[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67408-67409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2270]


The Drug Supply Chain Security Act Implementation: Product 
Tracing Requirements for Dispensers--Compliance Policy; Updated 
Guidance for Industry, Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; revised guidance document.

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SUMMARY: The Food and Drug Administration (FDA or we) is issuing a 
revised guidance document that extends the compliance policy described 
in the guidance for industry entitled ``DSCSA Implementation: Product 
Tracing Requirements for Dispensers--Compliance Policy.'' This revised 
guidance announces FDA's intention with regard to enforcement of 
certain product tracing requirements of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act 
(DSCSA). FDA does not intend to take action against dispensers who, 
prior to March 1, 2016, accept ownership of product without receiving 
transaction information, transaction history, and transaction 
statements (product tracing information), prior to or at the time of a 
transaction, or do not capture and maintain the product tracing 
information, as required by the FD&C Act.

DATES: Effective November 2, 2015. For information about enforcement 
dates, please see the SUPPLEMENTARY INFORMATION section.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-2270 for ``The Drug Supply Chain Security Act 
Implementation: Product Tracing Requirements for Dispensers--Compliance 
Policy; Revised Guidance for Industry.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the

[[Page 67409]]

Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 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

    On July 6, 2015, FDA published a Notice of Availability in the 
Federal Register (80 FR 38449) announcing a guidance document entitled 
``DSCSA Implementation: Product Tracing Requirements for Dispensers--
Compliance Policy.'' The guidance described FDA's intention with regard 
to enforcement of the product tracing information requirements under 
section 582(d)(1) of the FD&C Act (21 U.S.C. 360eee-1(d)(1)). FDA is 
issuing a revised guidance that extends the compliance policy described 
in the guidance. We are issuing this guidance consistent with our good 
guidance practices regulation (21 CFR 10.115). We are implementing this 
guidance without prior public comment because we have determined that 
prior public participation is not feasible or appropriate (21 CFR 
10.115(g)(2)). We made this determination because this guidance 
document provides information pertaining to certain statutory 
requirements that took effect on July 1, 2015, regarding the provisions 
to provide, capture, and maintain product tracing information under 
section 582(d)(1) of the FD&C Act, and it extends a compliance policy 
that would have expired for transactions after November 1, 2015. It is 
important that FDA provide this information before that date. Although 
this guidance document is immediately in effect, it remains subject to 
comment in accordance with the Agency's good guidance practices (21 CFR 
10.115(g)(3)).
    On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was 
signed into law. Section 202 of DSCSA adds sections 581 and 582 to the 
FD&C Act, which set forth new definitions and requirements for the 
tracing of products through the pharmaceutical distribution supply 
chain. Starting in 2015, trading partners (manufacturers, wholesale 
distributors, dispensers, and repackagers) were required under sections 
582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to exchange 
product tracing information when engaging in transactions involving 
certain prescription drugs. For dispensers, requirements for the 
tracing of products through the pharmaceutical distribution supply 
chain under section 582(d)(1) of the FD&C Act took effect on July 1, 
2015. FDA published a guidance document on July 6, 2015, stating that 
it does not intend to take action against dispensers who, prior to 
November 1, 2015, (1) accept ownership of product without receiving the 
product tracing information, as required by section 582(d)(1)(A)(i) of 
the FD&C Act, or (2) do not capture and maintain the product tracing 
information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.
    Some dispensers--primarily smaller, independent pharmacies and 
health systems--have expressed concern that they will be unable to 
comply with these requirements by November 1, 2015. Thus, FDA 
recognizes that these dispensers continue to need additional time to 
work with trading partners to ensure that the product tracing 
information required by section 582 of the FD&C Act is captured and 
maintained by dispensers. In light of these concerns, FDA does not 
intend to take action against dispensers who, prior to March 1, 2016: 
(1) Accept ownership of product without receiving product tracing 
information, prior to or at the time of a transaction, as required by 
section 582(d)(1)(A)(i) of the FD&C Act or (2) do not capture and 
maintain the product tracing information, as required by section 
582(d)(1)(A)(iii) of the FD&C Act. This compliance policy does not 
extend to other requirements of the FD&C Act applicable to dispensers 
and other trading partners, including those in section 582 of the FD&C 
Act, such as verification related to suspect and illegitimate product 
(including quarantine, investigation, notification, and recordkeeping) 
and requirements related to engaging in transactions only with 
authorized trading partners. The guidance document explains the scope 
of the compliance policy in further detail.
    The guidance represents the current thinking of FDA on this topic. 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. 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: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27841 Filed 10-30-15; 8:45 am]
BILLING CODE 4164-01-P