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USP 797 (2019)
A Roadmap to Understanding and Inspecting
Compliance with the Changes

With the announcement from USP, CriticalPoint will be postponing the webinar series until the USP Appointed Panel has made a decision on the pending appeals, which is expected to be announced in December.  At that time, we will work to reschedule and will send out registration information.  We sincerely apologize for the inconvenience but want to ensure that you are receiving training that reflects current standards.

The National Association of Boards of Pharmacy (NABP) is sponsoring a series of 6 webinars intended to improve state inspection of sterile compounding pharmacies through a review of the changes to USP 797 reflected in the 2019 version. The series will begin in September and continue twice per month through November. Each offering will be 60 minutes long with approximately 45 minutes of content followed by a 15 minute Q/A period. Webinars will be recorded and made available to those who were not able to participate in the live forum. One hour of ACPE credit will be awarded for each webinar (or recording) completed. Participation in the webinars will be limited to state board of pharmacy inspectors and other invited regulators.

During the series, CriticalPoint subject matter experts will identify changes to the sterile compounding requirements as well as address information on the behaviors, standard operating procedures, documentation and training by which Licensees may demonstrate compliance. Information on specific offerings in the series is listed below.


Webinar 1 Recording: Facilities, Engineering Controls and Certification for Sterile Compounding
September 4, 2019 – 2:00 pm EST

  • Use the new terminology for primary engineering controls (PECs).
  • List changes to the requirements for physical plants (buffer rooms, ante-rooms and segregated compounding areas (SCAs)).
  • Explain the change related to certification that requires action in the event primary or secondary engineering controls do not pass required testing.

*Postponed* Webinar 2: A New Beyond-Use Paradigm and Related Considerations
September 18, 2019 – 2:00 pm EST

  • Explain the conditions that do not represent compounding and are therefore not required to meet the standards of Chapter 797.
  • Describe Immediate Use Compounding, its conditions and how it was intended to be used.
  • Differentiate between the conditions and work practice requirements for Category 1 and Category 2 beyond-use dates (BUDs).
  • State how commercially prepared products and compounded sterile preparations may be used as components in CSPs.

*Postponed Due to USP Announcement* Webinar 3: Changes in Core Work Practices: Contamination Control and Use of Equipment
October 3, 2019 – 2:00 pm EST

  • List changes to the requirements for hand hygiene and garbing and how sink placement affects garbing sequence.
  • Describe material handling requirements in moving material from unclassified to buffer/SCA and then again from buffer/SCA to PEC.
  • Explain the specific requirements related to cleaning and disinfection of classified areas and SCAs.
  • Summarize requirements related to the use and maintenance of equipment used in compounding, as well as staff training requirements for this equipment.

*Postponed Due to USP Announcement* Webinar 4: Changes in Core Work Practices: CSP and Inventory Handling to Transport, Compounding Documentation and Release Testing
October 16, 2019 – 2:00 pm EST

  • List the requirements for storage, handling, packaging, shipping, labeling and transport of components and CSPs.
  • Describe release testing requirements and documentation.
  • Evaluate Licensee compliance with the elements of compounding documentation (master formulation records and compounding records).

*Postponed Due to USP Announcement* Webinar 5: Microbiological Air and Surface Sampling
November 5, 2019 – 2:00 pm EST

  • Describe the requirements for creating an environmental monitoring program, incubating media, reading and documenting sampling.
  • List viable air and surface sampling requirements outlined in Chapter 797.
  • Discuss expectations related to actions Licensees must take in the event that the environmental monitoring results exceed predetermined action levels.

*Postponed Due to USP Announcement* Webinar 6: Quality Management, Standard Operating Procedures and Staff Training
November 19, 2019 – 2:00 pm EST

  • Describe a quality management program for sterile preparations that includes both quality assurance and quality control components.
  • List the requirements for notification about and recall of out-of-specification dispensed CSPs, customer complaints and adverse event reporting.
  • Recognize required components of staff training as well as the responsibilities of the designated person.


Support for this project was provided by The Pew Charitable Trusts.

The views expressed herein are those of the author(s) and do not necessarily reflect the views of The Pew Charitable Trusts.