Authorized

• in the case of a manufacturer or repackager, having a valid registration in accordance with FDA;
• in the case of a wholesale distributor, having a valid license under State law;
• in the case of a third-party logistics provider, having a valid license under State law; and
• in the case of a dispenser, having a valid license under State law.

Product Identifier

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.

Standard 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.

Suspect Product

a product for which there is reason to believe that such product—

• is potentially counterfeit, diverted, or stolen;
• is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
• is potentially the subject of a fraudulent transaction; or
• appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

Illegitimate Product

a product for which credible evidence shows that the product –

• is counterfeit, diverted, or stolen;
• is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
• is the subject of a fraudulent transaction; or
• appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

Trading Partner

• a manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or
• a third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product.

Transaction History

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

Transaction Information

• the proprietary or established name or names of the product;
• the strength and dosage form of the product;
• the National Drug Code number of the product;
• Product Identifier (on and after 11/27/2023);
• the container size;
• the number of containers;
• the lot number of the product;
• the date of the transaction;
• the date of the shipment, if more than 24 hours after;
• the date of the transaction;
• the business name and address of the person from whom ownership is being transferred; and
• the business name and address of the person to whom ownership is being transferred.

Transaction Statement

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

• is authorized as required under the DSCSA;
• received the product from a person that is authorized as required under the DSCSA;
• received transaction information and a transaction statement from the prior owner of the product, as required under section DSCSA;
• did not knowingly ship a suspect or illegitimate product;
• had systems and processes in place to comply with verification requirements under DSCSA;
• did not knowingly provide false transaction information; and
• did not knowingly alter the transaction history.

Product Tracing

• Receive the 3Ts (TI, TS, and TH)
  • Receive the 3Ts for each product before or at the time of delivery
  • Missing or incorrect data must be amended with the ATP (Products should be quarantined until the 3Ts are amended/corrected)
  • Maintain copies of the 3Ts for six years
  • Written Agreements with vendors if they maintain your 3Ts on your behalf
• Provide copies of the 3Ts upon transfer of product, unless:
  • Providing products to another Pharmacy with common ownership (all other State Requirements must be followed)
  • Sales by Pharmacy to another Pharmacy to fulfill a specific patient prescription (all other State Requirements must be followed)
• Returns
  • Salable Returns may be made to the ATP the Pharmacy purchased from without the Pharmacy providing the 3Ts
  • Non-salable Returns may be made to the ATP from whom the product was purchased or to a returns processor without the Pharmacy providing the 3Ts
• Respond to FDA, Federal, and State requests for information within 48 hours

Product Identifier

• All products received must have the Product Identifier on the label
  • Serial Number
  • NDC
  • Lot Number
  • Expiration Date
• Exception
  • Products manufactured before 11/27/2018

Authorized Trading Partners

• Authorized Trading Partners are:
  • Manufacturers and repackagers registered with the FDA
  • Wholesalers licensed by the State
  • Dispensers (typically a Pharmacy) licensed by the State
  • Third-party logistics (3PL) Providers licensed by the State
• If you cannot verify their license or registration, you cannot conduct business with them
• Request and maintain updated copies of their FDA, DEA, and State Licenses and registrations

Verification

• Identify, Quarantine, and Investigate Suspect Products
• Work with trading partners and manufacturers during the investigation
• Illegitimate products
  • Notify FDA within 24 hours (FDA FORM 3911)
  • Notify relevant trading partners
  • Retain the product until you receive instructions from the FDA or Manufacturer
• Products determined to be good may be released from quarantine and dispensed
• Maintain all documentation related to the investigation for six years

Enhanced Drug Distribution Security

• The 3Ts become 2Ts (TI and TS)
• The TI must include the product identifier
• The 2Ts must be received in an electronic, secure, and interoperable format (FDA is pushing EPCIS) before or at the time of delivery
• Pharmacies will need to obtain GLN for EPCIS
• Verifications for suspect products must be down to the product identifier
• Respond to FDA, Federal, and State requests for information within 24 hours with the electronic 2Ts
• Salable returns may be made to the ATP it was purchased from only if the original TI and TS can be identified

Ultimately a Pharmacy should already be compliant with Product Tracing, Product Identifier, Authorized Trading Partner, and Verification as described above, this includes making sure you:

• Are receiving and know how to access your 3Ts for all of your covered products from all of your ATPs for the past 6 years (you will need to be able to retrieve them if requested)
• Have copies of your ATP Licenses and registrations
• Have a process to quarantine suspect, illegitimate, or products received with no corresponding 3Ts
• Are prepared to respond to requests for information from Federal and State regulators and your ATPs
• Have SOPs (covering Product Tracing, Product Identifier, Authorized Trading Partner, and Verification) and employee training (on your SOPs and identifying a suspect and illegitimate product)

If you are not sure if you are compliant, please give us a call.

Now is the time to start preparing for the Electronic Drug Distribution Security Requirements, this includes:

• Have Software that allows you to receive, review, and maintain the electronic TI and TS in the EPCIS for 11/27/2023 and beyond
• Obtain a GLN from GS1 for EPCIS file formats
• If you are building your own software start testing it now with all your ATPs
• If using ATP portals, you will need to use different portals for each ATP – and you will need to understand each of these portals
• Ensure all of your ATPs are providing data to your selected Software
• It takes time (weeks to months) for your ATPs to start sending the data to your selected DSCSA Service Provider, so do not wait
• Have training for your employees on the SOPs and Software (or portals)

Absolutely not. Your wholesaler is unable to do the following...

• Provide the Transaction Information (TI) and Transaction Statement (TS) in an electronic and interoperable format.
• Provide you with alerts when your received TI contains missing information and discrepancies.
• Conduct and document Product Verification.
• Assist you with audits from the FDA, State, and other entities.
• Quarantine and investigate suspect products.
• Conduct and document the Investigation of Suspect Products.
• Report Illegitimate products to the FDA.
• Create SOPs and train employees.
• Maintain copies of and track the expiration dates of all your wholesaler’s licenses and permits.
• Provide a one-stop solution for all of your wholesalers and manufacturers.

PRS and Advasur can help with everything.