Who, When, What and How – DSCSA Reporting By Wholesale Distributors and Logistics Providers
The Drug Supply Chain Security Act (DSCSA) sets out to provide a safe and secure process to get drugs all the way from the manufacturer’s laboratory and the manufacturing plant to the final consumer. There are a lot of steps along the way and the DSCSA places requirements and responsibilities on manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. What concerns us in this post today is the reporting requirements the Act places on wholesale distributors and logistics providers.
Wholesale distributors and third-party logistics providers (3PLs) are required to be licensed by the FDA. They are also required to submit annual reports. It’s easy enough to know who is a licensed wholesale distributor or 3PL because the FDA maintains a list of them all on its website. If a company claims to be licensed and is not on the FDA website the first assumption must be that it is not, in fact, licensed and further enquiry should be made before dealing with such a company.
It is possible for one company to be licensed as both a wholesale distributor and a logistics provider. In such cases, the company must submit to separate reports: one as a wholesale distributor and one as a logistics provider.
The FDA requires that each facility owned by a company should be given its own unique identifier and that these identifying numbers should be included in the reports.
Wholesale distributors: initial report
The first report submitted to the FDA by any wholesale distributor is known as the initial report. Note that a report has to be submitted for each facility; a single report for the whole company is not sufficient unless the company only has one site. This applies also to subsequent reports. The report falls into two sections:
Identifying information for the facility
- Name of the company (in the same form as it appears on the license)
- Address of the facility
- Contact information: the name, email address and telephone number of a person authorized to interact with FDA
- All trade names under which the company does business
Licensure information for each State
- Name of State
- State license number
- Date the license expires
- Significant disciplinary actions by any State or Federal agency occurring in the 12 months preceding the initial report identifying the type of disciplinary action, the date of final disciplinary action, and the state where the disciplinary action occurred
Documents associated with the disciplinary actions should accompany the report.
Third party logistics providers: initial report
The first report submitted to the FDA by any third party logistics provider is known as the initial report. Once again, a report has to be submitted for each facility; a single report for the whole company is not sufficient unless the company has only one site. The report falls into two sections:
Identifying information for the facility
- Name of the company (in the same form as it appears on the license)
- Address of the facility
- Contact information: the name, email address and telephone number of a person authorized to interact with FDA
- All trade names under which the company does business
Licensure information for each State
- Name of State
- State license number
- Date the license expires
- Significant disciplinary actions by any State or Federal agency occurring in the 12 months preceding the initial report identifying the type of disciplinary action, the date of final disciplinary action, and the state where the disciplinary action occurred
Documents associated with the disciplinary actions should accompany the report.
Some States don’t have a separate licensing arrangement for 3PLs and in such cases no license number or expiry date can be provided but the FDA still requires that each State in which a 3PL operates should be included on the report.
Subsequent reports
The requirements for reports submitted after the initial reports are that they should contain the same information as the initial reports and reports are required to be submitted in the timeframe January 1 to March 31 each year.
In addition, reports of significant disciplinary actions should be submitted to the FDA within 30 days of the final action or ruling by a State or Federal licensing authority. A report should also be sent for any facility that goes out of business or voluntarily withdraws from a State or Federal license.
How to report
The FDA maintains a reporting portal through which 3PLs and wholesale distributors can submit their annual reports. FDA asks for reports to be submitted as XML files in a standard Structured Product Labelling (SPL) format.
TrackTraceRx customers utilize the TrackTraceRx system to automatically submit this report. If you don’t have our system, please contact us and we will walk you through submitting this annual report manually.
