DSCSA Self Audit for Manufacturers

The Drug Supply Chain Security Act (DSCSA) includes requirements that manufacturers must follow when 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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