The Regulatory Process: The Evolution of a Regulation
This module will provide pharmacists with a review of the process by which regulations are proposed, reviewed and formalized. Additionally, it will provide resources to find federal laws that are undergoing the rulemaking process which may have an impact on the profession of pharmacy.
Learning Objectives
Upon completion of this activity, the participant will be able to:
- Describe the regulatory process of how a federal agency promulgates a regulation.
- Describe the difference between a law and a regulation.
- Identify where a pharmacist can locate a proposed federal regulations (Federal Register).
- Describe what is meant by Notice and Comment rule making.
Presenter
Fred Frankhauser, JD, MBA, RPh, is program director of the MS in Regulatory Affairs and Health Policy and the MS in Clinical Research programs at Massachusetts College of Pharmacy and Health Sciences.
Registration Fee: Free for MCPHS alumni and full-time employees; $12.00 for all other professionals. Registration is required to earn ACPE credit.
Release Date: March 9, 2022
Expiration Date: March 23, 2023
ACPE UAN: 0026-0000-22-104-H03-P | Knowledge
ACPE Topic Designator: Pharmacy Law
Contact Hours: 1.0 (0.1 CEU)
Massachusetts College of Pharmacy and Health Sciences 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 1.0 contact hour (0.1 CEUs).
To receive credit, participants must complete pre and post-assessments, view the entire presentation, and evaluate the session. Participant credit will be reported to the CPE Monitor upon conclusion. Transcripts may be printed from the CPE Monitor.
The policy of Massachusetts College of Pharmacy and Health Sciences is ensuring balance, independence, objectivity, and scientific rigor in all of its educational activities. Any individuals involved in planning or content creation for a continuing education activity are required to disclose financial relationships with ineligible companies that have occurred within the last 24 months. The intent of the policy is to identify and mitigate potential conflicts of interest that may affect the activity. All clinical medicine recommendations must be based on evidence accepted within the medical profession.
Fred Frankhauser has no relevant financial relationships with ineligible companies to disclose.
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.
Massachusetts College of Pharmacy and Health Sciences will identify, review, and mitigate all conflicts of interest disclosed prior to delivery of an educational activity to learners. Disclosure of a relationship is not intended to suggest or condone bias in any presentation, but provides participants with information that may be of potential importance when they are evaluating content.