
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60917-60918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25622]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2138]


Adverse Event Reporting for 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a final guidance for industry entitled 
``Adverse Event Reporting for Outsourcing Facilities Under Section 503B 
of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must 
submit adverse event reports to FDA. This guidance explains FDA's 
current thinking on adverse event reporting for these outsourcing 
facilities.

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'').

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-2138 for Adverse Event Reporting for Outsourcing Facilities 
Under Section 503B of the Federal Food, Drug, and Cosmetic Act; 
Guidance for Industry; Availability. 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

[[Page 60918]]

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. 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, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Adverse Event Reporting for Outsourcing Facilities Under 
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' On November 
27, 2013, President Obama signed the Drug Quality and Security Act 
(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. Section 503B(d)(4) of 
the FD&C Act defines an outsourcing facility, in part, as a facility 
that complies with all of the requirements of section 503B, including 
registering with FDA as an outsourcing facility and paying associated 
fees. 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 (NDAs) or abbreviated 
new drug applications (ANDAs)). 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(b)(5), an outsourcing facility must submit 
adverse event reports to FDA in accordance with the content and format 
requirements established through guidance or regulation under 21 CFR 
310.305 (or any successor regulations). This guidance explains how FDA 
intends to implement Sec.  310.305 with respect to outsourcing 
facilities.
    In the Federal Register of February 19, 2015 (80 FR 8872), 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 seven comments on the draft guidance.
    In response to received comments or on its own initiative, FDA made 
several changes to clarify particular points and to provide updated 
information.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. It does not create any rights for any 
person and is not binding on FDA or the public. An alternative approach 
can be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act

    This guidance contains collections of information that are subject 
to review by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information have been approved under OMB control number 0910-0800.

III. Electronic Access

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

    Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25622 Filed 10-7-15; 8:45 am]
BILLING CODE 4164-01-P


