[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45889-45890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0829]


Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form 
Drug Products; 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 ``Expiration 
Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.'' 
The guidance describes the circumstances under which FDA generally does 
not intend to take action regarding required stability studies for 
unit-dose repackaged solid oral dosage form drug products and 
appropriate expiration dates under those circumstances. This guidance 
finalizes the revised draft guidance for industry issued in August 
2017.

DATES: The announcement of the guidance is published in the Federal 
Register on July 30, 2020.

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

[[Page 45890]]

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-0829 for ``Expiration Dating of Unit-Dose Repackaged Solid 
Oral Dosage Form Drug Products.'' 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.govinfo.gov/content/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. 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: Bill Harvey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 4214, Silver Spring, MD 20993-0002, 240-
402-4180.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage 
Form Drug Products.'' The last few decades have seen an increasing 
demand in various health care settings for solid oral dosage form drug 
products repackaged into unit-dose containers, which hold a quantity of 
drug for administration as a single dose. The increase in unit-dose 
repackaging has led to questions regarding stability studies and 
appropriate expiration dates for these repackaged products. This 
guidance describes the circumstances under which FDA generally does not 
intend to take action regarding required stability studies for these 
repackaged products and appropriate expiration dates under those 
circumstances.
    This guidance finalizes the revised draft guidance of the same name 
issued in August 2017 (82 FR 37229). FDA received a few comments on the 
revised draft guidance and has modified this guidance by: (1) 
Describing why liquid dosage forms are excluded, (2) indicating 
approaches that may be used when conducting stability studies, and (3) 
making editorial changes to update references and improve clarity. 
Liquid dosage forms are substantially more susceptible to degradation 
than solid dosage forms. Because of the inherent stability risks, FDA 
does not intend to exercise enforcement discretion regarding the 
stability and expiration dating requirements in 21 CFR 211.137 and 
211.166 for repackaging liquid dosage forms.
    In conjunction with the publication of this guidance, FDA withdraws 
Compliance Policy Guide 480.200, ``Expiration Dating of Unit-Dose 
Repackaged Drugs,'' issued February 1, 1984, revised March 1995.
    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 ``Expiration Dating of Unit-Dose Repackaged 
Solid Oral Dosage Form Drug Products.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, this guidance refers to previously approved collections of 
information that are subject to review by the OMB under the PRA. The 
collections of information in 21 CFR parts 210 and 211 have been 
approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: July 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16526 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P