The US FDA has issued draft norms for annual reporting by prescription drug wholesale distributors and Third Party Logistics (TPL) providers. It has also insisted that the comments on the draft guidance will need to be submitted within 60 days by March end.
The draft guidance addresses questions and clarifies the regulator’s expectations for annual reporting by prescription drug wholesale distributors and TPL providers.
In 2014, FDA had published a draft guidance for industry entitled Drug Supply Chain Security Act of 2013 (DSCSA): Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers. This norm supplements the information in the Annual Reporting draft guidance by addressing questions and comments that FDA received.
Under the norms, if a manufacturer is engaged in wholesale distribution, he is required to report information related to its wholesale distributor license. However, the distribution of a manufacturer’s own drug is exempt from the definition of wholesale distribution.
The wholesale distributors or Third Party Logistics facilities that distribute only over-the-counter drugs need to not report to the regulator because the guidance was specific to only prescription drugs. The wholesale distributors and TPL facilities that only distribute and provide services related to animal drugs need not report. But the TPL facilities that provide services related to only prescription drug samples are required to report. Prescription drug samples are not exempt from the definition of product in section.
Wholesale distributors should report all licenses that authorize wholesale distribution. This includes licenses from any State that the wholesale distributorships the human prescription drug from.
For routine annual reporting, TPL facilities should not report the Drug Enforcement Agency (DEA) registration numbers or State controlled-substance licenses to FDA. The only exception is when there is a significant disciplinary action issued by the DEA or the State controlled-substance licensing authority that would limit the ability of an entity to distribute human prescription drug products. In that case, information about the DEA registration or State controlled-substance license should be reported because the disciplinary action is reported under that specific license or registration, stated the draft guidance.
The Unique Facility Identifier (UFI) is used to either obtain an account to report using the Center for Drug Evaluation and Research (CDER) Direct Electronic Submissions Portal or to report using an alternative mechanism such as through the FDA Electronic Submissions Gateway. The UFI is not required for each facility at this time. However, if a UFI is reported, the electronic system will perform a validation of the UFI against the company name and facility address that corresponds with that UFI. If the company name and address do not correspond with the information associated with the UFI, the system will not accept the submission. A UFI should be obtained for each separate address.