[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Pages 24754-24755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09872]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0800]
Guidance for Industry on Regulatory Classification of
Pharmaceutical Co-Crystals; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Regulatory
Classification of Pharmaceutical Co-Crystals.'' This guidance provides
applicants of new drug applications (NDAs) and abbreviated new drug
applications (ANDAs) with the Center for Drug Evaluation and Research's
(CDER's) current thinking on the appropriate regulatory classification
of pharmaceutical co-crystal solid-state forms. This guidance also
provides information about the data the applicant should submit to
support the appropriate classification of a co-crystal, as well as the
regulatory implications of the classification.
The recommendations in this guidance apply to materials that the
Agency has not previously evaluated and determined to be pharmaceutical
co-crystals. The recommendations do not apply to materials that the
Agency has previously designated as salts, complexes, or other non-co-
crystalline forms.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: 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. 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.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Andre Raw, Center for Drug Evaluation and Research, Food and Drug
Administration, Metro Park North II, 7500 Standish Pl., Rockville, MD
20855, 240-276-8500; or
Richard Lostritto, Center for Drug Evaluation and Research, Food and
Drug Administration, Bldg. 21, rm. 1626, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301-796-1900.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.''
This guidance provides applicants of NDAs and ANDAs with CDER's current
thinking on the appropriate regulatory classification of pharmaceutical
co-crystal solid-state forms. This guidance also provides information
about the data the applicant should submit to support the appropriate
classification of a co-crystal, as well as the regulatory implications
of the classification.
On December 2, 2011 (76 FR 75551), FDA announced the availability
of the draft version of this guidance. The public comment period closed
on March 1, 2012. A number of comments were received from the public,
all of which the Agency considered carefully as it finalized the
guidance and made appropriate changes. Any changes to the guidance were
minor and made to clarify statements in the draft guidance.
Co-crystals are solids that are crystalline materials composed of
two or more molecules in the same crystal lattice. These solid-state
forms, composed of an active pharmaceutical ingredient (API) with a
neutral guest compound (also referred to as a conformer), have been the
focus of significant interest in drug product development.
Pharmaceutical co-crystals have opened the opportunity for engineering
solid-state forms designed to have tailored properties to enhance drug
product bioavailability and stability, as well as enhance
processability of the solid material inputs in drug product
manufacture. Pharmaceutical co-crystals are of interest because they
offer the advantage of generating a diverse array of solid-state forms
from APIs that lack ionizable functional groups needed for salt
formation.
Traditionally, solid-state polymorphic forms of an API are
classified as either crystalline, amorphous, or solvate and hydrate
forms, and applicable regulatory schemes for these solid-state
polymorphic forms are well-defined. Co-crystals, however, are
distinguishable from these traditional pharmaceutical solid-state
forms. Unlike
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polymorphs, which generally speaking contain only the API within the
crystal lattice, co-crystals are composed of an API with a neutral
guest compound in the crystal lattice. Similarly, unlike salts, where
the components in the crystal lattice are in an ionized state, a co-
crystal's components are in a neutral state and interact via nonionic
interactions.
At present, no formal regulatory policy exists governing the
classification of pharmaceutical co-crystals. In response to this need
for regulatory guidance, the guidance provides the Agency's current
thinking on the appropriate classification of co-crystal solid-state
forms.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on regulatory classification of
pharmaceutical co-crystals. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
III. 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 314.94(a)(9) have been approved under
OMB control number 0910-0001. The collections of information in the
current good manufacturing practice (CGMP) regulations (21 CFR part
211) have been approved under OMB control number 0910-0139.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: April 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09872 Filed 4-25-13; 8:45 am]
BILLING CODE 4160-01-P