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This document is scheduled to be published in the Federal Register on 07/20/2017 and available online at https://federalregister.gov/d/201715204, and on Days.gov416401P DEPARTMENT OF HEALTH AND HUMAN

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Step 1: Obtain the necessary documentation and permits required to engage in enhanced drug distribution security.

02

Step 2: Understand the regulations and guidelines set forth by regulatory authorities for enhanced drug distribution security.

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Step 3: Implement robust security measures to protect drugs during distribution, including inventory controls, tracking systems, and physical security measures.

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Step 4: Train employees on enhanced drug distribution security protocols and procedures, ensuring they understand their roles and responsibilities.

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Step 5: Conduct regular audits and inspections to ensure compliance with enhanced drug distribution security requirements.

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Step 6: Continuously monitor and update security measures to adapt to evolving threats and industry best practices.

Who needs enhanced drug distribution security?

01

Pharmaceutical manufacturers and distributors

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Pharmacies and healthcare facilities

03

Government agencies regulating drug distribution

04

Wholesale drug distributors

05

Transportation companies involved in drug distribution

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Third-party logistics providers handling drug transportation

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Entities involved in the shipment and delivery of pharmaceutical products

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What is enhanced drug distribution security?

Enhanced drug distribution security refers to additional measures put in place to ensure the secure distribution of pharmaceuticals.

Who is required to file enhanced drug distribution security?

Manufacturers, distributors, and repackagers of pharmaceuticals are required to file enhanced drug distribution security.

How to fill out enhanced drug distribution security?

Enhanced drug distribution security can be filled out electronically through the designated platform provided by the regulatory authority.

What is the purpose of enhanced drug distribution security?

The purpose of enhanced drug distribution security is to prevent counterfeit or illegitimate pharmaceuticals from entering the supply chain.

What information must be reported on enhanced drug distribution security?

Information such as product details, shipping routes, and security measures must be reported on enhanced drug distribution security.

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