83 FR 48630 - Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; 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		48630-48631
FR Document		2018-20901

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.'' Specifically, this guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing facilities. This guidance describes how FDA generally intends to apply section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions under which FDA generally does not intend to take action for violations of certain provisions of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals.

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

[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48630-48631]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-20901]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4317]

Compounding and Repackaging of Radiopharmaceuticals by
Outsourcing Facilities; 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 Agency) is announcing
the availability of a final guidance for industry entitled
``Compounding and Repackaging of Radiopharmaceuticals by Outsourcing
Facilities.'' Specifically, this guidance sets forth FDA's policy
regarding compounding and repackaging of radiopharmaceuticals for human
use by entities that are registered with FDA as outsourcing facilities.
This guidance describes how FDA generally intends to apply section 503B
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to
radiopharmaceuticals compounded by outsourcing facilities, and it
describes the conditions under which FDA generally does not intend to
take action for violations of certain provisions of the FD&C Act when
an outsourcing facility repackages 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-4317 for ``Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing Facilities.'' 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 the 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 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
Outsourcing Facilities; Guidance for Industry.'' In 2013, the Drug
Quality and Security Act created a new section, 503B, of the FD&C Act
(21 U.S.C. 353b), which describes a new category of compounders called
outsourcing facilities. Section 503B of the FD&C Act describes the
conditions that must be satisfied for human drug products compounded by
or under the direct supervision of a licensed pharmacist in

[[Page 48631]]

an outsourcing facility to qualify for exemptions from the following
three sections of the FD&C Act:
Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning
labeling with adequate directions for use);
section 505 (21 U.S.C. 355) (concerning drug approval
requirements); and
section 582 (21 U.S.C. 360eee-1) (concerning drug supply
chain security requirements).
In contrast to section 503A (21 U.S.C. 353a), section 503B of the
FD&C Act does not exclude radiopharmaceuticals. Therefore, FDA's
overall policies regarding section 503B apply to the compounding of
radiopharmaceutical drug products. However, we have developed specific
policies that apply only to the compounding of radiopharmaceuticals by
outsourcing facilities using bulk drug substances and to the
compounding of radiopharmaceuticals by outsourcing facilities that are
essentially copies of approved drugs when such compounding is limited
to minor deviations, as that term is defined in the guidance. FDA is
also issuing this guidance in part to describe the conditions under
which the Agency does not generally intend to take action for
violations of sections 505 and 502(f)(1) of the FD&C Act when an
outsourcing facility 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 State-licensed nuclear
pharmacies, Federal facilities, and other facilities that are not
registered as outsourcing facilities, entitled ``Compounding and
Repackaging of Radiopharmaceuticals by State-Licensed Nuclear
Pharmacies, Federal Facilities, and Certain Other Entities.''
In the Federal Register of December 29, 2016 (81 FR 96005), 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 approximately three comments on the
draft guidance. In response to received comments or on its own
initiative, FDA made certain changes to the guidance to clarify
particular points. For example, the reference to the syringe as an
example of primary packaging was deleted in response to a comment
stating that a syringe containing a radiopharmaceutical should not be
described as ``primary packaging'' for labeling purposes because of the
unique risks associated with radioactive drug products. In addition,
FDA made revisions to align language used in this guidance with
language used in the guidance entitled ``Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities.''
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on ``Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing 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. 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 (OMB) under the
Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). Under the
PRA, Federal Agencies must obtain approval from OMB for each collection
of information they conduct or sponsor. ``Collection of information''
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party.
Specifically, the guidance references registration, adverse event
reporting, product reporting, and current good manufacturing practices
(CGMP) requirements for outsourcing facilities. The collections of
information for outsourcing facility registration have been approved
under OMB control number 0910-0777 (79 FR 69859, November 24, 2014).
The collections of information for adverse event reporting by
outsourcing facilities have been approved under OMB control number
0910-0800 (80 FR 60917, October 8, 2015). The collections of
information for electronic drug product reporting by outsourcing
facilities have been approved under OMB control number 0910-0827 (82 FR
129, January 3, 2017).

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. 2018-20901 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48631

an outsourcing facility to qualify for with radioactive drug products. In Dated: September 20, 2018.
exemptions from the following three addition, FDA made revisions to align Leslie Kux,
sections of the FD&C Act: language used in this guidance with Associate Commissioner for Policy.
• Section 502(f)(1) (21 U.S.C. language used in the guidance entitled [FR Doc. 2018–20901 Filed 9–25–18; 8:45 am]
352(f)(1)) (concerning labeling with ‘‘Compounding and Repackaging of BILLING CODE 4164–01–P
adequate directions for use); Radiopharmaceuticals by State-Licensed
• section 505 (21 U.S.C. 355) Nuclear Pharmacies, Federal Facilities,
(concerning drug approval and Certain Other Entities.’’ DEPARTMENT OF HEALTH AND
requirements); and HUMAN SERVICES
• section 582 (21 U.S.C. 360eee–1) This guidance is being issued
(concerning drug supply chain security consistent with FDA’s good guidance Food and Drug Administration
requirements). practices regulation (21 CFR 10.115).
In contrast to section 503A (21 U.S.C. This guidance represents the current [Docket No. FDA–2016–D–2268]
353a), section 503B of the FD&C Act thinking of FDA on ‘‘Compounding and
Insanitary Conditions at Compounding
does not exclude radiopharmaceuticals. Repackaging of Radiopharmaceuticals
Facilities; Revised Draft Guidance for
Therefore, FDA’s overall policies by Outsourcing Facilities.’’ It does not Industry; Availability
regarding section 503B apply to the establish any rights for any person and
compounding of radiopharmaceutical is not binding on FDA or the public. AGENCY: Food and Drug Administration,
drug products. However, we have You can use an alternative approach if HHS.
developed specific policies that apply it satisfies the requirements of the ACTION: Notice of availability.
only to the compounding of applicable statutes and regulations. This
radiopharmaceuticals by outsourcing guidance is not subject to Executive SUMMARY: The Food and Drug
facilities using bulk drug substances and Order 12866. Administration (FDA or Agency) is
to the compounding of announcing the availability of a revised
radiopharmaceuticals by outsourcing II. Paperwork Reduction Act of 1995 draft guidance for industry entitled,
facilities that are essentially copies of ‘‘Insanitary Conditions at Compounding
approved drugs when such This guidance contains collections of Facilities.’’ Drug products compounded
compounding is limited to minor information that are subject to review by under insanitary conditions could
deviations, as that term is defined in the the Office of Management and Budget become contaminated and cause serious
guidance. FDA is also issuing this (OMB) under the Paperwork Reduction adverse events, including death, in
guidance in part to describe the Act (PRA) of 1995 (44 U.S.C. 3501– patients. FDA is issuing this revised
conditions under which the Agency 3520). Under the PRA, Federal Agencies draft guidance to help compounding
does not generally intend to take action must obtain approval from OMB for facilities identify insanitary conditions
for violations of sections 505 and each collection of information they so that they can implement appropriate
502(f)(1) of the FD&C Act when an conduct or sponsor. ‘‘Collection of corrective actions. This revised draft
outsourcing facility repackages information’’ is defined in 44 U.S.C. guidance is also intended to help state
radiopharmaceuticals for human use. 3502(3) and 5 CFR 1320.3 and includes regulatory agencies understand some
Elsewhere in this issue of the Federal Agency requests or requirements that examples of what FDA considers to be
Register, FDA has announced the members of the public submit reports, insanitary conditions that could cause a
availability of a separate guidance keep records, or provide information to drug to become contaminated or
document concerning compounding and a third party. rendered injurious to health. This
repackaging of radiopharmaceuticals by Specifically, the guidance references guidance revises the draft guidance
State-licensed nuclear pharmacies, registration, adverse event reporting, entitled ‘‘Insanitary Conditions at
Federal facilities, and other facilities product reporting, and current good Compounding Facilities’’ that was
that are not registered as outsourcing manufacturing practices (CGMP) published on August 4, 2016.
facilities, entitled ‘‘Compounding and requirements for outsourcing facilities. DATES: Submit either electronic or
Repackaging of Radiopharmaceuticals The collections of information for written comments on the draft guidance
by State-Licensed Nuclear Pharmacies, outsourcing facility registration have by November 26, 2018 to ensure that the
Federal Facilities, and Certain Other been approved under OMB control Agency considers your comment on this
Entities.’’ draft guidance before it begins works on
number 0910–0777 (79 FR 69859,
In the Federal Register of December the final version of the guidance.
November 24, 2014). The collections of
29, 2016 (81 FR 96005), FDA issued a ADDRESSES: You may submit comments
notice announcing the availability of the information for adverse event reporting
by outsourcing facilities have been on any guidance at any time as follows:
draft version of this guidance. The
comment period on the draft guidance approved under OMB control number Electronic Submissions
ended on February 27, 2017. FDA 0910–0800 (80 FR 60917, October 8,
Submit electronic comments in the
received approximately three comments 2015). The collections of information for
following way:
on the draft guidance. In response to electronic drug product reporting by • Federal eRulemaking Portal:
received comments or on its own outsourcing facilities have been https://www.regulations.gov. Follow the
initiative, FDA made certain changes to approved under OMB control number instructions for submitting comments.
the guidance to clarify particular points. 0910–0827 (82 FR 129, January 3, 2017). Comments submitted electronically,
For example, the reference to the III. Electronic Access including attachments, to https://
daltland on DSKBBV9HB2PROD with NOTICES

syringe as an example of primary www.regulations.gov will be posted to
packaging was deleted in response to a Persons with access to the internet the docket unchanged. Because your
comment stating that a syringe may obtain the guidance at either comment will be made public, you are
containing a radiopharmaceutical https://www.fda.gov/Drugs/ solely responsible for ensuring that your
should not be described as ‘‘primary GuidanceComplianceRegulatory comment does not include any
packaging’’ for labeling purposes Information/Guidances/default.htm or confidential information that you or a
because of the unique risks associated https://www.regulations.gov. third party may not wish to be posted,

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Document Created: 2018-09-26 00:46:41
Document Modified: 2018-09-26 00:46:41

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 48630

83 FR 48630 - Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; 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