Compounding Fact Sheet

What are Compounded Medications?

Compounded medications are prescriptions that are written by a physician, veterinarian or other legally authorized prescriber and prepared for an individual patient. They are not commercially available; rather, they are prepared by a pharmacist to meet an individual’s unique needs as determined by the prescriber.
Compounded medications are necessary for a variety of reasons. Examples include:

  • When a child needs a dose smaller than the manufactured dose.
  • When a patient cannot tolerate an inactive ingredient in a manufactured medicine.
  • When a doctor believes a medicine is needed for his or her patient, but a manufacturer has discontinued the medicine for economic reasons.

Why is Accreditation Important?

With the demand forpatient-specific compounded medications increasing each year, patients, prescribers and payors want a way judge the quality of compounding pharmacies. While compounding pharmacy is regulated by the state, accreditation is an additional way to ensure a compounding pharmacy is meeting nationally accepted quality and safety standards.

The Pharmacy Compounding Accreditation Board Process

The Pharmacy Compounding Accreditation Board (PCAB®) is a not-for-profit corporation formed and led by eight national pharmacy organizations. Together, these leading organizations developed rigorous quality assurance, quality control and quality improvement standards for the practice of compounding pharmacy, as well as the PCAB Accreditation criteria and processes.

Examples of specific quality and safety standards include:

  • PCAB Accredited® compounding pharmacies can use only certain chemicals from highly reliable suppliers.
  • PCAB Accredited® compounding pharmacists and their technicians must receive regular, specialized training.
  • PCAB Accredited® compounding pharmacy must monitor the quality of the compounded preparations they dispense.

Pharmacies seeking accreditation must submit documented proof that they meet PCAB® quality standards, submit their policies and procedures for regular review, and open their doors to regular physical inspections.

More detailed information about PCAB® and the PCAB® Accreditation process can be found on its Web site at www.pcab.org