[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48631-48633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20903]


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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Insanitary Conditions at Compounding Facilities; Revised Draft 
Guidance for Industry; Availability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 Agency) is announcing 
the availability of a revised draft guidance for industry entitled, 
``Insanitary Conditions at Compounding Facilities.'' Drug products 
compounded under insanitary conditions could become contaminated and 
cause serious adverse events, including death, in patients. FDA is 
issuing this revised draft guidance to help compounding facilities 
identify insanitary conditions so that they can implement appropriate 
corrective actions. This revised draft guidance is also intended to 
help state regulatory agencies understand some examples of what FDA 
considers to be insanitary conditions that could cause a drug to become 
contaminated or rendered injurious to health. This guidance revises the 
draft guidance entitled ``Insanitary Conditions at Compounding 
Facilities'' that was published on August 4, 2016.

DATES: Submit either electronic or written comments on the draft 
guidance by November 26, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins works on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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,

[[Page 48632]]

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 https://www.regulations.gov or at the Dockets Management 
Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the revised 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 revised 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 revised draft guidance for 
industry entitled ``Insanitary Conditions at Compounding Facilities.'' 
Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 351(a)(2)(A)), a drug is adulterated if it has 
been prepared, packed, or held under insanitary conditions whereby it 
may have been contaminated with filth or rendered injurious to health. 
Drug products compounded under insanitary conditions could become 
contaminated and cause serious adverse events, including death, in 
patients. 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 a 2012 fungal meningitis outbreak associated with injectable 
drug products that a pharmacy compounded and shipped to patients and 
health care providers across the country, the Agency has identified 
insanitary conditions at many of the compounding facilities that it has 
inspected, and numerous compounders have voluntarily recalled drug 
products intended to be sterile and temporarily or permanently ceased 
sterile operations because of these findings. FDA does not inspect the 
vast majority of compounding facilities in the United States because 
they generally do not register with FDA unless they are outsourcing 
facilities. Therefore, unless FDA receives a complaint, such as a 
report of a serious adverse event or visible contamination, the Agency 
is often not aware of these facilities, their conditions and practices, 
and potential problems with the quality and safety of their drug 
products. It is critical that compounding facilities identify and 
remediate any insanitary conditions at their facilities before the 
conditions result in drug contamination and patient injury.
    In the Federal Register of August 4, 2016 (81 FR 51449), FDA 
announced the availability of a draft guidance for industry entitled, 
``Insanitary Conditions at Compounding Facilities.'' The draft guidance 
provided examples of insanitary conditions that the Agency has observed 
at compounding facilities it has inspected and considers to be 
insanitary conditions. The draft guidance also described corrective 
actions that compounding facilities should take when they identify such 
conditions and the regulatory actions FDA may take in response to 
identified insanitary conditions. FDA received comments on the draft 
guidance including feedback from various stakeholders (e.g., 
physicians, pharmacies), particularly concerning the implications of 
the policies described in the draft guidance for physicians who prepare 
drugs in their offices. FDA is revising the draft guidance to address 
the stakeholders' feedback and to provide further clarification on the 
insanitary conditions described in the guidance, as well as the actions 
FDA intends to take with respect to insanitary conditions. FDA is 
issuing this revised draft guidance to enable the public to further 
review and comment before finalization of FDA's policies concerning 
insanitary conditions. We

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expect that the guidance will help compounding facilities to identify 
insanitary conditions so that they can implement appropriate corrective 
actions, and will assist states in identifying insanitary conditions 
during their inspections of compounding facilities.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The revised 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. This guidance 
is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the revised draft 
guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20903 Filed 9-25-18; 8:45 am]
 BILLING CODE 4164-01-P


