bill Would Protect Compounded Drugs More Information

FAQs

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Pharmacy compounding is the customized preparation of a medication based on the need of a particular patient. These medications are prescribed by a physician, veterinarian, or other prescriber, 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 and are often life-saving.

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.

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 the State Board of Pharmacy. Additionally, 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.

  • 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.