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, 72838-72840 [2013-28978]
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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Proposed Rules
(b) Affected Ads
None.
(c) Applicability
This AD applies to all The Boeing
Company Model 717-200 airplanes,
certificated in any category.
(d) Subject
Joint Aircraft System Component (JASC)/
Air Transport Association (ATA) of America
Code 53, Fuselage.
(e) Unsafe Condition
This AD was prompted by multiple reports
of cracking in the overwing frames. We are
issuing this AD to detect and correct such
cracking, which could result in a severed
frame and might increase the loading of
adjacent frames, resulting in damage to the
adjacent structure and consequent loss of
structural integrity of the airplane.
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(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Inspections and Corrective Actions
At the applicable time specified in
paragraph (g)(1) or (g)(2) of this AD, do a
general visual inspection and a high
frequency eddy current (HFEC) inspection for
cracking of the left-side and right-side
overwing frames at station 737, and do all
applicable corrective actions, in accordance
with the Accomplishment Instructions of
Boeing Alert Service Bulletin 717–53A0036,
dated August 12, 2013, except as required by
paragraph (h)(3) of this AD. Do all applicable
corrective actions before further flight.
Except as required by paragraph (h)(2) of this
AD, repeat the inspections thereafter at the
applicable time specified in paragraph 1.E.,
‘‘Compliance,’’ of Boeing Alert Service
Bulletin 717–53A0036, dated August 12,
2013.
(1) For Group 1, Configuration 1 airplanes
identified in Boeing Alert Service Bulletin
717–53A0036, dated August 12, 2013: At the
time specified in table 1 of paragraph 1.E.,
‘‘Compliance,’’ of Boeing Alert Service
Bulletin 717–53A0036, dated August 12,
2013, except as provided by paragraph (h)(1)
of this AD.
(2) For Group 1, Configuration 2 airplanes
identified in Boeing Alert Service Bulletin
717–53A0036, dated August 12, 2013: At the
applicable time specified in paragraph
(g)(2)(i) or (g)(2)(ii) of this AD.
(i) For airplanes on which the overwing
frame has not been replaced: Within 9,300
flight cycles after accomplishing the
inspections specified in Boeing Multi
Operator Message (MOM) MOM–MOM–13–
0375–01B, dated May 9, 2013.
(ii) For airplanes on which the overwing
frame has been replaced: Within 12,000 flight
cycles after replacing the frame.
(h) Exceptions to Service Information
(1) Where Boeing Alert Service Bulletin
717–53A0036, dated August 12, 2013,
specifies a compliance time ‘‘after the
original issue date of this service bulletin,’’
this AD requires compliance within the
VerDate Mar<15>2010
13:50 Dec 03, 2013
Jkt 232001
specified compliance time after the effective
date of this AD.
(2) Where Boeing Alert Service Bulletin
717–53A0036, dated August 12, 2013,
specifies to contact Boeing for the
compliance time of an inspection repetitive
interval, this AD requires a compliance time
approved by the FAA in accordance with the
procedures specified in paragraph (j) of this
AD.
(3) Where Boeing Alert Service Bulletin
717–53A0036, dated August 12, 2013,
specifies to contact Boeing for repair
instructions, this AD requires repair before
further flight using a method approved in
accordance with the procedures specified in
paragraph (j) of this AD.
ACO, FAA, 3960 Paramount Boulevard,
Lakewood, CA 90712–4137; phone: 562–627–
5348; fax: 562–627–5210; email:
eric.schrieber@faa.gov.
(2) For service information identified in
this AD, Boeing Commercial Airplanes,
Attention: Data & Services Management, 3855
Lakewood Boulevard, MC D800–0019, Long
Beach, CA 90846–0001; telephone 206–544–
5000, extension 2; fax 206–766–5683;
Internet https://www.myboeingfleet.com.
(i) Credit for Previous Actions
This paragraph provides credit for only the
initial general visual inspection, HFEC
inspection, and frame replacement required
by paragraph (g) of this AD, if those actions
were performed before the effective date of
this AD using Boeing Multi Operator Message
(MOM) MOM–MOM–13–0375–01B, dated
May 9, 2013.
[FR Doc. 2013–29004 Filed 12–3–13; 8:45 am]
(j) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Los Angeles Aircraft
Certification Office (ACO), FAA, has the
authority to approve AMOCs for this AD, if
requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the ACO, send it to the
attention of the person identified in
paragraph (k) of this AD.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(3) An AMOC that provides an acceptable
level of safety may be used for any repair
required by this AD if it is approved by the
Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has
been authorized by the Manager, Los Angeles
ACO, to make those findings. For a repair
method to be approved, the repair must meet
the certification basis of the airplane and 14
CFR 25.571, Amendment 45, and the
approval must specifically refer to this AD.
(4) If the service information contains steps
that are labeled as RC (Required for
Compliance), those steps must be done to
comply with this AD; any steps that are not
labeled as RC are recommended. Those steps
that are not labeled as RC may be deviated
from, done as part of other actions, or done
using accepted methods different from those
identified in the specified service
information without obtaining approval of an
AMOC, provided the steps labeled as RC can
be done and the airplane can be put back in
a serviceable condition. Any substitutions or
changes to steps labeled as RC require
approval of an AMOC.
21 CFR Chapter I
(k) Related Information
(1) For more information about this AD,
contact: Eric Schrieber, Aerospace Engineer,
Airframe Branch, ANM–120L, Los Angeles
PO 00000
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Issued in Renton, Washington, on
November 26, 2013.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[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.
Notification; request for
nominations.
ACTION:
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.
SUMMARY:
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.
DATES:
Electronic Submissions
Submit electronic nominations in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
E:\FR\FM\04DEP1.SGM
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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Proposed Rules
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
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 https://
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 https://
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
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).
VerDate Mar<15>2010
13:50 Dec 03, 2013
Jkt 232001
not section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice for drugs).
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;
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72839
• 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
• 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 FDAapproved 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 https://
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
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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72840
Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Proposed Rules
through Friday, and will be posted to
the docket at https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA–2013–N–1523]
Drug Products That Present
Demonstrable Difficulties for
Compounding Under Sections 503A
and 503B of the Federal Food, Drug,
and Cosmetic Act; Request for
Nominations
AGENCY:
Food and Drug Administration,
HHS.
I. Background
Notification; request for
nominations.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
preparing to develop a list of drug
products that present demonstrable
difficulties for compounding (difficultto-compound list). To identify
candidates for this list, FDA is
encouraging interested groups and
individuals to nominate specific drug
products or categories of drug products
and is describing the information that
should be provided to the Agency in
support of each nomination.
DATES: Submit written or electronic
comments by March 4, 2014.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2013–N–
1523, by any of the following methods.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
Written Submissions
Submit written submissions 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–1523 for this
request for nominations. All comments
VerDate Mar<15>2010
13:50 Dec 03, 2013
Jkt 232001
received may be posted without change
to https://www.regulations.gov, including
any personal information provided. For
additional information on submitting
comments, 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
comments received, go to https://
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:
Section 503A of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 353a) describes the conditions
under which a human drug product
compounded for an identified
individual patient based on a
prescription is entitled to an exemption
from three sections of the FD&C Act: (1)
Section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice for drugs); (2)
section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use); and (3)
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)).
One of the conditions for such an
exemption is that the compounded drug
product is not a ‘‘drug product
identified by the Secretary by regulation
as a drug product that presents
demonstrable difficulties for
compounding that reasonably
demonstrate an adverse effect on the
safety or effectiveness of that drug
product’’ (section 503A(b)(3)(A) of the
FD&C Act).
Section 503A(d)(1) of the FD&C Act
requires that before issuing regulations
to implement section 503A(b)(3)(A) of
the FD&C Act, an advisory committee
on compounding be convened and
consulted ‘‘unless the Secretary
determines that the issuance of such
regulations before consultation is
necessary to protect the public health’’
(section 503A(d)(1) of the FD&C Act).
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
At a meeting on July 13 and 14, 2000,
the Pharmacy Compounding Advisory
Committee discussed and provided FDA
with advice about the Agency’s efforts
to develop a list of drugs that present
demonstrable difficulties for
compounding. FDA had published a
notice of that meeting in the Federal
Register of June 29, 2000 (65 FR 40104).
However, before a list could be
developed, the constitutionality of
section 503A was challenged in court
because it included restrictions on the
advertising or promotion of the
compounding of any particular drug,
class of drug, or type of drug and the
solicitation of prescriptions for
compounded drugs. These provisions
were held unconstitutional by the U.S.
Supreme Court in 2002.1 After the court
decision, FDA suspended its efforts to
develop the difficult-to-compound list.
The Drug Quality and Security Act
(DQSA) removes from section 503A of
the FD&C Act the provisions that had
been held unconstitutional by the U.S.
Supreme Court in 2002. By removing
these provisions, the new law removes
uncertainty regarding the validity of
section 503A, clarifying that it applies
nationwide. Therefore, FDA is
reinitiating its efforts to develop a list of
drug products that present demonstrable
difficulties for compounding that
reasonably demonstrate an adverse
effect on the safety or effectiveness of
that drug product.
In addition, the DQSA adds a new
section 503B to the FD&C Act (21 U.S.C.
353b) that creates a new category of
‘‘outsourcing facilities.’’ Outsourcing
facilities, as defined in section 503B, 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) and (2) section
505; but not section 501(a)(2)(B).
One of the conditions in section 503B
that must be satisfied to qualify for the
exemptions is that an outsourcing
facility does not compound a drug
identified (directly or as part of a
category of drugs) on a list published by
the Secretary of drugs or categories of
drugs that present demonstrable
difficulties for compounding that are
reasonably likely to lead to an adverse
effect on the safety or effectiveness of
the drug or category of drugs, taking into
account the risks and benefits to
patients, or the drug is compounded in
1 See Thompson v. Western States Med. Ctr., 535
U.S. 357 (2002).
E:\FR\FM\04DEP1.SGM
04DEP1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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 https://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).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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
https://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
[[Page 72840]]
through Friday, and will be posted to the docket at https://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
