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  6. What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)?
  1. Drug Supply Chain Security Act (DSCSA)

What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)?

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To help ensure the safety and security of the pharmaceutical supply chain in the U.S., DSCSA requirements aim to deter, detect, and remove potentially dangerous drugs from the supply chain.

This overview on key supply chain requirements is offered to help regulated firms navigate requirements and meeting their compliance obligations under the law.

Key Supply Chain Security Requirements

Authorized Trading Partner

Requirement: All trading partners must be authorized.

Applies to: Manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers1

Trading Partner

How do I check if a company is an authorized trading partner under DSCSA?

Manufacturer or repackager

Trading partners can check the FDA drug establishment registration database to determine a manufacturer’s or repackager’s registration status. 

Wholesale distributor

Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States.

 

  • Trading partners can check the FDA annual reporting database to determine if a wholesale drug distributor submitted an annual report and required information.
  • Trading partners can check the applicable state licensure website to determine if the wholesale drug distributor has a valid license in the state where they are conducting business.

 

Third-party logistics provider

  • Trading partners can check the FDA annual reporting database to determine if a third-party logistics provider submitted an annual report and the required information.
  • Trading partners can check the applicable state licensure website  to determine if a third-party logistics provider holds a valid license in the state they are conducting business.

 

A third-party logistics provider is considered to be licensed for purposes of the DSCSA until the effective date of the third-party logistics provider licensing regulations issued by FDA, unless FDA publishes notice of a finding that a 3PL does not utilize good handling and distribution practices. In cases where a state operates a specific third-party logistics provider licensing program, state requirements for third-party logistics licensures apply until the final regulations take effect. This information will be revised when final regulations are issued.

Dispensers, primarily pharmacies2

Trading partners can check the applicable state dispense licensing authorities, to determine if the dispenser is licensed in the state where they are conducting business.

Licensure and Registration

Requirement: Trading partners must either be appropriately licensed or hold a valid registration depending on their role, as outlined below.

Applies to: Manufacturers, repackagers, wholesale drug distributors, third-party logistics providers and dispensers1

Trading Partner

Specific Requirement

Resources

Manufacturers and Repackagers

Owners or operators of drug manufacturing establishments are required to register their establishments with FDA.

To learn about registration requirements, visit: Electronic Drug Registration and Listing System (eDRLS)

Wholesale distributors

Required to have a valid license in the state where they are conducting business, or under federal law.

To locate state licensure authorities, visit: Check Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers

Third-party logistics providers

Required to have a valid license in the state where they are conducting business, or under federal law.

A third-party logistics provider is considered to be licensed for purposes of the DSCSA until the effective date of the third-party logistics provider licensing regulations issued by FDA, unless FDA publishes notice of a finding that a 3PL does not utilize good handling and distribution practices. In cases where a state operates a specific third-party logistics provider licensing program, state requirements for third-party logistics licensures apply until the final regulations take effect . This information will be revised when final regulations are issued.

To locate state licensure authorities, visit: Check Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers  

Dispensers, primarily pharmacies2

Required to hold a valid license in the state they are conducting business.

To locate state dispense licensing authorities, visit: Locate a State-Licensed Pharmacy

Annual Reporting

Requirement: Report licensure and other information to FDA annually.

Applies to: Wholesale drug distributors and third-party logistics providers1

Specific Requirement

Resources

Report licensure and other information annually.

Recommended submission timeframes are from January 1–March 31 annually.

Product Tracing

Requirement: Provide, capture, and maintain information about transactions involving products distributed within the United States and the trading partners who engaged in such transactions of products. Since 2015, lot-level product tracing information including, the transaction information, transaction history, and transaction statement is required to be provided in a paper-based or electronic-based method to a subsequent purchasing trading partner. However, beginning on November 27, 2023, electronic-based approaches will be required to be used among all trading partners to meet the enhanced drug distribution security requirements, including electronic product tracing and verification of product at the package level. Certain DSCSA requirements may be the subject of compliance policies under which FDA intends to not take action to enforce such requirements until a specific date. A list of DSCSA compliance policies, along with all DSCSA guidance, can be found on our DSCSA Law and Policies web page.3

Applies to: Manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) 1, 2

Specific Requirements

Resources

Trading partners must provide to the subsequent purchaser transaction information, transaction history, and a transaction statement in paper or electronic format when engaging in transactions involving certain prescription drugs.

Trading partners must capture and maintain the applicable transaction information, transaction history, and transaction statement for not less than six years after the date of the transaction.

Trading partners may only accept ownership of product with the applicable transaction information, transaction history, and transaction statement.

 

Product Identifiers

Requirement: Add a product identifier to certain prescription drug packages and homogenous case of product intended to be introduced in a transaction into commerce.

Applies to: Manufacturers and repackagers1

Specific Requirements

Resources

Product identifiers are standardized graphics that include the product’s national drug code (NDC), serial number, lot number, and expiration date in both human- and machine-readable form. The machine-readable form is generally a two-dimensional data matrix barcode for packages and in a linear or two-dimensional data matrix barcode for homogenous cases.

Verification: Respond to Requests for Verification of the Product Identifier

Requirement: Establish systems and processes to respond to requests for verification of the product identifier on certain packages or homogenous cases of product.

Applies to: Manufacturers and repackagers1

Specific Requirements

Resources

Manufacturers and repackagers must establish systems and processes to promptly respond to requests for verification of a product identifier from an authorized trading partner.

FDA Guidance: Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

Verification: Verify Product Identifier of Saleable Return Product

Requirement: Establish systems and processes to be able to verify the product identifier on saleable return product.

Applies to: Manufacturers, repackagers, wholesale distributors1,3

Specific Requirements

Resources

Manufacturers, repackagers and wholesale distributors must establish systems and processes to determine whether the product identifier of saleable returned product corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or repackager.

FDA Guidance: Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

Verification: Determine if a Product is Suspect

Requirement: Establish systems and processes to determine whether product is suspect product.

Applies to: Manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) 1, 2

Specific Requirements

Resources

Trading partners must establish systems and processes to determine whether a product is a suspect product. When considering whether product is suspect product, trading partners should focus on drugs that potentially fall into one of the categories of drugs listed in the definition of suspect product: product that the trading partner has reason to believe is counterfeit, diverted, stolen, intentionally adulterated, the subject of a fraudulent transaction, or unfit for distribution.

Verification: Investigate and Quarantine Suspect Product

Requirement: Establish systems and processes to conduct an investigation into whether product is illegitimate product after determining that a product is suspect product, or upon receiving a request for verification from FDA. Establish systems and processes to quarantine suspect product because it may be counterfeit or otherwise unfit for distribution and potentially dangerous.

Applies to: Manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) 1, 2,3

Specific Requirements

Resources

Investigate: Trading partners must establish systems and processes in order to conduct an investigation, in coordination with other trading partners, as applicable, into whether a suspect product is an illegitimate product.

Such investigations must include validation of any applicable transaction history and transaction information in the trading partner’s possession and verifying the product identifier of the product.

Quarantine: Trading partners must establish systems and processes to quarantine suspect product.

Quarantine means the storage or    identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.

Quarantine of a suspect product may be accomplished using physical separation and/or other procedures. FDA interprets “other procedures” to include electronic means when a trading partner lacks physical possession of the product. FDA encourages trading partners to use both physical and electronic quarantine when possible to ensure accurate record keeping.

Verification: Cleared Product Notifications

Requirement: Establish systems and processes to promptly notify FDA when suspect product is determined not to be illegitimate.

Applies to: Manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies)1,2

Specific Requirements

Resources

Trading partners must establish systems and processes to promptly notify FDA if they determine after investigation

that a suspect product is not an illegitimate product and is therefore a cleared product. This notification is considered a cleared product notification.

 

FDA expects trading partners to inform the Agency about cleared product only if the suspect product is the subject of an FDA request for verification.

Verification: Quarantine and Disposition Illegitimate Product

Requirement: Establish systems and processes to quarantine and disposition illegitimate product.

Applies to: Manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies)1,2

Specific Requirements

Resources

Quarantine: Trading partners must establish systems and processes to quarantine illegitimate product after a determining that product is illegitimate product, or after receiving notification from FDA or a trading partner that a determination has been made that a product in the trading partner’s possession or control is illegitimate product.

Quarantine of an illegitimate product may be accomplished using physical separation and/or other procedures. FDA interprets “other procedures” to include electronic means when a trading partner lacks physical possession of the product.

Disposition: Trading partners must establish systems and processes to disposition illegitimate product.

Disposition involves the removal of product from the pharmaceutical distribution supply chain.

Verification: Notification of Illegitimate Product

Requirement: Establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found or if product with a high risk of illegitimacy is identified.

Applies to: Manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies)1,2

Specific Requirements

Resources

Trading partners must establish systems and processes to notify FDA and all appropriate immediate trading partners within 24-hours after determining a product is illegitimate.

Additionally, manufacturers are also required to notify FDA and appropriate trading partners within 24 hours after determining a product is at high risk for illegitimacy.


1 For trading partner definitions, see FDA Guidance: Identifying Trading Partners Under the Drug Supply Chain Security Act.

2 Dispensers means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control…or any other person authorized by law to dispense or administer prescription drugs. (See section 581(3) of the FD&C Act.)

3 Certain DSCSA requirements may be the subject of compliance policies under which FDA intends to not take action to enforce such requirements until a specific date. A list of DSCSA compliance policies, along with all DSCSA guidance, can be found on our DSCSA Law and Policies web page.

 
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