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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


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
Universal Activity Number: 0026-0000-22-104-H03-P | knowledge
Contact Hour: 1.0
Topic Designator: Pharmacy Law


ACPE logo

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 hours (.1 CEUs).

Requirements for Credit

In order to receive credit, the participant must view the entire presentation and complete the pre and post-tests, and evaluation form. Upon completion participant credit will be reported to CPE Monitor. Transcripts may be printed from CPE Monitor.


All participants will have the opportunity to review the educational session and speakers, and to identify future educational needs.

Statement of Disclosure

Massachusetts College of Pharmacy and Health Sciences adheres to the ACPE Standards for Integrity and Independence in Continuing Education. It is the policy of MCPHS that the speakers and planning committee members disclose all financial relationships with ineligible companies within the last 24 months, and that relevant conflicts of interest are mitigated. Speakers will disclose any off-label/unapproved use of drugs or devices during their presentation.

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.

No funding from industry provided for this event. No exhibitors will be present.