[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77528-77531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 0910-0858. 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, 
[email protected].

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 https://www.fda.gov/media/102615/download 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 https://www.fda.gov/media/102637/download).
Repackaging of Certain Human Drug Products by         January 13, 2017 (82 FR 4343).
 Pharmacies and Outsourcing Facilities (Repackaging
 Guidance) (available at https://www.fda.gov/media/90978/download 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 https://www.fda.gov/media/90986/download 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 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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[[Page 77530]]

 
                                                             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).
                                                --------------------------------------------------------------------------------------------------------
    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).
                                                --------------------------------------------------------------------------------------------------------
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).
                                                --------------------------------------------------------------------------------------------------------
    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