Notice2024-21676
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Primary source
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Published
September 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 184 (Monday, September 23, 2024)</title>
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[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77528-77531]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21676]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2583]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Drug
Compounding, Repackaging, and Related Activities Regarding Sections
503A and 503B of the Federal Food, Drug, and Cosmetic Act
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 October 23, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0858. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#114143504265707777517775703f7979623f767e67"><span class="__cf_email__" data-cfemail="c191938092b5a0a7a781a7a5a0efa9a9b2efa6aeb7">[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.
Human Drug Compounding, Repackaging, and Related Activities Regarding
Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
OMB Control Number 0910-0858--Extension
This information collection helps support implementation of
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 353a and 21 U.S.C. 353b), which govern
compounding by pharmacies, outsourcing facilities, and other entities.
Compounding is generally a practice in which a licensed pharmacist, a
licensed physician, or, in the case of an outsourcing facility, a
person under the supervision of a licensed pharmacist, combines, mixes,
or alters ingredients of a drug to create a medication tailored to the
needs of an individual patient. Although compounded drugs can serve an
important medical need for certain patients, they also present risks to
patients. FDA's compounding program aims to protect patients from
unsafe, ineffective, and poor-quality compounded drugs, while
preserving access to lawfully marketed compounded drugs for patients
who have a medical need for them. Respondents to the information
collection are pharmacies, outsourcing facilities, and other entities.
To assist respondents in complying with statutory requirements, we
have issued the following topic-specific guidance documents:
Table 1--Published Guidance Documents Regarding Sections 503A and 503B of the FD&C Act
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Title Notice of availability publication date
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Compounding and Repackaging of Radiopharmaceuticals September 26, 2018 (83 FR 48633).
by State-Licensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities
(Radiopharmaceutical Compounding and Repackaging
Guidance) (available at <a href="https://www.fda.gov/media/102615/download">https://www.fda.gov/media/102615/download</a> 102615/download).
[[Page 77529]]
Compounding and Repackaging of Radiopharmaceuticals September 26, 2018 (83 FR 48630).
by Outsourcing Facilities (Radiopharmaceutical
Compounding and Repackaging by Outsourcing
Facilities Guidance) (available at <a href="https://www.fda.gov/media/102637/download">https://www.fda.gov/media/102637/download</a>).
Repackaging of Certain Human Drug Products by January 13, 2017 (82 FR 4343).
Pharmacies and Outsourcing Facilities (Repackaging
Guidance) (available at <a href="https://www.fda.gov/media/90978/download">https://www.fda.gov/media/90978/download</a> 90978/download).
Mixing, Diluting, or Repackaging Biological Products January 19, 2018 (83 FR 2787).
Outside the Scope of an Approved Biologics License
Application (Biological Products Guidance)
(available at <a href="https://www.fda.gov/media/90986/download">https://www.fda.gov/media/90986/download</a> download).
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The guidance documents also describe conditions under which FDA
generally does not intend to take enforcement action for violations of
the FD&C Act. These guidance documents were issued consistent with
FDA's good guidance practice regulations in 21 CFR 10.115, which
provide for public comment at any time. The guidance documents
communicate FDA's current thinking on the respective topics and include
information collection that may result in expenditures of time and
effort by respondents. In FDA's notices of availability for the
guidance documents, we also solicited public comment under the PRA on
the information collection provisions. FDA has developed and maintains
a searchable guidance database available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Guidance
documents covered by this information collection may be found by
choosing ``Center for Drug Evaluation and Research'' from among the FDA
Organizations, and by selecting the term ``Compounding'' from among the
possible filters.\1\
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\1\ Guidance documents applicable to animal drug compounding
regulated by the Center for Veterinary Medicine would also be
returned if no FDA Organization is selected; this information
collection covers only those compounding guidance documents issued
by the Center for Drug Evaluation and Research and Center for
Biologics Evaluation and Research.
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In the Federal Register of June 12, 2024 (89 FR 49880), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this information collection as follows:
Table 2--Estimated Annual Reporting Burden \1\
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Number of Average
Recommended activity; guidance section Number of disclosures per Total annual burden per Total
respondents respondent disclosures disclosure hours
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Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance
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Biannual product reports identifying drug 2 2 4 3 12
products repackaged by the outsourcing
facility during the previous 6-month
period (section III.B of the
Radiopharmaceutical Compounding and
Repackaging Guidance by Outsourcing
Facilities).
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Repackaging Guidance
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Biannual product reports identifying drug 6 2 12 3 36
products repackaged by the outsourcing
facility during the previous 6-month
period (section III.A of the Repackaging
Guidance)................................
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Total................................. 8 ................ 16 ........... 48
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Outsourcing facilities submit their initial and biannual product
reports identifying drug products repackaged during the previous 6-
month period to FDA via the Agency's electronic Drug Registration and
Listing System as explained in the Radiopharmaceutical Compounding and
Repackaging Guidance by Outsourcing Facilities and the Repackaging
Guidance. We expect to receive no waiver requests from the electronic
submission process for initial product reports and semiannual reports.
Table 3--Estimated Annual Recordkeeping Burden \1\
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Number of Number of records Total annual Total
Recommended activity; guidance section recordkeepers per recordkeeper records Average burden per recordkeeping hours
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Radiopharmaceutical Compounding and Repackaging Guidance
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Consultation between the compounder and 10 25 250 0.05 (3 minutes).......................... 12.5
prescriber and the notation on the
prescription or order documenting the
prescriber's determination of clinical
difference (section III.A of the
Radiopharmaceutical Compounding and
Repackaging Guidance).
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Biological Products Guidance *
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Maintaining records of testing performed in 5 30 150 0.083 (5 minutes)......................... 12.5
accordance with Appendix A of the Biological
Products Guidance (section III.B of the
Biological Products Guidance).
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Total...................................... 15 ................. 400 .......................................... 25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 4--Estimated Annual Third-Party Disclosure 1 2
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Number of
Recommended activity; guidance section Number of disclosures per Total annual Average burden per disclosure Total
respondents respondent disclosures hours
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Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance
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Designing, testing, and producing each label on 2 5 10 0.5 (30 minutes).......................... 5
immediate containers, packages, and/or outer
containers (section III.B of the
Radiopharmaceutical Compounding and
Repackaging Guidance by Outsourcing
Facilities).
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Repackaging Guidance
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Designing, testing, and producing each label on 6 36 216 1......................................... 216
immediate containers, packages, and/or outer
containers (section III.A of the Repackaging
Guidance).
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Biological Products Guidance
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Designing, testing, and producing the label, 15 5 75 0.5 (30 minutes).......................... 37.5
container, packages, and/or outer containers
for each mixed, diluted, or repackaged
biological product (section III.B of the
Biological Products Guidance).
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Designing, testing, and producing each label on 5 300 1,500 0.5 (30 minutes).......................... 750
immediate containers, packages, and/or outer
containers for each licensed allergenic
extract (section III.C of the Biological
Products Guidance).
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Total...................................... 28 ................. 1,801 .......................................... 1,009
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals may not sum due to rounding.
For purposes of our analysis, we characterize the burden associated
with the time and effort expended on the information collection
recommendations discussed in the respective guidance documents as
either reporting, recordkeeping, or third-party disclosure activities.
We reconfigured the original table by splitting it into three tables to
better differentiate between the estimated annual reporting,
recordkeeping, and third-party disclosure burden. At the same time, our
findings show that compliance with recordkeeping requirements
applicable to compounded and repackaged drug products is standard
practice in the compounding and selling of these drug products under
States' pharmacy laws and other State laws governing recordkeeping by
healthcare professionals and healthcare facilities. Therefore, we
excluded from our estimate recordkeeping practices discussed in the
respective guidance documents we consider usual and customary.
For the Repackaging Guidance, to correct a clerical error, we have
adjusted the number of disclosures per respondent from 21 to 36 because
each respondent is estimated to average 6 different products and
average 6 different strengths, which requires 36 (6 x 6) unique labels
per respondent. The initial narrative reflected that each product would
come in six different strengths and thus require six unique labels, but
due to a clerical error, this information was not correctly included in
the table. We also adjusted the number of respondents to six to match
the number of respondents designing, testing, and producing labels. In
addition, we adjusted the total number of disclosures per respondent to
two given the biannual reporting requirement.
For the Radiopharmaceutical Compounding and Repackaging by
Outsourcing Facilities Guidance, a row for biannual product reporting
was added to capture product reporting that was inadvertently omitted.
Our estimated burden for the information collection reflects
constant respondent numbers. The original numbers were based on the
information the program received from product reporting data. We do not
have a mechanism in place to determine whether or not these numbers
have fluctuated upward or downward; however, based on analogous
observations of industry through program experience (some product
reports), we believe these numbers are constant. Repackagers who are
also registered as outsourcing facilities (OF) are not entity types
that are individually regulated as repackagers. They are subsumed in
the OF entity type and not easily distinguishable. They may or may not
report their repackaging operations.
We are updating the information collection to include burden
attendant to reporting and disclosure recommendations found in the
Agency guidance documents that was inadvertently omitted in the
original information collection due to clerical errors. The burden
estimate is adjusted
[[Page 77531]]
to reflect a resulting increase of 114 hours and 94 responses annually.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21676 Filed 9-20-24; 8:45 am]
BILLING CODE 4164-01-P
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