JOM Pharmaceutical Services, Inc.

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


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


H.R. 3204, The Drug Quality and Security Act (DQSA) was signed into law on November 27, 2013. Title II, the Drug Supply Chain Security Act outlines a staged implementation extending over 10 years requiring the use of the serialized product identifiers by all pharmaceutical supply chain partners at the unit level including repackagers, wholesalers, and pharmacies. The first of these provisions, requiring exchange of Transaction Information, History, and Statement takes effect on January 1, 2015.


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/

How is Johnson & Johnson complying with serialization regulations?


By 2018, 75 percent of all pharmaceutical products in the global market will require some form of serialization. Johnson & Johnson has launched a multi-year, worldwide effort to not only comply with these regulations but utilize serialization as a means to continue providing safe medicines to the patients who need them. These enhancements include retrofits to manufacturing, distribution, labeling and technology platforms to enable the addition of unique identifiers to our products and means to trace them effectively through the supply chain.


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.


For more information, please contact the End- to- End Traceability team at (800) 631-5273.