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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-N-2583]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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, 
                        *PRAStaff@fda.hhs.gov.*


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
Title
Notice of availability publication dateCompounding and Repackaging of Radiopharmaceuticals 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*)
September 26, 2018 (83 FR 48633).( print page 77529)Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance) (available at 
                            *https://www.fda.gov/​media/​102637/​download*)
September 26, 2018 (83 FR 48630).Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (Repackaging Guidance) (available at 
                            *https://www.fda.gov/​media/​90978/​download*)
January 13, 2017 (82 FR 4343).Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (Biological Products Guidance) (available at 
                            *https://www.fda.gov/​media/​90986/​download*)
January 19, 2018 (83 FR 2787).
 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] 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
Recommended activity; guidance section
Number of
                             respondents
Number of
                             disclosures 
                             per respondent
Total
                             annual 
                             disclosures
Average
                             burden per 
                             disclosure
Total
                             hours**Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance**Biannual product reports identifying drug 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).
2
2
4
3
12**Repackaging Guidance**Biannual product reports identifying drug products repackaged by the outsourcing facility during the previous 6-month period (section III.A of the Repackaging Guidance)
6
2
12
3
36Total
8

16

481
                         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
Recommended activity; guidance section
Number of
                             recordkeepers
Number of
                             records per 
                             recordkeeper
Total
                             annual 
                             records
Average burden
                             per recordkeeping
Total
                             hours**Radiopharmaceutical Compounding and Repackaging Guidance**Consultation between the compounder and 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)
10
25
250
0.05 (3 minutes)
12.5( print page 77530)**Biological Products Guidance ***Maintaining records of testing performed in accordance with Appendix A of the Biological Products Guidance (section III.B of the Biological Products Guidance)
5
30
150
0.083 (5 minutes)
12.5Total
15

400

251
                         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
Recommended activity; guidance section
Number of
                             respondents
Number of
                             disclosures per 
                             respondent
Total
                             annual 
                             disclosures
Average burden
                             per disclosure
Total
                             hours**Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance**Designing, testing, and producing each label on immediate containers, packages, and/or outer containers (section III.B of the Radiopharmaceutical Compounding and Repackaging Guidance by Outsourcing Facilities)
2
5
10
0.5 (30 minutes)
5**Repackaging Guidance**Designing, testing, and producing each label on immediate containers, packages, and/or outer containers (section III.A of the Repackaging Guidance)
6
36
216
1
216**Biological Products Guidance**Designing, testing, and producing the label, container, packages, and/or outer containers for each mixed, diluted, or repackaged biological product (section III.B of the Biological Products Guidance)
15
5
75
0.5 (30 minutes)
37.5Designing, testing, and producing each label on immediate containers, packages, and/or outer containers for each licensed allergenic extract (section III.C of the Biological Products Guidance)
5
300
1,500
0.5 (30 minutes)
750Total
28

1,801

1,0091
                         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 × 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 
                    ( print 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.


# Footnotes

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. Back to Citation


[FR Doc. 2024-21676 Filed 9-20-24; 8:45 am] BILLING CODE 4164-01-P