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The past few years have seen a number of legislative and regulatory changes at the federal level; both with the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). This article will address key changes impacting pharmacy practice in the areas of compounding, drug supply chain security, biosimilars, and the regulation of controlled substances in order to prevent diversion and abuse.
The passage of the Drug Quality and Security Act of 2013 (DQSA) updates the Federal Food, Drug, and Cosmetic Act (FDCA) in the areas of human drug compounding and drug supply chain security.1 Previously, compounding was mostly regulated by individual states under section 503A of the FDCA. In the years to come, the FDA will continue to clarify regulations surrounding compounding and drug supply chain security.
The FDA has developed policy regarding biological medications, particularly around nearly identical biological products (biosimilars) and their therapeutic substitution. A new online publication called the “Purple Book” lists biological products, and specifies those that are biosimilar and/or interchangeable....
This program was developed by The Rx Consultant and published by Continuing Education Network, Inc. The Rx Consultant accepts no advertising or financial support from the pharmaceutical industry and is funded solely by the purchase of programs. The Rx Consultant is dedicated to providing unbiased, balanced information to health care practitioners.
Programs developed by The Rx Consultant are written by health care providers with expertise in the topic area, peer-reviewed, extensively edited, and fact-checked. This development process was created to insure that every program presents information that is current, accurate, relevant to "real world" health care providers, and written in an easy reading, "plain English" style.
The Rx Consultant is a publication of Continuing Education Network, Inc.
ACPE Universal Activity Number: 0428-0000-17-007-H03-P
Chief Editor and CE Administrator
Terry M. Baker, PharmD
Tracy Farnen, PharmD
James Chan, PharmD, PhD
Pharmacy Quality and Outcomes Coordinator
Associate Clinical Professor
Richard Ron Finley, B.S. Pharm.,R.Ph.
Consult Pharmacist Aging and Adult Health Services
Julio R. Lopez, PharmD, FCSHP
Adjunct Clinical Professor
Assistant Clinical Professor
Visiting Associate Professor and Lecturer
Pamela Mausner, MD
Helen Berlie, Pharm.D. CDE, BCACP
Ambulatory Care Specialist - Diabetes
Senior Editorial Advisor
Gerard Hatheway, PharmD, PhD
Belinda M. Danielson, RPh
Christopher M. DeSoto, PharmD
Angie S. Graham, PharmD
Cynthia Chan Huang, PharmD, MBA
Fred Plageman, PharmD
Editorial Advisor and Clinical Practice Consultant for Nurse Practitioners
Meuleman, RN, C, MS
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