DSCSA Pharmaceutical Serialization Updates and New Guidance

The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. Title II of this act was the Drug Supply Chain Security Act (DSCSA) to enhance the FDA’s ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

The requirements also included improvements for the detection and removal of potentially dangerous drugs from the U.S. drug supply chain.

2023 was a busy year with multiple new FDA Guidance documents being published to provide clarity to the DSCSA.

• December 7, 2023: Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

• November 20, 2023: Federal Register Notice: Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements; Request for Information and Comments
• September 5, 2023 – DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry

• August 30, 2023 – Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies
• August 30, 2023 – Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act
• August 25, 2023 – Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies
• August 10, 2023 – Federal Register Notice: Development of Small Dispensers Assessment Under the Drug Supply Chain Security Act; Request for Comments

Who Does the DSCSA Requirements Apply to?  Prescription Drug:

• Manufacturers
• Wholesale Distributors
• Dispensers
• Repackager

Key Elements of the November 2013 DSCSA Law:

• Product Identification: Manufacturers and repackagers are required to affix a product identifier on certain prescription drug packages.
• Product Tracing: Distributors of prescription drugs are required to provide information about the drug, and who handled the drug in the US supply chain.
• Product Verification: Distributors of prescription drugs are required to have systems in place to verify the product identifier on prescription drug packages.
• Detection and Response: Trading partners, such as manufacturers, dispensers, and packagers, are required to have established systems for identifying and responding to suspect and illegitimate product in the supply chain distribution.
• Notification: Trading partners are required to establish a system to FDA notification and other stakeholders when illegitimate product is found.
• Licensing: National standards established for the licensing of wholesale drug distributors and third-partly logistics (3PL) partners.

Key Take Aways from the December 7, 2023, Final Guidance on DSCSA Verification Systems

• Trading partners are required to have systems in place to determine whether a product is suspect. The systems are required to ensure that a trading partner makes consistent, effective, and timely determination that a product is suspect. (Effective procedures and Training should be in place)
• A Quarantine process is required to be in place for suspect product at each trading partner. Processes should be in place for Quarantine of product and conducting an investigation with trading partners. (Quarantine of product physically, electronically, or both)
• Investigations with trading partners are required to be conducted promptly for suspect illegitimate product. The FDA expects partners to share results of their investigations with each other.
• Investigations into illegitimate product are required to verify the product identifier down to the package level.
• The manufacturer is required to have the ability to confirm that the National Drug Code (NDC) and lot number reported in the manufacturer’s records corresponds to the information assigned to the suspect product.
• The manufacturer is then required to verify the product identifier by confirming the NDC, Serial Number, Lot Number, and Expiration Date of the product identifier affixed to the package of the suspect product corresponds to the information originally assigned to the product by the manufacturer.
• Repackagers and Dispensers must also be able to validate the transaction history of the prescription drug.

The FDA encourages trading partners to periodically evaluate their systems for conducting investigations.   Contact Quality Audit Consulting today to conduct a gap assessment audit of your DSCSA investigations system.

• Trading partners are required to have a system in place to promptly notify the FDA when suspect product is determined to be a legitimate product and is cleared product. Cleared product notifications are to be submitted to drugnotifications@fda.hhs.gov.
• If a product is investigated and it is determined that it is an illegitimate product, trading partners are required to quarantine the illegitimate product from product intended for distribution until the product has been dispositioned. The FDA encourages both physical and electronic quarantine.
• Trading partners are required to have a system in place for notifying the FDA of an illegitimate product. Trading partners are required to immediately identify all illegitimate products in its possession or control.
• Records of suspect product investigations are required to be maintained for a period of at least 6 years.
• Manufacturers and repackagers are required to have systems in place to respond to requests for verification of the product identifier from an authorized trading partner no later than 24 hours after receiving the request.

Schedule a call with Quality Audit Consulting today to discuss a DSCSA gap assessment for you or your trading partner.

Contact: matt@qualityauditconsulting.com