what you need to know about the drug quality security act (dqsa)
DESCRIPTION
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. For more information, visit www.datexcorp.com.TRANSCRIPT
What You Need to Know about the Drug Quality Security Act (DQSA)
By Laura M. OlsonDirector of Sales and Marketing
Initial Implementation Phases
DQSA Policy Background
New regulation was needed to:
• Address threats to patient safety and security
• Address documented history of counterfeit product
• Improve effectiveness of product recalls
• Provide a uniform policy nationwide
New U.S. Federal law H.R. 3204, the Drug Quality Security Act (DQSA) also known as the Drug Supply-Chain Security Act (DSCSA)
• Signed by President Obama - goes into effect January 1, 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, imaging products, veterinary medicine.
About the DQSA
Who is Covered?
• Manufacturers• Repackagers• Wholesale Distributors• Third Party Logistics Providers• Dispensers
Special note: an individual entity can operate in more than one capacity
About the DQSA
• FDA starts regulating the pharmaceutical supply chain with implementation of this law
• This is the first time the FDA has been given sweeping oversight of the drug supply chain
• Companies need to work out technology and process issues related to the implementation of phase 1 of Title II of DQSA
About the DQSA
DQSA Covers:
• Traceability requirements generally apply to each product and transaction
• Product= prescription drugs in finished dosage form intended for human use
• Transaction= transfer of product between persons in which a change of ownership occurs
About the DQSA
What is Exchanged:
• Transaction information (TI)
• Transaction history (TH)
• Transaction statement (TS)
About the DQSA
Terminology
• TI=Transaction information
• TH=Transaction history
• TS=Transaction statement
• Dispensers:
Retail pharmacies and hospital pharmacies
Group of chain pharmacies under common ownership & control
Affiliated warehouses or distribution centers
Any person legally authorized to dispense or administer prescription drugs
and their affiliated warehouses or distribution centers under common
ownership or control
Terminology
Dispensers that act as a wholesale distributor are required to comply with wholesaler responsibilities.
This provision also applies to other supply chain entities.
Terminology
Authorized Trading Partners
Must have valid registration, federal or state license required by DQSA
Entities that transfer ownership are required to state that they are “authorized as required under the” DQSA
Transferring Entities must provide applicable license number or registration in the transaction statement
Product Identification
SNI=Standard Numerical Identifier
Set of characters or numbers that is used to provide a unique identification eachpackage or homogenous case composed of the National Drug Code correspondingto the specific product and respective package configuration combined with a unique serial number (alphanumeric) with a maximum of 20 characters.
Product Identification
Package
Defined as the “smallest individual saleable unit of a product for distribution by aManufacturer or Repackager that is intended by the Manufacturer for ultimate saleto the Dispenser of such product”.
21 U.S.C. § 360eee(11)
Product Identification
Product Identifier
This is a GS-1 compliant standardized graphic that includes:
• In both machine-readable data carrier and human readable form:
Lot numberExpiration date of the product Standardized numerical identifier
For Pharmaceutical Manufacturers
Product tracking at lot level:
• Must provide/receive transaction history, information & statements prior to or at the time of change of ownership of a drug product
• Provide a list of transaction information of all changes of ownership going back to manufacturer
January 1, 2015 Timeline:
For Dispensers
January 1, 2015:
• Authorized trading partners only
Initial Timeline:
Verification of product & transactions in the case of suspected product:
• Must be able to validate product with partners as well as transaction history
• Must have systems in place to support investigating suspect products
• Must have systems to notify FDA & all immediate trading partners about suspect product
For Pharmaceutical Manufacturers
January 1, 2015 Timeline:
Request for information
• When requested, must be able to provide transaction info, history & statements for product within 48 hours of request
For Pharmaceutical Manufacturers
January 1, 2015 Timeline:
November 27, 2017 Timeline:
For Pharmaceutical Manufacturers
Product Identifiers: Serialization
• All drug products are required to be encoded with a unique product identifier that must be at the smallest saleable unit
• Without this unique identifier, downstream partners may not purchase the drug product
November 27, 2017 Timeline:
For Pharmaceutical Manufacturers
Package Level Verification
• Drug products must be able to be verified at the package level SNI (standardized numerical identifier)
November 27, 2017 Timeline:
For Pharmaceutical Manufacturers
Request for Verification
• Required response time for drug product verification by a trading partner for a product that is in the possession of the trading partner
• 24 hours to respond
• Drug product identifier including SNI
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