Selecting Proper Components for a Pharmacy Compliance Strategy

Selecting Proper Components for a Pharmacy Compliance Strategy
Posted in: Pharmacy

A comprehensive pharmacy compliance strategy is the best practice to ensure your facility is able to contribute to the health and safety of your community. So, where do you begin and what tools are at your disposal to make compliance easier? Learn more in this article.

Pharmacies play an important role in the public’s health and safety by providing assurance that medications are tracked, stored, and dispensed properly. State and federal regulations create a framework for pharmacy compliance that aims to protect both patients and workers. As a pharmaceutical industry professional, knowing the laws and agencies that apply to your facility is a top priority. Incorporating that knowledge into a comprehensive compliance strategy is the best practice towards maintaining pharmacy compliance — here’s how.

What to Know about FDA and DEA Requirements

Two federal laws are central to the pharmaceutical industry and address the safety of controlled substances throughout the supply chain. These laws are resources that should be included in your facility’s compliance references. They are the Drug Supply Chain Security Act (DSCSA) enforced by the Food and Drug Administration, and the Controlled Substances Act (CSA), enforced by the Drug Enforcement Administration.


FDA: The Drug Supply Chain Security Act (DSCSA)

The DSCSA was enacted in 2013 to identify all substances regulated under existing federal law into one of five schedules based on medical use, potential for abuse, and safety or dependence liability. The DSCSA ensures the integrity of the U.S. drug supply and outlines the requirements that pharmacies must follow in order to protect patients. This law mandates confirmation of licensing and registration, product tracing documentation, and response to illegitimate prescription medications.

DEA: The Controlled Substances Act (CSA)

The CSA sets the regulations for the handling, storage, and distribution of controlled substances that pass through your pharmacy. Enforced by the DEA, these regulations include transfer and disposal, security related to theft or loss, record keeping, inventory, prescription validity, ordering, and dispensing requirements.

What to Include in Your Pharmacy Compliance Strategy

Keeping compliant and managing pharmacy inventory relies on having the right strategy in place. This should include a few key components that will help ensure staff training, communication, and alignment with current regulations. The specifics of what to include depend on the pharmacy’s location and the types of patients or customers served. Overall, every strategy should include the following basics:

  • Guidelines on proper documentation of pharmaceutical transactions
  • Resources on state and federal regulation updates
  • Compliance policies and training guidelines
  • Schedule of annual compliance tasks and due dates
  • Centralized database of policy and information resources

While staff may be adhering to regulations, they may not be aware of the documentation requirements. This oversight is a common compliance issue that can be easily remedied by providing staff with an overview of documentation requirements. When fully aware of requirements, pharmacy staff can help improve quality assurance, compliance, and issue reporting.

Staying current on federal, state, and other regulation updates requires keeping these resources available to relevant staff and communicating updates in an effective manner. While the federal laws offer high-level guidelines, some state and substance-specific regulations, such as those for hazardous materials, are subject to more frequent updates. An effective pharmacy compliance strategy includes tracking and communicating the updates that apply to your facility.

Training policies and procedures are essential to pharmacy compliance and remain the best defense against noncompliance consequences, such as penalties or fines. A training program can be straightforward and simple but needs to be executed on a regular basis to ensure that all staff are informed on current procedures. With everyone on the same page, a compliance audit or inspection can be efficient and stress-free.

Setting up a calendar that identifies compliance components in a dated checklist is a simple yet effective measure to keep your pharmacy protocols up to date. This resource can outline tasks and the frequency with which to monitor them, as well as provide reminders for important communication updates. Together with a central database of resources and information, this strategy element can provide assurance that your facility stays in compliance.

Implementing the Right Tools for Pharmacy Compliance

A significant part of any pharmacy compliance strategy is empowering staff with the right tools. Solutions such as Primex OneVue Sense can help staff with pharmacy asset monitoring and meeting compliance regulations. Going above and beyond the Centers for Disease Control and Prevention's recommended use of digital data loggers as a temperature monitoring device, OneVue sensor options can be installed to monitor storage conditions and access to sensitive medications and supplies.  Coupled with the web-based OneVue® software platform, the automated system and centralized data storage can provide on-demand reporting that helps demonstrate compliance.

Primex OneVue offers a suite of options that can alleviate the administrative challenges associated with pharmacy compliance and empower staff to focus on patient care and quality assurance. Interested in learning more about how we can help your facility meet compliance documentation requirements? Reach out today!



US FDA: Drug Supply Chain Security Act (DSCSA)

DEA: Controlled Substances Act (CSA)


December 18, 2020
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