[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40424-40426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17433]


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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; 
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 final guidance for industry entitled ``Child-
Resistant Packaging Statements in Drug Product Labeling.'' This 
guidance is intended to assist applicants,

[[Page 40425]]

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: The announcement of the guidance is published in the Federal 
Register on August 14, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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 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 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 this 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 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 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, 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 child-resistant packaging, such 
statements must comply with FDA's statutory and regulatory 
requirements. The 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 CPSC 
regulatory standards and test procedures for CRP, as applicable. 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.

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    CPSC's regulations list ``special packaging standards'' 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). It should be noted that ``child-resistant'' should 
not be equated with ``child-proof,'' because CRP is not designed to 
completely eliminate the possibility of an accidental pediatric 
ingestion. It can only impede access to harmful products and is 
recognized by public health experts as only one component of preventing 
these events. 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). 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 in labeling. All of the 
stakeholder comments on the draft guidance were carefully reviewed and, 
where appropriate, clarifying edits were made in the final guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    This 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), and 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 guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: August 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17433 Filed 8-13-19; 8:45 am]
BILLING CODE 4164-01-P