[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32882-32883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15095]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4318]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other 
Entities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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: Fax written comments on the collection of information by August 
15, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#650a0c17043a161007080c16160c0a0b250a08074b000a154b020a13"><span class="__cf_email__" data-cfemail="2f40465d4e705c5a4d42465c5c4640416f40424d014a405f01484059">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Guidance for Industry on Compounding and Repackaging of 
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal 
Facilities, and Certain Other Entities.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
<a href="/cdn-cgi/l/email-protection#316163706245505757715755501f5959421f565e47"><span class="__cf_email__" data-cfemail="06565447557267606046606267286e6e7528616970">[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.

Guidance for Industry on Compounding and Repackaging of 
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal 
Facilities, and Certain Other Entities

OMB Control Number--NEW

    This information collection supports the Agency guidance document 
entitled ``Guidance for Industry on Compounding and Repackaging of 
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal 
Facilities, and Certain Other Entities.''
    Under current law, radiopharmaceuticals that are compounded by 
entities that are not registered with FDA as outsourcing facilities, 
and radiopharmaceuticals that are repackaged, are subject to all 
applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) related to drug production. Because Congress explicitly excluded 
radiopharmaceuticals from section 503A of the FD&C Act (21 U.S.C. 353a) 
(see section 503A(d)(2)), compounded radiopharmaceuticals are not 
eligible for the exemptions under section 503A from section 505 of the 
FD&C Act (21 U.S.C. 355) (concerning new drug approval requirements), 
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) (concerning 
labeling with adequate directions for use), and section 501(a)(2)(B) of 
the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good 
manufacturing practice requirements). In addition, the FD&C Act does 
not provide an exemption for repackaged radiopharmaceuticals.
    FDA developed this guidance document to describe the conditions 
under which the Agency generally does not intend to take action for 
violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act 
when a State-licensed nuclear pharmacy, Federal facility, or other 
facility that is not an outsourcing facility and that holds a 
radioactive materials license for medical use issued by the Nuclear 
Regulatory Commission or by an Agreement State compounds or repackages 
radiopharmaceuticals for human use.
    One of the guidance document's conditions is that the compounded 
radiopharmaceutical is not essentially a copy of an approved 
radiopharmaceutical. If a compounder intends to rely on a determination 
from a prescriber that there is a change between the compounded 
radiopharmaceutical and the comparable approved radiopharmaceutical 
that produces a clinical difference for an identified individual 
patient, either the prescribing practitioner or the compounder 
documents the determination on the prescription or order in writing. 
This documentation reflects a conversation with the prescribing 
practitioner, and the compounder maintains records of the prescription 
or order documenting this determination.
    In the Federal Register of December 29, 2016 (81 FR 96011), FDA 
published a notice of availability for the draft guidance, including a 
60-day notice soliciting public comment on the information collection 
recommendations. Several comments were received and are discussed 
below; however, none of the comments suggested we revise the burden 
estimate from our 60-day notice.
    (Comment 1) One commenter said documentation of a minor deviation 
from an approved radiopharmaceutical should remain at the facility that 
performed the minor deviation.
    (Response 1) The documentation condition (i.e., documentation of a 
prescriber's determination that there is a change that produces a 
clinical difference between the compounded radiopharmaceutical and the 
comparable FDA-approved radiopharmaceutical for an identified 
individual patient) does not apply to compounding that consists only of 
minor deviations as defined in the guidance document (i.e., a change 
from the approved labeling in radioactivity, volume, or the step-by-
step procedures made when compounding the radiopharmaceutical from an 
FDA-approved drug product in a patient-ready dose). The documentation 
condition applies to compounding a radiopharmaceutical that involves 
manipulation other than minor deviations.
    (Comment 2) One commenter supports the requirement for notating 
clinical differences, particularly for documenting both the change to 
the radiopharmaceutical and the reason that the change is important for 
the patient.
    (Response 2) FDA concurs with this commenter's views about the 
importance of the documentation.

[[Page 32883]]

FDA's guidance document states that the documentation condition would 
be met if the prescription for the compounded radiopharmaceutical makes 
clear that the prescriber identified the relevant change between the 
approved radiopharmaceutical and the compounded radiopharmaceutical and 
the clinical difference that the change produces for the patient.
    (Comment 3) One commenter recommended that the guidance document 
require written documentation when a commercially manufactured 
radiopharmaceutical is compounded for a patient because the 
radiopharmaceutical is unavailable due to a drug shortage.
    (Response 3) The guidance document explains that FDA does not 
consider a compounded radiopharmaceutical to be essentially a copy of a 
marketed FDA-approved radiopharmaceutical if the FDA-approved 
radiopharmaceutical is on FDA's drug shortage list (see section 506E of 
the FD&C Act (21 U.S.C. 356e)) at the time of compounding and 
distribution. FDA maintains a database for drug shortages. If the 
Agency identifies a compounded radiopharmaceutical that has the 
characteristics of a drug that is ``essentially a copy,'' FDA intends 
to review its database to determine whether there was a shortage of the 
approved radiopharmaceutical at the time of compounding and 
distribution.
    FDA estimates the burden of this collection of information as 
follows:

                                                Table 1--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
              Type of reporting                  Number of      disclosures    Total annual         Average burden  per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    The total estimated third-party disclosure burden for the guidance 
document is shown above.
    We estimate that a total of approximately 10 compounders annually 
(``No. of Respondents'' in table 1, line 1) will consult a prescriber 
to determine whether they decided that the compounded 
radiopharmaceutical has a change that produces a clinical difference 
for an identified individual patient as compared to the comparable 
approved radiopharmaceutical. We estimate that compounders will 
document this determination on approximately 250 prescriptions or 
orders for compounded radiopharmaceuticals (``Total Annual 
Disclosures'' in table 1, line 1). We estimate that the consultation 
between the compounder and the prescriber and noting this determination 
on each prescription or order that does not already document this 
determination will take approximately 3 minutes per prescription or 
order.
    In the Federal Register of December 29, 2016 (81 FR 96011), FDA 
also estimated the annual recordkeeping burden for maintaining records 
of prescriptions or orders documenting certain information from 
prescribers. While acquiring additional information from the public 
about State pharmacy practices since we published 81 FR 96011, FDA has 
determined that because the time, effort, and financial resources 
necessary to comply with this collection of information would be 
incurred by compounders in the normal course of their activities, it is 
excluded from the definition of ``burden'' under 5 CFR 1320.3(b)(2). 
FDA understands that maintaining records of prescriptions for 
compounded drug products is part of the usual course of the practice of 
compounding and selling drugs and is required by States' pharmacy laws 
and other State laws governing record keeping by healthcare 
professionals and healthcare facilities.

    Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15095 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P


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