Document ID: FDA-2016-D-4318-0023
Agency: fda
Document Type: Notice
Title: Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities; Guidance for Industry; Availability
Posted Date: 2018-09-26T04:00Z

[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48633-48634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.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 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