[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56033-56035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6526]


Grandfathering Policy for Packages and Homogenous Cases of 
Product Without a Product Identifier; Draft Guidance for Industry; 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, the Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Grandfathering Policy for Packages and Homogenous Cases of Product 
Without a Product Identifier.'' This draft guidance specifies whether 
and under what circumstances packages and homogenous cases of product 
not labeled with a product identifier shall be exempted, as 
grandfathered, from certain requirements of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on the draft 
guidance by January 26, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 
concerning the collection of information proposed in the draft guidance 
by January 26, 2018.

ADDRESSES: You may submit comments on any guidance at any time 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

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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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-D-6526 for ``Grandfathering Policy for Packages and Homogenous 
Cases of Product Without a Product Identifier; Draft Guidance for 
Industry.'' 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 Dockets Management Staff 
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 Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Abha Kundi, 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]; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Grandfathering Policy for Packages and Homogenous Cases of 
Product Without a Product Identifier.'' 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 the DSCSA added section 582 to the FD&C 
Act, which established product tracing requirements for manufacturers, 
repackagers, wholesale distributors, and dispensers. The DSCSA phases 
in its requirements over a period of 10 years.
    A critical set of phased product tracing requirements outlined in 
section 582 of the FD&C Act (21 U.S.C. 360eee-1) relate to the product 
identifier. Among its provisions, section 582 requires that each 
package and homogenous case of product in the pharmaceutical 
distribution supply chain bear a product identifier that is encoded 
with the product's standardized numerical identifier, lot number, and 
expiration date by specific dates. Under the statute, manufacturers 
must begin affixing or imprinting a product identifier to each package 
and homogenous case of a product intended to be introduced into 
commerce no later than November 27, 2017. Repackagers are required to 
do the same no later than November 27, 2018.
    Sections 582(c)(2), (d)(2), and (e)(2)(A)(iii) of the FD&C Act 
restrict trading partners' ability to engage in transactions involving 
packages and homogenous cases of product that are not labeled with a 
product identifier after specific dates. Beginning November 27, 2018, 
repackagers may not engage in a transaction involving a package or 
homogenous case of a product that is not encoded with a product 
identifier. Similar restrictions go into effect for wholesale 
distributors and dispensers on November 27, 2019, and November 27, 
2020, respectively.
    Section 582(a)(5)(A) of the FD&C Act gives FDA authority to exempt 
packages and homogenous cases of product without a product identifier 
from the product tracing requirements discussed above. We are required 
to issue guidance that specifies whether and under what circumstances 
we will exercise this authority. The draft guidance addresses this 
requirement. As explained in the draft guidance, only packages and 
homogenous cases of product that are in the pharmaceutical distribution 
supply chain at the time of the effective date of the requirements of 
section 582 are eligible for an exemption under section 582(a)(5)(A).
    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 on the 
grandfathering policy for packages and homogenous cases of product 
without a product identifier. Guidance documents generally do 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. For this 
particular document, section 582 of the FD&C Act gives FDA authority to 
issue binding guidance specifying the circumstances under which 
packages and homogenous cases of product that are not labeled with a 
product identifier shall be exempted from the requirements of section 
582 of the FD&C Act. Thus, insofar as section IV of this

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guidance specifies the circumstances under which packages and 
homogenous cases of product that are not labeled with a product 
identifier and that are in the pharmaceutical distribution supply chain 
at the time of the effective date of the requirements of section 582 of 
the FD&C Act shall be exempted from certain requirements of section 
582, it will have binding effect upon finalization.

II. Electronic Access

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

    Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25457 Filed 11-24-17; 8:45 am]
BILLING CODE 4164-01-P