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Sterile Compounding History and Basics: Review of USP 797 – Aseptic Technique 2021/2022

Pharmacists routinely compound medications in response to patient needs. Many state licensing boards require that pharmacists engaged in or overseeing sterile products compounding obtain additional education specific to this area in order to maintain their licensure. This course will provide the background for the need for such education and provide concrete examples of best practice. This activity is intended for practicing pharmacists who work in or oversee sterile compounding processes and procedures. 

Learning Objectives

At the completion of this activity, the participant will be able to:

  • Define general principles of USP <797>.
  • Identify how complying with USP <797> can prevent medication errors associated with contamination.
  • Describe examples of deviations from USP <797> associated with adverse events related to CSPs.
  • Describe the differences in manipulations when compounding sterile compounding sterile products in a vertical versus a horizontal laminar airflow hood.


Kathleen M. Gura, PharmD, BCNSP, FASHP, FPPA, FASPEN, FMSHP is the manager for Pharmacy Research Program and a member of the Clinical Nutrition Service in the Division of GI/Nutrition at Boston Children's Hospital. Dr. Gura is an Assistant Professor of Pediatrics at Harvard Medical School, and is an adjunct faculty member at MCPHS University, Northeastern University and the University of Connecticut. She is a member of the Center for Advanced Intestinal Rehabilitation and the Home PN Program at Boston Children’s Hospital. Dr. Gura received her BS and PharmD from Massachusetts College of Pharmacy and Health Sciences in Boston. Certified as a Nutritional Support Pharmacist, Dr. Gura is a Fellow of the ASHP, ASPEN, PPA and MSHP. She was named the 2020 Nutrition Champion by the American Society for Parenteral and Enteral Nutrition and the winner of the 2021 Oley Foundation’s Research Award. Dr. Gura is the author of numerous book chapters on pediatric nutrition and has written more than 140 peer reviewed articles on topics such as the intestinal failure associated liver disease, parenteral nutrition compounding, and the use of parenteral nutrition in the neonate. She recently served as an associate editor for JPEN and joined the board of directors for ASPEN in June 2021. She is currently a member of the FDA’s Pharmaceutical Compounding Advisory Committee.

Free for MCPHS alumni, faculty and staff. For all others the fee is $12.00.


ACPE logo

Release Date: September 27, 2021
Expiration Date: September 27, 2022
ACPE UAN: 0026-0000-21-041-H07-P | Knowledge-based
Topic Designator: Compounding
Contact Hours: 1.5 (0.15 CEU)


Massachusetts College of Pharmacy and Health Sciences (MCPHS) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. MCPHS designates this educational activity for a total of of 1.5 contact hours (0.15 CEUs).

Requirements for Credit

In order to receive credit, the participant must view the entire presentation and complete the pre and post-tests, and evaluation form. Upon completion participant credit will be reported to CPE Monitor. Transcripts may be printed from CPE Monitor.

Statement of Disclosure

MCPHS adheres to the ACPE Standards for Integrity and Independence in Continuing Education. It is the policy of MCPHS that the speakers and planning committee members disclose all financial relationships with ineligible companies, and that relevant conflicts of interest are mitigated. Speakers will disclose any unlabeled/unapproved use of drugs or devices during their presentation.

Kathleen Gura holds the following relationships with ineligible companies. These relationships are not relevant to the content being presented.

  • Consultant: Otsuka Pharmaceutical Company, Northsea Therapeutics
  • Advisory Board: Fresenius Kabi, Alcresta Scientific, Pfizer Pharmaceutical, Baxter Pharmaceutical
  • Royalties: Fresenius Kabi, Lexicomp/UpToDate

Massachusetts College of Pharmacy and Health Sciences Continuing Education staff members hold no financial relationships with ineligible companies, related to the content of this presentation.

No funding from industry provided for this event. No exhibitors will be present.