Overview

This home-study pharmacy law program provides an in-depth review of new and pending Massachusetts pharmacy legislation, along with recent federal regulatory updates related to the compounding of controlled substances. Originally presented as a live continuing education activity on December 2, 2025, this recorded session offers timely and practical guidance for pharmacists navigating an evolving legal and regulatory landscape.

Participants will examine how state and federal laws shape pharmacy practice, define professional responsibilities, and influence day-to-day operational decision-making. The program highlights key regulatory principles governing compounding practices and the handling of controlled and other sensitive medications. In addition, learners will gain insight into the legislative and regulatory processes and explore strategies for effectively engaging with policy development that impacts the profession.

This activity is approved for 2.0 contact hours (0.2 CEUs) of pharmacy law continuing education home study credit.

Target Audience

Pharmacists in all practice settings.

Learning Objectives

Upon completion of this educational activity, pharmacists will be able to:

Dennis Lyons, BS, RPh
2025 Massachusetts Legislative Update

• Explain differences between legislation and regulation.
• Identify pending and past legislation impacting pharmacists in Massachusetts.
• Review existing laws and regulations that have changed the scope of pharmacist practice.
• Identify specific strategies and actions that can be taken by pharmacists to affect the legislative process.

Karla Palmer, J.D.
Is the Future Formulated? Compounding of Controlled Substances in 2025

• Explain the differences between FDCA Sections 503A and 503B as they relate to compounding with controlled substances.
• Define “anticipatory compounding” as it is applied under current FDA and DEA guidance.
• Discuss the concept of constructive transfer of controlled substances and related regulatory implications.
• Describe the DEA’s current requirements and monitoring expectations for compounding facilities handling controlled substances.

Evaluation

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

Statement of Disclosure

In accordance with the Accreditation Council for Pharmacy Education (ACPE) Standards for Continuing Pharmacy Education, The University of Rhode Island College of Pharmacy requires that program faculty disclose any relationship (e.g., shareholder, recipient of research grant, consultant or member of an advisory committee) that the faculty may have with commercial companies whose products or services may be mentioned in their presentations. No one involved in the planning of this program has any relevant financial relationships to disclose.

Speakers

Dennis Lyons, B.S., R.Ph.
DGL Healthcare Consulting 

Dennis Lyons is an accomplished expert in pharmacy healthcare law and regulations. He owns and manages DGL Healthcare Consulting, where he provides strategic public policy and regulatory counsel and government relations support in the pharmacy and cannabis industries.  Mr. Lyons has extensive experience in pharmacy and health care with over 40 years of experience in public, private and academic organizations at the senior management level.  He regularly consults with boards, public officials, health care leaders, and professional associations on health care policy and legislative advocacy. Mr. Lyons currently represents the Massachusetts Independent Pharmacists Association (MIPA) providing legislative advocacy on such matters as PBM reform, Pharmacist Provider Status and compensation for pharmacy services. Mr. Lyons holds a B.S. from MCPHS University and is a registered pharmacist.  He frequently lectures on the topic of regulatory affairs. 

Karla Palmer, J.D.
Director, Hyman, Phelps & McNamara, PC 

As a litigator with over 33 years’ experience, Karla advises clients throughout the pharmaceutical supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of legal and regulatory issues. These matters include DEA and FDA regulations and guidance, government inspections and investigations, Form 483 observations, warning letters, consent decrees, and administrative and federal proceedings. She represents entities and individuals in matters involving their DEA registration, including investigations, orders to show cause, immediate suspension matters, hearings and federal appeals of the same. Karla is a nationally recognized leader in the compounding space, both for Section 503A and 503B facilities. She regularly counsels clients on all aspects of compliance with state and federal statutes, regulations and guidance. Karla has written about and addressed industry audiences across the country on FDA and compliance matters, including all aspects of the passage and implementation of the 2013 Drug Quality and Security Act including both compounding and supply chain issues, its guidance documents, and implementing regulations. 

CE Credit

Steps to complete the program and claim credit:

1. Watch the video at the top of this page.
2. Login or create an account in LUX LMS, URI’s learning management and CE reporting system, using your email address and professional license number. Complete all required account set up fields to ensure accurate CE reporting.
3. Select “Available On-Line Activities” or “Home Study Programs” to find the educational activity.
4. Select Take Post-Test and proceed to secure online payment (Visa, MC, AMEX, Discover and Electronic Checks are accepted).

Requirements for Credit

Completion of the online educational activity and a program evaluation are required to earn credit. No partial credit is available for this program. Evaluations must be completed at www.uripharmacycpd.org within 60 days. This program offers one contact hour (0.20 ceus) of Immunization CE for Pharmacists.

Pharmacy Accreditation Statement

The University of Rhode Island College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This knowledge-based program will provide 2.0 Contact Hour (0.2 CEU) for pharmacists. UAN: 0060-9999-25-055-H03-P

Release Date: December 15, 2025        Expiration Date: December 15, 2026.