[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Insanitary Conditions at Compounding Facilities; Draft Guidance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availability of a draft guidance for industry entitled ``Insanitary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 FDA is issuing this draft
guidance to assist compounding facilities in identifying insanitary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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 3, 2016.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]
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