PREPARE YOUR SUPPLY CHAIN:

ADAPT TO PHARMACEUTICAL HANDLING CHANGES

Who This Affects

• Pharmaceutical Manufacturers

• Re-packagers

• Wholesale Distributors

• 3PLs

• Dispensers

New DQSA Regulation for 3PLs

Logistics providers will be required to obtain licensing described in the Drug Quality and Security Act.

Reporting requirements will be adapted for new regulatoryrequirements

DQSA establishes standards/ requirements for product traceabilityof pharmaceutical products throughout the supply chain

*These changes started to go into effect in November 27, 2014

New DQSA Regulation for 3PLs

1. 3PLs are redefined under DQSA

• Coordinate logistics services in interstate commerce• Entity does not own the product• Do not have the responsibility to sell product being handled

2. 3PLs are subject to federal regulations for product traceability and transaction verification

New DQSA Regulation for 3PLs

3. 3PLs can no longer operate using state licensing programs that are not in compliance with regulations established under federal licensing programs

4. 3PLs must report:• Facility identification data for licensed facilities• Licensure information• Recommended data: contact information, unique facility

identifiers, license expiration dates, disciplinary action details

New Pharmaceutical LicensingStandards

National licensure standards have been created:

• 3PLs must obtain licenses from states where product is beingdistributed and/or distributed to

• FDA may individually license 3PLs that cannot receive licenses directly from the state and if no accreditation can be obtained

Purpose of New Regulation

Assist in prevention of counterfeit and contaminated productreaching consumers

Regulations took into consideration both internal and externalquality threats

Tools to Assist in DQSA Compliance forYour 3PL

• Mobile Solutions

• RFID

• Inventory Management Software

• Full track & trace functionality

• Compliant label generation

• Ingredient tracking

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