83 FR 48633 - Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 187 (September 26, 2018)

Page Range		48633-48634
FR Document		2018-20902

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities.'' This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies, Federal facilities, and other entities that hold a radioactive materials (RAM) license for medical use issued by the Nuclear Regulatory Commission (NRC) or by an Agreement State. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it generally does not intend to take action for violations of certain provisions of the FD&C Act when these entities compound or repackage radiopharmaceuticals.

Federal Register, Volume 83 Issue 187 (Wednesday, September 26, 2018)

[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48633-48634]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-20902]

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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, Federal Facilities, and Certain Other
Entities; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a guidance for industry entitled
``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed
Nuclear Pharmacies, Federal Facilities, and Certain Other Entities.''
This guidance sets forth FDA's policy regarding compounding and
repackaging of radiopharmaceuticals for human use by State-licensed
nuclear pharmacies, Federal facilities, and other entities that hold a
radioactive materials (RAM) license for medical use issued by the
Nuclear Regulatory Commission (NRC) or by an Agreement State. Because
such radiopharmaceuticals are not eligible for exemptions from
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
related to the production of drugs, FDA is issuing this guidance to
describe the conditions under which it generally does not intend to
take action for violations of certain provisions of the FD&C Act when
these entities compound or repackage radiopharmaceuticals.

DATES: The announcement of the guidance is published in the Federal
Register on September 26, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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, Federal
Facilities, and Certain Other Entities.'' Received 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 Dockets Management Staff 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 Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this 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-

[[Page 48634]]

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 guidance document.

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

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry
entitled ``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 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 (21 U.S.C. 355)
(concerning new drug approval requirements), section 502(f)(1) (21
U.S.C. 352(f)(1)) (concerning labeling with adequate directions for
use), and section 501(a)(2)(B) (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.
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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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FDA is issuing this guidance 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 RAM license for medical
use issued by the NRC or by an Agreement State compounds or repackages
radiopharmaceuticals for human use.
Elsewhere in this issue of the Federal Register, FDA has announced
the availability of a separate guidance document concerning compounding
and repackaging of radiopharmaceuticals by outsourcing facilities
entitled ``Compounding and Repackaging of Radiopharmaceuticals by
Outsourcing Facilities.''
In the Federal Register of December 29, 2016 (81 FR 96011), FDA
issued a notice announcing the availability of the draft version of
this guidance. The comment period on the draft guidance ended on
February 27, 2017. FDA received comments on the draft guidance. In
response to received comments or on its own initiative, FDA made
several changes that are reflected in this final guidance. For example,
in response to requests in comments for clarification regarding the
beyond-use-date, FDA added a recommendation that sterile
radiopharmaceuticals should be compounded in compliance with USP
Chapter <797>. In addition, to address questions raised in comments,
FDA clarified the applicability of this guidance to various settings in
which radiopharmaceuticals are administered, such as nuclear medicine
departments and imaging centers, by clarifying that the policies in the
guidance apply to facilities that are not outsourcing facilities and
that hold a RAM license for medical use issued by the NRC or by an
Agreement State.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities.'' 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. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

This guidance contains collections of information that are subject
to review by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information have been approved under OMB control number 0910-0858.

III. Electronic Access

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

Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20902 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P

48634 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices

0002. Send one self-addressed adhesive document concerning compounding and Dated: September 20, 2018.
label to assist that office in processing repackaging of radiopharmaceuticals by Leslie Kux,
your requests. See the SUPPLEMENTARY outsourcing facilities entitled Associate Commissioner for Policy.
INFORMATION section for electronic ‘‘Compounding and Repackaging of [FR Doc. 2018–20902 Filed 9–25–18; 8:45 am]
access to the guidance document. Radiopharmaceuticals by Outsourcing BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT: Sara Facilities.’’
Rothman, Center for Drug Evaluation In the Federal Register of December
and Research, Food and Drug 29, 2016 (81 FR 96011), FDA issued a DEPARTMENT OF HEALTH AND
Administration, 10903 New Hampshire notice announcing the availability of the HUMAN SERVICES
Ave., Bldg. 51, Silver Spring, MD 301– draft version of this guidance. The
796–3110. comment period on the draft guidance Food and Drug Administration
SUPPLEMENTARY INFORMATION: ended on February 27, 2017. FDA [Docket No. FDA–2018–N–3305]
received comments on the draft
I. Background Allergenic Products Advisory
guidance. In response to received
FDA is announcing the availability of comments or on its own initiative, FDA Committee; Notice of Meeting
a guidance for industry entitled made several changes that are reflected
‘‘Compounding and Repackaging of AGENCY: Food and Drug Administration,
in this final guidance. For example, in HHS.
Radiopharmaceuticals by State-Licensed response to requests in comments for
Nuclear Pharmacies, Federal Facilities, clarification regarding the beyond-use- ACTION: Notice.
and Certain Other Entities.’’ Under date, FDA added a recommendation that
current law, radiopharmaceuticals that SUMMARY: The Food and Drug
sterile radiopharmaceuticals should be Administration (FDA) announces a
are compounded by entities that are not compounded in compliance with USP
registered with FDA as outsourcing forthcoming public advisory committee
Chapter <797>. In addition, to address meeting of the Allergenic Products
facilities, and radiopharmaceuticals that questions raised in comments, FDA
are repackaged, are subject to all Advisory Committee (APAC). The
clarified the applicability of this general function of the committee is to
applicable provisions of the FD&C Act guidance to various settings in which
related to the production of drugs. provide advice and recommendations to
radiopharmaceuticals are administered, the Agency on FDA’s regulatory issues.
Because Congress explicitly excluded such as nuclear medicine departments
radiopharmaceuticals from section 503A The meeting will be open to the public.
and imaging centers, by clarifying that
of the FD&C Act (21 U.S.C. 353a) (see DATES: The meeting will be held on
the policies in the guidance apply to
section 503A(d)(2)),1 compounded November 7, 2018, from 9 a.m. to 4 p.m.
facilities that are not outsourcing
radiopharmaceuticals are not eligible for facilities and that hold a RAM license ADDRESSES: FDA White Oak Campus,
the exemptions under section 503A for medical use issued by the NRC or by 10903 New Hampshire Ave., Bldg. 31
from section 505 (21 U.S.C. 355) an Agreement State. Conference Center, the Great Room (Rm.
(concerning new drug approval 1503), Silver Spring, MD 20993–0002.
requirements), section 502(f)(1) (21 This guidance is being issued Answers to commonly asked questions
U.S.C. 352(f)(1)) (concerning labeling consistent with FDA’s good guidance including information regarding special
with adequate directions for use), and practices regulation (21 CFR 10.115). accommodations due to a disability,
section 501(a)(2)(B) (21 U.S.C. The guidance represents the current visitor parking, and transportation may
351(a)(2)(B)) (concerning current good thinking of FDA on ‘‘Compounding and be accessed at: https://www.fda.gov/
manufacturing practice requirements). Repackaging of Radiopharmaceuticals AdvisoryCommittees/AboutAdvisory
In addition, the FD&C Act does not by State-Licensed Nuclear Pharmacies, Committees/ucm408555.htm. For those
provide an exemption for repackaged Federal Facilities, and Certain Other unable to attend in person, the meeting
radiopharmaceuticals. Entities.’’ It does not establish any rights will also be webcast and will be
FDA is issuing this guidance to for any person and is not binding on available at the following link: https://
describe the conditions under which the FDA or the public. You can use an collaboration.fda.gov/vrbpac2018/.
Agency generally does not intend to alternative approach if it satisfies the
FOR FURTHER INFORMATION CONTACT:
take action for violations of sections requirements of the applicable statutes
and regulations. This guidance is not Serina Hunter-Thomas, Center for
505, 502(f)(1), and 501(a)(2)(B) of the Biologics Evaluation and Research,
FD&C Act when a State-licensed nuclear subject to Executive Order 12866.
Food and Drug Administration, 10903
pharmacy, Federal facility, or other II. Paperwork Reduction Act of 1995 New Hampshire Ave., Bldg. 71, Rm.
facility that is not an outsourcing 6338, Silver Spring, MD 20993–0002,
facility and that holds a RAM license for This guidance contains collections of 240–402–5771, serina.hunter-thomas@
medical use issued by the NRC or by an information that are subject to review by fda.hhs.gov, or FDA Advisory
Agreement State compounds or the Office of Management and Budget Committee Information Line, 1–800–
repackages radiopharmaceuticals for under the Paperwork Reduction Act of 741–8138 (301–443–0572 in the
human use. 1995 (44 U.S.C. 3501–3520). The Washington, DC area). A notice in the
Elsewhere in this issue of the Federal collections of information have been Federal Register about last minute
Register, FDA has announced the approved under OMB control number modifications that impact a previously
availability of a separate guidance 0910–0858. announced advisory committee meeting
III. Electronic Access cannot always be published quickly
daltland on DSKBBV9HB2PROD with NOTICES

1 Section 503A of the FD&C Act describes the

conditions that must be met for drug products
enough to provide timely notice.
compounded by a licensed pharmacist in a State- Persons with access to the internet Therefore, you should always check the
licensed pharmacy or Federal facility, or by a may obtain the guidance at either Agency’s website at https://
licensed physician, to qualify for exemptions from https://www.fda.gov/Drugs/Guidance www.fda.gov/AdvisoryCommittees/
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
ComplianceRegulatoryInformation/ default.htm and scroll down to the
‘‘this section shall not apply to . . . Guidances/default.htm or https:// appropriate advisory committee meeting
radiopharmaceuticals.’’ www.regulations.gov. link, or call the advisory committee

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Document Created: 2018-09-26 00:46:34
Document Modified: 2018-09-26 00:46:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		The announcement of the guidance is published in the Federal Register on September 26, 2018.
Contact		Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 301-796-3110.
FR Citation		83 FR 48633

83 FR 48633 - Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 187 (September 26, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration