[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54808-54809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19596]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0800]


Regulatory Classification of Pharmaceutical Co-Crystals; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Regulatory 
Classification of Pharmaceutical Co-Crystals.'' This guidance provides 
applicants planning to submit new drug applications (NDAs) and 
abbreviated new drug applications (ANDAs) with information on the 
appropriate regulatory classification of pharmaceutical co-crystal 
solid-state forms. This guidance also provides information about the 
data that applicants should submit to support the appropriate 
classification of a co-crystal as well as the regulatory implications 
of the classification. This draft guidance revises the guidance for 
industry entitled ``Regulatory Classification of Pharmaceutical Co-
Crystals'' issued in April 2013.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 17, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2011-D-0800 for ``Regulatory Classification of Pharmaceutical Co-
Crystals.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New

[[Page 54809]]

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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Richard (Rik) Lostritto, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4148, Silver Spring, MD 20993-0002, 301-
796-1697.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' 
This guidance provides NDA and ANDA applicants with information on the 
appropriate regulatory classification of pharmaceutical co-crystal 
solid-state forms.
    Co-crystals are crystalline materials composed of two or more 
different molecules, typically drug and co-crystal formers 
(``coformers''), in the same crystal lattice. Pharmaceutical co-
crystals have opened up opportunities for engineering solid-state forms 
beyond conventional solid-state forms of an active pharmaceutical 
ingredient (API), such as salts and polymorphs. Co-crystals can be 
tailored to enhance drug product bioavailability and stability and to 
enhance the processability of APIs during drug product manufacture. 
Another advantage of co-crystals is that they generate a diverse array 
of solid-state forms for APIs that lack ionizable functional groups, 
which is a prerequisite for salt formation.
    This guidance revises the guidance for industry ``Regulatory 
Classification of Pharmaceutical Co-Crystals'' issued in April 2013, 
which classifies co-crystals as a drug product intermediate (or as an 
in-process material). This classification has contributed to 
uncertainty regarding the interpretation of the guidance because in a 
commercial setting, co-crystals are typically manufactured in drug 
substance facilities, yet when classified as a drug product 
intermediate, additional current good manufacturing practice 
requirements apply. Therefore, the guidance has not been conducive to 
the development of co-crystals. In response to this and other feedback 
from stakeholders, FDA has reconsidered the appropriate classification 
of co-crystals. This revision addresses the concern by providing 
information on the appropriate classification of co-crystal solid-state 
forms, the data that should be submitted to support the classification, 
and the regulatory implications of such a classification.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on regulatory 
classification of pharmaceutical co-crystals. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. This guidance refers to 
information collection provisions that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 
314.50(d)(1) and 314.94(a)(5) and (a)(9) have been approved under OMB 
control number 0910-0001.

III. Electronic Access

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

    Dated: August 11, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19596 Filed 8-16-16; 8:45 am]
 BILLING CODE 4164-01-P