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Current Topics in Sterile Compounding: The Drug Quality and Security Act
This activity is for pharmacists and is sponsored by Postgraduate Healthcare Education, LLC (PHE).
There has been no commercial support for this activity.
Erin Albert, MBA, PharmD, JD, PAHM
Health Outcomes Pharmacist – Myers and Stauffer, LC
CEO – Pharm, LLC
Angela V. Ockerman, BS, RPh, PharmD
Butler University College of Pharmacy and Health Sciences
Erin Albert, MBA, PharmD, JD, PAHM and Angela V. Ockerman, BS, RPh, PharmD, hereby state that they have no relevant affiliation or financial relationship or relationship to products or devices with a commercial interest related to the content of this activity to disclose.
The following reviewer, Jay Campbell, JD, RPh, hereby states he has no relevant affiliation or financial relationship or relationship to products or devices with a commercial interest related to the content of this activity to disclose.
The following reviewer, L. Michael Posey, BSPharm, MA, hereby states
he has no relevant affiliation or financial relationship or
relationship to products or devices with a commercial interest related
to the content of this activity to disclose.
Susanne Batesko, RN, BSN, Robin Carrino, and Jeannette Wick, RPh, MBA, FASCP, as well as the planners, managers, and other individuals, not previously disclosed, who are in a position to control the content of Postgraduate Healthcare Education (PHE) continuing education (CE) activities hereby state that they have no relevant conflicts of interest and no financial relationships or relationships to products or devices during the past 12 months to disclose in relation to this activity. PHE is committed to providing participants with a quality learning experience and to improve clinical outcomes without promoting the financial interests of a proprietary business.
Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Credits: 2.0 hours (0.20 ceu)
Published: September 22, 2016
Last Review: September 28, 2018
Expires: October 31, 2018
Type of Activity: Knowledge
Fee Information: $6.97
Estimated time to complete activity: 120 minutes
This accredited activity has been designed for pharmacists.
HOW TO EARN CREDIT
During the period September 22, 2016 through October 31, 2018 participants must 1) read the learning objectives and faculty disclosures; 2) study the educational activity; and 3) complete the post-test and the evaluation form. To answer the questions, click on your selected choice for each answer then proceed to the next question. Once completed, click on Grade Exam at the bottom of the page. Your post-test will automatically be graded. If you successfully complete the post-test (score of 70% or higher), your statement of participation will be made available immediately. Click on the View Statement of Participation link and print the statement for your records. If you receive a score lower than 70%, you will receive a message notifying you that you did not pass the post-test. You will have 2 opportunities to pass the post-test. To receive Credit, you must provide your date of birth and NABP number. All Credit information will be uploaded into CPE monitor within 30 days.
To present information on the laws and oversight governing compounding pharmacies and newly designated outsourcing facilities.
Upon completion of this activity, participants should be better able to:
- Discuss the issues that led to the introduction and passage of the Drug Quality and Security Act (DQSA);
- List the provisions for compounding and outsourcing facilities stipulated in the DQSA;
- Compare and contrast the definitions of compounding and outsourcing facilities provided in Sections 503A and 503B of the Federal Food, Drug & Cosmetic Act (FDCA); and
- Describe the process for becoming an outsourcing facility under Section 503B of the FDCA.
REQUIRED COMPUTER HARDWARE/SOFTWARE
Please ensure the computer system you plan to use meets the following minimum requirements:
- Operating System: Windows 98 or higher & Macintosh 2.2 or higher
- Internet Browser (Mac &/Windows): Internet Explorer 6.0 or higher, Google Chrome, Safari 5.0.6 or higher, Firefox 3.0.3 or higher & Opera 5 or higher
- Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible
- Monitor Screen Resolution: 320 x 480 or higher
- Media Viewing Requirements: Adobe Reader, Microsoft PowerPoint, Flash Player & HTML5
Disclosure of Unlabeled Use and Disclaimer
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of Postgraduate Healthcare Education, LLC. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients' conditions, and possible contraindications on dangers in use, (review of any applicable manufacturer's product information) and comparison with recommendations of other authorities.
The author, sponsor, and publisher of this continuing education activity have made all reasonable efforts to ensure that all information contained herein is accurate in accordance with the latest available scientific knowledge at the time of acceptance for publication. However, because information regarding drugs (their administration, dosages, contraindications, adverse reactions, interactions, special warnings, precautions, etc.) is subject to constant change, the reader is advised to check the manufacturer's package insert for information concerning recommended dosages and potential problems and cautions prior to dispensing or administering the drug. Special precautions should be taken when a drug is new, or highly toxic, or is unfamiliar to the dispenser or administrant. This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the U.S. Food and Drug Administration (FDA). Neither the publisher nor sponsor promotes the use of any agent outside of approved labeling. Statements made in this monograph have not been evaluated by the FDA. Nutritional products discussed are not intended for the diagnosis, treatment, cure, or prevention of any disease.