Helping FDA-Approved Medicine Go Down

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Our Story

Beginning in 1938, the regulation and control of new drugs sold in the United States became regulated by The Federal Food, Drug, and Cosmetic Act requiring every new drug be the subject of an approved NDA or Abbreviated NDA (ANDA), in order to ensure Americans safe access to drugs
  • In 1938, the regulation and control of new drugs sold in the United States became regulated by the Federal Food, Drug, and Cosmetic Act, requiring every new drug be the subject of an approved NDA or Abbreviated NDA (ANDA), in order to ensure Americans safe access to drugs.
  • In 1962, the Kefauver-Harris Amendment mandated that drug manufacturers provide evidence of the effectiveness, in addition to the safety, of new drugs before approval.
  • But there is a problem - Not all drugs dispensed by pharmacies and charged to plan sponsors are FDA-approved.
  • Based on multiple studies, the Food and Drug Administration (FDA) claims that 1-2% of prescriptions are not approved, and the Office of Inspector General OIG claims that, "1% of Medicaid prescriptions are not approved," (corroborated by the Centers for Medicare and Medicaid Services (CMS)).

Impact & Meaning

  • Dispensing and consuming FDA-unapproved medications creates multiple risks and jeopardizes the safety of patients, pharmacies, and plan sponsors.
    • Multiple federal and state Laws
    • ERISA compliance
    • Pharmacy Board regulations
    • Plan fiduciary responsibility
Claims Risk

Electuary Wants to Help

Prescription Review

Review

Identification of FDA-unapproved medications

Medication Analysis

Analyze

Quantify risk based on compliance review.

Risk Reduction

Reduce Risk

Eliminate FDA-unapproved medication prior to dispensing with continuous pharmacy compliance services

Electuary's Solution for Safer Scripts

Real-Time Monitoring for Pharmacy Safety and Compliance

Our proprietary database of 20,000+ National Drug Codes will:

  • Identify FDA-unapproved medications retrospectively
  • Provide real-time marketing status review of NDCs
  • Inform patients, pharmacies, plan sponsors, and Pharmacy Benefit Managers (PBMs) of medications that are not approved
  • Offer alternative approved medications in the same therapeutic class
  • Allow for informed compliant care decisions

Our medication database is continuously updated and current, inclusive of the newest available medications

We strive to protect patients, plan sponsors, pharmacies, and PBMs from this unforeseen risk

Our pharmacy supply chain compliance service monitors FDA-unapproved medications prior to claim adjudication and fulfillment, mitigates multiple risks, and eliminates waste and unnecessary expenditure.

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