Specialized Services 503B Compounding Pharmacy Compliance Services

Navigate the complex intersection of pharmaceutical manufacturing and compounding with specialized compliance strategies that satisfy FDA requirements while enabling business growth.

Contact us »

Where compounding meets cGMP compliance

503B outsourcing facilities occupy a unique regulatory space: more stringent than traditional compounding but with flexibilities not available to conventional manufacturers. This positioning creates opportunities for innovative patient care but demands sophisticated compliance approaches that many organizations struggle to implement.

The explosive growth in 503B facilities—driven by drug shortages, personalized medicine, and direct-to-consumer healthcare—has intensified FDA scrutiny. Inspections focus on sterile processing, stability programs, and release testing while expecting cGMP-level quality systems. Success requires understanding both traditional pharmaceutical requirements and 503B-specific allowances.

Our 503B specialists understand this unique regulatory landscape. We've guided facilities from initial registration through successful FDA inspections, always balancing compliance requirements with operational realities of high-mix, variable-volume production.



fda-BlogIllustration-DevelopingPlan

 

Our 503B compliance services include:

  • cGMP-compliant quality system design and implementation

  • FDA inspection response and remediation support

  • Validation master planning tailored to 503B operations

  • Sterile compounding process validation

  • Environmental monitoring program development

  • Stability program design and management

  • Product release testing and documentation strategies

  • Beyond-use date (BUD) justification and stability protocols

  • Equipment qualification and validation prioritization

  • Cleaning validation for multi-product facilities

  • FDA inspection readiness and mock inspections

  • State board and FDA compliance integration

  • SOP creation, harmonization, and documentation systems

Key compliance areas we address include but are not limited to:

  • cGMP requirements
  • Sterility assurance and contamination control
  • Product quality testing and release
  • Adverse event reporting
  • Product labeling requirements
  • Facility registration and product reporting
  • Prescription requirement exemptions
  • Interstate commerce compliance

Click to expand How we support 503B compounding pharmacy compliance

fda-Hero-GCPAudit

Our team brings the combined expertise of former FDA officials, quality system architects, and sterile manufacturing specialists. We assess your operations against FDA expectations, design risk-based remediation or buildout plans, and strengthen systems for sustained inspection readiness.

We emphasize:

  • Quality system integration: Embed cGMP principles into day-to-day compounding operations.

  • Process validation: Establish scientifically justified controls for aseptic processes, cleaning, and equipment.

  • Environmental control: Create robust EM programs with real-time data tracking and trending.

  • Stability and testing: Implement protocols that support appropriate BUDs and reliable release decisions.

  • Continuous improvement: Build monitoring and CAPA systems that evolve with operations and regulatory expectations.

Contact us »

Why outsourcing facilities partner with us

  • Specialized expertise: Deep understanding of 503B unique requirements
  • FDA perspective: Former officials who know enforcement priorities
  • Practical solutions: Compliance approaches that work for compounding
  • Growth enablement: Scale operations while maintaining compliance
  • Inspection ready: Proven track record of successful FDA inspections

Contact us »

Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

Read our brochure »

Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management of Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of remediation requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific 503B compounding needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.