Rare Disease Pharmacy Center of Excellence Designation

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As precision medicine emerges, rare disease diagnoses and associated orphan drugs continue to grow. Rare diseases currently affect 30 million Americans and there are about 7,000 recognized rare diseases. In the past few years, significant progress has been made in rare disease treatment; an average of 140 drugs have been designated as orphan drugs by the FDA each year over the past decade. URAC addresses this growing need with its Rare Disease Pharmacy Center of Excellence Designation.

URAC recognizes that individuals with rare disease diagnoses require in-depth, often long-term medical and pharmacy management. The role of pharmacies caring for individuals with these rare diseases is central to their treatment.

URAC’s Rare Disease Pharmacy Center of Excellence Designation:

  • Builds on URAC’s leadership position in specialty pharmacy
  • Recognizes pharmacists’ critical role in the management of individuals living with rare disease
  • Recognizes that manufacturers select highly skilled specialty pharmacies in their network
  • Positions and elevates specialty pharmacies who wish to contract with rare disease manufacturers

This program is a designation addition to Specialty Pharmacy Accreditation and will be valid while the Specialty Pharmacy Accreditation is held by an organization. Program standards address: patient management, staff education, coordinated patient care and transitions of care.


Who may apply?

An organization must be a licensed pharmacy in good standing, operating in the U.S. The organization must hold or be seeking URAC’s Specialty Pharmacy Accreditation. An eligible Rare Disease Pharmacy treats patients taking an orphan medication (a medication without any non-orphan indications).

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