DSCSA REQUIREMENTS ARE ALREADY HERE

The final requirements for DSCSA will go into effect on 11/27/2023, but did you know most DSCSA regulations are already in effect, and Pharmacies must follow them now? The Authorized Training Partners (ATP), Product Identifier, Product Tracing, and Verification sections of DSCSA are already in place and have many requirements for Pharmacy. The final requirement, Enhanced Drug Distribution Security (EDDS), will go into effect on 11/27/2023, bringing new requirements to the table and tweaking some existing requirements.

DSCSA REQUIREMENTS IN PLACE TODAY

There are four requirements in place today that every Pharmacy needs to follow. While enforcement has been light, we have seen State Boards of Pharmacies, PBMs, and the FDA requesting proof of compliance and product tracing data.

Authorized Trading Partners (ATP)

The first area that Pharmacies must comply with is ensuring that they are ordering products from legitimate suppliers. These will be state-licensed wholesalers, FDA-registered manufacturers/repackagers, and other state-licensed pharmacies (in limited cases). You should also monitor them to ensure their licenses and permits are renewed.

We have seen entities requesting Pharmacy to provide copies of our ATP licenses, registrations, or Primary Source Verification (PSV) screenshots.

Product Identifier

As of November 2018, all newly packaged products covered by DSCSA must have a “Product identifier” in a human-readable and a machine-readable 2d barcode. The product identifiers are made of the Standardized Numerical Identifier (NDC (or GTIN) and Serial Number), Lot Number, and Expiration date.

The Standardized Numerical Identifier uniquely identifies the individual package; no other packages will share that Standardized numerical identifier (NDC and Serial Number combination).

Product Tracing

Since 2016, all products covered by DSCSA must be accompanied by the 3Ts (transaction information, transaction statement, and transaction history). The 3Ts must be received before or at the time of product delivery and match the data on the physical product. The 3Ts can be in any format (paper, pdf, email, etc.), provided the required contents are all present.

If the Pharmacy returns products to the ATP they purchased from, the 3Ts do not need to be provided. You will also not need to give the 3Ts if you are “returning” non-salable products to an ATP.

If you get a request for DSCSA transaction data from the FDA or another regulator, the DSCSA regulations provide you with up to 48 hours to respond.

Verification

The Pharmacy must review all products and transaction data coming into the Pharmacy to ensure they are not suspect or illegitimate, including counterfeit, diverted, stolen, resulting from a fraudulent transaction, or unfit for distribution.

All suspect products should be investigated, and the Pharmacy must notify the FDA and ATPs within 24 hours if they are illegitimate.

Putting These Four Requirements (ATP, Product Identifier, Product Tracing, and Verification) Together

Let’s put this all together:

  1. Have proof that you are ordering from legitimate suppliers. This means having copies of licenses and ensuring your copies are kept up to date.
  2. Ensure the products you receive have the Product identifier in a human and machine-readable form on the packaging.
  3. Ensure you receive the transaction data (TI, TH, and TS) for all incoming products before or during delivery.
  4. Respond to the FDA (and other regulators) within 48 hours.
  5. Review all incoming products to ensure they are legitimate (e.g., they are not counterfeit, diverted, stolen, resulting from a fraudulent transaction, or unfit for distribution) and that you have matching transaction data. Work with ATPs to investigate when you believe a product is suspect. Notify the FDA when you discover an illegitimate product.
  6. Maintain all documentation related to DSCSA for no less than six years.
  7. Having SOPs and employee training addressing all aspects of DSCSA.

DSCSA REQUIREMENTS GOING INTO EFFECT ON 11/27/2023

Why have you heard about DSCSA for the past year or so? The last part of the DSCSA Regulations to go into effect are the Enhanced Drug Distribution Security (EDDS) Requirements on 11/27/2023. The central aspect of this section is the requirement that the transaction data (TI and TS) are sent/provided to the Pharmacy in a secure, electronic, and interoperable format. A key note to remember, the Transaction History (TH) will no longer be required as part of the transaction data.

Enhanced Drug Distribution Security (EDDS)

On and after 11/27/2023, the Product Tracing Data must be in a secure, electronic, and interoperable format. In July 2022, the FDA recommended using the EPCIS Format for this function. The EPCIS format will require all Pharmacies to obtain a Global Location Number (GLN). Additionally, EDDS requires that the Product Identifier be placed on the transaction information, and the transaction history requirement will sunset.

Note: Technically, EPCIS and GLN are not required by law. However, the FDA highly recommends using EPCIS since it is designed to share detailed information through a supply chain. The recommendation by the FDA has led to most wholesalers and manufacturers starting to migrate over to the EPCIS standards and requiring its use. The EPCIS format requires the use of a GLN.

Additionally, Pharmacies must ensure they can respond to the FDA (and other regulators) within 24 hours of a request for information.

Putting all of the DSCSA Pharmacy Requirements (ATP, Product Identifier, Product Tracing, Verification, and EDDS) Together

Let’s put it all together again, but with the EDDS Requirements (italicized are the new EDDS requirements):

  1. Have proof that you are ordering from legitimate suppliers. This means having copies of licenses and ensuring your copies are kept up to date.
  2. Ensure the products you receive have the Product identifier in a human and machine-readable format on the packaging.
  3. Ensure you receive the transaction data (TI and TS) for all incoming products before or during delivery in an electronic, secure, and interoperable format. EPCIS will likely be this format for all suppliers.
  4. Have software or a system that can read these files in the EPCIS Format.
  5. Ensure your Pharmacy has a GLN.
  6. Respond to the FDA (and other regulators) within 24 hours.
  7. Sellable returns to the ATP you purchased the product from must match the original Transaction data they provide. They will not accept products they did not sell you.
  8. Review all incoming products to ensure they are legitimate (e.g., they are not counterfeit, diverted, stolen, resulting from a fraudulent transaction, or unfit for distribution) and that you have matching transaction data. Work with ATPs to investigate when you believe a product is suspect. Notify the FDA when you discover an illegitimate product.
  9. Maintain all documentation related to DSCSA for no less than six years.
  10. Having SOPs and employee training addressing all aspects of DSCSA.

CONCLUSION

As you can see, most of the DSCSA Regulations are already in effect, and Pharmacies should have SOPs in place to comply, do employee training, and have access to their transaction data (transaction information (TI), statement (TS), and history (TH)) within 48 hours. The EDDS requirements are coming into effect on 11/27/2023. The two main areas that Pharmacies need to be concerned with, as it relates to EDDS, are the updated following requirements:

  • The transaction data (transaction information (TI) and statement (TS)) be in an electronic, secure, and interoperable format (in almost all cases, this will be an EPCIS file and will require the Pharmacy to have a GLN)
  • The TI contains the Product Identifier (NDC, Serial Number, Lot #, and Expiration date) of the package shipped

These two requirements require the Pharmacy to have software or another system to review and maintain the incoming transaction data and allow the Pharmacy to check that the physical Product Identifier on the bottle matches the reported Product Identifier on the electronic transaction data.

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.