[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Proposed Rules]
[Pages 72838-72840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28978]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA-2013-N-1524]
Bulk Drug Substances That May Be Used To Compound Drug Products
in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic
Act, Concerning Outsourcing Facilities; Request for Nominations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; request for nominations.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is preparing
to develop a list of bulk drug substances (bulk drugs) that may be used
to compound drug products in accordance with section 503B of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), concerning
outsourcing facilities. To identify candidates for this bulk drugs
list, interested groups and individuals may nominate specific bulk drug
substances, and FDA is describing the information that should be
provided to the Agency in support of each nomination.
DATES: Submit either electronic or written nominations for the bulk
drug substances list by March 4, 2014.
ADDRESSES: You may submit nominations, identified by Docket No. FDA-
2013-N-1524, by any of the following methods.
Electronic Submissions
Submit electronic nominations in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
[[Page 72839]]
Written Submissions
Submit written nominations in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-1524 for this request for nominations. All
nominations received may be posted without change to http://www.regulations.gov, including any personal information provided. For
additional information on submitting nominations, see the ``Request for
Nominations'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
nominations 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.
FOR FURTHER INFORMATION CONTACT: Marissa Chaet Brykman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Suite 5100, Silver Spring, MD 20993-0002,
301-796-3110.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Quality and Security Act (DQSA) adds a new section 503B to
the FD&C Act (21 U.S.C. 353b) that creates a new category of
``outsourcing facilities.'' \1\ Outsourcing facilities, as defined in
section 503B of the FD&C Act, are facilities that meet certain
conditions described in section 503B, including registering with FDA as
an outsourcing facility. If these conditions are satisfied, a drug
compounded by or under the direct supervision of a licensed pharmacist
in an outsourcing facility is exempt from two sections of the FD&C Act:
(1) Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of
drugs with adequate directions for use) and (2) section 505 (21 U.S.C.
355) (concerning the approval of human drug products under new drug
applications (NDAs) or abbreviated new drug applications (ANDAs)); but
not section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current
good manufacturing practice for drugs).
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\1\ The DQSA also removes from section 503A of the FD&C Act the
provisions that had been held unconstitutional by the U.S. Supreme
Court in 2002. See Thompson v. Western States Med. Ctr., 535 U.S.
357 (2002).
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One of the conditions in section 503B of the FD&C Act that must be
satisfied to qualify for the exemptions is that an outsourcing facility
does not compound using a bulk drug substance unless: (1) The bulk drug
substance appears on a list established by the Secretary identifying
bulk drug substances for which there is a clinical need, or the drug
compounded from such bulk drug substance appears on the drug shortage
list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at
the time of compounding, distribution, and dispensing; (2) ``if an
applicable monograph exists under the United States Pharmacopeia, the
National Formulary, or another compendium or pharmacopeia recognized by
the Secretary for purposes of this paragraph, the bulk drug [substance
complies] with the monograph;'' (3) the bulk drug substance is
manufactured by an establishment that is registered under section 510
of the FD&C Act (21 U.S.C. 360); and (4) the bulk drug substance is
accompanied by a valid certificate of analysis (see section 503B(a)(2)
of the FD&C Act).
Section 503B of the FD&C Act refers to the definition of ``bulk
drug substance'' in FDA regulations at 21 CFR 207.3(a)(4): ``any
substance that is represented for use in a drug and that, when used in
the manufacturing, processing, or packaging of a drug, becomes an
active ingredient or a finished dosage form of the drug, but the term
does not include intermediates used in the synthesis of such
substances'' (see section 503B(a)(2)).
II. Request for Nominations
To identify candidates for this list, FDA is seeking public input
in the form of specific bulk drug nominations. All interested groups
and individuals may nominate specific bulk drug substances for
inclusion on the list.
Nominations should include the following information about the bulk
drug substance being nominated and the product(s) that will be
compounded using such substance, and any other relevant information
available. If the information requested is unknown or unavailable, that
fact should be noted accordingly.
Bulk Drug Substance
Ingredient name;
Chemical name;
Common name(s);
Chemical grade or description of the strength, quality,
and purity of the ingredient;
Information about how the ingredient is supplied (e.g.,
powder, liquid);
Information about recognition of the substance in foreign
pharmacopeias and the status of its registration(s) in other countries,
including whether information has been submitted to USP for
consideration of monograph development;
A bibliography of available safety and efficacy data,\2\
including any relevant peer-reviewed medical literature; and
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\2\ FDA recognizes that the available safety and efficacy data
supporting consideration of a bulk drug substance for inclusion on
the list may not be of the same type, amount, or quality as is
required to support an NDA.
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An explanation of why there is a clinical need to compound
from the bulk drug substance.
Compounded Product
Information about the dosage form(s) into which the drug
substance will be compounded (including formulations);
Information about the strength(s) of the compounded
product(s);
Information about the anticipated route(s) of
administration of the compounded product(s);
Information about the past and proposed use(s) of the
compounded product(s), including the rationale for its use or why the
compounded product(s), as opposed to an FDA-approved product, is
necessary; and
Available stability data for the compounded product(s).
FDA cannot guarantee that all drugs nominated during the nomination
period will be considered for inclusion on the next published bulk
drugs list. Nominations received during the nomination period that are
supported by the most complete and relevant information will likely be
evaluated first. Nominations that are not evaluated during this first
phase will receive consideration for list amendments, because the
development of this list will be an ongoing process. Individuals and
organizations also will be able to petition FDA to make additional list
amendments after the list is published.
Interested persons may submit either electronic nominations to
http://www.regulations.gov or written nominations to the Division of
Dockets Management (see ADDRESSES). It is only necessary to send one
set of nominations. Identify nominations with the docket number found
in brackets in the heading of this document. Received nominations may
be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday
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through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28978 Filed 12-2-13; 11:15 am]
BILLING CODE 4160-01-P