[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89112-89113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29588]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0609]


Drug Supply Chain Security Act Implementation: Identification of 
Suspect Product and Notification; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Drug Supply 
Chain Security Act Implementation: Identification of Suspect Product 
and Notification.'' The guidance addresses provisions in the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug 
Supply Chain Security Act (DSCSA). The guidance is intended to aid 
certain trading partners (manufacturers, repackagers, wholesale 
distributors, and dispensers) in identifying a suspect product and 
specific scenarios that could significantly increase the risk of a 
suspect product entering the pharmaceutical distribution supply chain. 
The guidance also describes how trading partners should notify FDA of 
illegitimate product and sets forth a process for terminating 
notifications of illegitimate product in consultation with FDA. This 
guidance also includes a new section, for comment purposes only, that 
describes when manufacturers should notify FDA of a high risk that a 
product is illegitimate. Aside from that section, this guidance is a 
final guidance subsequent to the draft guidance that was issued on June 
11, 2014.

DATES: You may submit either electronic or written comments on Agency 
guidances at any time. However, the portion of this guidance that 
describes when manufacturers should notify FDA if there is a high risk 
that a product is illegitimate, is being distributed for comment 
purposes only. To ensure that the Agency considers your comment on this 
draft section before it begins work on the final version of this 
section of the guidance, submit either electronic or written comments 
on this section by February 7, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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-2014-D-0609 for ``Drug Supply Chain Security Act Implementation: 
Identification of Suspect Product and Notification; Guidance for 
Industry; Availability.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the 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 https://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

[[Page 89113]]

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 https://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.
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Bldg. 4th Floor, Silver Spring, MD 20993-0002; 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 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

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

    FDA is announcing the availability of a guidance for industry 
entitled ``Drug Supply Chain Security Act Implementation: 
Identification of Suspect Product and Notification.'' The guidance 
addresses provisions in the FD&C Act, as amended by the DSCSA (Pub. L. 
113-54). Section 202 of the DSCSA adds section 582(h)(2) to the FD&C 
Act (21 U.S.C. 360eee-1(h)(2)), which requires FDA to issue guidance to 
aid certain trading partners (manufacturers, repackagers, wholesale 
distributors, and dispensers) in identifying a suspect product and 
terminating notifications. The guidance identifies specific scenarios 
that could significantly increase the risk of a suspect product 
entering the pharmaceutical distribution supply chain, and provides 
recommendations on how trading partners can identify such product and 
determine whether the product is a suspect product as soon as 
practicable.
    Beginning January 1, 2015, section 582 of the FD&C Act required 
trading partners, upon determining that a product in their possession 
or control is illegitimate, to notify: (1) FDA and (2) all immediate 
trading partners that they have reason to believe may have received the 
illegitimate product, not later than 24 hours after making the 
determination. Manufacturers are additionally required under section 
582(b)(4)(B)(ii)(II) of the FD&C Act to notify FDA and any immediate 
trading partners that the manufacturer has reason to believe may 
possess a product manufactured by (or purported to be manufactured by) 
the manufacturer, not later than 24 hours after the manufacturer 
determines or is notified by FDA or a trading partner that there is a 
high risk that a product is illegitimate. Section III.C of this 
guidance, entitled ``For Manufacturers: High Risk of Illegitimacy 
Notification'' and highlighted in grey, describes notifications related 
to products that pose a high risk of illegitimacy, and is marked ``for 
comment purposes only'' to provide an opportunity for comment before it 
is finalized. The guidance also addresses how trading partners should 
notify FDA using Form FDA 3911. In addition, in accordance with section 
582(h)(2) of the FD&C Act, the guidance sets forth the process by which 
trading partners must terminate the notifications using Form FDA 3911, 
in consultation with FDA, regarding illegitimate product and, for a 
manufacturer, a product with a high risk of illegitimacy, under section 
582(b)(4)(B), (c)(4)(B), (d)(4)(B), and (e)(4)(B) of the FD&C Act.
    In the Federal Register of June 11, 2014 (79 FR 33564), FDA 
announced the availability of a draft guidance entitled ``Drug Supply 
Chain Security Act Implementation: Identification of Suspect Product 
and Notification.'' FDA has carefully considered the comments received 
and made the following changes in response to the comments: Section C, 
``For Manufacturers: High Risk of Illegitimacy Notifications,'' on pgs. 
8-11 of the guidance, is a new section added in response to comments 
and questions received. In addition, FDA made minor changes to the Form 
FDA 3911 and to the instructions for completing the form.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Drug Supply Chain Security Act 
Implementation: Identification of Suspect Product and Notification.'' 
It does not establish any rights for any person and, with the exception 
of section IV.B, 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 guidance at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0806.

    Dated: December 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29588 Filed 12-8-16; 8:45 am]
 BILLING CODE 4164-01-P