
[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51449-51450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2268]


Insanitary Conditions at Compounding Facilities; Draft Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Insanitary 
Conditions at Compounding Facilities.'' Drug products compounded under 
insanitary conditions could become contaminated and cause serious 
adverse events in patients, including death. FDA is issuing this draft 
guidance to assist compounding facilities in identifying insanitary 
conditions so that they can implement appropriate corrective actions, 
and to assist State regulatory agencies in understanding some examples 
of what FDA considers to be insanitary conditions.

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 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 3, 2016.

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

[[Page 51450]]

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-2016-D-2268 for ``Insanitary Conditions at Compounding 
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 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 draft 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 draft guidance for industry 
entitled ``Insanitary Conditions at Compounding Facilities.'' Under 
section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 351(a)(2)(A)), a drug is deemed to be adulterated 
if it has been prepared, packed, or held under insanitary conditions 
whereby it may have been contaminated with filth, or whereby it may 
have been rendered injurious to health. Drug products compounded under 
insanitary conditions could become contaminated and cause serious 
adverse events in patients, including death. Although sections 503A and 
503B of the FD&C Act (21 U.S.C. 353a and 353b) provide exemptions for 
compounded drugs from specified provisions of the FD&C Act if certain 
conditions are met, neither section provides an exemption from section 
501(a)(2)(A) of the FD&C Act. Any drug that is prepared, packed, or 
held under insanitary conditions is deemed to be adulterated under the 
FD&C Act, including drugs produced by a compounding facility.
    Since the 2012 fungal meningitis outbreak associated with 
injectable drug products that a compounding facility produced and 
shipped across the country, FDA has identified insanitary conditions at 
many of the compounding facilities that it has inspected, and numerous 
compounding facilities have voluntarily recalled drug products intended 
to be sterile and temporarily or permanently ceased sterile operations 
as a result of these findings. However, FDA does not inspect the vast 
majority of compounding facilities in the United States because they 
generally do not register with FDA unless they elect to become 
outsourcing facilities. Therefore, FDA is often not aware of these 
facilities and potential problems with their drug products, or 
conditions and practices, unless it receives a complaint such as a 
report of a serious adverse event or visible contamination. It is 
critical that compounding facilities avoid the presence of insanitary 
conditions and identify and remediate any insanitary conditions at 
their facilities before the conditions result in drug contamination and 
patient injury.
    FDA is issuing this draft guidance to assist compounding facilities 
in identifying insanitary conditions so that they can implement 
appropriate corrective actions, and to assist State regulatory agencies 
in understanding some examples of what FDA considers to be insanitary 
conditions.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on insanitary 
conditions at compounding 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.

II. 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 http://www.regulations.gov.

    Dated: July 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18461 Filed 8-3-16; 8:45 am]
 BILLING CODE 4164-01-P


