This Annual Reporting is a must!
The Annual Reporting by Prescription Drug Wholesale Distributors and 4 Third-Party Logistics Providers deadline will be on March 31st 2015. This means that if you are pharmaceutical wholesaler you must submit your company information to the FDA. The actual FDA guidance:
This guidance describes FDA’s expectations for prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) for the annual reporting to FDA as required under the Drug Supply Chain Security Act of 2013 (DSCSA). Under section 584(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-3(b)), beginning November 27, 2014, 3PLs must report certain information to FDA, including State licensure information for each facility and the name and address for each facility. Under section 503(e)(2)(A) (21 U.S.C. 353(e)(2)(A) (as amended by the DSCSA), beginning January 1, 2015, wholesale distributors also must report certain information to FDA, including State licensure information for each facility, contact information for each facility, and any significant disciplinary actions taken by a State or the Federal Government. This guidance outlines the information that should be submitted to FDA, the timing of the submissions, a preferred format 28 for the submissions, and a preferred method for reporting to FDA.
“The DSCSA requires contact information to be submitted by wholesale distributors.”
What needs to be submitted:
The DSCSA requires contact information to be submitted by wholesale distributors. FDA considers contact information to include the email address and telephone number of the person who will interact with the FDA. In addition to the specific information required by DSCSA to be submitted to the Agency, FDA has identified additional information that will enhance efficiencies and improve accuracy in the management of the licensing and facility information submitted to the Agency. Therefore, FDA is requesting that certain additional information be submitted to FDA on a voluntary basis. This additional information will be useful to FDA in its enforcement of the Act and to stakeholders as they make decisions about their drug product distribution. Furthermore, FDA is requesting the same information from wholesale distributors and 3PLs. The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.
Where do you need to go to submit this information?
If you are a client of TrackTraceRx, we assist you in this submittal. If not please look at these links:
The actual form:
https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP:2674113566440:::::
To register for the form:
https://direct.fda.gov/apex/f?p=100:5:105890746929503::NO:::
When should you fill out this information?
Wholesale distributors: January 1, 2015–March 31, 2015
What about for newly registered company?
Wholesale distributor and 3PL facilities that are newly licensed after the dates noted above should initially report within 30 days of obtaining a State or Federal license.
When do I have to re-submit my information on an annual basis?
Wholesale distributors: January 1–March 31 annually
What else?
Reports of significant disciplinary actions should be submitted to FDA when a final action or ruling has been made by a State or Federal licensing authority.
Wholesale distributors: within 30 days of final action
A company should notify FDA if a facility goes out of business or decides to voluntarily withdraw a State or Federal license.
How do i submit this report?
FDA prefers the use of extensible markup language (XML) files in a standard Structured Product 268 Labeling (SPL)4 format.
or
Register and fill out the form here:
https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP:2674113566440:::::
Follow our Step-by-Step guide here:
http://blog.tracktracerx.com/wholesale-distributor3pl-annual-reporting-instructions/
