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U.S. FDA Regulations for Outsourcing Facilities

Compounding pharmacies may elect to register with FDA as outsourcing facilities. FDA requires registered outsourcing facilities to:

  1. Pay an annual establishment fee to FDA.
  2. Submit drug product reports to FDA upon initial registration, and thereafter in June and December of each subsequent year.
  3. Submit adverse event reports.
  4. Designate a Registrant Contact for FDA communications.

Note: FDA Now Requires Outsourcing Facilities to Submit Drug Product Reports in Structured Product Labeling (SPL) format through FDA’s Electronic Submission Gateway (ESG).

As your FDA Registrant Contact, Registrar Corp helps you comply with the above requirements, including guidance on FDA’s Small Business Adjustment Factors.

For more information about designating Registrar Corp as your FDA Registrant Contact, complete the form below:

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