SEction 503B Regulatory Compliance

Vigilare’s Solution Drives Regulatory Compliance for the Compounding Pharmacy Industry

In response to the Drug Quality and Security Act (Compounding Quality Act) enacted November 2013, Vigilare has developed a cost effective Adverse Events Reporting solution specifically for Compounding Pharmacies registered as an Outsourcing Facility under section 503B of the Food Drug and Compounding Act. 

Vigilare Addresses the Specific Regulatory Requirements

Develop and Implement written procedures for:

  • Surveillance
  • Receipt
  • Evaluation
  • Reporting

Report all serious, unexpected adverse drug events:

  • Associated with the use of compounded prescription drug product
  • “Alert Report” must be sent to FDA within 15 working days
  • All events reported to FDA must be fully investigated
  • Follow-up Reports must be reported to FDA with any new information
  • All submissions to FDA must be made using approved electronic gateway

All Records including source documents must be maintained:

  • In a retrievable format - Accessible to FDA for audits
  • Retained for 10 years

Vigilare Services Advantages

  • Worry free compliance with regulatory requirements
  • Developed by leading drug safety experts
  • Full set of Applicable SOPs
  • Rapid implementation of validated systems to meet regulatory requirements
  • Provides continuing resources to maintain compliance
  • Cost effective solution to meet regulatory obligations
  • On-going costs billed on a monthly activity based model

Full implementation of the Vigilare Solution will deliver Compound Pharmacy compliance with all aspects of Adverse Event reporting regulation and Inspection Readiness for FDA audits.

Contact us for further information info@vigilareintl.com

See text of Drug Quality and Security Act (also cited as Compounding Quality Act) on the FDA website.

Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act on the FDA website.

See 21 CFR 310.305 for reporting content and format requirements under the DQSA on the FDA website.