Compounding Pharmacies

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  1. Design of New or Renovation of the Existing Compounding Pharmacies
                - Sterile/Hazardous Preparations USP <797>; <800>
                - Non-sterile Preparations USP <795>
                - Qualification of the Facility & Operations   
  2. Regulatory Considerations: FD&C Act Section 503B for the Compounding of Bulk Preparations and FDA Oversight
  3. Compliance Considerations:  Relevant GMPs for the Compounding of Bulk Preparations                                  
  4. Accreditation Considerations
  5. Technical/Management Assistance for the Operation of Compounding Pharmacies

It includes:

  • Development/review of  general administrative systems/procedures
  • Formulation/compounding, packaging & storage procedures
  • Aseptic manufacturing, microbiology procedures, sterilization, sterility testing
  • Environmental Monitoring program
  • Quality Control release testing & expiration dating (beyond dating) procedures
  • Documentation & Training of Staff