[Federal Register Volume 87, Number 2 (Tuesday, January 4, 2022)]
[Notices]
[Pages 228-229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3077]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Obtaining Information 
To Understand Challenges and Opportunities Encountered by Compounding 
Outsourcing Facilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by February 3, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0883. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
<a href="/cdn-cgi/l/email-protection#dc8c8e9d8fa8bdbaba9cbab8bdf2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="fbaba9baa88f9a9d9dbb9d9f9ad5939388d59c948d">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Obtaining Information To Understand Challenges and Opportunities 
Encountered by Compounding Outsourcing Facilities

OMB Control Number 0910-0883--Extension

    This information collection supports FDA research in obtaining a 
range of information pertaining to human prescription drug compounding 
by outsourcing facilities. Generally, drug compounding is the practice 
of combining, mixing, or altering ingredients of a drug to create a 
medication tailored to an individual patient's needs. Although 
compounded drugs can serve an important medical need for certain 
patients when an approved drug is not medically appropriate, compounded 
drugs also present a risk to patients. Compounded drugs are not FDA-
approved; therefore, they do not undergo FDA premarket review for 
safety, effectiveness, and quality.
    Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 353a) describes the conditions that must be satisfied for 
compounded human prescription drug products to be exempt from certain 
sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 
351(a)(2)(B)) (current good manufacturing practice (CGMP) 
requirements), (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (labeling of 
drugs with adequate directions for use), and (3) section 505 (21 U.S.C. 
355) (approval of drugs under new drug applications or abbreviated new 
drug applications).
    The Drug Quality and Security Act of 2013 (Pub. L. 113-54) created 
``outsourcing facilities''--a new industry sector of drug compounders 
held to higher quality standards to protect patient health. Section 
503B of the FD&C Act (21 U.S.C. 353b) describes the conditions that 
outsourcing facilities must satisfy for drug products compounded in an 
outsourcing facility by or under the direct supervision of a licensed 
pharmacist to be exempt from certain sections of the FD&C Act. 
Outsourcing facilities are intended to offer a more reliable supply of 
compounded drugs that hospitals, clinics, and other providers need.
    FDA continues to find concerning quality and safety problems during 
inspections of outsourcing facilities. FDA has implemented and will 
continue to implement programs to support compounding quality and 
compliance. One initiative is FDA's Compounding Quality Center of 
Excellence (Center of Excellence), https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence, which was 
developed to focus on improving the quality of compounded human 
prescription drugs to promote patient safety. One of our top priorities 
is to help ensure that compounded drugs are safe by focusing on 
quality. FDA, State regulators, pharmacy associations, and compounders, 
including outsourcing facilities, share the responsibility for patient 
safety.
    The Center of Excellence engages and collaborates with compounders, 
including outsourcing facilities, and other stakeholders to improve the 
overall quality of compounded drugs. Furthermore, the Center of 
Excellence promotes collaboration to help compounders implement robust 
quality management systems that are better for business and the safety 
of patients.
    To help strengthen the outsourcing facility industry's ability to 
provide quality compounded drugs to patients who need them, the Center 
of Excellence offers training sessions and opportunities to develop 
manufacturing quality and other policies for outsourcing facilities, 
including CGMPs.
    The Center of Excellence offers several training sessions 
(available at https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence-training-programs). Self-guided 
training sessions teach the following topics: (1) Environmental 
monitoring, (2) sterile drug compounding, (3) cleanroom performance 
tests, and (4) conducting investigations and formulating corrective and 
preventive actions. Instructor-led sessions teach the regulatory 
framework for these topics: (1) Human drug compounding, (2) airflow 
practices, (3) insanitary conditions and sterility, (4) stability and 
beyond use dates, (5) requirements for outsourcing facility guides, and 
(6) conducting investigations and formulating corrective and preventive 
actions. Management and staff from outsourcing facilities have attended 
the training sessions. Feedback on the training sessions has been 
positive, and interest in the sessions continues to grow.
    In addition, the Center of Excellence is conducting in-depth 
research to better understand outsourcing facilities' challenges and 
opportunities in different areas to help guide decisions regarding 
future training and other engagement. Outsourcing facilities encounter 
the following challenges and opportunities: (1) Operational barriers 
and opportunities related to the outsourcing facility market and 
business viability, (2) knowledge and operational barriers and 
opportunities related to

[[Page 229]]

compliance with Federal policies and good quality drug production, and 
(3) barriers and opportunities related to outsourcing facility 
interactions with FDA.
    FDA used previous research results under this information 
collection to develop an understanding of the outsourcing facility 
sector, the sector's challenges, and opportunities for advancement. The 
information collected was an essential tool to help FDA identify 
knowledge and information gaps, operational barriers, and views on 
interactions with FDA. FDA has presented this information in public 
settings, such as stakeholder meetings. Continuing this collection will 
enable FDA to deepen our understanding of the outsourcing facility 
sector and increase our efficacy in developing a Center of Excellence 
that is responsive to outsourcing facilities' needs. The research 
results will inform FDA's future activities for the Center of 
Excellence in the areas of communication, education, training, and 
other engagement with outsourcing facilities to address challenges and 
support advancement.
    Researchers engage with pharmacists, staff, management from 
outsourcing facilities, similar compounding businesses, and related 
stakeholders and may use surveys, interviews, and focus groups to 
obtain information about outsourcing facilities' challenges and 
opportunities. Within this context, we may pose the following questions 
or similar, related questions:
    1. What financial and operational considerations inform outsourcing 
facility operational and business model decisions?
    2. What factors impact developing a sustainable outsourcing 
facility business?
    3. What financial and operational considerations inform outsourcing 
facility product decisions?
    4. Do outsourcing facilities understand the Federal laws and 
policies that apply to them? What, if any, knowledge gaps do we need to 
address?
    5. What are outsourcing facilities' challenges when implementing 
Federal CGMP requirements?
    6. How do outsourcing facilities implement quality practices at 
their facilities?
    7. How do outsourcing facilities develop CGMP and quality 
expertise? How do they obtain this knowledge, and what training do they 
need?
    8. What are the economic consequences of CGMP noncompliance and 
product failures for outsourcing facilities?
    9. What are outsourcing facility management and staff views on 
current interactions with FDA? How do they want the interactions to 
change?
    10. What are outsourcing facilities' understanding of how to engage 
with FDA during and following an inspection?
    In the Federal Register of October 1, 2021 (86 FR 54450), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment from an industry 
association relating to the quality of questions previously posed to 
industry stakeholders concerning outsourcing facilities. Specifically, 
the commenter stated that the proposed questions included in the 60-day 
notice were insufficient to fully acquire information relating to the 
challenges and opportunities outsourcing facilities face. Accordingly, 
the commenter provided a number of additional questions for FDA to use, 
which the commenter believes will better solicit relevant information. 
FDA has considered the commenter's additional questions and will take 
them under advisement for possible inclusion in future studies. 
However, at this time FDA will not include the commenter's questions in 
this particular study because we believe the proposed questions listed 
in the 60-day notice will sufficiently solicit the specific information 
we are currently seeking.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Surveys, focus groups, and interviews..............................             300                2              600                1              600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our original request for the information collection was approved 
January 21, 2020; however, the subsequent public health emergency 
inhibited our ability to administer the requested survey. We have 
therefore made no adjustments to our current burden estimate.

    Dated: December 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28465 Filed 1-3-22; 8:45 am]
BILLING CODE 4164-01-P


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