[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53880-53882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23306]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3462]
Verification Systems Under the Drug Supply Chain Security Act for
Certain Prescription Drugs; Draft Guidance for Industry; Availability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 or Agency) is announcing
the availability of a draft guidance for industry entitled
``Verification Systems Under the Drug Supply Chain Security Act for
Certain Prescription Drugs.'' The draft guidance addresses the
verification systems that manufacturers, repackagers, wholesale
distributors, and dispensers must have in place to comply with the
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug
Supply Chain Security Act (DSCSA). Specifically, this draft guidance
covers the statutory verification system requirements that include
quarantine and investigation of a product determined to be suspect and
quarantine and disposition of a product determined to be illegitimate.
The draft guidance also addresses the statutory requirement for
notification to the Agency of a product that has been cleared by a
manufacturer, repackager, wholesale distributor, or dispenser after a
suspect product investigation because it is determined that the product
is not an illegitimate product.
DATES: Submit either electronic or written comments on the draft
guidance by December 24, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
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
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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): 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-2018-D-3462 for ``Verification Systems Under the Drug Supply Chain
Security Act for Certain Prescription Drugs; Draft 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 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: Sarah Venti, 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 ``Verification Systems Under the Drug Supply Chain Security
Act for Certain Prescription Drugs.'' The DSCSA (Title II of Pub. L.
113-54) was signed into law on November 27, 2013. Section 202 of the
DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-1), which
established the requirement that trading partners have systems in place
to enable them to comply with certain verification obligations.
The draft guidance provides recommendations for robust verification
systems for the determination, quarantine, and investigation of suspect
products as well as quarantine and disposition of illegitimate
products. As explained in the draft guidance, verification systems may
include existing standard operating procedures or other processes or
procedures provided that the verification systems ensure that the
trading partner meets its obligations under section 582 of the FD&C
Act. This draft guidance also addresses the manner in which FDA
recommends that trading partners submit cleared product notifications
(i.e., notifications that a suspect product is not an illegitimate
product). Finally, the draft guidance also addresses the statutory
requirements for verification, including verification of saleable
returns, at the package level for product identifiers on packages and
homogenous cases intended to be introduced in a transaction into
commerce. While DSCSA also requires trading partners to notify the
Agency of illegitimate products or products with high risk of
illegitimacy, this requirement was previously discussed in a separate
guidance document, and is therefore not addressed in this draft
guidance.
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 verification
systems for certain human, finished, prescription drugs under section
582 of the FD&C Act. 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. This draft guidance is not subject to Executive Order
12866.
II. Paperwork Reduction Act of 1995
This draft guidance includes information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520)
(PRA). In accordance with the PRA, prior to publication of any final
guidance document, FDA intends to solicit public comment and obtain OMB
approval for any information collections recommended in this guidance
that are new or that would represent material modifications to those
previously approved collections of information found in FDA regulations
or guidance.
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III. Electronic Access
Persons with access to the internet may obtain the draft guidance
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: October 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23306 Filed 10-24-18; 8:45 am]
BILLING CODE 4164-01-P