Legal and Regulatory Developments Affecting Pharmacy in 2016

Activity Preview

In 2016, there continued to be federal legislative and regulatory activities shaping, and in some cases, advancing the practice of pharmacy.  The federal provider status legislation (H.R. 592, S. 314) continued to gain steam, with 296 House co-sponsors, and 51 Senate co-sponsors, at the writing of this article.  Another piece of legislation which gained momentum and was actually signed into law in 2016, was the Comprehensive Addiction and Recovery Act of 2016 (CARA) (Public Law No: 114-198) to address the nation’s opioid addiction epidemic.  The law directly impacts pharmacists and pharmacy practice through provisions related to prescription drug monitoring programs (PDMPs), at-risk Medicare beneficiaries, naloxone, opioid prescribing guidelines and practices, and patient and practitioner education.  In addition to congressional activity, federal agencies, including the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), Department of Labor (DoL), Substance Abuse and Mental Health Services Administration (SAMHSA) and Environmental Protection Agency (EPA) released a number of proposed and final rules and guidance documents relevant to the pharmacy profession.

This article, which is current as of November 2016, describes 2016 federal legislative and regulatory activities affecting pharmacy practice, including policies that were only introduced or proposed.  This year, as always, APhA has advocated aggressively on behalf of pharmacists and pharmacy technicians, educating public and private sector decision makers about the value of pharmacists’ services and the role of pharmacists and pharmacy technicians in improving patient care.  

Learning Objectives

After participating in this activity, the pharmacist will be able to:

  1. Discuss pharmacy provider status activities that took place in 2016.
  2. Analyze pending legislation and bills that became law in 2016 that impact pharmacy practice.
  3. Describe the effect of proposed Medicare Part D changes for 2016 and 2017 on the practice of pharmacy. 
  4. Explain how select agency actions, including, but not limited to, guidance and proposed rules from the Centers for Medicare & Medicaid Services (CMS) and Food and Drug    Administration (FDA), affect pharmacy practice.

Activity Type: Knowledge-based
Target Audience
: Pharmacists
Learning Level: 1

Accreditation Information


The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  This activity is approved for 2.0 contact hour of CPE credit (0.20 CEUs). The ACPE Universal Activity Numbers for this activity are 0202-0000-17-001-H03-P  and 0202-0000-17-001-H03-T. 

To obtain 2.0 contact hour of CPE credit (0.2 CEUs) for "Legal and Regulatory Developments Affecting Pharmacy in 2016" complete the assessment with a grade of 70% or better, evaluation questions, and CLAIM credit. Participants will need to have a valid username and password to claim credit. After your credit has been claimed, please visit CPE monitor for your transcript.  

APhA continuing pharmacy education policy provides you with two opportunities to successfully complete this continuing pharmacy education assessment. Please note that you will not be permitted to submit the assessment a third time. The current policy of the APhA Education Department is not to release the correct answers to any of our CPE tests. This policy is intended to maintain the integrity of the CPE activity and the assessment.

Initial release date: January 1, 2017
Expiration date: January 1, 2020 - NO CREDIT GRANTED AFTER THIS DATE


"Legal and Regulatory Developments Affecting Pharmacy in 2016” is a home-study continuing education activity for pharmacists developed by the American Pharmacists Association.

Advisory Board

Michael A. Moné, BSPharm, JD, FAPhA
Chair, Government Affairs Committee
American Pharmacists Association

Stacie Maass, BSPharm, JD
Senior Vice President, Pharmacy Practice & Government Affairs
American Pharmacists Association

Alicia Kerry Mica
Senior Lobbyist
American Pharmacists Association

Michael Baxter
Director, Regulatory Affairs
American Pharmacists Association

Jenna Ventresca, JD
Associate Director, Health Policy
American Pharmacists Association


APhA’s Government Affairs and editorial staff declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.  For complete APhA staff disclosures, please visiti


This activity is free for members and not available for non-members.

System Requirements

Computer and Internet access is required to complete this activity.  Please visit our website to view the System Requirements to have a positive learning experience.

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE# 0202-0000-17-001-H03-P 0.2 CEUs January 01, 2017 - January 01, 2020
ACPE# 0202-0000-17-001-H03-T 0.2 CEUs January 01, 2017 - January 01, 2020