[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Pages 73083-73086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28711]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2083]


Draft Guidance for Industry on Drug Supply Chain Security Act 
Implementation: Annual Reporting by Prescription Drug Wholesale 
Distributors and Third-Party Logistics Providers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Drug Supply 
Chain Security Act Implementation: Annual Reporting by Prescription 
Drug Wholesale Distributors and Third-Party Logistics Providers.'' This 
draft guidance addresses new provisions in the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain 
Security Act (DSCSA). The draft guidance describes FDA's expectations 
for prescription drug wholesale distributors (wholesale distributors) 
and third-party logistics providers (3PLs) about reporting to FDA under 
the DSCSA.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 9, 2015. Submit either electronic or written 
comments concerning the collection of information proposed in the draft 
guidance by February 9, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, 4147, Silver Spring, MD 
20993; or the Office of Communication, Outreach and Development, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Suzanne Barone, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Drug Supply Chain Security Act Implementation: Annual 
Reporting by Prescription Drug Wholesale Distributors and Third-Party 
Logistics Providers.'' This guidance is being issued to facilitate 
implementation of new reporting provisions under the DSCSA. On November 
27, 2013, the DSCSA (Title II of Pub. L. 113-54) was signed into law. 
The DSCSA outlines new requirements for the licensing of prescription 
drug wholesale distributors and 3PLs.
    Section 204 of the DSCSA amends section 503(e) of the FD&C Act (21 
U.S.C. 353(e)) and outlines requirements for reporting by wholesale 
distributors. Section 503(e)(2)(A) of the FD&C Act (as amended) 
requires wholesale distributors to report annually, beginning on 
January 1, 2015. Information to be reported includes State licensure 
information and contact information for each facility. Wholesale 
distributors are also to report to FDA any significant disciplinary 
actions taken by the State or Federal Government, such as revocation or 
suspension of a license. Section 204 of the DSCSA also amends section 
503(e)(2)(B) of the FD&C Act and requires FDA to make information about 
wholesale distributors' licensure available to the public on FDA's Web 
site. Updates to the public information are to be made on a schedule to 
be determined by FDA.
    Section 205 of the DSCSA adds section 584 to the FD&C Act. Section 
584 sets forth requirements for licensure and reporting by 3PLs. Under 
section 584 of the FD&C Act (as amended) (21 U.S.C. 360eee-3), 3PLs are 
required to report annually to FDA, beginning on November 27, 2014 (1 
year after the date of enactment of the DSCSA). Third-party logistic 
providers are required to report State licensure information, name and 
address for each facility, and all trade names under which each 
facility conducts business.

[[Page 73084]]

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking about 
information that should be submitted to FDA, the timing of the 
submissions, a preferred format for the submissions, and a preferred 
method for reporting to FDA by wholesale distributors and 3PLs. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    The draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of the information collection 
are given under this section with an estimate of the reporting burdens. 
Included in the estimate is the time for reviewing instructions, 
searching existing data sources, and completing and reviewing the 
collection of information annually.
    We invite comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Drug Supply Chain Security Act Implementation: Annual 
Reporting by Prescription Drug Wholesale Distributors and Third-Party 
Logistics Providers.
    Description: On November 27, 2013, the DSCSA was signed into law. 
Section 503(e)(2) of the FD&C Act requires licensed wholesale 
distributors to report annually, beginning January 1, 2015. Information 
to be reported includes each State by which the wholesale distributor 
is licensed and the appropriate identification number of each license; 
and the name, address, and contact information of each facility at 
which, and all trade names under which, the wholesale distributor 
conducts business. Wholesale distributors are also required to report 
any significant disciplinary actions, such as revocation or suspension 
of a license. In addition, FDA is requesting the voluntary submission 
of a unique facility identifier, the expiration date of each State 
license, and documents associated with the disciplinary action, such as 
consent decree, final State Board ruling, etc.
    The DSCSA also outlines reporting requirements for 3PLs. Under 
section 584 of the FD&C Act (as amended), 3PLs are required to report 
to FDA annually, beginning 1 year after the enactment of the DSCSA 
(November 27, 2014), the State by which a facility is licensed and the 
appropriate identification number and the name, address, and all trade 
names under which the facility conducts business. Because certain 
additional information will be useful to FDA in its enforcement of the 
Act, FDA is also requesting that 3PLs voluntarily provide the same 
information as wholesale distributors. 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.

A. Estimates of Reporters

    The exact number of wholesale distributors required to report to 
FDA is unknown because the license status information for each 
wholesale distributor facility is currently maintained by each State. 
The DSCSA excludes several categories of businesses from the definition 
of wholesale distribution that may have been licensed by States as 
wholesale distributors before the DSCSA was enacted. FDA estimates that 
about 5,000 wholesale distributor facilities will report to FDA. This 
number is based on estimates of active wholesale facilities that 
distribute pharmaceuticals which include drugs, proprietaries, and 
sundries according to Dun & Bradstreet. This number may be an 
overestimation since this category may contain distributors that do not 
distribute prescription drugs.
    The exact number of prescription drug 3PLs in the United States is 
also unknown because prior to the enactment of DSCSA, most states 
licensed 3PLs as wholesale distributors with the exception of 
Florida.\1\ The International Warehouse Logistics Association (IWLA) 
has stated that the best estimate of the number of 3PLs involved with 
prescription drugs is indicated by the number licensed by Florida.\2\ 
Therefore, FDA is using the number of 3PLs licensed by Florida as an 
estimate of the number of 3PLs in the United States. The Florida Drugs, 
Devices, and Cosmetics Licensee Files database (on July 16, 2014) 
contains 136 warehouses licensed as 3PLs, located in 28 different 
states. The location of each facility was verified by license number.
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    \1\ Title XXXIII chapter 499 Florida statues (http://www.flsenate.gov/laws/statutes/2011/0499.01)
    \2\ ``Third-Party Logistics Providers Licensure Requirements'' 
Pat O'Connor, IWLA, presented at DQSA: Meeting Supply 
Responsibilities, Food and Drug Law Institute, February 20, 2014, 
Washington, DC.
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B. Initial Report

    FDA estimates that the time and effort for wholesale distributors 
and 3PLs to make the initial report to FDA will be greater than 
reporting for subsequent reports made thereafter because of the amount 
of information submitted will include all State licensure information. 
Subsequent reports submitted to FDA will only include information that 
needs to be updated or added.
    Each wholesale distributor must report the following information 
for each facility:
     Name, address, and contact information (including email 
address and telephone number),
     each State license and license identifying number,
     all trade names that the facility conducts business as 
(dba), and
     significant disciplinary actions.
    In addition, FDA is requesting that wholesale distributors report 
the following information:
     Expiration dates for each State license,
     unique facility identifier (D-U-N-S number), and
     documents associated with the disciplinary action, such as 
a consent decree, final State Board ruling, etc.
    3PLs should submit the same information as wholesale distributors, 
including significant disciplinary actions. Some of this information is 
required under the DSCSA to be submitted by 3PLs including name, 
address, State license, and State license identifying number; the other 
categories are voluntary for 3PLs.
    The information listed above is readily available to the 
facilities, including the unique facility identifier. FDA currently 
prefers D-U-N-S number as the unique facility identification for the 
location of each facility. For a facility that has not been assigned a 
number, a number may be obtained for no cost directly from Dun & 
Bradstreet (http://www.dnb.com). Each facility may have differing

[[Page 73085]]

numbers of State license information to input and may or may not have 
any significant disciplinary actions for each State. FDA is providing a 
Web portal for the efficient entry and submission of this information. 
Companies using this portal will not have to convert the information to 
report into an extensible markup language (XML) file in the Structured 
Product Label (SPL) format and submit it separately through the FDA 
gateway. No special computer program or expertise is required if the 
Web portal is used. We estimate that it will take wholesale 
distributors and 3PLs on average about 0.5 hours per facility to 
collect and input this information for the initial reporting, for a 
total burden for the first year of 2,568 hours. Refer to table 1.

C. Subsequent Annual Reports

    FDA will maintain the information submitted previously for each 
facility's initial report. This information will be readily accessible 
through the FDA-supplied Web portal. This eliminates the need for re-
entry of all of the information each year. We estimate that it will 
take 0.25 hours each subsequent year to review and update information 
such as, but not limited to, a license expiration date following 
renewal or a resolution of a disciplinary action. The total annual 
burden for wholesale distributors and 3PLs is 1,284 hours (table 2).

D. Significant Disciplinary Action Reports

    Wholesale distributors are required and 3PLs are requested to 
report significant disciplinary actions. The number of distributors and 
3PLs that will have significant disciplinary action taken against them 
is unknown. Disciplinary actions are currently handled by the 
individual States' regulatory authorities. FDA does not believe that 
the number of significant disciplinary actions that would limit the 
ability of a wholesale distributor or 3PL to warehouse and/or 
distribute prescription drugs would be greater than 1 percent of the 
total number of facilities that report on an annual basis. This would 
be equivalent to approximately 50 wholesale distributors and 2 3PLs. 
Significant disciplinary action information requested should be readily 
available to each wholesale distributor and 3PL involved in the action. 
FDA estimates that it will take 0.5 hours for the wholesale distributor 
or 3PL to access the system, input information, and upload documents 
(if available) using the Web portal. FDA estimates that the total 
annual burden of reporting significant disciplinary action is 26 hours 
(table 3).

E. Other Voluntary Reports

    FDA is also requesting that a wholesale distributor or 3PL notify 
FDA within 30 days if a facility goes out of business or voluntarily 
withdraws a State or Federal license. FDA estimates that this reporting 
type will occur infrequently; involving five wholesale distributor 
facilities and one 3PL facility per year. We estimate that it will take 
0.25 hours to update the company or license status. FDA estimates that 
the total annual burden of reporting these voluntary reports is 1.5 
hours (table 4).
    Description of Respondents: Respondents are prescription drug 
wholesale distributors and third-party logistics providers and might 
include small businesses in these categories.

                                       Table 1--Initial Report Burden 1 2
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                                                  Number of
   Initial reporting to FDA       Number of     responses per   Total initial   Average  burden     Total hours
                                 respondents     respondent       responses       per response
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Wholesale Distributors.......           5,000               1           5,000  0.5 hour (30                2,500
                                                                                minutes).
3PLs.........................             136               1             136  0.5 hour (30                   68
                                                                                minutes).
                              ------------------------------------------------                   ---------------
    Total....................  ..............  ..............  ..............  .................            2568
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\1\ Any fraction is rounded up to a whole number.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                     Table 2--Subsequent Reports Burden \1\
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                                                  Number of
   Annual reporting to FDA        Number of     responses per       Total       Average  burden     Total hours
                                 respondents     respondent       responses       per response
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Wholesale distributors.......           5,000               1           5,000  0.25 hour (15               1,250
                                                                                minutes).
3PLs.........................             136               1             136  0.25 hour (15                  34
                                                                                minutes).
                              ------------------------------------------------                   ---------------
    Total....................  ..............  ..............  ..............  .................           1,284
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                           Table 3--Significant Disciplinary Action Report Burden \1\
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                                                  Number of
   Significant disciplinary       Number of     responses per       Total       Average  burden     Total hours
           actions               respondents     respondent       responses       per response
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Wholesale distributors.......              50               1              50  0.5 hour (30                   25
                                                                                minutes).
3PLs.........................               2               1               2  0.5 hour (30                    1
                                                                                minutes).
                              ------------------------------------------------                   ---------------

[[Page 73086]]

 
    Total....................  ..............  ..............  ..............  .................              26
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                   Table 4--Other Voluntary Reports Burden \1\
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                                                  Number of
   Other voluntary reports        Number of     responses per       Total       Average  burden     Total hours
                                 respondents     respondent       responses       per response
----------------------------------------------------------------------------------------------------------------
Wholesale distributors.......               5               1               5  0.25 hour (15                1.25
                                                                                minutes).
3PLs.........................               1               1               1  0.25 hour (15                0.25
                                                                                minutes).
                              ------------------------------------------------                   ---------------
    Total....................  ..............  ..............  ..............  .................            1.50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

F. Capital Costs

    There are no capital costs associated with this collection and 
reporting of information if the FDA-provided Web portal is used for 
reporting.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: December 3, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28711 Filed 12-8-14; 8:45 am]
BILLING CODE 4164-01-P