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Federal Drug Supply Chain Security Act (DSCSA) Frequently Asked Questions

Federal Drug Supply Chain Security Act (DSCSA) Frequently Asked Questions

What is the U.S. Federal Drug Supply Chain Security Act (DSCSA)?

Johnson & Johnson is committed to ensuring the integrity and safety of our supply chain. We embrace product identification and have a comprehensive serialization and traceability program that delivers benefits to our patients, customers and the industry.

In 2013, the United States Food and Drug Administration (FDA) enacted the Drug Supply Chain Security Act (DSCSA), a ten-year phased approach with requirements aimed at deterring, detecting and removing potentially dangerous drugs from the supply chain.

Johnson & Johnson has met every milestone for the November 27, 2023, deadline and is extending robust supply chain security, traceability and reporting to all customers. With the addition of a one-year enforcement discretion and system stabilization period enacted by the FDA, Johnson & Johnson will support the customer adoption of using our Transaction Information data and collaborate with our industry partners to ensure an end-to-end interoperable trace system.

Should you have any questions, please refer to our list of contacts below.

General DSCSA Inquiries or Delivery Issues
Continue to contact U.S. Pharmaceuticals Customer Service:
Email: [email protected]
Phone: (800) 631-5273

Transaction Data

Serialized transaction information has been sent electronically to system integrated trading partners via Electronic Product Code Information Systems (EPCIS).  All other trading partners may access their serialized transaction data on our web portal at https://sta.ich4ls.cloud.sap/index.html#/staLogin/JNJ

If Patriot Pharmaceuticals, LLC is hosting your Transaction Information and Transaction Statement (TI/TS) data in a web portal; you may access your delivery information through the Single Transaction Access Portal (No GLN registration).

Single Transaction Access portal instructions

Should you require additional assistance, please contact Customer Service at
(800) 631-5273 or [email protected].

Suspect / Potential Illegitimate Product Investigations
If you would like to notify Johnson & Johnson about potential suspect or illegitimate product, please contact [email protected].

What is the JOM Pharmaceutical Services, Inc. approach to comply with DSCSA Transaction, Statement, and History information?

JOM Pharmaceutical Services, Inc. has chosen to comply by passing DSCSA Transaction Information and Statement electronically via Johnson & Johnson Customer Connect.

Please follow these steps to obtain your lot level compliance information.

Are there specific products distributed by JOM Pharmaceutical Services, Inc. that are impacted by DSCSA?

`Product' means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing.

Per the definition in the DSCSA, all Janssen Pharmaceuticals, Inc., Janssen Products, LP, and Janssen Biotech, Inc. products distributed by JOM Pharmaceutical Services, Inc. on the list below are impacted.

http://jom.com/products.html

Where can I obtain more information regarding the DSCSA?

http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/

The use of NDC as product identifier vs. NDC with ‘Mod Code’ extension?

For logistics purposes, JOM often uses ‘Mod Codes’, a two digit identifiers, at the end of the NDC to identify a product with change in quantity, presentation, or insert. If searching for an NDC on the pack list, our primary means of DSCSA compliance, please refer to the first 10 digits in ‘NDC’ column.

What is the ‘Transaction Date’ and what is the ‘Ship Date’?

All JOM pack lists will contain only one date. This date will always reflect the ‘Transaction Date’ per the DSCSA lot level requirements. This date is also normally the ‘Shipment Date’ per DSCSA requirements unless there is an extenuating logistics reason for it to differ. (e.g.; weather, natural disaster, weekend pickup, etc.)

How does JOM plan to display ‘strength of product’ for products with multiple APIs?

JOM has chosen to not include ‘strength of product ‘in the description field for products with multiple active ingredients. The best example of this is our oral contraceptive products which contain multiple active ingredients of differing strengths.