[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4343-4345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1524]


Repackaging of Certain Human Drug Products by Pharmacies and 
Outsourcing Facilities; Final 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 the Agency) is 
announcing the availability of a final guidance for industry entitled 
``Repackaging of Certain Human Drug Products by Pharmacies and 
Outsourcing Facilities.'' This guidance describes the conditions under 
which FDA does not intend to take action for violations of certain 
provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 
when a State-licensed pharmacy, a Federal facility, or an outsourcing 
facility repackages certain human drug products.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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'').

[[Page 4344]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2014-D-1524 for ``Repackaging of Certain Human Drug Products by 
Pharmacies and Outsourcing Facilities.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the 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: Sara Rothman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Repackaging of Certain Human Drug Products by Pharmacies and 
Outsourcing Facilities.'' FDA regards repackaging as the act of taking 
a finished drug product from the container in which it was distributed 
by the original manufacturer and placing it into a different container 
without further manipulation of the drug. If a drug is manipulated in 
any other way, including if the drug is reconstituted, diluted, mixed, 
or combined with another ingredient, that act is not considered 
repackaging.
    Repackaged drugs are generally not exempt from any of the 
provisions of the FD&C Act related to the production of drugs. For 
example, repackaged drugs are generally subject to the premarket 
approval, misbranding, adulteration, and drug supply chain security 
provisions of the FD&C Act, including section 505 (concerning new drug 
applications), section 502(f)(1) (concerning labeling with adequate 
directions for use), section 501(a)(2)(B) (concerning current good 
manufacturing practice (CGMP)), and section 582 (drug supply chain 
security requirements) (21 U.S.C. 355, 352(f)(1), 351(a)(2)(B), and 
360eee-1).
    Further, drugs that are repackaged are not subject to sections 503A 
and 503B of the FD&C Act (21 U.S.C. 353a and 353b). Therefore, drugs 
repackaged by state-licensed pharmacies, Federal facilities, or 
outsourcing facilities are not eligible for the exemptions provided 
under those sections.
    This guidance describes the conditions under which FDA does not 
intend to take action for violations of sections 505, 502(f)(1), 582, 
and, where specified in the guidance, section 501(a)(2)(B) of the FD&C 
Act, when a state-licensed pharmacy, Federal facility, or outsourcing 
facility repackages certain drug products.
    In the Federal Register of February 19, 2015 (80 FR 8884), FDA 
issued a notice announcing the availability of the draft version of 
this guidance. The comment period on the draft guidance ended on May 
20, 2015. FDA received approximately 625 comments on the draft 
guidance. In response to received comments or on its own initiative, 
FDA made several changes. For example, FDA removed from the guidance 
the condition concerning ``anticipatory repackaging'' (repackaging 
before the receipt of a patient-specific prescription) of no more than 
a 14-day supply. FDA made this change partly in response to comments 
indicating that pharmacies sometimes need to repackage more than a 14-
day supply of repackaged drug products in advance of a prescription. 
FDA also revised the conditions concerning beyond-use-dates (BUDs) for 
repackaged drugs to reflect BUDs for compounded drugs in, as 
applicable, United States Pharmacopeia (USP) Chapter <795>, the USP's 
proposed revision to Chapter <797>, and FDA's guidance concerning 
current good manufacturing practice requirements for outsourcing 
facilities.
    FDA received comments on the draft guidance from hospital 
organizations regarding the potential implications of the proposed 
policies in the draft guidance concerning patient-specific 
prescriptions for drugs repackaged for in-patient settings. The final 
guidance notes that FDA is considering the applicability of the 
policies described in this guidance to in-patient settings, including 
long-term care facilities and hospitals, and intends to address these 
issues in separate guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
current thinking of FDA on repackaging human drug products by 
pharmacies, Federal facilities, and outsourcing facilities. 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.

[[Page 4345]]

II. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). Under the 
PRA, Federal Agencies must obtain approval from OMB for each collection 
of information they conduct or sponsor. ``Collection of information'' 
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
Agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information before submitting the 
collection to OMB for approval. To comply with this requirement, in the 
Federal Register of February 19, 2015, we gave interested persons 60 
days to comment on the information collection provisions in the draft 
guidance (80 FR 8884 at 8885).
    After publishing the 60-day notice requesting public comment, 
section 3507 of the PRA (44 U.S.C. 3507) requires Federal Agencies to 
submit the proposed collection to OMB for review and clearance. In 
compliance with 44 U.S.C. 3507, we will be submitting a proposed 
collection of information to OMB for review and clearance. FDA is 
issuing this guidance as final with portions of it subject to OMB 
approval of the collection of information and shaded gray. Those 
provisions that are shaded gray and subject to OMB approval will be 
final if the collection of information is approved. If the collection 
is approved, FDA will publish a notice in the Federal Register 
concerning OMB approval and providing an OMB control number for these 
provisions.
    The guidance also references registration and adverse event 
reporting for outsourcing facilities. The collections of information 
for outsourcing facility registration have been approved by OMB under 
OMB control number 0910-0777. The collections of information for 
adverse event reporting by outsourcing facilities have been approved by 
OMB under OMB control number 0910-0800.

III. Electronic Access

    Persons with access to the Internet can obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00723 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P