Do you find complying with the Drug Supply Chain Security Act (DSCSA) overwhelming and confusing?

Are you worried about the risk of non-compliance and the costly penalties that come with it? If so, you’re not alone. Many businesses struggle to keep up with DSCSA regulations, which can lead to compliance issues and severe consequences.

If you tried this on your own, complying with DSCSA would be a complex and demanding task.

The good news is, PRS and Advasur have developed a solution that can help. Our DSCSA360 program is designed to ensure that you meet all the necessary requirements to avoid penalties and maintain a strong reputation.

PRS and Advasur have partnered to provide DSCSA 360™. This program includes all of the below features and tools to ensure 360 degrees of DSCSA Compliance:

  • Easy to follow Compliance Guide to walk you through the implementation process
  • Required Policies and Procedures/SOPs
  • Required forms
  • Support from Compliance experts to help you every step of the process
  • Works, on your behalf, with your authorized trading partners to begin collecting your electronic transaction data automatically
  • Provides all of the electronic transaction data from all your authorized trading partners on one easy-to-use website
  • Provides alerts to you when there is suspect data in your transaction information
  • Provides alerts to you when recall information matches products you have received
  • Provides alerts to you when your authorized trading partner licenses and credentials are expiring
  • DSCSA Audit assistance is available at no cost
  • Provides Employee Training on the Software and SOPs
  • Training and education on identifying suspect products
  • Scanning of incoming products

Advasur has been at the forefront of Track & Trace requirements since the law’s creation. Like PRS, Advasur was built by pharmacists for pharmacists. Their ultimate goal is to provide a turn-key outsourced solution so you can focus your attention on the most important part of your job, your patients.

PRS is proud to partner with Advasur. Together, we have developed the most convenient and complete DSCSA solution at an affordable price.

*This product is endorsed by FPN and NCPA, representing over 15,000 Independent Pharmacies.

Solve Your DSCSA Compliance Issues Today!

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What is DSCSA?

Without a compliance solution in place, you'll have no help when the law goes into effect this November.

The DSCSA was passed in 2013 to create a federal track and trace program for prescription medicines in the United States. DSCSA aims to prevent, detect, and respond to suspect and illegitimate medication in the United States Supply Chain.

The law established a 10-year roadmap with enforcement and adaptations in 2015 and 2018 related to Product Tracing, Product identifiers, Authorized Trading Partners, and Verification.   The last section of the law, Electronic Drug Distribution Security (EDDS), goes into effect on 11/27/2023. Among other things, EDDS directs all trading partners to have in place a secure, electronic, and interoperable system for the exchange of transaction documentation [transaction information (TI) and transaction statements (TS)] to enable the tracing of prescription medications.

Speak with one of our Compliance Experts today!

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.

FAQs

The Drug Supply Chain Security Act (DSCSA) aims to protect the United States Drug Supply Chain from counterfeit and adulterated medication. The law was passed in 2013 and has been rolled out in phases since 2015, with the last phase becoming effective on 11/27/2023.

The Pharmacy requirements of DSCSA can be broken down into the five following areas:

 

  • Authorized Trading Partners – Ensure you order your products from Licensed and permitted Drug Wholesalers or direct manufacturers. You should also monitor them to ensure their licenses and permits are renewed.
  • Product Identifier – All products covered by DSCSA must contain a Product identifier (Serial Number, NDC, Lot Number, and Expiration Date) on their manufacturer label. The Product identifier should be in a human-readable and a machine-readable 2d barcode.
  • Product Tracing – 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. Before 11/27/2023, this may be in a paper or electronic format. Additionally, Pharmacies will need to ensure that they are able to respond to the FDA (and other regulators) within 48 hours of a request for information
  • Verification – The Pharmacy must review all products and the transaction data coming into the Pharmacy to ensure they are not suspect or illegitimate. All suspect products should be investigated, and the Pharmacy must notify the FDA and ATPs within 24 hours if they are illegitimate.
  • Electronic 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.

The DSCSA regulations require all manufacturers, wholesalers, and dispensers (including pharmacies) to be compliant when there is a transaction related to a covered medication.

Currently, only prescriptions medication are covered by DSCSA, with the following exceptions:

 

  • blood or blood components intended for transfusion
  • radioactive drugs or radioactive biological products
  • imaging drugs
  • intravenous product (including for products for the replenishment of fluids and electrolytes, products used to maintain the equilibrium of water and minerals, or products that are intended for irrigation, or sterile water, whether intended for such purposes or injection
  • medical gases
  • homeopathic drugs marketed
  • drug compounded in compliance with section 503A or 503B

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. 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. Additionally, Pharmacies will need to ensure that they are able to respond to the FDA (and other regulators) within 24 hours of a request for information.

Need additional information about this program or any other Pharmacy Compliance and Credentialing services or products? Contact our compliance specialists today.  Our specialists can help you even if you are already working with another compliance program.

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201 Depot Street, Suite 200
Latrobe, PA 15650

Phone: 800-338-3688
Fax: 724-539-1388

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