[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Pages 10260-10261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0631]


Requirements for Transactions With First Responders Under Section 
582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice of availability.

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SUMMARY:  The Food and Drug Administration (FDA or we) is announcing 
the availability of a guidance for industry entitled ``Requirements for 
Transactions with First Responders under Section 582 of the Federal 
Food, Drug, and Cosmetic Act--Compliance Policy.'' This guidance 
describes FDA's compliance policy regarding certain requirements in the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) for trading 
partners engaged in transactions with first responders. This compliance 
policy is in effect until further notice by FDA.

DATES:  Effective February 29, 2016. 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-2016-D-0631 for ``Requirements for Transactions with First 
Responders under Section 582 of the Federal Food, Drug, and Cosmetic 
Act--Compliance Policy; 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 Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

[[Page 10261]]

     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.
    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 
Building, 4th Floor, 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

    We are announcing the availability of a guidance for industry 
entitled ``Requirements for Transactions with First Responders under 
Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance 
Policy.'' 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 compliance with certain 
statutory requirements described in this document that are currently in 
effect. In addition, because FDA's compliance policy regarding the 
provisions to provide, capture, and maintain product tracing 
information under section 582(d)(1) of the FD&C Act (21 U.S.C. 360eee-
1(d)(1)) will expire on March 1, 2016 (see 80 FR 67408, November 2, 
2015), it is important that FDA provide this information before that 
date to avoid potential disruptions in the supply chain. 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)). FDA is particularly interested in comments related to 
the scope of this guidance. FDA will consider any comments received and 
may revise the scope of the enforcement policy described in this 
guidance as appropriate.
    On November 27, 2013, the Drug Supply Chain Security Act (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 (21 U.S.C. 360eee and 360eee-
1), which set forth new definitions and requirements for the tracing of 
products through the pharmaceutical distribution supply chain. Starting 
in 2015, certain trading partners (manufacturers, wholesale 
distributors, dispensers, and repackagers) generally 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. These trading partners were also 
generally required under sections 582(b)(4), (c)(4), (d)(4) and (e)(4) 
to have systems in place to enable the verification of suspect and 
illegitimate product. Furthermore, sections 582(b)(3), (c)(3), (d)(3), 
and (e)(3) specify that the trading partners of manufacturers, 
wholesale distributors, dispensers, and repackagers must be 
``authorized'' within the meaning of section 581(2) of the FD&C Act.
    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 notice of 
availability for a revised guidance document on November 2, 2015, 
stating that it does not intend to take action against dispensers who, 
prior to March 1, 2016, 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 do not capture and maintain the product tracing 
information, as required by section 582(d)(1)(A)(iii) of the FD&C Act 
(80 FR 67408).
    As described in the guidance, FDA understands that transactions 
between dispensers and first responders may present challenges related 
to compliance with certain requirements in section 582 of the FD&C Act 
related to the exchange of product tracing information, conducting 
business only with authorized trading partners, and having verification 
systems in place. To minimize possible disruptions to the activities of 
first responders, FDA does not intend to take action against certain 
trading partners and first responders as described in the guidance. 
This compliance policy is in effect until further notice by FDA.
    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 guidance 
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: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04227 Filed 2-26-16; 8:45 am]
 BILLING CODE 4164-01-P