Per the Federal Drug Administration (FDA), “Section 503B(d)(4) of the FD&C Act defines an outsourcing facility as a facility at one geographic location or address that— (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section.”

In order to become an FDA-registered facility manufacturing compounded sterile products (CSPs) for office-use administration, the facility must comply with current Good Manufacturing Practices (cGMPs), pay an annual registration fee, and expect an FDA and Drug Enforcement Agency (DEA) inspection every two years. Most states also require additional licensing as a manufacturer/outsourcer.

Prestige Pharmacy Outsourcing Advisors offers services to pharmacies at every stage of the 503B registration process.

Currently Registered 503B
Outsourcing Facilities

  • Gap Analysis Survey
  • Preparation for FDA inspection
  • Mock Audits
  • Assistance with Plans of Correction based upon recent inspection(s)
  • SOP Revision and Development
  • Staff Training
  • Compliance training
  • Providing an on-site consultant during inspections
  • Phone Consultations

For Pharmacies considering
503B registration

  • Gap Analysis Survey
  • Development of cGMP Standard Operating Procedures
  • Referral source for Equipment IQ, OQ, PQ Validation and Calibration
  • Preparation for initial FDA inspection
  • Compliance training

We also provide assistance with FDA inspection responses for 503A pharmacies as well as assist with the PCAB accreditation process.

A benefit for a pharmacy to become 503B registered is that the facility deals directly with physicians’ offices and can convert the business model to cash rather than dependent on billing patients’ insurance. Even though some states allow for office-use compounded preparations, the FDA doesn’t allow 503A pharmacies to prepare compounded products for office-use administration without a 503B registration.

Along with avoiding the cumbersome paperwork associated with patient-specific prescriptions, physicians’ typically order in bulk providing 503B facilities with a larger cash flow.