82 FR 36148 - Child-Resistant Packaging Statements in Drug Product Labeling; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 148 (August 3, 2017)

Page Range		36148-36149
FR Document		2017-16379

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Child- Resistant Packaging Statements in Drug Product Labeling.'' This guidance is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in prescription and over-the-counter human drug product labeling. The guidance discusses what information should be included to support CRP statements and to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.

Federal Register, Volume 82 Issue 148 (Thursday, August 3, 2017)

[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36148-36149]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-16379]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2163]

Child-Resistant Packaging Statements in Drug Product Labeling;
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Child-
Resistant Packaging Statements in Drug Product Labeling.'' This
guidance is intended to assist applicants, manufacturers, packagers,
and distributors who choose to include child-resistant packaging (CRP)
statements in prescription and over-the-counter human drug product
labeling. The guidance discusses what information should be included to
support CRP statements and to help ensure that such labeling is clear,
useful, informative, and, to the extent possible, consistent in content
and format.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 2, 2017.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): 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-2163 for ``Child-Resistant Packaging Statements in Drug
Product Labeling.'' 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 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: https://www.thefederalregister.org/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.

[[Page 36149]]

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 to 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: Richard Lostritto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301-796-
1697; 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 ``Child-Resistant Packaging Statements in Drug Product
Labeling.'' In 1970, the Poison Prevention Packaging Act (PPPA) was
enacted to protect children (under 5 years of age) from unintentional
exposure to household substances including food, drugs, and cosmetics.
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a drug
that has packaging or labeling that is in violation of a regulation
issued pursuant to section 3 or 4 of the PPPA is deemed to be
misbranded. FDA was responsible for enforcing the PPPA until 1973, when
jurisdiction was transferred to the U.S. Consumer Product Safety
Commission (CPSC). Because of FDA's authority to regulate labeling for
prescription and nonprescription drug products, if firms choose to make
statements in their labeling for such products about CRP, such
statements must comply with FDA's statutory and regulatory
requirements. The draft guidance explains that to ensure that CRP
statements on labeling are not false or misleading, such statements
should only be used when the drug product packaging has been shown to
comply with the applicable CPSC regulatory standards and test
procedures for CRP. This guidance is intended to apply to FDA-regulated
drug products that bear CRP statements, regardless of whether CRP is
required for such products under 16 CFR 1700. For example, bulk
packages of prescription drugs that are shipped to pharmacies for
repackaging by a pharmacist are not required to utilize CRP, but a firm
may nevertheless choose to use CRP (and a CRP statement) for such
drugs.
CPSC's regulations list ``special packaging standards'' (also
referred to herein as child-resistant packaging, or CRP) for a wide
range of household products, including most oral prescription drugs and
many nonprescription drug products (see 16 CFR 1700 for substances
requiring special packaging and the relevant packaging standards and
testing procedures). There are different ways to make packaging child-
resistant, with the most common forms being a child-resistant closure
(e.g., a ``safety cap'') and certain unit-dose blister packaging (e.g.,
puncture-resistant and peel-push blisters).
Child-resistant packaging is regarded as an important public health
safety tool for avoiding harmful outcomes related to unsupervised
pediatric ingestions. FDA advocates that all drugs, irrespective of the
type of packaging, be stored safely out of reach and sight of children
to further the overall public health efforts to address this safety
issue.
Because health care professionals and consumers may not be able to
determine on visual inspection whether the packaging is child-
resistant, a labeling statement may help to identify this attribute.
Therefore, in this guidance, we recommend text that may be appropriate
to consider when including CRP statements on the containers and
packaging of products.
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 current thinking of FDA on child-
resistant packaging statements in drug product labeling. 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. Because FDA's
guidance documents do not bind the public or FDA to any requirements,
this guidance is not considered to be subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information 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 for submitting labeling in
original and supplemental new drug applications (NDAs), abbreviated new
drug applications (ANDAs), and biologics license applications (BLAs) in
21 CFR 314.50(e) and (l), 314.94(a)(8), 314.70, and 314.97, and 21 CFR
601.2 and 601.12 has been approved under OMB control number 0910-0001
and 0910-0338, respectively. The collection of information for
preparing prescription drug product labeling under 21 CFR 201.56 and
201.57 has been approved under OMB control number 0910-0572. The
collection of information for Drug Facts labeling under 21 CFR 201.66
has been approved under OMB control number 0910-0340. The collection of
information for Medication Guides has been approved under OMB control
number 0910-0393. The collection of information for submitting
chemistry, manufacturing, and controls information in original and
supplemental NDAs, ANDAs, and BLAs in 21 CFR 314.50(d)(1),
314.94(a)(9), 314.70, and 314.97, and 21 CFR 601.2 and 601.12 has been
approved under OMB control number 0910-0001 and 0910-0338,
respectively.

III. Electronic Access

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

Dated: July 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16379 Filed 8-2-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices 36149

Submit written requests for single FDA-regulated drug products that bear the Office of Management and Budget
copies of the draft guidance to the CRP statements, regardless of whether (OMB) under the Paperwork Reduction
Division of Drug Information, Center for CRP is required for such products under Act of 1995 (44 U.S.C. 3501–3520). The
Drug Evaluation and Research, Food 16 CFR 1700. For example, bulk collection of information for submitting
and Drug Administration, 10001 New packages of prescription drugs that are labeling in original and supplemental
Hampshire Ave., Hillandale Building, shipped to pharmacies for repackaging new drug applications (NDAs),
4th Floor, Silver Spring, MD 20993– by a pharmacist are not required to abbreviated new drug applications
0002; or to the Office of utilize CRP, but a firm may nevertheless (ANDAs), and biologics license
Communication, Outreach and choose to use CRP (and a CRP applications (BLAs) in 21 CFR 314.50(e)
Development, Center for Biologics statement) for such drugs. and (l), 314.94(a)(8), 314.70, and 314.97,
Evaluation and Research, Food and CPSC’s regulations list ‘‘special and 21 CFR 601.2 and 601.12 has been
Drug Administration, 10903 New packaging standards’’ (also referred to approved under OMB control number
Hampshire Ave., Bldg. 71, Rm. 3128, herein as child-resistant packaging, or 0910–0001 and 0910–0338, respectively.
Silver Spring, MD 20993–0002. Send CRP) for a wide range of household The collection of information for
one self-addressed adhesive label to products, including most oral preparing prescription drug product
assist that office in processing your prescription drugs and many labeling under 21 CFR 201.56 and
requests. See the SUPPLEMENTARY nonprescription drug products (see 16 201.57 has been approved under OMB
INFORMATION section for electronic CFR 1700 for substances requiring control number 0910–0572. The
access to the draft guidance document. special packaging and the relevant collection of information for Drug Facts
FOR FURTHER INFORMATION CONTACT:
packaging standards and testing labeling under 21 CFR 201.66 has been
Richard Lostritto, Center for Drug procedures). There are different ways to approved under OMB control number
Evaluation and Research, Food and make packaging child-resistant, with the 0910–0340. The collection of
most common forms being a child- information for Medication Guides has
Drug Administration, 10903 New
resistant closure (e.g., a ‘‘safety cap’’) been approved under OMB control
Hampshire Ave., Bldg. 51, Rm. 4132,
and certain unit-dose blister packaging number 0910–0393. The collection of
Silver Spring, MD 20993, 301–796–
(e.g., puncture-resistant and peel-push information for submitting chemistry,
1697; or Stephen Ripley, Center for
blisters). manufacturing, and controls
Biologics Evaluation and Research, Child-resistant packaging is regarded
Food and Drug Administration, 10903 information in original and
as an important public health safety tool supplemental NDAs, ANDAs, and BLAs
New Hampshire Ave., Bldg. 71, Rm. for avoiding harmful outcomes related
7301, Silver Spring, MD 20993–0002, in 21 CFR 314.50(d)(1), 314.94(a)(9),
to unsupervised pediatric ingestions. 314.70, and 314.97, and 21 CFR 601.2
240–402–7911. FDA advocates that all drugs,
SUPPLEMENTARY INFORMATION: and 601.12 has been approved under
irrespective of the type of packaging, be OMB control number 0910–0001 and
I. Background stored safely out of reach and sight of 0910–0338, respectively.
children to further the overall public
FDA is announcing the availability of health efforts to address this safety III. Electronic Access
a draft guidance for industry entitled issue.
‘‘Child-Resistant Packaging Statements Persons with access to the Internet
Because health care professionals and may obtain the draft guidance at either
in Drug Product Labeling.’’ In 1970, the consumers may not be able to determine
Poison Prevention Packaging Act https://www.fda.gov/Drugs/
on visual inspection whether the GuidanceComplianceRegulatory
(PPPA) was enacted to protect children packaging is child-resistant, a labeling
(under 5 years of age) from Information/Guidances/default.htm,
statement may help to identify this https://www.fda.gov/BiologicsBlood
unintentional exposure to household attribute. Therefore, in this guidance,
substances including food, drugs, and Vaccines/GuidanceCompliance
we recommend text that may be RegulatoryInformation/Guidances/
cosmetics. Under the Federal Food, appropriate to consider when including
Drug, and Cosmetic Act (the FD&C Act), default.htm, or https://www.regulations.
CRP statements on the containers and gov.
a drug that has packaging or labeling packaging of products.
that is in violation of a regulation issued This draft guidance is being issued Dated: July 31, 2017.
pursuant to section 3 or 4 of the PPPA consistent with FDA’s good guidance Anna K. Abram,
is deemed to be misbranded. FDA was practices regulation (21 CFR 10.115). Deputy Commissioner for Policy, Planning,
responsible for enforcing the PPPA until The draft guidance, when finalized, will Legislation, and Analysis.
1973, when jurisdiction was transferred represent the current thinking of FDA [FR Doc. 2017–16379 Filed 8–2–17; 8:45 am]
to the U.S. Consumer Product Safety on child-resistant packaging statements BILLING CODE 4164–01–P
Commission (CPSC). Because of FDA’s in drug product labeling. It does not
authority to regulate labeling for establish any rights for any person and
prescription and nonprescription drug is not binding on FDA or the public. DEPARTMENT OF HEALTH AND
products, if firms choose to make You can use an alternative approach if HUMAN SERVICES
statements in their labeling for such it satisfies the requirements of the
products about CRP, such statements applicable statutes and regulations. Food and Drug Administration
must comply with FDA’s statutory and Because FDA’s guidance documents do
regulatory requirements. The draft not bind the public or FDA to any [Docket No. FDA–2015–N–2489]
guidance explains that to ensure that requirements, this guidance is not
mstockstill on DSK30JT082PROD with NOTICES

CRP statements on labeling are not false Receipt of Notice That a Patent
considered to be subject to Executive
or misleading, such statements should Infringement Complaint Was Filed
Order 12866.
only be used when the drug product Against a Biosimilar Applicant
packaging has been shown to comply II. Paperwork Reduction Act of 1995
AGENCY: Food and Drug Administration,
with the applicable CPSC regulatory This draft guidance refers to HHS.
standards and test procedures for CRP. previously approved collections of
ACTION: Notice.
This guidance is intended to apply to information that are subject to review by

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Document Created: 2017-08-03 07:24:48
Document Modified: 2017-08-03 07:24:48

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), 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 on the draft guidance by October 2, 2017.
Contact		Richard Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301-796- 1697; 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.
FR Citation		82 FR 36148

82 FR 36148 - Child-Resistant Packaging Statements in Drug Product Labeling; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 148 (August 3, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration