Drug Supply Chain Security Act

Responsible and Compliant Pharmaceutical Handling and Traceability

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DSCSA Overview

Ensure that your pharmaceutical inventory is FDA compliant

Humanitarian Software has invested in compliance with FDA regulations for many years. We provide fully integrated, DSCSA compliant modules for EDI, Advance Shipment Notifications (ASNs), Inventory Control and more. HELM is fully DSCSA compliant and provides the tools organizations need to ensure their pharmaceutical product handling and distribution processes are compliant.

DSCSA Details

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of the DQSA, The Drug Supply Chain Security Act (DSCSA), outlines the procedure to build an electronic system to identify and monitor prescription drugs that are distributed in the US. This aids in protecting both traders and consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

Additionally, the DSCSA oversees the FDA in establishing national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to the FDA every year.

Dispensers must now exchange “product tracing information” with the FDA when a transaction takes place. Product tracing information consists of: Transaction information (TI), transaction history (TH), and transaction statements (TS).

Major provisions of the DSCSA include:

  • Product tracing (by 2015 lot-level, by 2023 package-level)
  • Product verification
    • Quarantine and investigation (steps for detection and response)
    • Notification, recordkeeping
  • Product identification (applied to product beginning 2017)
  • Wholesale distributor and Third-party logistics provider standards for licensure
  • Enhanced system (electronic, interoperable system to trace products at the package-level by 2023)
  • Penalties for non-compliance
  • National uniform policy

For more information, read the Drug Supply Chain Security Act. Find a list of DCSCA policy documents and FDA’s implementation plan. Additionally, read the key provisions of the law and find out if you are ready for DSCSA’s requirements.

DSCSA Transaction Information

Transaction Information (TI)

  • Proprietary or established name or names of the product
  • Strength and dosage form of the product
  • National Drug Code number of the product
  • Container size
  • Number of containers
  • Lot number of the product
  • Date of the transaction
  • Date of the shipment, if more than 24 hours after the date of the transaction
  • Business name and address of the person from whom and whom ownership is being transferred

Transaction History (TH)

A statement, in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

Transaction Statement (TS)

A statement, in paper or electronic form, that the entity transferring ownership in a transaction –

  • Is authorized as required under DSCSA
  • Received the product from a person that is authorized as required under DSCSA
  • Received transaction information and a transaction statement from the prior owner of the product, as required under the law
  • Did not knowingly ship a suspect or illegitimate product
  • Had systems and processes in place to comply with verification requirements under the law
  • Did not knowingly provide false transaction information
  • Did not knowingly alter the transaction history

Becoming DSCSA compliant is of great importance if your enterprise handles pharmaceutical aid. We have widespread experience using VANs (value added networks) to provide secure communications and management reporting in order to help our clients become complaint with DSCSA standards.

We have also worked with Tracelink to track pharmaceutical shipments and set up Electronic Data Interchange (EDI) trading partners in an effort to provide integrated compliance and eliminate harmful drugs from ever reaching the field.

HELM comes with all the tools needed to help your company become DSCSA compliant, including full handling of TI, TS, and TH information and modules to store pharmaceutical data. You are able to track shipments from the time the pharmaceuticals were manufactured to their final delivery point, making gathering critical information extremely convenient when it’s time to report.

HELM Compliance

  • Integrated EDI module to pull ASN 856 data from donors and vendors
  • ASN (Advance Shipment Notification) module to store inbound pharma data and pedigree
  • Outbound distribution and ASN data for full shipment pedigrees
  • Full handling of TI, TS, and TH information
  • Internal traceability from receipt to shipment with license plating to tie TI information like lot and expiration back to the original manufacturer/receipt

Key DSCSA Information

The Drug Supply Chain Security Act (DSCSA) outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements began at various stages in 2015. The requirements, development of standards, and the system for product tracing will continue to be phased in until 2023. FDA will continue working with trading partners and other stakeholders to effectively implement the requirements.

Lot-level product tracing: provide transaction information information, history, and statement. See DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (Revised) for additional information.

To assist manufacturers, repackagers, wholesale distributors, and dispensers to comply with the new product tracing requirements, FDA has published a draft guidance for industry, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs:  How to exchange product tracing information.

  • Accept ownership of product with applicable transaction information, transaction history, and transaction statements.
    • If your trading partner does not provide the proper transaction documentation, work with your trading partner to promptly get the proper documentation and to minimize disruption in the supply chain.

To assist manufacturers, repackagers, wholesale distributors, and dispensers to comply with the new verification requirements, FDA published the draft guidance for industry, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.

  • Establish systems to:
    • Quarantine and investigate suspect product to determine if it is illegitimate.
    • Notify FDA and immediate trading partners, if illegitimate product is found.

Check with your trading partner directly to confirm they are authorized, or

  • For manufacturers and repackagers, check FDA’s drug establishment registration database for registration;
  • For wholesale distributors, third-party logistics providers and dispensers, you can check with your respective state authority to confirm licensure.

Note, third-party logistics providers are considered to be licensed under the DSCSA until the effective date of the third-party logistics provider licensing regulations issued by FDA, unless the third-party logistics provider is licensed by a state having a specific third-party logistics provider licensing program.

To assist third-party logistics providers and wholesale distributors to comply with the new reporting requirements, FDA published a draft guidance, Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers. The draft guidance outlines the information that should be submitted to FDA, the timing of the submissions, a preferred format for the submissions, and a preferred method for reporting using FDA’s CDER Direct Electronic Submissions Portal.

The “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act” Guidance Document exempts certain dispensers who “may lack the resources to provide product tracing information for these transactions” from the provision of “specific product tracing information“  to subsequent purchasers of a subscription drug. It also recognizes that “first responders may lack the resources to comply with certain requirements under section 582(d) of the FD&C Act, including receipt, capture and maintenance of product tracing information and verification.”

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