83 FR 2787 - Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 13 (January 19, 2018)

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This final guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy.

[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2787-2789]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00916]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1525]


Mixing, Diluting, or Repackaging Biological Products Outside the 
Scope of an Approved Biologics License Application; 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 final guidance for industry entitled 
``Mixing, Diluting, or Repackaging Biological Products Outside the 
Scope of an Approved Biologics License Application.'' This final 
guidance describes the conditions under which FDA does not intend to 
take action against a State-licensed pharmacy, a Federal facility, or 
an outsourcing facility that mixes, dilutes, or repackages certain 
biological products outside the scope of an approved biologics license 
application (BLA). It also describes the conditions under which FDA 
does not intend to take action when a State-licensed pharmacy, a 
Federal facility, an outsourcing facility, or a physician prepares 
prescription sets of allergenic extracts for subcutaneous 
immunotherapy.

DATES: The announcement of the guidance is published in the Federal 
Register on January 19, 2018.

ADDRESSES: You may submit 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

[[Page 2788]]

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-2014-D-1525 for ``Mixing, Diluting, or Repackaging Biological 
Products Outside the Scope of an Approved Biologics License 
Application.'' 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 http://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, 10903 New Hampshire Ave., Bldg. 51, Rm. 
2201, Silver Spring, MD 20993-0002; or the Office of Communication, 
Outreach and Development, Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 
71, Rm. 3128, 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: Sara Rothman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20903, 301-796-
3110; or Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Mixing, Diluting, or Repackaging Biological Products Outside 
the Scope of an Approved Biologics License Application.'' Certain 
licensed biological products may sometimes be mixed, diluted, or 
repackaged in a way not described in the approved labeling for the 
product to meet the needs of a specific patient. For example, for some 
biological products there is no licensed pediatric strength and/or 
dosage form. In addition, there may be certain circumstances when a 
person would remove a licensed biological product from its original 
container and place it into a different container(s) (repackage it), in 
a manner that is not within the scope of the approved labeling for the 
product. As described in the guidance, mixed, diluted, or repackaged 
biological products are not eligible for the statutory exemptions 
available to certain compounded drugs under sections 503A and 503B of 
the FD&C Act (21 U.S.C. 353a and 353b). In addition, a biological 
product that is mixed, diluted, or repackaged outside the scope of an 
approved BLA is considered an unlicensed biological product under 
section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262).
    This guidance describes the conditions under which FDA does not 
intend to take action for violations of section 351 of the PHS Act, and 
section 502(f)(1) (21 U.S.C. 352(f)(1)), section 582 (21 U.S.C. 360eee-
1), and where specified, section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) 
of the FD&C Act, when a state-licensed pharmacy, a Federal facility, or 
an outsourcing facility dilutes, mixes, or repackages certain 
biological products outside the scope of an approved BLA.
    In the Federal Register of January 13, 2017 (82 FR 4358), FDA 
issued a notice announcing the availability of the revised draft 
version of this guidance. The comment period on the draft guidance 
ended on March 14, 2017. FDA received 11 comments on the revised draft 
guidance. In response to received comments or on its own initiative, 
FDA made revisions to clarify certain points. For example, FDA added a 
footnote indicating that the Agency is considering the applicability of 
the policies described in this guidance to hospitals and health systems 
and intends to address these issues in separate guidance. FDA also 
clarified that one of the conditions under which the Agency does not 
intend to take action for the violations listed above is that any 
components used in mixing or diluting a licensed biological product are 
sterile, pharmaceutical grade, and otherwise appropriate for such use.
    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 mixing, diluting, or repackaging biological 
products outside

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the scope of an approved BLA. 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

    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. 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, in the 
Federal Register of January 13, 2017, we gave interested persons 60 
days to comment on the information collection provisions in the draft 
guidance (82 FR 4358 at 4359).
    The information collection provisions in this guidance will be 
submitted to OMB for review as required by section 3507(d) of the PRA. 
These provisions are not in effect until they display a currently valid 
OMB control number. FDA will publish a notice in the Federal Register 
announcing OMB's decision regarding the information collection 
provisions in this guidance.
    The guidance also references registration and adverse event 
reporting for outsourcing facilities. The collections of information 
for outsourcing facility registration have been approved by OMB under 
OMB control number 0910-0777. The collections of information for 
adverse event reporting by outsourcing facilities have been approved by 
OMB under OMB control number 0910-0800.

III. Electronic Access

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

    Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00916 Filed 1-18-18; 8:45 am]
 BILLING CODE 4164-01-P