BCPS Regulatory Section – What do I Need to Study?

bcps regulatory section

The BCPS exam is challenging.  To date, it is the hardest exam I have ever taken.  Understanding statistics is vital to passing which everyone knows. Also vital to passing is the BCPS Regulatory section.  Many people ask, what exactly do I need to study here?

The formal terminology for the regulatory section of the BCPS exam is, “System-Based Standards and Population-Based Pharmacotherapy”.  Find the BPS Content Outline here. When I read “standards and population-based pharmacotherapy”, I think of agencies that create and assess standards (i.e. Joint Commission, NCQA).  When I think of population-based pharmacotherapy, I think of public health and agencies that assess, monitor safety, and approve drugs (FDA, ISMP, etc.).

Here’s a list of topics for the Regulatory section of the BCPS exam that you must know! I would seek to understand what each term is and how information might be applied in a given situation.

BCPS Regulatory Section List of Important Topics


  • Food and Drug Administration (and all the subgroups); CBER, CDER, MedWatch, DMEPA etc.
  • Centers for Disease Control
  • United States Pharmacopeia
  • Institute of Safe Medication Practices
  • NIH
  • Institute of Medicine
  • AHQR
  • Joint Commission
  • ORYX
  • ACO
  • NQF
  • NCQA
  • OSHA
  • ACPE


  • Drug development and approval process
  • Formulary management
  • Meaningful Use
  • Research within an institution
  • IRB
  • Educating residents and students
  • Patient education materials
  • Medicare and Medicaid (CMS)
  • REMS programs
  • Affordable Care Act
  • P&T Committee
  • Drug discounts/patient assistance
  • 340B
  • Scope of practice/collaborative practice agreements

This is a bare-bones minimum that I would begin to tackle for the regulatory section of the BCPS exam.  I think by having an understanding of what these agencies do will help you get a better grasp of being able to handle the regulatory section of the BCPS.

If you are looking for a comprehensive study guide on Regulatory issues pertaining to the BCPS exam, we have created a 30-page Regulatory study guide. This has been available as of the end of December 2018 as part of our 6 month and 1-year all-access passes. Don’t worry if you have already purchased these, it will automatically pull in when you log in to your account as long as you are still within your designated access time period.



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Written By Eric Christianson

January 30, 2019

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