[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48630-48631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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