Document ID: FDA-2021-D-0241-0001
Agency: fda
Document Type: Notice
Title: Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry; Availability
Posted Date: 2021-12-17T05:00Z

[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71648-71650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27351]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0241]

Inspection of Injectable Products for Visible Particulates; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Inspection 
of Injectable Products for Visible Particulates.'' Visible particulates 
in injectable products can jeopardize patient safety. This draft 
guidance addresses the development and implementation of a holistic, 
risk-based approach to visible particulate control that incorporates 
product development, manufacturing controls, visual inspection 
techniques, particulate identification, investigation, and

[[Page 71649]]

corrective actions designed to assess, correct, and prevent the risk of 
visible particulate contamination. The draft guidance also clarifies 
that meeting an applicable U.S. Pharmacopeia (USP) compendial standard 
alone is not generally sufficient for meeting the current good 
manufacturing practice (CGMP) requirements for the manufacture of 
injectable products.

DATES: Submit either electronic or written comments on the draft 
guidance by February 15, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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, 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-2021-D-0241 for ``Inspection of Injectable Products for Visible 
Particulates.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 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; Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 
the Policy and Regulations Staff (HFV-6), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. 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: Eric Dong, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002, 240-402-4172; Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911; or Laura Huffman, Center for 
Veterinary Medicine (HFV-140), Food and Drug Administration, Metro Park 
North 2 (MPN2), Rm. Hotel CVM, 7500 Standish Pl., Rockville, MD 20855, 
240-402-0664.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Inspection of Injectable Products for Visible 
Particulates.'' Visible particulates in injectable products can 
jeopardize patient safety. The draft guidance addresses a holistic 
approach to visible particulate control that incorporates risk 
assessment, prevention, inspection, identification, and remediation of 
visible particulates in injectable products.
    Adherence to FDA's CGMP requirements. as set forth in section 501 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351) 
and 21 CFR parts 210 and 211 for drug, animal drug, and biological 
products; 21 CFR 600.10 through 600.15 for biological products; and 21 
CFR part 4 for combination products, is essential for the control of 
visible particulates in injectable products. Adherence to compendial 
standards can also assist manufacturers in complying with CGMP 
requirements. USP General Chapter <1> Injections and Implanted Drug 
Products (Parenterals)--Product Quality Tests states that ``[t]he 
inspection process should be designed and qualified to ensure that 
every lot of all parenteral preparations is essentially free from 
visible particulates'' as defined in USP General Chapter <790> Visible 
Particulates in Injections. Injectable

[[Page 71650]]

products with a USP monograph are required to meet the applicable 
criteria from these USP General Chapters (see section 501(b) of the 
FD&C Act). Noncompendial products should also be ``essentially free 
from visible particulates'' as defined in USP General Chapter <790>.
    Applying acceptance criteria, such as the criterion outlined in USP 
General Chapter <790>, is an important component of the overall visible 
particulate control program, but meeting these acceptance criteria 
alone is not sufficient to ensure compliance with the applicable CGMP 
requirements identified above, which cover a broader array of 
manufacturing practices than product inspection. Full compliance with 
CGMP requirements is needed to ensure the continued supply of pure, 
safe, and effective injectable products.
    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 ``Inspection 
of Injectable Products for Visible Particulates.'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR parts 211, 314, and 601 have been approved 
under OMB control numbers 0910-0139, 0910-0001, and 0910-0308, 
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 14, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27351 Filed 12-16-21; 8:45 am]
BILLING CODE 4164-01-P