
[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Proposed Rules]
[Pages 72838-72840]
From the Federal Register Online via the Government Printing 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.

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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


