FDA Releases Draft Guidance on Wholesale Drug Distributor and 3PL License Reporting Under DSCSADecember 10, 2014
By Andrew J. Hull* & William T. Koustas –
Piece by piece, FDA has been releasing guidance documents to implement the Drug Supply Chain Security Act (“DSCSA”). As we reported last week (see our previous post here), FDA created a database to allow wholesale drug distributors and third-party logistics providers (“3PLs”) to comply with the DSCSA’s annual state licensure reporting requirements. Unexpectedly, and perhaps caught up in the holiday spirit, FDA has now published a draft guidance, entitled “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers” (“Draft Guidance”), to provide some much-needed direction for wholesale distributors and 3PLs attempting to comply with DSCSA reporting requirements.
Under the DSCSA, wholesale distributors and 3PLs are required to report certain facility and state licensure information to FDA on an annual basis. FDCA §§ 503(e)(2), 584(b). 3PLs were required to begin reporting this information as of November 27, 2014, and wholesale distributors must begin to report on January 1, 2015. While FDA is required by statute to make all reported information from wholesale distributors public on its website, the Draft Guidance states that FDA will also make all information reported by 3PLs available on its website. The Draft Guidance lays out what must be reported in initial and subsequent reports, when such reports must be made to FDA, and how to make such reports.
Content of Reports
The Draft Guidance distinguishes between information that wholesale distributors and 3PLs must report (i.e., as required by statute) and information that, according to FDA, they should report on a voluntary basis. Additionally, FDA requests in the Draft Guidance that wholesale distributors and 3PLs report the same information in order for there to be one “public database to serve as a single repository of licensing and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.” Draft Guidance at 3.
By statute, wholesale distributors must report certain information for each facility they operate:
1) Identifying information for the facility
- Name of the company (While not required by statute, FDA recommends providing the company name in the same form as it appears on the license)
- Address of the facility
- Contact information (While not required by statute, FDA recommends providing the name of a contact person to interact with FDA, an email address, and a telephone number)
- All trade names that the company does business as (i.e., any other names listed as “dba”)
2) Licensure information for each state
- State license number (identification number)
- Significant disciplinary actions by any state or federal agency (FDA recommends describing any significant disciplinary action that occurred in the 12 months preceding the initial report by identifying the type of disciplinary action, the date of final disciplinary action, and the state where the disciplinary action occurred)
In addition, the Draft Guidance states that wholesale distributors should report the following information for each facility they operate:
1) A unique facility identifier (FDA recommends a Dun & Bradstreet number)
2) Expiration date for the license
3) Documents associated with the disciplinary action, such as a consent decree, final state board ruling, etc.
By statute, 3PLs must report certain information for each facility they operate:
1) Name of company (While not specifically required by statute, FDA recommends providing the company name in the same form as it appears on the license)
2) Address of the facility
3) All trade names that the company does business as (i.e., any other names listed as “dba”)
4) Licensure information for each state
- State license number (identification number)
In addition, the Draft Guidance states that 3PLs should report the following information for each facility:
1) Name of contact person to interact with FDA
2) Email address
3) Telephone number
4) Unique facility identifier
5) Expiration date for the license
6) Significant disciplinary actions by any state or federal agency that occurred in the 12 months preceding the initial report
- State where disciplinary action occurred
- Date of final action
- Type of disciplinary action
- Description of violation
- Documents associated with the disciplinary action, such as a consent decree, final state board ruling, etc.
While 3PLs are considered to be licensed under the DSCSA until the effective date of FDA’s forthcoming 3PL licensing regulations, the Draft Guidance clarifies that they are still required to report to FDA under the DSCSA, even if they are not licensed under a state 3PL licensing program.
All annual reports submitted by wholesale distributors and 3PLs subsequent to the initial reports are considered subsequent reports. The Draft Guidance states that the same mandatory and voluntary information set forth in the initial reports is also required in subsequent reports.
Initial reports by wholesale distributors must be submitted between January 1 – March 31, 2015, while 3PLs must submit the same information between November 27, 2014 – March 31, 2015. Facilities that obtain new federal or state licenses after these dates should submit their initial report within 30 days of obtaining the license.
Subsequent annual reports for wholesale distributors and 3PLs are due annually during the annual reporting period of January 1st – March 31st.
Significant disciplinary action reports for both wholesale distributors and 3PLs should be submitted to FDA within 30 days of final action.
Facilities that go out of business or voluntarily withdraw a license should notify FDA within 30 days.
Method of Reporting
The Draft Guidance states that FDA prefers that reports be submitted with extensible markup language (“XML”) files in Structured Product Labeling (“SPL”) format. Information can be submitted by a link to a web portal on FDA’s website.
All in all, FDA’s Draft Guidance seems to provide some clarity for wholesale distributors and 3PLs attempting to comply with DSCSA reporting requirements. FDA’s interpretation of the statutory reporting date allows submission of required information by March 27, 2015, which seems reasonable in light of impending (and expired) statutory deadlines for reporting. Now, with a method of reporting in place and direction from FDA, wholesale distributors and 3PLs should have a better understanding of the process of complying with the DSCSA licensure reporting requirements. We may update this post as we further digest the Draft Guidance.
* Admitted only in Virginia. Work supervised by the Firm while D.C. application pending.