BCPS Regulatory Study Guide – Prepare to Pass

BCPS Regulatory Study Guide

Because your colleagues have requested it, the BCPS Regulatory Study Guide is now a reality! 20% of the BCPS exam is based on regulatory questions.  That is approximately 30 questions!  If you don’t pass your exam by a question or two, those 30 questions begin to look pretty important.  Understanding the topics on the regulatory section of the BCPS exam can make or break your exam. There isn’t much study material specifically available for the regulatory section of the BCPS exam.

Problem solved. We’ve created the BCPS Regulatory Study Guide by following the BCPS content outline.  In the content outline, this is also referred to as domain 3: System-Based Standards and Population-Based Pharmacotherapy.

Our BCPS Regulatory Study Guide from Meded101.com is 30+ pages of content.  We’ve done the leg work of simplifying over 60+ topics that includes defining important terminology, regulatory agencies, resources, and legislation. The study guide is in PDF format and can be instantly downloaded following purchase.

BCPS Regulatory Study Guide – Content Outline

Here’s the outline of the BCPS Regulatory Study Guide from Meded101.

  1. Food and Drug Administration (FDA)
  2. MedWatch
  3. Center for Drug Evaluation and Research (CDER)
  4. Center for Biologics Evaluation and Research (CBER)
  5. Biologics License Application (BLA)
  6. Purple Book and Orange Book
  7. Division of Medication Error Prevention and Analysis (DMEPA)
  8. Institute of Safe Medicine Practices (ISMP)
  9. ISMP Medication Errors Reporting Program (MERP)
  10. ISMP Vaccine Errors Reporting Program (VERP)
  11. Vaccine Adverse Event Reporting System (VAERS)
  12. United States Pharmacopeia (USP)
  13. National Institute of Health (NIH)
  14. Agency for Healthcare Quality and Research (AHQR)
  15. Institute of Medicine (IOM)
  16. Medication Errors
  17. Just Culture
  18. The Joint Commission (TJC) or formerly, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
  19. ORYX Initiative
  20. Accountable Care Organization (ACO)’
  21. National Quality Forum (NQF)
  22. Meaningful Use
  23. Conflicts of interest (ethics)
  24. Training Students and Residents
  25. Educating Healthcare Professionals and Patients
  26. HCAHPS – Hospital Consumer Assessment of Healthcare Providers and Systems
  28. National Committee for Quality Assurance (NCQA)
  29. Healthcare Effectiveness Data and Information Set (HEDIS measures)
  30. Health Insurance Portability and Accountability Act (HIPAA)
  31. Centers for Medicare and Medicaid (CMS)
  32. Medicare Part A
  33. Medicare Part B
  34. Medicare Part C
  35. Medicare Part D
  36. Children’s Health Insurance Program
  37. Health Insurance Marketplace
  38. CMS Innovation Center
  39. Risk Evaluation and Mitigation Strategy (REMS)
  40. Elements to Assure Safe Use (ETASU) – part of the REMS program
  41. OSHA (Occupational Safety and Health Administration)
  42. Biologics Control Act of 1902
  43. Food and Drugs Act of 1906.
  44. 1938 Food, Drug, and Cosmetic Act
  45. Durham-Humphrey Amendment of 1951
  46. Kefauver-Harris of 1962
  47. Tamper Resistant Packaging Regulation of 1982
  48. Orphan Drug Act of 1983
  49. Prescription Drug Marketing Act (1988)
  50. 1993 – MedWatch Created
  51. Dietary Supplement Health and Education Act (DSHEA) – 1994
  52. FDA Modernization Act of 1997
  53. Medicare Prescription Drug Improvement and Modernization Act of 2003
  54. The Affordable Care Act of 2010 (AKA Obamacare)
  55. Institutional Review Board (IRB)
  56. PHI (Protected Health Information)
  57. Medication Use Evaluation (MUE)
  58. Formulary
  59. Pharmacy and Therapeutics Committee (P&T)
  60. Cost-Minimization Analysis
  61. Cost-Effectiveness Analysis
  62. Cost-Utility Analysis
  63. Cost-Benefit Analysis
  64. Collaborative Practice Agreement (CPA) for Pharmacists
  65. Scope of Practice
  66. Cost Containment in the Hospital Setting
  67. 340B Drug Discount Program
  68. Drug Shortages
  69. Drug Recalls

The really cool part about the BCPS Regulatory Study Guide is that it is FREE with the 6 month or 1 year BCPS All Access Package!  The All Access package contains a 20+ hour review course, statistics study guide, 2 – 175 question practice exams, medication comparison tables, and now the BCPS regulatory study guide!

Don’t underestimate the importance of studying for the regulatory section of the BCPS exam!


I cannot thank you enough – very much appreciated- the charts / tests and slides had a huge impact on my passing the BCPS. Your site made a huge difference and is very well organized. I really feel you covered the areas Pharmacology, Regulatory, and Biostatistics very well.

Joseph Dougherty

I would like to say thank you for your BCPS study material. Having practiced as a pharmacist for just over 10 years in Australia, I have always try to keep myself up-to-date with current guidelines, the latest evidence, and clinical knowledge. However, having failed twice previously, I needed guidance that is succinct and focused on pharmacotherapy and pharmacy practice in the US context – your study material provided exactly that. I have done basic biostatistics post-graduate and your stat study guide was a good revision for me (especially the table showing an overview of important statistical tests). I think your recently-added regulatory study guide was what really pushed me over the pass mark – that 32-page was enough for me to understand the important roles each organization plays in the US healthcare system.

Alex Chan

I purchased both courses from ASHP and ACCP. Your questions give the material from ACCP a run for its money, inasmuch as you present valid, valuable clinical information.

Mary B.

I was surprised by the ease it took me to understand the key concepts while reviewing your BCPS study guide. It was very reader-friendly and well written. For someone like me who has not had enough exposure to statistics, let alone biostatistics, it was of tremendous value.

Mike M.

The questions on this exam are similar in format and content to the actual NAPLEX exam. It’s an affordable way to assess your preparation and help you identify areas for additional study.

Alissa G.

The questions are great and so are the explanations- it’s so much easier to learn from a peer. Thank you for being willing to do this!

Jessica H.

Thanks for providing the mock exam – it was a big help for me.

Maria V.