Federal Compounding Regulations and United States Pharmacopeia Requirements
This activity is for pharmacy technicians and is sponsored by Postgraduate Healthcare Education, LLC (PHE).
There has been no commercial support for this activity.
Stacey Schneider, PharmD
Freelance Medical Writer
Stacey Schneider, PharmD 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 reviewer, Justine Kheloussi, CPhT, MBA 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, MSHF, BSN, RN, Mary Camillo, and 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. PHEe 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)
Type of Activity: Knowledge
Fee Information: $4.50
Estimated time to complete activity: 120 minutes
July 20, 2022
July 20, 2025
This accredited activity has been designed for pharmacy technicians.
HOW TO OBTAIN CREDIT
During the period July 20, 2022, through July 20, 2025, 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.
This activity will describe the legal and regulatory history of compounding. The role of the United States Pharmacopeia in relation to setting reference standards, developing monographs, and the requirements for compounding nonsterile and sterile products will also be discussed.
Upon completion of this program, participants should be better able to:
- Indicate the federal laws that have defined the regulatory history of compounding
- List the regulatory requirements for 503A and 503B pharmacies
- Define the requirements in USP Chapter <795> in relation to compounding nonsterile products
- Define the requirements in USP Chapter <797> in relation to compounding sterile products
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
- Peripherals: Computer speakers or headphones
- 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 activity have not been evaluated by the FDA. Nutritional products discussed are not intended for the diagnosis, treatment, cure, or prevention of any disease.