DSCSA Self Audit for Wholesale Distriburtors

The Drug Supply Chain Security Act (DSCSA) includes requirements that drug wholesale distributors must follow when buy, sell, and service products in the supply chain. This is a self audit to assess your company's progress made and your readiness for the FDA's interoperability requirement in 2023.

Company Name*

How many pharmacies do you own?

Name*

Title

Email*

Phone*

City, State*

I heard about FDA's DSCSA from:

FDA

Wholesalers

Solution Providers

GPO

My friends

Google

Other

DSCSA 2015 requirements*

I satisfy these DSCSA 2015 requirements:

A. I only do business with authorized trading partners

B. I have systems to quarantine suspect products then report to the FDA

C. I can verify drugs utilizing a secure electronic database

D. I do all of the above

E. I do some of the above

F. I do none of the above

G. I need help

DSCSA 2017 Requirements*

I satisfy these DSCSA 2017 requirements:

A. I receive electronic transaction history, information, and statement (3Ts)

B. I don't receive 3Ts

C. I need help

DSCSA 2020 Requirements*

I satisfy these DSCSA 2020 requirements:

A. I only buy or sell Rx products with 2D data matrix barcode

B. I verify suspect products using the serial data

C. I do all of the above

D. I do one of the above

E. I need help

DSCSA 2023 Requirements

I satisfy these DSCSA 2023 requirements:

A. I plan to exchange serial data

B. I plan to verify serialized products

C. I plan to respond to FDA requests

D. I plan to do all of the above

E. I need help

My DSCSA solutions are:*

The portals from my wholesaler and suppliers

A third-party DSCSA solution

My inventory system

I don't have a solution

The name/provider of my solution is:

I am able to scan 2D data matrix barcodes

Yes

My concerns about DSCSA are:

Patient safety

FDA and State compliance

Disciplinary actions

The cost of DSCSA solutions

My other concerns are:

I would like help from LSPediA

Yes

Send me a copy of my responses

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