In four months, the Enhanced Drug Distribution System (EDDS) requirements of the Drug Supply Chain Security Act (DSCSA) will go into effect. The EDDS changes the fundamentals of some existing DSCSA provisions that Pharmacies are required to comply with now, which we will discuss in addition to the upcoming EDDS requirements.

Where are We Now with the DSCSA?

Before moving into the new EDDS Requirements, let’s quickly discuss the existing requirements that Pharmacies should already comply with and have corresponding SOPs (policies and procedures). These can be broken down into four areas:

  • Authorized Trading Partners: The Pharmacy must validate the State License, FDA Permits (for manufacturers), and DEA Permits (if ordering controlled substances) of all ATPs they are ordering products.
  • Product Identifier: The Pharmacy should only receive products containing the Product Identifier in a human and machine-readable format on the manufacturer bottle. If a package was manufactured before 11/27/2017 or repackaged before 11/28/2018, they are grandfathered in and do not require the Product Identifier.
  • Product Tracing: The Pharmacy currently receives the 3Ts (Transaction Information, Transaction History, and Transaction Statement) for all products they receive. The Pharmacy is required to maintain the 3Ts for six years.
  • Verification: The Pharmacy reviews the 3Ts and physical products to determine if the product is legitimate. The Pharmacy investigates suspect products and notifies the FDA and Trading partners when an illegitimate product is identified. The Pharmacy responds to information requests promptly and assists in FDA and ATP investigations of a suspect or illegitimate product.

While some of the above DSCSA requirements may change with the EDDS, none of them are going away with the EDDS.

Regulatory Start Date of EDDS?

The start date for EDDS is 10 (ten) years after the enactment date of the DSCSA, which makes the start date 11/27/2023.

What is EDDS?

In its most general, the EDDS requires Manufacturers, Wholesalers, Pharmacies, and other Dispensers to send and receive transaction data (Transaction Information and Transaction Statement) in a secure, interoperable, and electronic format. The Transaction Information must include the Product Identifier (NDC or GTIN, Serial Number, =Lot Number, and Expiration Date).

DSCSA Regulatory Definition

 

Product identifier: The term `product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.

Receiving electronic and interoperable transaction data is hurdle #1 for Pharmacies. This hurdle does have a few ways for Pharmacies to leap into compliance, including:

  • Portals: Use their Authorized Trading Partner (ATP) portals to collect the data. Using portals should be relatively easy if you only order products from one or two ATPs. If you have many ATPs, this could be complicated as you need to check multiple ATP portals daily to verify receipt of the electronic data. You will also need a written agreement for your ATPs to maintain your Transaction Data on your behalf. You also want to ensure their portal has functions similar to a DSCSA Software Service Provider, as listed below.
  • In-House Software: Build software to collect transaction data from all your ATPs. You will need an experienced software designer to develop your software. You should ensure that the software you create is similar in functionality to what a DSCSA Software Service Provider described below.
  • DSCSA Software Service Provider: Use a DSCSA Software Service Provider. A reputable DSCSA Software Provider will:
    • Have software that receives transaction data from all of your ATPs
    • Allow you to review and document the receipt of the transaction data
    • Alert you when data is suspect
    • Allow the scanning of the physical products (more in the next section)
    • Store the transaction data for a period of no less than six years
    • Have SOPs for handling the existing DSCSA requirements and upcoming EDDS requirements
    • Assist you with audits
    • Send out alerts when there is a product recall
    • Allow you to send Transaction Information and Statements upon request
    • Provide you with a written agreement to maintain your Transaction Data
    • Have a help desk with support that understands Pharmacy operations

Note: The Transaction History requirement is no longer required when EDDS goes into effect.

Do I need to be able to track the receipt of products down to the Package level?

Yes. Since the Transaction Information will include the Product Identifier and the physical product will have the Product Identifier, Pharmacies need to verify that the physical package received matches the actual package data listed in the Transaction Information said was sent.

The FDA does not say how they expect Pharmacies or any other supply chain members to conduct this “verification” of the physical product to the Transaction Information. To accomplish this verification, a pharmacy employee could manually verify the Product Identifier on the bottle with the Product Identifier in the electronic Transaction Information. A more efficient and accurate method would be to use scanning technologies to scan the 2D barcode on the bottle and have DSCSA Software compare the scanned data against the electronic Transaction Information. You would want to ensure the DSCSA Software you build or buy can alert you when a scanned product does not match and a line item on the Transaction Data has not been scanned.

Also, when you investigate a suspect product, you will verify the product down to the package level using a Product Identifier. The verification requires that you communicate with your ATPs to verify the legitimacy of the Product Identifier on the package.

One thing to realize, no other US Pharmaceutical Supply Chain package will have the same Standardized Numerical Identifier.

DSCSA Regulatory Definition

 

Standardized Numerical Identifier: The term `standardized numerical identifier’ means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.

How quickly do I need to be able to respond to the FDA or other regulators?

The Pharmacy currently has 48 hours to respond to information requests from the FDA or other regulators. With EDDS, this response time has been cut to 24 hours since the electronic Transaction Data should be much simpler to search and find the Transaction Data. You also need to be able to respond to information requests from your ATPs in a timely manner.

Is anything changing for the return of products purchased on or after 11/27/2023?

Yes, your ATPs will now be checking to ensure the Product Identifier of the Product returned matches the Transaction Data of a product that the ATP sold to you.

Conclusion

The EDDS requirements are going into effect on 11/27/2023, and Pharmacies should be preparing now to ensure they can receive interoperable electronic Transaction Data. The Pharmacy should also be in the process of amending its existing SOPs (policies and procedures) to match the EDDS. The EDDS requires the Pharmacy to:

  • Have software or another system to review and maintain the incoming Transaction Data
  • Check that the physical Product Identifier on the bottle matches the reported Product Identifier on the electronic Transaction Data.
  • Respond to FDA and regulators within 24 hours
  • Require your ATPs to verify that the Product Identifier of products you return to them matches the Product Identifier they sold to your Pharmacy

The PRS DRUGSUPPLYTrack™ and Advasur 360™ have been combined to create DSCSA 360™ to ensure your Pharmacy has the tools to be compliant today and into the future. If you have any questions about DSCSA, please do not hesitate to call us at 1-800-338-3688.