USP 797

Requirements Needed for Compounding Pharmacies Using USP 797


This 5-day course addresses the major requirements for compounding pharmacies for design, operations, microbiology, and aseptic procedures. Compounding pharmacies have had difficulties with these issues and this course will provide an understanding of the subjects and the differences between 503a and 503b accounts. The course will also highlight the current 483’s and warning letters and discuss the mistakes and explain in detail how these issues could have been avoided. 

Course outline     Who should attend?     Course materials     Instructors    Next date and location     Pricing and Registration

Course outline

Day One

  1. What are the regulations?
    1. Basic definitions
    2. USP <797>
      1. Overview of the sections and what is required
    3. USP <800>
      1. Overview of the sections and what is required
    4. FDA 503a license
      1. Review of the regulation and what is required
    5. FDA 503b license
      1. Review of the regulation and what is required
      2. Overview of 21CFR 210/211
    6. 2004 aseptic guidance document
      1. Facility
      2. Validation
    7. Comparison of the documents

Day Two

  1. Facilities
    1. Understanding the cleanrooms — How does it work?
      1. Issues with soft walls
      2. Pressure
      3. Temperature and humidity
      4. Layouts
    2. Facility systems
      1. HVAC
      2. Water
      3. Gases
      4. Clean steam
    3. Design issues — How to correct them
      1. Placement of equipment and return air vents
      2. Laminar flow hoods and biosafety cabinets and placement of those items
      3. Flows — people, material, product, waste
      4. Surfaces
    4. Certification — What is required
    5. Smoke studies — at-rest and in-operations

Day Three

  1. Environmental Monitoring
    1. Basic microbiology — Understanding contamination for cleanrooms
    2. Testing
      1. NVP
      2. Air viable
      3. Settling plates
      4. Surface sampling
    3. Compliance with regulations
      1. Locations
      2. Frequency
      3. Methods
      4. Equipment
    4. Sterility testing — USP methods
    5. Investigations and CAPAs
      1. How to write and perform
      2. What is needed

Day Four

  1. Aseptic Techniques
    1. Operations in a laminar flow hood
    2. Operations in a biosafety cabinet
    3. Media fills — Requirements for USP <797>, 21CFR 211, aseptic guide document 483's, and warning letters
      1. What went wrong
    4. Mock training for aseptic

Day Five

  1. Operations
    1. People — Source of contamination
    2. Gowning
      1. Types
      2. Procedures
      3. Class and regulation
    3. Cleaning and sanitization
      1. Methods
      2. Disinfectants
      3. Testing
      4. Frequency
    4. Transfer of materials

Who should attend?

  • Compounding pharmacy owners
  • Compounding pharmacy managers
  • Pharmacy technicans
  • Cleanroom designers


Course materials

  • Copy of PowerPoint presentation in course binder
  • Copy of USP <797>

Continuing Education Units: 3 CEUs



Gordon Ely
Jan Eudy
Les Miller
Kyle Mulder


Next date and location

December 9 - 13, 2019
8:30 a.m. - 4:00 p.m. daily
DoubleTree by Hilton Hotels Dallas - DFW Airport North
4441 W. John Carpenter Freeway
Irving, Texas
Online registration closes December 2!

Click here to book your discounted hotel room.



Registration information

Buy 3 Get 1 Free! Register three attendees from your company for the same training course and receive a complimentary fourth registration for another person in your company to attend that course. Contact IEST at 847-981-0100 to arrange this option. (Complimentary registration applies to registration of equal or lesser value. Not valid with any other offers or promotions.)

Registration Fees Regular





  • Cancellation Policy is:
    Transfers: Registrations are transferable to another person for the same event. A $35 transfer fee applies. Transfer of a member registration to a nonmember registration will be charged the difference in fees.

    Cancellations: Cancellation requests received 60 days or more prior to the start of the event will receive a full refund LESS a $75 administration fee. Cancellation requests received 30-59 days prior to the start of the event will receive a 50% refund. No refunds will be issued for cancellation requests received less than 30 days prior to the start of the event. IEST reserves the right to cancel course(s), in which case registrants will receive a refund of the fee. IEST is not responsible for any refund or remuneration for hotel, transportation, additional registration fees, tours, or other expenses related to attendance beyond the registration fee refund.
  • Program and instructor(s) are subject to change.
  • All registrations include morning and afternoon breaks and lunch.
  • Payment must accompany registration; there is no invoicing. IEST does not accept purchase orders as a method of payment.
  • All member dues must be current at the time of registration to qualify for the member rates.
  • All education training courses earn Continuing Education Units.

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