The new Drug Quality Security Act (DQSA) signed into law by President Obama in November 2013 takes effect January 2015. Designed to address threats to patient safety and security, the new federal law will improve the effectiveness of product recalls and provide one uniform policy nationwide. DQSA pre-empts the new California e-pedigree law as well as the 30 or so other state drug pedigree laws nationwide. This new law affects pharma manufacturers, repackagers, wholesale distributors, third party logistics providers and dispensers. This law marks the first time that the FDA has been given sweeping oversight of the pharmaceutical supply chain.
1. What You Need to Know about the Drug Quality Security Act (DQSA) By LauraM. Olson DirectorofSales and Marketing InitialImplementation Phases
2. DQSA Policy Background New regulation was needed to: • Address threats to patient safety and security • Address documented history of counterfeit product • Improveeffectiveness of product recalls • Provide a uniform policy nationwide
3. New U.S. Federal law H.R. 3204,the DrugQuality Security Act (DQSA) also knownas the DrugSupply-ChainSecurity Act (DSCSA) • Signedby President Obama -goes into effect January1,2015 • Pre-empts the California law and the 30 or so other state drug pedigree laws nationwide • Bill excludes certain classes such as blood-derived products, imagingproducts, veterinarymedicine. About the DQSA
4. Whois Covered? • Manufacturers • Repackagers • Wholesale Distributors • ThirdParty Logistics Providers • Dispensers Special note: an individual entity canoperate in morethan one capacity About the DQSA
5. • FDA starts regulatingthe pharmaceutical supply chainwith implementation of this law • This is the first time the FDAhas been given sweeping oversight of the drugsupply chain • Companies need to work out technology andprocess issues related to the implementation of phase 1 of Title IIof DQSA About the DQSA
6. DQSA Covers: • Traceability requirements generally apply to each product and transaction • Product= prescription drugs in finisheddosage form intended for humanuse • Transaction= transfer of product between persons inwhich a changeof ownership occurs About the DQSA
7. What is Exchanged: • Transaction information (TI) • Transaction history(TH) • Transaction statement (TS) About the DQSA
8. Terminology • TI=Transactioninformation • TH=Transactionhistory • TS=Transactionstatement • Dispensers: Retail pharmacies and hospital pharmacies Group of chain pharmacies undercommonownership &control Affiliated warehouses or distribution centers Anyperson legally authorizedto dispense or administer prescription drugs and theiraffiliated warehouses or distribution centers undercommon ownership orcontrol
9. Terminology Dispensersthat act as a wholesale distributor are requiredto comply with wholesaler responsibilities. This provision also applies to other supply chainentities.
10. Terminology Authorized Trading Partners Must havevalid registration, federal or state licenserequired by DQSA Entities that transfer ownership arerequired to state that they are“authorized as requiredunderthe” DQSA TransferringEntities must provide applicable license numberor registration in thetransaction statement
11. Product Identification SNI=Standard Numerical Identifier Set of characters or numbersthat is used to provide a uniqueidentification each package or homogenous case composed of the National DrugCode corresponding to the specific product and respective package configuration combined with a uniqueserial number(alphanumeric) with a maximum of 20characters.
12. Product Identification Package Defined as the“smallest individual saleable unit of a product for distribution by a Manufactureror Repackager that is intended by theManufacturerfor ultimate sale to the Dispenser of suchproduct”. 21U.S.C. §360eee(11)
13. Product Identification ProductIdentifier This is a GS-1compliant standardized graphic that includes: • Inboth machine-readabledata carrier and humanreadable form: Lot number Expiration date of theproduct Standardized numerical identifier
14. For Pharmaceutical Manufacturers Product trackingat lot level: • Must provide/receive transaction history, information &statements prior to orat the time of changeof ownership of a drug product • Provide a list of transaction information of all changesof ownership going back to manufacturer January 1,2015Timeline:
15. For Dispensers January 1, 2015: • Authorizedtrading partners only Initial Timeline:
16. Verification of product & transactionsin the case of suspected product: • Must beable to validate product with partnersas well as transaction history • Must havesystems inplace to support investigating suspect products • Must havesystems to notify FDA & all immediate trading partners about suspect product For Pharmaceutical Manufacturers January 1,2015Timeline:
17. Request for information • When requested, must be able to provide transaction info, history & statements for product within 48hours of request For Pharmaceutical Manufacturers January 1,2015Timeline:
18. November 27,2017Timeline: For Pharmaceutical Manufacturers Product Identifiers: Serialization • All drugproducts are required to beencoded with a uniqueproduct identifier that must beat thesmallest saleable unit • Without this uniqueidentifier, downstream partnersmay not purchasethe drug product
19. November 27,2017Timeline: For Pharmaceutical Manufacturers Package Level Verification • Drugproducts must beable to beverified at the package level SNI(standardized numericalidentifier)
20. November 27,2017Timeline: For Pharmaceutical Manufacturers Request for Verification • Requiredresponse time for drugproduct verification by a trading partner for a product that is in the possession of the trading partner • 24hoursto respond • Drugproduct identifier including SNI
21. Contact Us 800.933.2839 Onlinedemonstration firstname.lastname@example.org Web chat Datex Corporation @Datexcorp www.DatexCorp.com
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