Evoluciona Pharma

Compounding Compliance Disclaimer

Evoluciona Pharma is a 503A sterile compounding pharmacy that prepares customized medications pursuant to
valid prescriptions from licensed healthcare providers.

Nature of Compounded Medications

Compounded medications are prepared by licensed pharmacists to meet the specific needs of individual patients when
commercially available medications may not be appropriate.

Compounded medications:

  • Are not FDA-approved finished drug products
  • Are prepared based on a valid prescription from a licensed prescriber
  • May vary in formulation based on clinical requirements

FDA Regulatory Status

Compounded medications prepared by Evoluciona Pharma are regulated under Section 503A of the Federal Food, Drug,
and Cosmetic Act (FDCA). Under this framework, compounded medications are exempt from certain FDA approval
requirements applicable to commercially manufactured drugs, and compounding pharmacies must comply with applicable federal
and state pharmacy regulations.

No FDA Approval Claims

Compounded medications prepared by Evoluciona Pharma have not been evaluated or approved by the U.S. Food and Drug Administration (FDA)
for safety, effectiveness, or quality. Evoluciona Pharma does not manufacture or market FDA-approved finished drug products.

Medical Decision Responsibility

All prescribing decisions are made solely by licensed healthcare providers. Evoluciona Pharma does not provide medical diagnoses,
recommend specific treatments, or replace clinical judgment of a licensed practitioner.

Intended Audience

Information provided on this website is intended only for licensed healthcare professionals and authorized medical practices.
This website is not intended for consumer-directed pharmaceutical marketing.

Regulatory Compliance

Evoluciona Pharma operates in compliance with applicable requirements, including:

  • Federal Food, Drug, and Cosmetic Act (FDCA) Section 503A
  • Applicable state pharmacy regulations
  • United States Pharmacopeia (USP) standards where applicable

Relevant USP chapters may include USP <795> (Non-Sterile Compounding), USP <797> (Sterile Compounding), and USP <800> (Hazardous Drugs).

Contact

Evoluciona Pharma
10402 Fountaingate Drive
Stafford, TX 77477
United StatesPhone: +1 (231) 990-8990
Email: info@evolucionapharma.com