Note: If you attended the live CE activity AND received CE credit (i.e. a pharmacist CE statement of credit with ACPE UAN 0221-0000-17-426-L07-P), you are NOT allowed to also receive credit for this home-study on-demand web activity.
USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations is undergoing revision and is expected to be published for public comment in Fall 2018. This revision will be harmonized with ongoing updates to USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings.
Through an interactive learning process, faculty will shed light on difficult concepts and common concerns related to the implementation of new sterile compounding regulations, while providing attendees with immediate feedback and reinforcement of key points. This session will address challenging and practical questions that have been asked by your pharmacy colleagues at previous educational events that focused on sterile compounding.
In addition, attendees will learn about the proposed changes to USP <797>, including the components of batch release testing. In addition, the regulatory hierarchy for handling hazardous drugs will be reviewed, together with engineering controls required for compliance with USP <800>. Pharmacists will be better able to assess compliance with the standards required by both USP Chapters and to identify areas in which further action is needed.
The target audience for this activity includes pharmacists in health-system settings. After completing the activity, participants should be able to:
- Identify proposed changes to USP Chapter <797>.
- List components of batch release testing and other activities that support batch release.
- Describe the regulatory hierarchy for handling hazardous drugs.
- List engineering controls required for compliance with USP Chapter <800>.
- Outline a plan to assess compliance with USP Chapters <797> and <800> standards and identify action items.
Louis S. Diorio, RPh, FAPhA
LDT Health Solutions, Inc.
Wayne, New Jersey
Fred Massoomi, PharmD, FASHP
Senior Director of Health-system & Hospital Services
Susan J. Schniepp
Regulatory Compliance Associates, Inc.
Albuquerque, New Mexico
Release Date: 1-22-2018
Expiration Date: 1-22-2021
ProCE, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221-0000-19-048-H07-P has been assigned to this home study knowledge-based activity (initial release date 1-22-18). This activity is approved for 1.5 contact hours (0.15 CEUs) in states that recognize ACPE providers. The activity is provided at no cost to participants. Participants must complete the online post-test and activity evaluation to receive pharmacy CE credit. Statements of completion will be issued online at www.ProCE.com and proof of completion will be posted in NABP CPE Monitor profiles. No partial credit will be given.
It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants any significant financial interest or affiliation with companies that manufacture or market products discussed during their presentation. Mr. Diorio is a shareholder of LDT Health Solutions, Inc. Dr. Massoomi is an employee of Visante, Inc. and a Speaker for ICU Medical. Ms. Schniepp is a Consultant for Regulatory Compliance Associates, an auditor for NSF, and a Consultant for PharMEDium Services, LLC. A portion of grant funds received by ProCE from PharMEDium Services, LLC will be used to compensate the faculty for this presentation.
Please note: The opinions expressed in this activity should not be construed as those of the CE provider. The information and views presented in this activity are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include the use of drugs and/or devices for unlabeled indications, which should be considered experimental. Participants are advised to consult manufacturer product information and the professional literature, and use professional judgment in applying the presented information in patient-care activities.
This activity is provided by ProCE, Inc. and is supported by an educational grant from PharMEDium Services, LLC.
The material presented in this CE activity does not reflect the views of ProCE, Inc. or the commercial sponsor. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.