Regulatory Affairs: Regulatory Aspects of Sterile Compounding
Activity Overview
Please read the following information about this continuing pharmacy education (CPE) activity before accessing the presentation using links located at the bottom of this page.
Accreditation for Pharmacists
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity provides 1 hour (0.1 CEU) of continuing pharmacy education credit (ACPE activity #0204-0000-16-438-H03-T).
Target Audience
This continuing pharmacy education series was planned to meet the needs of pharmacy technicians in a variety of settings, and it would be particularly beneficial for pharmacy technicians, supervisors, and educators who are interested in learning the regulatory affairs: regulatory aspects of sterile compounding.
Activity Content
Expert faculty will review published guidelines and standards pertaining to compounded sterile products (CSPs) with a special emphasis on key sections of USP Chapter 797. Pharmacy technicians will learn how to assist with regulatory compliance and patient safety.
Learning Objectives
After participating in this knowledge-based educational activity, participants should be able to
- Describe published guidelines and standards pertaining to compounded sterile products (CSPs).
- Explain key sections of USP Chapter <797>.
- Identify areas of USP Chapter <797> where pharmacy technicians can assist with regulatory compliance and patient safety.
Faculty
Angela Cassano, Pharm.D., BCPS, FASHP
President
Pharmfusion Consulting, LLC
Midlothian, Virginia
A graduate of Campbell University School of Pharmacy, Dr. Cassano completed two residencies at Virginia Commonwealth University, including a joint specialty residency in adult internal medicine and pediatrics. During her career, she has held positions as a hospital clinical pharmacist, clinical assistant director, and assistant health system director of quality assurance and drug safety.
Dr. Cassano established Pharmfusion Consulting in 2005 as an independent consulting company assisting primarily health-system pharmacies with improving pharmacy operations through clinical expertise and practice. The company focuses on safe medication practices, integration of pharmacy technicians and medical technology into pharmacy practice models, and sterile compounding.
Dr. Cassano frequently makes presentations at the local, state, and national educational conferences and has held positions in the American Pharmacists Association (APhA) and the American Society of Health-Systems Pharmacists (ASHP). She currently serves on the ASHP Section of Inpatient Care Practitioners (SICP) Section Advisory Group on Medication Safety and was recently awarded the distinction of Fellow of ASHP.
Disclosure Statement
In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Guidelines for Standards for Commercial Support, ASHP requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual or his or her spouse/partner has a financial relationship (e.g., employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or services may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on presentations.
All faculty and planners for ASHP education activities are qualified and selected by ASHP and required to disclose any relevant financial relationships with commercial interests. ASHP identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity.
The following faculty and planners have no relationships pertinent to this activity.
Angela Cassano, Pharm.D., BCPS, FASHP
Sylvia Q. Banzon, B.A., CPhT, CQIA, HACP, PMP, TFCSHP
Edna Bowser, CPhT
Rebecca B. Brewer, CPhT
Al Carter, Pharm.D., M.S.
Donna Hamilton, R.Ph, MBA
Mary McHugh, R.Ph.
Bradley Miller, CPhT, PhTR
Erin M. Ryman, B.S., CPhT
Rita Shane, Pharm.D., FASHP, FCSHP
Angela Triggs, R.Ph.
ASHP staff has no relevant financial relationships to disclose.
Methods and Format
This activity is available in three formats:
- Web-Based CE. An online activity consisting of audio and slides (optional PDF handout with slides):
Launch Presentation - Podcast. An audio-only version of the presentation that can be downloaded to your computer or portable MP3 player (optional PDF handout with slides)
Launch Podcast - Monograph. E-publication
Launch Monograph
Participants must complete the entire activity, take the activity assessment and evaluation to receive continuing education credit. A minimum score of 70% is required on the test for credit to be awarded. A copy of the assessment test is provided as a study aid in the handout. CE credit will be reported directly to CPE Monitor. The estimated time to complete this activity is 1 hour (allow additional time to complete the assessment and evaluation).