Monday 18 July 2022

4 Important FDA Regulations for Pharmacies

 Image: M. Belnap

As a pharmacy, you need to know the different FDA regulations that apply to your business. We will discuss four of the most important regulations pharmacies need to know about in 2022. If you understand and follow these regulations, you can help ensure that your pharmacy operates legally and safely.

By Megan Belnap

Drug Supply Chain Security Act (DSCSA)

Congress passed the Drug Quality and Security Act (DQSA) in November 2013. The Act aims to create a system that tracks prescription drugs throughout the supply chain in the United States. At the end of the day, the goal is to provide patients with safe and effective medications by preventing counterfeits from entering the supply chain.

The Lowest Price Act

The "Medicare Advantage and Part D Drug Pricing Transparency Act of 2018" became effective on or after January 1, 2020. This act prevents medical providers of Medicare Advantage plans and Medicare Part D prescription drug plans from employing gag clauses that prevent pharmacists from informing Medicare patients if their co-pays are different from those they would have to pay otherwise.

USP 800

A new USP 800 standard from the United States Pharmacopeial Convention (USP) requires changes to standard operating procedures (SOPs) across an organization to protect healthcare workers, patients, and the environment from accidental exposure to hazardous drugs (HDs). This regulation applies to all phases of HD handling, from receipt through disposal, and it covers both sterile and non-sterile compounding.


The regulation is based on existing best practices, so many organizations have already complied with it. However, certain SOPs will need to be updated to meet the new requirements. As an example, the storage area for HDs must now be ventilated, and those involved in compounding must always wear PPE. Also, surfaces in the compounding area need to be decontaminated regularly.


By following these and other new regulations, healthcare organizations can ensure the safety of their employees, patients, and the environment. To make sure your pharmacy meets the above regulations, a company like Compliance Insight can help you adhere to DSCSA requirements.

Resource Conservation and Recovery Act (RCRA) standards

The rule was released in the early months of 2019 to clarify how organizations are responsible for disposing of hazardous and controlled substance pharmaceuticals in waste streams. A new and updated set of requirements is included in the regulation for identifying, managing, and disposing of these pharmaceuticals. Employees are also required to be trained in the new procedures. Environmental protection and public health are important reasons for compliance with the regulation.


The new regulations are crucial for ensuring the safety of employees, patients, and the environment. To protect public health and maintain the quality of the drug supply, compliance with these regulations is essential.

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