81 FR 96011 - Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 250 (December 29, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities.'' This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies and Federal facilities that are not registered as outsourcing facilities. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it does not intend to take action for violations of certain provisions of the FD&C Act when a State-licensed nuclear pharmacy or Federal facility compounds or repackages radiopharmaceuticals.

[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96011-96013]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed 
Nuclear Pharmacies and Federal Facilities.'' This guidance sets forth 
FDA's policy regarding compounding and repackaging of 
radiopharmaceuticals for human use by State-licensed nuclear pharmacies 
and Federal facilities that are not registered as outsourcing 
facilities. Because such radiopharmaceuticals are not eligible for 
exemptions from provisions of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) related to the production of drugs, FDA is issuing this 
guidance to describe the conditions under which it does not intend to 
take action for violations of certain provisions of the FD&C Act when a 
State-licensed nuclear pharmacy or Federal facility compounds or 
repackages radiopharmaceuticals.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 27, 2017. Submit either electronic or written 
comments concerning the collection of information proposed in the draft 
guidance by February 27, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-4318 for ``Compounding and Repackaging of 
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal 
Facilities.'' Received

[[Page 96012]]

comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Edisa Gozun, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    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 FD&C Act related to the production of 
drugs. Because Congress explicitly excluded radiopharmaceuticals from 
section 503A of the FD&C Act (21 U.S.C. 353a) (see section 
503A(d)(2)),\1\ 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 (CGMP) requirements). In addition, Congress did not exempt 
repackaged radiopharmaceuticals from any provisions of the FD&C Act.
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    \1\ Section 503A of the FD&C Act describes the conditions that 
must be met for drug products compounded by a licensed pharmacist in 
a State-licensed pharmacy or Federal facility, or by a licensed 
physician, to qualify for exemptions from sections 505, 502(f)(1), 
and 501(a)(2)(B) of the FD&C Act. Section 503A(d)(2) of the FD&C Act 
states that ``this section shall not apply to . . . 
radiopharmaceuticals.''
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    Because State-licensed nuclear pharmacies and Federal facilities 
sometimes compound or repackage radiopharmaceuticals for patients, but 
radiopharmaceuticals are not eligible for the exemptions in section 
503A of the FD&C Act, FDA is issuing this guidance to describe the 
conditions under which the Agency 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 or a Federal facility that is 
not an outsourcing facility compounds or repackages 
radiopharmaceuticals for human use.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a separate draft guidance document concerning 
compounding and repackaging of radiopharmaceuticals by outsourcing 
facilities entitled ``Compounding and Repackaging of 
Radiopharmaceuticals by Outsourcing Facilities.''
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Compounding 
and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear 
Pharmacies and Federal Facilities.'' It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information that 
they conduct or sponsor. Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
document, FDA invites comments on the following topics: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    One of the conditions of the draft guidance 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

[[Page 96013]]

comparable approved radiopharmaceutical that produces for an identified 
individual patient a clinical difference, the determination is 
documented on the prescription or order in writing by either (1) the 
prescribing practitioner, or (2) the compounder, reflecting a 
conversation with the prescribing practitioner. The compounder 
maintains records of the prescription or order documenting this 
determination.
    We estimate that annually a total of approximately 10 compounders 
(``No. of Respondents'' in table 1, line 1) will consult a prescriber 
to determine whether he or she has made a determination 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.
    A compounder also maintains records of prescriptions or orders 
noting the determination that a prescriber has determined that the 
compounded radiopharmaceutical has a change that produces a clinical 
difference for an identified individual patient. We estimate that the 
compounder will take approximately 2.1 hours to maintain the records of 
250 prescriptions or orders documenting the prescriber's determination 
of clinical difference (``Total Hours'' in table 2). We estimate that 
maintaining such records will take approximately 30 seconds per 
prescription or order.
    FDA estimates the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                     Number of
               Type of reporting                    Number of     disclosures per    Total annual      Average burden per disclosure       Total hours
                                                   respondents       respondent      disclosures
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Consultation between the compounder and                      10               25              250   3 minutes..........................            12.5
 prescriber or health care facility, and the
 notation on the prescription or order
 documenting the prescriber's determination of
 clinical difference.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                     Number of
               Type of reporting                    Number of       records per      Total annual     Average burden per recordkeeping     Total hours
                                                  recordkeepers     recordkeeper       records
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Maintenance of records of prescriptions or                   10               25              250   30 seconds.........................             2.1
 orders documenting the prescriber's
 determination of clinical difference.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31513 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P