83 FR 48631 - Insanitary Conditions at Compounding Facilities; Revised Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 187 (September 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 187 (September 26, 2018)
| Page Range | 48631-48633 | |
| FR Document | 2018-20903 |
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)] [Notices] [Pages 48631-48633] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20903] ----------------------------------------------------------------------- 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Food and Drug Administration [Docket No. FDA-2016-D-2268] Insanitary Conditions at Compounding Facilities; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled, ``Insanitary Conditions at Compounding Facilities.''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 FDA is issuing this revised draft guidance to help compounding facilities identify insanitary conditions so that they can implement appropriate corrective actions. This revised draft guidance is also intended to help state regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug to become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 This guidance revises the draft guidance entitled ``Insanitary Conditions at Compounding Facilities'' that was published on August 4, 2016. DATES: Submit either electronic or written comments on the draft guidance by November 26, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins works on the final version of the guidance.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.thefederalregister.org/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 [[Page 48633]] 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
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an outsourcing facility to qualify for with radioactive drug products. In Dated: September 20, 2018.
exemptions from the following three addition, FDA made revisions to align Leslie Kux,
sections of the FD&C Act: language used in this guidance with Associate Commissioner for Policy.
• Section 502(f)(1) (21 U.S.C. language used in the guidance entitled [FR Doc. 2018–20901 Filed 9–25–18; 8:45 am]
352(f)(1)) (concerning labeling with ‘‘Compounding and Repackaging of BILLING CODE 4164–01–P
adequate directions for use); Radiopharmaceuticals by State-Licensed
• section 505 (21 U.S.C. 355) Nuclear Pharmacies, Federal Facilities,
(concerning drug approval and Certain Other Entities.’’ DEPARTMENT OF HEALTH AND
requirements); and HUMAN SERVICES
• section 582 (21 U.S.C. 360eee–1) This guidance is being issued
(concerning drug supply chain security consistent with FDA’s good guidance Food and Drug Administration
requirements). practices regulation (21 CFR 10.115).
In contrast to section 503A (21 U.S.C. This guidance represents the current [Docket No. FDA–2016–D–2268]
353a), section 503B of the FD&C Act thinking of FDA on ‘‘Compounding and
Insanitary Conditions at Compounding
does not exclude radiopharmaceuticals. Repackaging of Radiopharmaceuticals
Facilities; Revised Draft Guidance for
Therefore, FDA’s overall policies by Outsourcing Facilities.’’ It does not Industry; Availability
regarding section 503B apply to the establish any rights for any person and
compounding of radiopharmaceutical is not binding on FDA or the public. AGENCY: Food and Drug Administration,
drug products. However, we have You can use an alternative approach if HHS.
developed specific policies that apply it satisfies the requirements of the ACTION: Notice of availability.
only to the compounding of applicable statutes and regulations. This
radiopharmaceuticals by outsourcing guidance is not subject to Executive SUMMARY: The Food and Drug
facilities using bulk drug substances and Order 12866. Administration (FDA or Agency) is
to the compounding of announcing the availability of a revised
radiopharmaceuticals by outsourcing II. Paperwork Reduction Act of 1995 draft guidance for industry entitled,
facilities that are essentially copies of ‘‘Insanitary Conditions at Compounding
approved drugs when such This guidance contains collections of Facilities.’’ Drug products compounded
compounding is limited to minor information that are subject to review by under insanitary conditions could
deviations, as that term is defined in the the Office of Management and Budget become contaminated and cause serious
guidance. FDA is also issuing this (OMB) under the Paperwork Reduction adverse events, including death, in
guidance in part to describe the Act (PRA) of 1995 (44 U.S.C. 3501– patients. FDA is issuing this revised
conditions under which the Agency 3520). Under the PRA, Federal Agencies draft guidance to help compounding
does not generally intend to take action must obtain approval from OMB for facilities identify insanitary conditions
for violations of sections 505 and each collection of information they so that they can implement appropriate
502(f)(1) of the FD&C Act when an conduct or sponsor. ‘‘Collection of corrective actions. This revised draft
outsourcing facility repackages information’’ is defined in 44 U.S.C. guidance is also intended to help state
radiopharmaceuticals for human use. 3502(3) and 5 CFR 1320.3 and includes regulatory agencies understand some
Elsewhere in this issue of the Federal Agency requests or requirements that examples of what FDA considers to be
Register, FDA has announced the members of the public submit reports, insanitary conditions that could cause a
availability of a separate guidance keep records, or provide information to drug to become contaminated or
document concerning compounding and a third party. rendered injurious to health. This
repackaging of radiopharmaceuticals by Specifically, the guidance references guidance revises the draft guidance
State-licensed nuclear pharmacies, registration, adverse event reporting, entitled ‘‘Insanitary Conditions at
Federal facilities, and other facilities product reporting, and current good Compounding Facilities’’ that was
that are not registered as outsourcing manufacturing practices (CGMP) published on August 4, 2016.
facilities, entitled ‘‘Compounding and requirements for outsourcing facilities. DATES: Submit either electronic or
Repackaging of Radiopharmaceuticals The collections of information for written comments on the draft guidance
by State-Licensed Nuclear Pharmacies, outsourcing facility registration have by November 26, 2018 to ensure that the
Federal Facilities, and Certain Other been approved under OMB control Agency considers your comment on this
Entities.’’ draft guidance before it begins works on
number 0910–0777 (79 FR 69859,
In the Federal Register of December the final version of the guidance.
November 24, 2014). The collections of
29, 2016 (81 FR 96005), FDA issued a ADDRESSES: You may submit comments
notice announcing the availability of the information for adverse event reporting
by outsourcing facilities have been on any guidance at any time as follows:
draft version of this guidance. The
comment period on the draft guidance approved under OMB control number Electronic Submissions
ended on February 27, 2017. FDA 0910–0800 (80 FR 60917, October 8,
Submit electronic comments in the
received approximately three comments 2015). The collections of information for
following way:
on the draft guidance. In response to electronic drug product reporting by • Federal eRulemaking Portal:
received comments or on its own outsourcing facilities have been https://www.regulations.gov. Follow the
initiative, FDA made certain changes to approved under OMB control number instructions for submitting comments.
the guidance to clarify particular points. 0910–0827 (82 FR 129, January 3, 2017). Comments submitted electronically,
For example, the reference to the III. Electronic Access including attachments, to https://
daltland on DSKBBV9HB2PROD with NOTICES
syringe as an example of primary www.regulations.gov will be posted to
packaging was deleted in response to a Persons with access to the internet the docket unchanged. Because your
comment stating that a syringe may obtain the guidance at either comment will be made public, you are
containing a radiopharmaceutical https://www.fda.gov/Drugs/ solely responsible for ensuring that your
should not be described as ‘‘primary GuidanceComplianceRegulatory comment does not include any
packaging’’ for labeling purposes Information/Guidances/default.htm or confidential information that you or a
because of the unique risks associated https://www.regulations.gov. third party may not wish to be posted,
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![Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48633
expect that the guidance will help (NRC) or by an Agreement State. 2016–D–4318 for ‘‘Compounding and
compounding facilities to identify Because such radiopharmaceuticals are Repackaging of Radiopharmaceuticals
insanitary conditions so that they can not eligible for exemptions from by State-Licensed Nuclear Pharmacies,
implement appropriate corrective provisions of the Federal Food, Drug, Federal Facilities, and Certain Other
actions, and will assist states in and Cosmetic Act (FD&C Act) related to Entities.’’ Received comments will be
identifying insanitary conditions during the production of drugs, FDA is issuing placed in the docket and, except for
their inspections of compounding this guidance to describe the conditions those submitted as ‘‘Confidential
facilities. under which it generally does not Submissions,’’ publicly viewable at
This revised draft guidance is being intend to take action for violations of https://www.regulations.gov or at the
issued consistent with FDA’s good certain provisions of the FD&C Act Dockets Management Staff between 9
guidance practices regulation (21 CFR when these entities compound or a.m. and 4 p.m., Monday through
10.115). The revised draft guidance, repackage radiopharmaceuticals. Friday.
when finalized, will represent the DATES: The announcement of the • Confidential Submissions—To
current thinking of FDA on ‘‘Insanitary guidance is published in the Federal submit a comment with confidential
Conditions at Compounding Facilities.’’ Register on September 26, 2018. information that you do not wish to be
It does not establish any rights for any ADDRESSES: You may submit either made publicly available, submit your
person and is not binding on FDA or the electronic or written comments on comments only as a written/paper
public. You can use an alternative Agency guidances at any time as submission. You should submit two
approach if it satisfies the requirements follows: copies total. One copy will include the
of the applicable statutes and information you claim to be confidential
regulations. This guidance is not subject Electronic Submissions with a heading or cover note that states
to Executive Order 12866. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
following way: CONFIDENTIAL INFORMATION.’’ The
II. Electronic Access
• Federal eRulemaking Portal: Agency will review this copy, including
Persons with access to the internet https://www.regulations.gov. Follow the the claimed confidential information, in
may obtain the revised draft guidance at instructions for submitting comments. its consideration of comments. The
either https://www.fda.gov/Drugs/ Comments submitted electronically, second copy, which will have the
GuidanceComplianceRegulatory including attachments, to https:// claimed confidential information
Information/Guidances/default.htm or www.regulations.gov will be posted to redacted/blacked out, will be available
https://www.regulations.gov. the docket unchanged. Because your for public viewing and posted on
Dated: September 20, 2018. comment will be made public, you are https://www.regulations.gov. Submit
Leslie Kux, solely responsible for ensuring that your both copies to the Dockets Management
Associate Commissioner for Policy. comment does not include any Staff. If you do not wish your name and
[FR Doc. 2018–20903 Filed 9–25–18; 8:45 am] confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
BILLING CODE 4164–01–P
such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
DEPARTMENT OF HEALTH AND confidential business information, such must identify this information as
HUMAN SERVICES as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Food and Drug Administration information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
[Docket No. FDA–2016–D–4318] more information about FDA’s posting
comments, that information will be
Compounding and Repackaging of posted on https://www.regulations.gov. of comments to public dockets, see 80
Radiopharmaceuticals by State- • If you want to submit a comment FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
Licensed Nuclear Pharmacies, Federal
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
Facilities, and Certain Other Entities;
public, submit the comment as a 23389.pdf.
Guidance for Industry; Availability Docket: For access to the docket to
written/paper submission and in the
AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper read background documents or the
HHS. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
ACTION: Notice of availability. received, go to https://
Written/Paper Submissions www.regulations.gov and insert the
SUMMARY: The Food and Drug Submit written/paper submissions as docket number, found in brackets in the
Administration (FDA or the Agency) is follows: heading of this document, into the
announcing the availability of a • Mail/Hand Delivery/Courier (for ‘‘Search’’ box and follow the prompts
guidance for industry entitled written/paper submissions): Dockets and/or go to the Dockets Management
‘‘Compounding and Repackaging of Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
Radiopharmaceuticals by State-Licensed Drug Administration, 5630 Fishers Rockville, MD 20852.
Nuclear Pharmacies, Federal Facilities, Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any
and Certain Other Entities.’’ This • For written/paper comments guidance at any time (see 21 CFR
guidance sets forth FDA’s policy submitted to the Dockets Management 10.115(g)(5)).
daltland on DSKBBV9HB2PROD with NOTICES
regarding compounding and Staff, FDA will post your comment, as Submit written requests for single
repackaging of radiopharmaceuticals for well as any attachments, except for copies of this guidance to the Division
human use by State-licensed nuclear information submitted, marked and of Drug Information, Center for Drug
pharmacies, Federal facilities, and other identified, as confidential, if submitted Evaluation and Research, Food and
entities that hold a radioactive materials as detailed in ‘‘Instructions.’’ Drug Administration, 10001 New
(RAM) license for medical use issued by Instructions:All submissions received Hampshire Ave., Hillandale Building,
the Nuclear Regulatory Commission must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993–
VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1](https://thefederalregister.org/doc/83_FR_48818/page/3.svg)
Document Created: 2018-09-26 00:46:59
Document Modified: 2018-09-26 00:46:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 48631 |
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