[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)]
[Notices]
[Pages 129-130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1428]


Electronic Drug Product Reporting for Human Drug Compounding 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act; 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 guidance for industry entitled 
``Electronic Drug Product Reporting for Human Drug Compounding 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act.'' The final guidance addresses new provisions in the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug 
Quality and Security Act (DQSA) and updates reporting instructions for 
drug compounders that choose to register as outsourcing facilities. 
Such compounders must report information on the drugs they compounded 
in Structured Product Labeling (SPL) format using FDA's electronic 
submissions system unless FDA grants a request for a waiver of such 
requirement because use of electronic means is not reasonable for the 
person requesting the waiver. This guidance supersedes the revised 
draft guidance entitled ``Electronic Drug Product Reporting for Human 
Drug Compounding Outsourcing Facilities Under Section 503B of the 
Federal Food, Drug, and Cosmetic Act.''

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: 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): 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-2013-N-1428 for ``Electronic Drug Product Reporting for Human Drug 
Compounding Outsourcing Facilities Under Section 503B of the Federal 
Food, Drug, and Cosmetic Act.'' 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 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

[[Page 130]]

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 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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: Lysette Deshields, Center for Drug 
Evaluation and Research Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993 301-796-3100.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Electronic Drug Product Reporting for Human Drug Compounding 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act.'' In the Federal Register of November 24, 2014 (79 FR 
69857), FDA announced the availability of a revised draft guidance for 
industry entitled ``Electronic Drug Product Reporting for Human Drug 
Compounding Outsourcing Facilities Under Section 503B of the Federal 
Food, Drug, and Cosmetic Act.'' On November 27, 2013, President Obama 
signed the DQSA into law (Pub. L. 113-54). The DQSA added a new section 
503B to the FD&C Act (21 U.S.C. 353b). Under section 503B(b), a 
compounder can register as an outsourcing facility with FDA. If the 
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a 
drug compounded by or under the direct supervision of a licensed 
pharmacist in an outsourcing facility is exempt from certain sections 
of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1)) 
(concerning the labeling of drugs with adequate directions for use) and 
section 505 (21 U.S.C. 355) (concerning the approval of human drug 
products under new drug applications or abbreviated new drug 
applications). Drugs compounded in outsourcing facilities are not 
exempt from the requirements of section 501(a)(2)(B) of the FD&C Act 
(21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing 
practice for drugs).
    Under section 503B, an outsourcing facility must, at the time of 
initial registration and twice each year, in June and December, submit 
to FDA a report identifying the drugs compounded by the facility during 
the previous 6-month period. For each identified drug, the outsourcing 
facility must report the following information to FDA for each product 
that it compounds:
     The active ingredient and strength of active ingredient 
per unit;
     the source of the active ingredient (bulk or finished 
drug);
     the National Drug Code (NDC) number of the source drug or 
bulk active ingredient, if available;
     the dosage form and route of administration;
     the package description;
     the number of individual units produced; and
     the NDC number of the final product, if assigned.\1\
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    \1\ Section 503B(b)(2)(A)(ii) of the FD&C Act.
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    This final guidance explains that registered outsourcing facilities 
must provide reports to FDA on compounded drugs in SPL format using 
FDA's electronic submissions system unless FDA grants a request for a 
waiver of such requirement because use of electronic means is not 
reasonable for the person requesting the waiver. It supersedes the 
revised draft guidance entitled ``Electronic Drug Product Reporting for 
Human Drug Compounding Outsourcing Facilities Under Section 503B of the 
Federal Food, Drug, and Cosmetic Act.''
    The comment period for the revised draft guidance ended on January 
23, 2015. FDA received three comments on the draft. In response to 
received comments or on its own initiative, FDA made the following 
changes and updates in the final guidance: (1) Clarified FDA's 
definition of the source of the active ingredient used to compound the 
final product and the information the outsourcing facility should 
submit to FDA, including the appropriate format of the NDC code; (2) 
clarified what information submitted as part of a product report will 
be made public; and (3) made grammatical and other minor editorial 
changes for clarity. In some cases, comments raised issues that were 
not directly pertinent to the topics addressed in the revised draft 
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 ``Electronic Drug Product Reporting for 
Human Drug Compounding Outsourcing Facilities Under Section 503B of the 
Federal Food, Drug, and Cosmetic Act.'' 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 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 have been approved under OMB control number 0910-0827.

III. Electronic Access

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

    Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31789 Filed 12-30-16; 8:45 am]
 BILLING CODE 4164-01-P