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What Pharmacy Professionals Need To Know About USP795 & USP797

Ultimate Guide To USP795 USP797 Pharmacy Compliance

In an era where the pharmaceutical supply chain is vast and complex, ensuring the safety and integrity of prescription medicines has become a top priority. The Drug Supply Chain Security Act (DSCSA), enacted in November 2013, lays the groundwork for a comprehensive system to track prescription drugs as they journey through the supply chain.

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As the DSCSA gears up to go into a one-year stabilization period at the end of August 2023. This period extends enforcement flexibility until November 2024, to give supply chain partners the time they need to stabilize data exchange. This next year will uncover the implications and how pharmacists play a crucial role in safeguarding patients.


The DSCSA Unveiled

The DSCSA, a pivotal piece of legislation that has been in the works for a decade, serves a singular mission: to ensure the safety and authenticity of prescription medicines as they traverse the intricate pharmaceutical supply chain. The DSCSA aims to protect consumers by readily identifying compromised pharmaceutical products that may be counterfeit, stolen, contaminated, dangerous, or harmful.

It introduces an electronic, interoperable system for the exchange of transaction documentation, including transaction information (TI), transaction history (TH), and transaction statements (TS). This system, known as T3, promises to provide full traceability of medications throughout the pharmaceutical supply chain.


The Countdown to Compliance

With the law set to become fully effective in November 2024 the pharmaceutical industry is gearing up for a transformation. The DSCSA will compel all stakeholders in the supply chain including manufacturers, wholesale distributors, repackagers, dispensers, and third-party logistics providers to implement compliant systems and processes to ensure the safety and authenticity of prescription drugs.

Under the DSCSA, dispensers refer to retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership that do not act as a wholesale distributor, and any other person authorized by law to dispense or administer prescription drugs and the affiliated warehouses or distribution centers of such entities.


Navigating the Stabilization Period

While the DSCSA’s enforcement date looms, the FDA has recognized the challenges faced by many stakeholders in achieving full compliance. To address this, they introduced a one year stabilization period. This period is not a delay in enacting the law, but rather a necessary step to ensure that medications continue to flow smoothly through the supply chain while trading partners finalize their DSCSA-compliant systems.


The Pharmacists’ Vital Role

Pharmacists stand on the front lines of patient care, and their role under the DSCSA is pivotal in protecting patients from counterfeit or substandard drugs. Currently, Pharmacists are required to confirm that your trading partners are appropriately licensed or registered, receive and maintain products tracing documentation, and identify, investigate and report suspect and illegitimate products.


Verifying Licensing and Registration

Pharmacists must ensure the licensing or registration of their trading partners, including manufacturers, repackagers, wholesale distributors, and third-party logistics providers. Additionally, they should confirm the licensing of pharmacies through the respective state authorities. The FDA has published guidance on how to verify the licensing or registration of trading partners, offering a valuable resource for pharmacists.


Managing Tracing Documentation

Under the DSCSA, pharmacies can only accept prescription drugs accompanied by the correct product tracing documentation, including transaction information (TI), history (TH), and statement (TS). If a trading partner fails to provide this documentation, pharmacies must work with them to promptly obtain it. Pharmacies are also responsible for maintaining this documentation for six years and must provide it to trading partners if they sell prescription drugs.


Investigating and Handling Suspect and Illegitimate Drugs

Pharmacists are entrusted with investigating and handling any suspicious prescription drugs, including those that may be counterfeit, diverted, stolen, intentionally adulterated, or otherwise unfit for distribution. When faced with a suspect product, pharmacists must quarantine it and carry out a thorough investigation to determine its legitimacy. If the product is deemed illegitimate, pharmacists should collaborate with the manufacturer and take specific steps to ensure patients do not receive these drugs. Furthermore, pharmacists must promptly notify the FDA and the trading partners they purchased the drug from and sold it to.


What to Expect November 2023

Starting from November 2023, dispensers are mandated to employ secure, interoperable electronic methods for tracking and tracing acquired products. Dispensers will collaborate with their trading partners to choose an interoperable electronic system.

Pharmacies should be capable of utilizing this system to exchange transaction details for receipt and returns, validate products at the package level, and furnish transaction information for a product if an investigation into suspect or illegitimate products arises. This FDA has released preliminary guidance on the standards for interoperable exchange. Entities like NABP are actively involved in constructing an exchange platform to fulfill the DSCSA interoperability requirements.


Interoperable Exchange

Trading collaborators are obligated to securely exchange necessary transaction information (TI), and transaction statements (TS) using electronic, interoperable methods. The transaction information must specifically incorporate the product identifier at the package level for each package included in the transaction. [Section 582(g)(1)(B) of the FD&C Act].


Interoperable Verification. 

Trading partners must be able to verify the product identifier on a package or sealed homogenous case in a secure, electronic, interoperable manner.


Interoperable Tracing. 

Trading partners must maintain secure, electronic, interoperable systems and processes to provide TI and TS in response to a request for it and to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.


Supply Chain and Inventory Management Specialty Certificate

To help pharmacists and pharmacy technicians prepare for their crucial role under the DSCSA, we offer a comprehensive and informative freeCE course: Pharmacy Technician Enhanced Training: Supply Chain and Inventory Management.

Our specialty certificate course equips pharmacy technicians with the knowledge and skills needed to excel in supply chain and inventory management. Pharmacy technicians will learn about the laws and regulations governing the safety and security of the drug supply chain.

The course covers the different types and purposes of supply chain entities, as well as processes and practices related to inventory management. Upon completion, technicians receive an instantly downloadable certificate and a Credly Badge.

In conclusion, the DSCSA represents a significant leap forward in the quest to safeguard the pharmaceutical supply chain and protect patients from counterfeit or substandard drugs. Pharmacists and pharmacy technicians are the unsung heroes of this mission, playing a crucial role in ensuring that prescription medications are traceable, safe, and authentic.

Together, we can ensure the safety and integrity of the pharmaceutical supply chain and protect patients from substandard drugs. Join us and be part of this vital mission.


  • 2023 DSCSA requirements. PDSA Online. (2020, August 20).

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