PDSA Sends Comments to FDA in Response to Licensing and Reporting Drafted Guidance

PDSA_LogoAs a member of the Pharmaceutical Distribution Security Alliance, IWLA members contributed to the comments sent to the Federal Register on the U.S. Food and Drug Administration (FDA) “Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-party Logistics Providers.”

From Nov. 27, 2014, to March 31, 2015, 3PLs must report licensure (state licensure included if applicable) information for each facility and provide the name/address of each facility to the FDA. After the first year, the reporting requirement must be done on an annual basis, from Jan. 1 to March 31.

Here is a recap of what the industry found in this guidance and the recommendations made to the FDA:

  1. Significant differences were uncovered between the reporting requirements guidance and the DSCSA statutory text.
    1. DSCSA outlines different requirements for third-party providers and wholesale distributors. The drafted guidance does not.
    2. The statute does not require submission of a facility identifier, the guidance and completion within the portal requires a D-U-N-S number.
    3. DSCSA limits the information that can be publicized through the database, the guidance does not.
    4. DSCSA establishes a public database for wholesaler distributors only, while the guidance publicizes 3PLs as well.
  2. DSCSA outlines a clear and concise definition for a wholesale distributor and a 3PL. The PDSA comments urge the FDA to reiterate those definitions in the guidance so that it is clear to the industry and under state definitions.
  3. Add language to clarify the reporting of licensing within 30 days of receipt of license information, not effective dates. Similarly the reporting of disciplinary action within 30 days of the final
  4. Eliminate the D-U-N-S facility identification number requirement on the basis that:
    1. Wholesale distributors and 3PLs can be co-located in a facility.
    2. Many 3PLs obtain a D-U-N-S number for multiple facilities.
    3. Obtaining D-U-N-S numbers takes significant time/effort.
    4. D-U-N-S numbers can easily be traced to a location which raises security issues.
  5. Add language to allow a single contact to be responsible for multiple facilities.
  6. Educate the industry on the functionality of the online portal via webinar. PDSA outlines several recommendations for the online portal:
    1. Import functionality from a single Excel file.
    2. Editing functionality once submitted.
    3. Expand the portal to include licensing renewals.
    4. Optional additional information is required in order to complete submissions.

Read the comments here. Stay tuned for continued discussion with the FDA.

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