Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Draft Guidance for Industry; Availability, 56033-56035 [2017-25457]
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56033
Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
TABLE 1—CERTIFICATES AND USES
Type of certificate
Use
‘‘Supplementary Information Certificate to Foreign Government Requests‘‘, ‘‘Exporter’s Certification Statement Certificate to Foreign
Government‘‘, ‘‘Exporter’s Certification Statement Certificate to Foreign Government (For Human Tissue Intended for Transplantation)‘‘.
‘‘Supplementary Information Certificate of Exportability Requests‘‘, Exporter’s Certification Statement Certificate of Exportability’’.
‘‘Supplementary Information Certificate of a Pharmaceutical Product‘‘,
‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical
Product‘‘.
‘‘Supplementary Information Non-Clinical Research Use Only Certificate‘‘, ‘‘Exporter’s Certification Statement (Non-Clinical Research
Use Only)‘‘.
FDA will continue to rely on selfcertification by manufacturers for the
first three types of certificates listed in
table 1. Manufacturers are requested to
self-certify that they are in compliance
with all applicable requirements of the
For the export of products legally marketed in the United States.
For the export of products not approved for marketing in the United
States (unapproved products) that meet the requirements of sections
801(e) or 802 of the FD&C Act.
Conforms to the format established by the World Health Organization
and is intended for use by the importing country when the product in
question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or
reviewing a license.
For the export of a non-clinical research use only product, material, or
component that is not intended for human use which may be marketed in, and legally exported from the United States under the
FD&C Act.
FD&C Act, not only at the time that they
submit their request to the appropriate
center, but also at the time that they
submit the certification to the foreign
government.
The appropriate FDA centers will
review product information submitted
by firms in support of their certificate
and any suspected case of fraud will be
referred to the appropriate offices.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA center
Center
Center
Center
Center
for
for
for
for
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Biologics Evaluation and Research ....................
Devices and Radiological Health .......................
Drug Evaluation and Research ..........................
Veterinary Medicine ............................................
2,651
11,175
3,680
1,819
1
1
1
1
2,651
11,175
3,680
1,819
1
2
1
1
2,651
22,350
3,680
1,819
Total ..............................................................................
........................
........................
........................
........................
30,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
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).
[FR Doc. 2017–25456 Filed 11–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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.
VerDate Sep<11>2014
16:59 Nov 24, 2017
Jkt 244001
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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
SUMMARY:
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.
DATES:
[Docket No. FDA–2017–D–6526]
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
• 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
E:\FR\FM\27NON1.SGM
27NON1
56034
Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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/201523389.pdf.
VerDate Sep<11>2014
16:59 Nov 24, 2017
Jkt 244001
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, drugtrackandtrace@
fda.hhs.gov; 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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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
E:\FR\FM\27NON1.SGM
27NON1
Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
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/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.
fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/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
Electronic Records; Electronic
Signatures
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0076]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Signatures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Fax written comments on the
collection of information by December
27, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0303. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7729, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DATES:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
OMB Control Number 0910–0303—
Extension
This information collection supports
FDA regulations; specifically, in part 11
(21 CFR part 11), which sets forth
criteria for acceptance of electronic
records, electronic signatures, and
handwritten signatures executed to
electronic records as equivalent to paper
records. Under these regulations,
records and reports may be submitted to
FDA electronically provided the Agency
has stated its ability to accept the
records electronically in an Agencyestablished public docket and that the
other requirements of part 11 are met.
The recordkeeping provisions in part
11 (§§ 11.10, 11.30, 11.50, and 11.300)
require the following standard operating
procedures to assure appropriate use of,
and precautions for, systems using
56035
electronic records and signatures: (1)
§ 11.10 specifies procedures and
controls for persons who use closed
systems to create, modify, maintain, or
transmit electronic records; (2) § 11.30
specifies procedures and controls for
persons who use open systems to create,
modify, maintain, or transmit electronic
records; (3) § 11.50 specifies procedures
and controls for persons who use
electronic signatures; and (4) § 11.300
specifies controls to ensure the security
and integrity of electronic signatures
based upon use of identification codes
in combination with passwords. The
reporting provision (§ 11.100) requires
persons to certify in writing to FDA that
they will regard electronic signatures
used in their systems as the legally
binding equivalent of traditional
handwritten signatures.
The burden created by the
information collection provision of this
regulation is a one-time burden
associated with the creation of standard
operating procedures, validation, and
certification. The Agency anticipates the
use of electronic media will
substantially reduce the paperwork
burden associated with maintaining
FDA required records. The respondents
are businesses and other for-profit
organizations, State or local
governments, Federal Agencies, and
nonprofit institutions.
In the Federal Register of June 19,
2017 (82 FR 27838), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received in response to the
information collection topics solicited
in the notice. However, one comment
was received regarding a related Agency
draft guidance entitled, ‘‘Use of
Electronic Records and Electronic
Signatures in Clinical Investigations
Under 21 CFR part 11—Questions and
Answers,’’ and the comment has been
directed to the appropriate Agency
components for consideration.
We therefore estimate the burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
11.100 ..................................................................................
4,500
1
4,500
1
4,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
16:59 Nov 24, 2017
Jkt 244001
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27NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 56034]]
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,
drugtrackandtrace@fda.hhs.gov; 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
[[Page 56035]]
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
