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PTCB Pharmacy Law PTCB Test Prep
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Regulatory Bodies of Pharmacy!

Feb 25th, 2020
regulatory bodies of pharmacy

Pharmacy Regulatory Bodies

Regulatory bodies of pharmacy are routinely tested on the PTCB exam.

Here, we review the facts you need to know about the major agencies. Bear in mind that during the exam, many of these organizations may be represented in acronym form. For example – the Joint Commission may be represented as TJC.

It’s important that you are familiar with identifying these acronyms.

Below, we review the five major regulatory bodies of pharmacy in the United States:

  • Food and Drug Administration (FDA)
  • Drug Enforcement Administration (DEA)
  • The Joint Commission (TJC)
  • State Boards of Pharmacy (BOP)
  • National Association of the Boards of Pharmacy (NABP)

Food and Drug Administration

Perhaps the most widely known of the regulatory bodies of pharmacy, the FDA is responsible for ensuring safe and effective standards in:

  • Food
  • Medicines
  • Biologic products
  • Radioactive products
  • Cosmetics

The FDA oversees the regulation of products. As such, if there is a potential hazard to the public, the FDA can inform the manufacturer, pharmacy, and general public. The FDA also uses a system known as MedWatch – a system that catalogs any reported adverse effects to the FDA. The pharmacist, pharmacy technician, or other healthcare professional is obliged to report adverse events through MedWatch. Medication events should never go unreported.

Drug Enforcement Administration

The DEA – or Drug Enforcement Administration – was formed as a consequence of the Controlled Substances Act, 1970.

The function of the DEA is to oversee and enforce legislation relating to controlled substances. For example: if controlled substances were to go missing or are stolen from a pharmacy, Form 106 must be promptly completed and sent to the DEA.

Similarly, the DEA sets out the 5 schedules of controlled substances. Schedule I drugs are the most potent and addictive; Schedule II drugs requiring special ordering requirements by the pharmacy; whereas Schedule III through to V drugs do not have these special ordering requirements.

The DEA also has the following two functions:

  • Prosecute offenders who breach legislation.
  • Reduce the use of illicit drugs in the United States.

As a prospective pharmacy technician, it’s incumbent upon you to understand the important role the DEA plays in the safe use of controlled substances. After all, if the pharmacy technician is unaware of the legislation, they may act in breach of that legislation. Furthermore, pharmacy technicians may be obliged to comply with any investigation undertaken by the DEA.

The Joint Commission

The TJC – or The Joint Commission – is the organization in the United States that accredits and certifies healthcare organizations.

The TJC remains an independent organization that functions to ensure the best possible treatment outcomes for patients. It achieves this by accrediting healthcare organizations that meet its high standards.

For example, when surveys of hospital pharmacies take place, the TJC monitors the degree of quality of how medications are managed. Improper management of medicines has the potential to put patient safety at risk.

The Joint Commission is obliged to act where breaches of quality have been identified. As with the DEA, pharmacy technicians may be obliged to cooperate with any investigation undertaken by TJC.

State Boards of Pharmacy

As the name suggests, the State Boards of Pharmacy (BOP) are those pharmacy boards that cater to the needs of their own state – establishing state-specific laws and regulations that influence and impact pharmacy and the safe use of medicines.

More pertinently, the BOP is also responsible for certifying and licensing pharmacy personnel – which, in some states, includes pharmacy technicians.

The BOP is responsible for state exams for pharmacy professionals, ensuring that licensed professionals retain a consistent professional standard throughout their careers.

National Association of the Boards of Pharmacy

The NABP is the last of our regulatory bodies of pharmacy; an association that assists boards of pharmacy (BOP) by ensuring there are consistent standards among each state board.

However, the NABP does not have the force of law behind it.

Instead, it acts as a professional means to discuss the trajectory of pharmacy and how best to improve it on a state-by-state level.

Final Thoughts

For the PTCB exam, it’s important that pharmacy technicians:

  • Can identify regulatory bodies, including from their widely used acronyms
  • Understand the role of each regulatory body
  • The impact of the regulatory body on how pharmacy technicians conduct themselves
  • How technicians are obliged to comply with these laws

It is these four criteria that are examinable on the PTCB test. Take a few moments to study each of these organizations – preferably in flashcard form – and review and revise on a weekly basis.

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PTCB Test Prep Author

Author:

Elaine Walker

Elaine joined PTCB Test Prep in 2017, currently serving as the lead product development manager overseeing both course development and quality improvement. Mrs. Walker is a graduate of California State University and has worked as a pharmacy technician for over twenty years – with particular interests in pediatric pharmacy, extemporaneous compounding, and hospital pharmacy. Over the past 8-years, she has helped prepare thousands of students for the PTCB examination.