82 FR 37229 - Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 152 (August 9, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.''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 This revised draft guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to assign under those conditions. Through this notice, FDA is hoping to decrease the regulatory burdens of drug regulations on manufacturers of these products, while at the same time ensuring patient safety. Since FDA's guidance documents do not bind the public or FDA to any requirements, they have not been considered to be subject to Executive Order 12866.

[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37229-37230]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16719]


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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Drug Products; Revised Draft Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled 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 revised draft 
guidance describes the conditions under which FDA does not intend to 
take action regarding required stability studies for these repackaged 
products and the expiration date to assign under those conditions. 
Through this notice, FDA is hoping to decrease the regulatory burdens 
of drug regulations on manufacturers of these products, while at the 
same time ensuring patient safety. Since FDA's guidance documents do 
not bind the public or FDA to any requirements, they have not been 
considered to be subject to Executive Order 12866.

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 
revised 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 10, 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-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.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.
    Submit written requests for single copies of the revised 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. Send one self-addressed adhesive label to assist that 
office in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the revised draft 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 revised draft guidance for 
industry

[[Page 37230]]

entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage 
Form Drug Products.'' FDA's current good manufacturing practice (CGMP) 
regulations for finished pharmaceuticals require that each drug product 
bear an expiration date determined by appropriate stability testing and 
that the date must be related to any storage conditions stated on the 
labeling, as determined by stability studies (21 CFR 211.137(a) and 
(b)). Samples used for stability testing must be in the same container-
closure system as that in which the drug product is marketed (21 CFR 
211.166(a)(4)). For unit-dose repackaged products, U.S. Pharmacopeial 
Convention (USP) General Chapter <1178> recommends that the expiration 
date ``not exceed (1) 6 months from the date of repackaging; or (2) the 
manufacturer's expiration date; or (3) 25% of the time between the date 
of repackaging and the expiration date shown on the manufacturer's bulk 
article container of the drug being repackaged, whichever is earlier.''
    For solid oral dosage forms repackaged in unit-dose containers, the 
revised draft guidance states that FDA does not intend to take action 
regarding the requirements of Sec. Sec.  211.137 and 211.166 (i.e., 
expiration dating determined by stability studies) under certain 
conditions. This revised draft guidance describes these conditions.
    This draft guidance revises an earlier draft guidance for industry, 
``Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy 
Guide.'' Changes include the following:
     Shortens the expiration date to be used under certain 
conditions for solid oral dosage forms repackaged in unit-dose 
containers from 12 months to 6 months or 25 percent of the time 
remaining until the expiration date on the container of the original 
manufacturer's product, whichever time period is shorter.
     Provides for an expiration date exceeding 6 months if 
supportive data from appropriate studies are available and other 
conditions are met.
     Excludes from the scope of the guidance products 
repackaged by State-licensed pharmacies, Federal facilities, and 
outsourcing facilities as defined under section 503B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353b).
     Excludes from the scope of the guidance all dosage forms 
other than solid oral dosage forms.
     Provides for the use of containers meeting USP <671> Class 
B standards if certain conditions are met.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The revised draft 
guidance, when finalized, will represent 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.
    The current Compliance Policy Guide 480.200, ``Expiration Dating of 
Unit-Dose Repackaged Drugs,'' issued February 1, 1984, revised March 
1995, will be withdrawn when the revised draft guidance is finalized.

II. The Paperwork Reduction Act of 1995

    This revised 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 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 draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16719 Filed 8-8-17; 8:45 am]
BILLING CODE 4164-01-P