
[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36148-36149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Child-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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 2, 2017.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.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.

[[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


