FDA Guidance Breakdown: Verification Systems Under DSCSA for Certain Prescription Drugs
FDA Guidance Breakdown: Verification Systems Under DSCSA for Certain Prescription Drugs
The FDA finalized its guidance on DSCSA verification systems. Here are the key takeaways.
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On December 7, the FDA released a final guidance outlining procedures that trading partners must follow to establish systems for identifying, quarantining, and investigating suspicious or illegitimate products under the Drug Supply Chain Security Act (DSCSA). The guidance also describes the process for handling saleable returns.
According to DSCSA, trading partners are required to have verification systems in place to determine whether a product is suspicious, as well as systems for quarantining and investigating suspicious products and processing saleable returns.
Although the law was supposed to take effect on November 27th, the FDA announced that it would be giving manufacturers and trading partners a one-year extension to allow more time to "stabilize" their track and trace systems.
FDA said the guidance:
“…serves to inform trading partners regarding the information that should be reviewed and communicated with other trading partners when investigating whether a suspect product is illegitimate. This guidance also serves to inform trading partners of the information that should be included in responding to requests for verification of the product identifier from FDA and other trading partners, where applicable, and in verifying the product identifier of saleable returned product.”
This final guidance contains minor revisions from a draft guidance issued in March 2022.
More specifically:
The final guidance removes language stating that if a trading partner does not receive a response from a manufacturer or repackager within 24 hours of making a request for a verification, the product will be considered suspect and is not to be distributed or dispensed.
It clarifies that dispensers do not need to provide transaction information for saleable returns.
It clarifies that “verification” involves confirming that the product identifier affixed or imprinted upon a package or homogeneous case corresponds to the Standardized Numerical Identifier (SNI) or lot number and expiration date assigned to the product.
It also clarifies that when a trading partner does not receive a timely response to a verification request, the product that is the subject of the request will not automatically be classified as suspect.
It adds new language stating that “on a case-by-case basis, FDA may consider ‘other such reasonable time’ for responding to requests for verification of the product identifier under limited circumstances.” These circumstances include power outages, transportation infrastructure disruptions, local regional disruptions, and the scope of the request. In these situations, “FDA expects manufacturers and repackagers to make a good faith effort to provide a rapid response, but FDA understands that they may need to follow-up with their trading partner with additional information.”
Background
The DSCSA, passed in 2013, aims to create a system to track and trace certain prescription drugs as they are distributed in the United States. This law is part of a larger effort to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The Act outlines steps to build an electronic, interoperable system by November 2023, which will identify and trace certain prescription drugs as they are distributed within the United States.
A few relevant key elements of the law include:
Product identification: It requires manufacturers and repackagers to affix a product identifier on certain prescription drug packages.
Product tracing: It obligates entities involved in the distribution of prescription drugs to provide information about a drug and who handled it each time it is sold in the U.S. market.
Product verification: it requires entities involved in the distribution of prescription drugs to establish systems and processes to verify the product identifier on certain prescription drug packages.
Detection and response: It requires trading partners to establish systems and processes for identifying and responding to suspect and illegitimate products in their distribution networks.
Notification: It requires trading partners to establish systems and processes for notifying the FDA and other stakeholders when an illegitimate product is found.
Licensing: it establishes national standards for the licensing of wholesale drug distributors and third-party logistics providers.
This guidance provides specific recommendations and interpretations from the FDA on how entities involved in the pharmaceutical supply chain should develop and implement systems to meet the verification requirements under the DSCSA.
Key takeaways from the guidance
The guidance refers to the requirements outlined by Section 582 of the FD&C Act, which were amended by the DSCSA. It’s focused on verification systems for various trading partners such as manufacturers, wholesale distributors, dispensers, and repackagers, especially regarding suspect and illegitimate products.
It applies to verification systems that must be established in accordance with sections 582(b)(4), (c)(4), (d)(4), and (e)(4) of the FD&C Act.
Verification systems requirements (pages 9-12)
The guidance discusses identifying suspect products, quarantine, and investigation procedures. It outlines responsibilities for trading partners in such cases and emphasizes robust investigation protocols and validation of transaction history.
Systems for identifying suspect products: Trading partners must have systems in place to determine whether a product is suspect, ensuring timely and effective identification. This includes focusing on drugs that could be counterfeit, diverted, stolen, intentionally adulterated, the subject of a fraudulent transaction, or unfit for distribution.
Quarantine and investigation procedures: Required steps include physical or electronic quarantine of suspect products and conducting robust investigations in coordination with other trading partners. These investigations must validate transaction history and information.
Cleared product notification (pages 12-13)
The guidance presents guidelines for notifying the FDA when a suspect product is determined not to be illegitimate. It also specifies the components of cleared product notifications and the recordkeeping requirements.
Notifying the FDA: Trading partners must promptly notify the FDA if a suspect product, upon investigation, is determined not to be illegitimate. This notification is needed only if the suspect product is the subject of an FDA request for verification of the product identifier.
Recordkeeping requirements: Records of suspect product investigations, including all cleared product notifications, must be maintained for at least 6 years after the conclusion of the investigation.
Handling of illegitimate products (pages 13-14)
The guidance outlines procedures for quarantining, disposing of, and documenting illegitimate products. It also provides instructions for retaining samples for further analysis.
Quarantine and disposition: Trading partners must quarantine illegitimate products within their possession or control until dispositioned, with procedures in place for both physical and electronic quarantine.
Sample retention: Samples of the illegitimate product must be retained for further examination or analysis by the manufacturer, FDA, or other appropriate officials.
Recordkeeping: Maintain records of the disposition of illegitimate products for not less than 6 years after the conclusion of the disposition.
Notifications for illegitimate/high-risk products (pages 14-15)
The guidance outlines how to notify the FDA and trading partners about illegitimate products or those at high risk. It also guides on coordinating between trading partners in such scenarios.
Notification requirements: Systems must be in place for notifying the FDA and immediate trading partners of an illegitimate product and, for manufacturers, products with a high risk of illegitimacy.
Coordination with trading partners: FDA emphasizes the importance of communication and coordination with trading partners when dealing with notifications of illegitimate or high-risk products.
Verification of product identifier requests (pages 15-16)
This section discusses systems for manufacturers and repackagers to respond to verification requests of product identifiers from authorized trading partners.
Response systems: Manufacturers and repackagers must have systems to respond to verification requests of product identifiers from authorized trading partners within 24 hours or in a reasonable time as determined by the FDA based on circumstances.
Specific circumstantial responses (page 19)
The guidance concludes with specific guidelines for response times to requests for verification of product identifiers, particularly for manufacturers and repackagers based on different circumstances:
Rapid response expectation: Manufacturers and repackagers should provide a rapid response to requests for verification of a product identifier. The guidance suggests that a best practice is to respond no later than one business day from receipt of the request.
24-hour requirement: The guidance interprets a 24-hour requirement to mean that a response should be provided rapidly, ideally within one business day of receiving the request for verification.
Circumstances affecting response time: On a case-by-case basis, the FDA may consider "other such reasonable time" for responding to requests under limited circumstances such as power outages, transportation infrastructure disruptions, or local regional disruptions. In such situations, manufacturers and repackagers are expected to make a good-faith effort to provide a rapid response but may need to follow up with their trading partner with additional information.
Standards for verifying product identifiers: The systems should allow the manufacturer or repackager to respond to the request with a clear statement as to whether the product identifier has been verified. If the manufacturer or repackager identifies a product identifier that does not correspond to the standardized numerical identifier or lot number and expiration date assigned to the product, the manufacturer or repackager must treat the product as suspect.
Further distribution of products: A trading partner should not further distribute or dispense product until they receive a response to their request for verification of the product identifier from a manufacturer or repackager.
A few questions for your gap analysis
Here are some salient questions that impacted firms should consider in light of this final guidance:
Verification System Setup
Does our firm have a verification system in place as required by Section 582 of the FD&C Act?
Are all elements of our system, including processes and procedures, in alignment with DSCSA requirements for suspect and illegitimate products?
Identification and Handling of Suspect Products
Do we have clear protocols to determine if a product is suspect?
Is there an effective system to quarantine suspect products immediately upon identification?
Investigation of Suspect Products
What steps are in place for investigating suspect products? Are these steps thorough and in line with FDA guidelines?
How do we validate transaction history and information as part of our investigation process?
Notification Protocols for Cleared Products
Do we have a procedure for notifying the FDA when a suspect product is cleared?
Are our recordkeeping practices for cleared product notifications compliant with the 6-year requirement?
Handling of Illegitimate Products
What are our procedures for the quarantine and disposition of illegitimate products?
How do we ensure compliance with the FDA's requirements for sample retention of illegitimate products?
High Risk of Illegitimacy Notifications
Is there a system in place for notifying FDA and trading partners about products with a high risk of illegitimacy?
How do we coordinate with trading partners when dealing with illegitimate or high-risk products?
Verification Requests Response
Are we able to respond to verification requests of product identifiers from authorized trading partners within the FDA's specified timeframes?
Do we have a clear understanding of what constitutes a “reasonable time” for response as determined by the FDA, based on different circumstances?
Recordkeeping and Compliance
Are our recordkeeping practices compliant with the DSCSA requirements for both suspect and illegitimate products?
Have we conducted regular audits to ensure ongoing compliance with FDA guidelines and DSCSA requirements?
Training and Awareness
Does our staff have adequate training and awareness about the DSCSA requirements and our internal procedures for verification systems?
Are there any gaps in knowledge or practice among our staff regarding the handling of suspect or illegitimate products?
Unsure of or unsatisfied with your answers to any of these questions? Contact us for expert auditing and remediation support.
Recommendations
Here are a few additional best practices we recommend considering:
Create and maintain an internal database of suspect and illegitimate products. This database should include detailed information on past incidents and trends in counterfeit or adulterated products. Use this data to refine the criteria for identifying suspect products.
Implement a data analytics and/or machine learning tool to analyze transaction histories and product identifiers. These technologies can help in quickly flagging anomalies or patterns indicative of suspect products.
Set up secure, real-time communication channels with trading partners. This facilitates rapid information sharing about suspect products, enabling quicker response and containment.
To the degree possible, automate the process of responding to verification requests to ensure compliance with the 24-hour response guideline. This can include automated systems for flagging requests, generating initial responses, and tracking follow-up actions.
Regularly conduct mock recall exercises and verification drills. This helps in assessing the readiness of your systems and staff in responding to real-life scenarios involving suspect or illegitimate products.
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