Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket, 65770-65774 [2015-27270]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Joint Meeting of the Pulmonary-Allergy
Drugs Advisory Committee and the
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: PulmonaryAllergy Drugs Advisory Committee and
the Drug Safety and Risk Management
Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 10, 2015, from 8 a.m.
to 4 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
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accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Cindy Hong, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
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default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
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Agenda: The committees will discuss
the safety of codeine in children 18
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years of age and younger. Codeine (most
often in combination with
acetaminophen) is used for the
treatment of pain in children; however,
it is contraindicated for the management
of pain after tonsillectomy and/or
adenoidectomy. Codeine (in
combination with other medicines) is
used for the relief of cough associated
with upper respiratory allergies or the
common cold in children.
Codeine is available by prescription
and also through the over-the-counter
(OTC) Drug Monograph for Cold, Cough,
Allergy, Bronchodilator, and
Antiasthmatic Drug Products (21 CFR
341.14, 21 CFR 341.74, and 21 CFR
341.90).
The focus of the meeting will be the
risk of serious adverse events, such as
respiratory depression and death,
including reports in children who are
CYP2D6 ultra-rapid metabolizers. The
committees will discuss whether the use
of codeine in children should be
restricted further beyond the current
contraindication described previously
and whether codeine should be
available through the OTC Drug
Monograph.
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material available to the public no later
than 2 business days before the meeting.
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will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. Written
submissions may be made to the contact
person on or before November 24, 2015.
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be scheduled between approximately 11
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names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 16, 2015. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
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open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 17, 2015.
Persons attending FDA’s advisory
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Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27196 Filed 10–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3469]
Bulk Drug Substances That Can Be
Used To Compound Drug Products in
Accordance With Section 503B of the
Federal Food, Drug, and Cosmetic Act;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
establishment of public docket.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
developing a list of bulk drug
substances (active ingredients) that can
be used to compound drug products in
accordance with the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (the
503B bulks list). The Agency previously
solicited nominations for the list, but
some of the nominated substances were
not supported by sufficient information
for FDA to evaluate them. FDA is
establishing a public docket where these
substances can be renominated with
sufficient supporting information or to
SUMMARY:
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Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
receive nominations of bulk drug
substances that were not previously
nominated for consideration for
inclusion on the 503B bulks list.
Interested parties can also submit
comments on nominated substances via
this docket.
DATES: Nominations and comments may
be submitted to this docket at any time.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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’’).
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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–
2015–N–3469 for ‘‘Bulk Drug
Substances That Can Be Used To
Compound Drug Products in
Accordance With Section 503B of the
Federal Food, Drug, and Cosmetic Act;
Establishment of a Public Docket.’’
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Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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
https://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: https://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 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:
Philantha Bowen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5175,
Silver Spring, MD 20993–0002, 301–
796–2466.
SUPPLEMENTARY INFORMATION:
new section 503B to the FD&C Act (21
U.S.C. 353b), outsourcing facilities 1
may qualify for certain exemptions from
the FD&C Act if the conditions set forth
in the statute are satisfied. Those
conditions include that an outsourcing
facility does not compound drug
products using a bulk drug substance
unless the bulk drug substance appears
on a list established by the Secretary
identifying bulk drug substances for
which there is a clinical need (the 503B
bulks list), or the drug product
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) (FDA drug
shortage list) at the time of
compounding, distribution, and
dispensing, and each of the following
conditions are met: (1) If an applicable
monograph exists under the United
States Pharmacopeia (USP), 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; (2) 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 (3) the bulk drug substance is
accompanied by a valid certificate of
analysis (see section 503B(a)(2) of the
FD&C Act).
Section 503B refers to the definition
of ‘‘bulk drug substance’’ in FDA
regulations at § 207.3(a)(4) (21 CFR
207.3(a)(4)). (See section 503B(a)(2) of
the FD&C Act.) As defined in
§ 207.3(a)(4), a ‘‘bulk drug substance’’ is
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.
An ‘‘active ingredient’’ is any
component that is intended to furnish
pharmacological activity or other direct
effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease, or to
affect the structure or any function of
the body of man or other animals. The
term includes those components that
may undergo chemical change in the
manufacture of the drug product and be
present in the drug product in a
modified form intended to furnish the
specified activity or effect. (See
§ 210.3(b)(7) (21 CFR 210.3(b)(7)).)
I. Background
1 ‘‘Outsourcing facilities’’ are facilities that meet
certain conditions described in section 503B of the
FD&C Act, including registering with FDA as an
outsourcing facility.
Under the Drug Quality and Security
Act (Pub. L. 113–54), which added a
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Any component other than an active
ingredient is an ‘‘inactive ingredient.’’
(See § 210.3(b)(8).) Inactive ingredients
used in compounded drug products,
which commonly include flavorings,
dyes, diluents, or other excipients, need
not appear on the Secretary’s list of bulk
drug substances to be eligible for use in
compounding drug products and will
not be included on the list.
In a document dated November 27,
2013, published in the Federal Register
of December 4, 2013 (78 FR 72838), FDA
invited all interested persons to
nominate bulk drug substances for
inclusion on the 503B bulks list. Over
2,000 substances were nominated.
However, many of the nominations were
not for bulk drug substances used in
compounding as active ingredients, or
they did not include sufficient
information to allow FDA to evaluate
the nominated substances for placement
on the list. To improve the efficiency of
the process for developing the 503B
bulks list, FDA reopened the
nomination process in July 2014 (79 FR
37747, July 2, 2014), and provided more
detailed information on what it needs to
evaluate nominations for the list. FDA
stated that bulk drug substances that
were previously nominated would not
be further considered unless they were
renominated with adequate support to
permit a meaningful evaluation.
Substances that were already eligible for
use in compounding or that were not
adequately supported would not be
evaluated for placement on the list.
In response to the July 2, 2014,
request for nominations, approximately
2,590 unique substances were
nominated. Of the nominated
substances, approximately 1,750 are not
eligible for inclusion on the list because
they are either a finished drug product,
a biological product subject to licensure
in a biologics license application (BLA),
a radiopharmaceutical drug product, a
substance with no currently accepted
medical use that is included on
Schedule I of the Controlled Substances
Act (CSA) (21 U.S.C. 812(c)), or they
appear on the list published by FDA of
substances that have been withdrawn or
removed from the market because such
drug products or components of such
drug products have been found to be
unsafe or not effective. Of the
substances that are not biological
products subject to licensure in a BLA,
finished drug products,
radiopharmaceuticals, do not appear on
Schedule I in the CSA, and do not
appear on the withdrawn or removed
list, approximately 650 substances were
nominated with insufficient supporting
evidence for FDA to evaluate them.
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II. Establishment of a Docket
As described in section III.B of the
draft guidance entitled ‘‘Interim Policy
on Compounding Using Bulk Drug
Substances Under Section 503B of the
Federal Food, Drug, and Cosmetic Act,’’
FDA is establishing a public docket so
that interested parties can comment on
nominated bulk drug substances,
nominate bulk drug substances that
were not previously nominated for the
503B bulks list, or renominate with
adequate supporting information bulk
drug substances that were previously
nominated but that were not supported
by sufficient information for FDA to
evaluate them. Docket No. FDA–2013–
N–1524 is closed for comment.
Therefore, this new docket can be used
for commenting on nominations
previously submitted to that docket as
well as for submitting new nominations.
In the Federal Register document
seeking nominations, FDA stated that
the following information about clinical
need is necessary to provide adequate
support for nominations to the 503B
bulks list:
• A statement describing the medical
condition(s) that the drug product to be
compounded with the nominated bulk
drug substances is intended to treat;
• A list of FDA-approved drug
products, if any, that address the same
medical condition;
• If there are any FDA-approved drug
products that address the same medical
condition, an explanation of why a
compounded drug product is necessary;
• If the approved drug product is not
suitable for a particular patient
population, an estimate of the size of the
population that would need a
compounded drug product;
• A bibliography of safety and
efficacy data for the drug product
compounded using the nominated
substance, if available, including any
relevant peer-reviewed medical
literature; and
• If there is an FDA-approved drug
product that includes the bulk drug
substance nominated, an explanation of
why the drug product proposed to be
compounded must be compounded
from bulk rather than with the FDAapproved drug product.
Therefore, to be considered for
placement on the 503B bulks list, this
information should be submitted for
each nominated substance.
Interested groups and individuals
may nominate specific bulk drug
substances for inclusion on the 503B
bulks list, renominate previously
nominated substances with additional
information, or comment on nominated
substances. Nominations will only be
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evaluated if they are for specific active
ingredients that meet the definition of a
bulk drug substance in § 207.3(a)(4).
Nominated substances that do not meet
this definition will not be included on
the list. To fully evaluate a bulk drug
substance using the criteria identified in
this document, FDA needs the following
information about both the nominated
bulk drug substance and the drug
product(s) that will be compounded
using such substance:
A. Active Ingredients
1. Confirmation That the Nominated
Substance Is a Bulk Drug Substance
• A statement that the nominated
substance is an active ingredient that
meets the definition of ‘‘bulk drug
substance’’ in § 207.3(a)(4), and an
explanation of why the substance is
considered an active ingredient when it
is used in compounded drug products,
citing specific sources that describe the
active properties of the substance.
2. General Background on the Bulk Drug
Substance
• Ingredient name;
• chemical name;
• common name(s); and
• identifying codes, as available, from
FDA’s Unique Ingredient Identifiers
(UNII) used in the FDA/USP Substance
Registration System, available at https://
fdasis.nlm.nih.gov/srs/. Because
substance names can vary, this code,
where available, will be used by the
Agency to confirm the exact substance
nominated and to identify multiple
nominations of the same substance so
the information can be reviewed
together.
• Chemical grade of the ingredient;
• description of the strength, quality,
stability, and purity of the ingredient,
and a copy of a certificate of analysis
that is representative of the
characteristics of the nominated
ingredient;
• information about how the
ingredient is supplied (e.g., powder,
liquid); and
• 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.
B. Clinical Need To Compound
For FDA to be able to meaningfully
evaluate a substance, the information
provided regarding the clinical need for
compounding with a bulk drug
substance must be specific to the
particular substance nominated and
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drug product to be compounded. A
‘‘boilerplate’’ or general explanation of
clinical need for compounding with
bulk drug substances will not enable
FDA to conduct an adequate review.
Prescribers of the compounded drug
products who may be in the best
position to explain why there is a
clinical need for a compounded drug
product may provide data in support of
a nomination. The following
information about clinical need is
necessary to provide adequate support
for nominations to the 503B bulks list:
• A statement describing the medical
condition(s) that the drug product to be
compounded with the nominated bulk
drug substances is intended to treat (i.e.,
what patient need is met by the drug
product compounded with the bulk
drug substance);
• a list of FDA-approved drug
products, if any, that address the same
medical condition;
• if there are FDA-approved drug
products that address the same medical
condition, an explanation of why a
compounded drug product is necessary
(i.e., why the approved drug product is
not suitable for a particular patient
population);
• if the approved drug product is not
suitable for a particular patient
population, an estimate of the size of the
population that would need a
compounded drug product (e.g., for a
drug product compounded from bulk
because of patient allergies or other
intolerances to excipients in FDAapproved drug products, FDA expects
the supporting information to include a
good faith estimate of the patient
population with the specific medical
condition that suffers from the allergy or
intolerance, with citations to the
literature regarding the incidence of the
condition or a statement that a search
was conducted and no references were
found); 2
• a bibliography of safety and efficacy
data for the drug compounded using the
nominated substance,3 if available,
including any relevant peer-reviewed
medical literature; and
• if there is an FDA-approved drug
product that includes the bulk drug
substance nominated, an explanation of
why the drug product proposed to be
compounded must be compounded
from bulk rather than with the FDAapproved drug product.
General or boilerplate statements
regarding the need to compound from
the bulk drug substance or the benefits
of compounding generally will not be
considered sufficient. Note that the
Agency does not consider supply issues,
such as backorders, that do not rise to
the level of a drug shortage listed on
FDA’s drug shortage Web site as
evidence of a clinical need for
compounding with a bulk drug
substance, and section 503B of the
FD&C Act already allows compounding
from bulk drug substances if the
compounded drug product is on the
FDA drug shortage list. Similarly,
considerations of cost and convenience
will not be considered indicators of
clinical need.
C. Information on the Drug Product
That Will Be Compounded With the
Bulk Drug Substance
• Information about the dosage
form(s) into which the bulk drug
substance will be compounded;
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• information about the strength(s) of
the compounded drug product(s);
• information about the anticipated
route(s) of administration of the
compounded drug product(s); and
• information about the previous
use(s) of the compounded drug
product(s).
D. Process for Submitting Nominations
and Comments
Because the prior deadline for
submitting nominations has passed,
FDA is opening this docket so that
interested persons can submit
nominations of bulk drug substances
and provide adequate support for FDA
to evaluate whether those substances
should be placed on the 503B bulks list.
Bulk drug substances that were
previously nominated and for which
inadequate information was provided 4
need to be renominated with the
information identified in this document
to be considered for inclusion on the
503B bulks list. Nominators are
encouraged to submit as much of the
information identified in this document
as possible. Unless adequate supporting
data is received for a bulk drug
substance, FDA will be unable to
consider it further for inclusion on the
list.
For efficient consolidation and review
of nominations, nominators are
encouraged to submit their nominations
in an editable Excel file. Specifically,
nominators are encouraged to format
their nominations as follows:
Column A—What information is requested?
Column B—Put data specific to the nominated substance
What is the name of the nominated ingredient?
Is the ingredient an active ingredient that meets the definition of ‘‘bulk
drug substance’’ in § 207.3(a)(4)?
Provide the ingredient name.
Provide an explanation for why it is considered an active ingredient
when it is used in specific compounded drug products, and provide
citations to specific sources that describe its active properties.
Chemical name.
Common name.
UNII code.
Provide the chemical grade.
Provide the strength, quality, stability, and purity information and attach
a certificate of analysis.
Describe how the ingredient is supplied (e.g., powder, liquid).
List the foreign pharmacopeias or other countries in which it is registered.
Put yes, no, or unknown. If yes, state the status of the monograph, if
known.
What
What
Does
What
What
is the chemical name of the substance?
is the common name of the substance?
the substance have a UNII code?
is the chemical grade of the substance?
is the strength, quality, stability, and purity of the ingredient?
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How is the ingredient supplied?
Is the substance recognized in foreign pharmacopeias or registered in
other countries?
Has information been submitted about the substance to the USP for
consideration of monograph development?
2 For example, if there is a need to compound a
drug product from bulk drug substances due to
patient sensitivity to a preservative or other
excipient in the approved drug product, the
supporting data is expected to set forth the number
of patients for whom the drug product is prescribed
that are allergic or sensitive to that particular
excipient.
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3 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 a new drug application. Note that data
regarding safety and efficacy, while relevant, is not
indicative of a clinical need for a particular bulk
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drug substance, and additional information
regarding the clinical need must be provided.
4 As referenced in this document, a list of the
substances in this category is available at
https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/UCM467373.pdf.
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Column A—What information is requested?
Column B—Put data specific to the nominated substance
What medical condition(s) is the drug product compounded with the
bulk drug substances intended to treat?
Are there other drug products approved by FDA to treat the same medical condition?
If there are FDA-approved drug products that address the same medical condition, why is there a clinical need for a compounded drug
product?
Are there safety and efficacy data on compounded drugs using the
nominated substance?
Describe the medical condition(s) that the drug product compounded
with the bulk drug substances is intended to treat.
List the other approved treatments.
If there is an FDA-approved drug product that includes the bulk drug
substance nominated, is it necessary to compound a drug product
from the bulk drug substance rather than from the FDA-approved
drug product?
What dosage form(s) will be compounded using the bulk drug substance?
What strength(s) will be compounded from the nominated substance?
tkelley on DSK3SPTVN1PROD with NOTICES
What are the anticipated route(s) of administration of the compounded
drug product(s)?
Has the bulk drug substance been used previously to compound drug
product(s)?
Is there any other relevant information?
In addition to nominating new
substances or renominating substances
previously nominated without sufficient
supporting information, individuals and
organizations will be able to comment
via the docket established by this notice
on substances nominated for the 503B
bulks list that have not yet been
addressed in a Federal Register
document proposing substances for the
503B bulks list. Comments may be
submitted regarding nominations
submitted to both this docket and
nominations previously submitted to
Docket No. FDA–2013–N–1524.
Comments may provide any relevant
information about particular bulk drug
substances, including that in support of,
or in opposition to, the placement of a
nominated bulk drug substance on the
503B bulks list. However, comments
submitted should not address the 503B
bulks list generally or other matters
related to the Agency’s regulation of
compounding. Comments about
nominated substances that have been
addressed by the Agency in a Federal
Register document proposing
substances for the 503B bulks list
should be submitted to the docket for
the document in which the substance is
addressed.
Please do not submit comments that
have already been submitted to other
dockets. Such submissions are
duplicative and not helpful to the
Agency. If comments on particular
documents or issues are submitted to
this docket rather than the docket
specifically opened for the particular
document or issue, the comment might
not be considered as the specific
VerDate Sep<11>2014
18:24 Oct 26, 2015
Jkt 238001
Provide a justification for clinical need, including an estimate of the size
of the population that would need the compounded drug.
Provide a bibliography of safety and efficacy data for the drug compounded using the nominated substance, if available, including any
relevant peer-reviewed medical literature.
Provide an explanation of why it is necessary to compound from the
bulk drug substance.
State the dosage form(s).
List the strength(s) of the drug product(s) that will be compounded from
the nominated substance, or a range of strengths, if known.
List the route(s) of administration of the compounded drug product(s).
Describe previous uses of the bulk drug substance in compounding.
Provide any other information you would like FDA to consider in evaluating the nomination.
documents are being finalized and
issues considered. FDA will not respond
to questions submitted to this docket.
Information in the docket will be
publicly available. Therefore, we
remind nominators and commenters not
to submit personal or confidential
information.
Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27270 Filed 10–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3455]
Medical Devices; Exemptions From
Premarket Notifications; Class II
Devices; Autosomal Recessive Carrier
Screening Gene Mutation Detection
System; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing its
intent to exempt from the premarket
notification requirements autosomal
recessive carrier screening gene
mutation detection systems, subject to
certain limitations. These devices are
qualitative in vitro molecular diagnostic
systems used for genotyping of
clinically relevant variants in genomic
deoxyribonucleic acid (DNA) isolated
SUMMARY:
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
from human specimens intended for
prescription use or over-the-counter use.
These devices are intended for
autosomal recessive disease carrier
screening in adults of reproductive age.
These devices are not intended for copy
number variation, cytogenetic, or
biochemical testing. FDA is publishing
this notice in order to obtain comments
regarding the proposed exemption.
DATES: Submit electronic or written
comments by November 27, 2015.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65770-65774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27270]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3469]
Bulk Drug Substances That Can Be Used To Compound Drug Products
in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic
Act; Establishment of a Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; establishment of public docket.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is developing
a list of bulk drug substances (active ingredients) that can be used to
compound drug products in accordance with the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (the 503B bulks list). The Agency
previously solicited nominations for the list, but some of the
nominated substances were not supported by sufficient information for
FDA to evaluate them. FDA is establishing a public docket where these
substances can be renominated with sufficient supporting information or
to
[[Page 65771]]
receive nominations of bulk drug substances that were not previously
nominated for consideration for inclusion on the 503B bulks list.
Interested parties can also submit comments on nominated substances via
this docket.
DATES: Nominations and comments may be submitted to this docket at any
time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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-2015-N-3469 for ``Bulk Drug Substances That Can Be Used To Compound
Drug Products in Accordance With Section 503B of the Federal Food,
Drug, and Cosmetic Act; Establishment of a Public Docket.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://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 https://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: https://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 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: Philantha Bowen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5175, Silver Spring, MD 20993-0002, 301-
796-2466.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Drug Quality and Security Act (Pub. L. 113-54), which
added a new section 503B to the FD&C Act (21 U.S.C. 353b), outsourcing
facilities \1\ may qualify for certain exemptions from the FD&C Act if
the conditions set forth in the statute are satisfied. Those conditions
include that an outsourcing facility does not compound drug products
using a bulk drug substance unless the bulk drug substance appears on a
list established by the Secretary identifying bulk drug substances for
which there is a clinical need (the 503B bulks list), or the drug
product 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) (FDA drug shortage list) at the time of compounding,
distribution, and dispensing, and each of the following conditions are
met: (1) If an applicable monograph exists under the United States
Pharmacopeia (USP), 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; (2) 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 (3)
the bulk drug substance is accompanied by a valid certificate of
analysis (see section 503B(a)(2) of the FD&C Act).
---------------------------------------------------------------------------
\1\ ``Outsourcing facilities'' are facilities that meet certain
conditions described in section 503B of the FD&C Act, including
registering with FDA as an outsourcing facility.
---------------------------------------------------------------------------
Section 503B refers to the definition of ``bulk drug substance'' in
FDA regulations at Sec. 207.3(a)(4) (21 CFR 207.3(a)(4)). (See section
503B(a)(2) of the FD&C Act.) As defined in Sec. 207.3(a)(4), a ``bulk
drug substance'' is 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.
An ``active ingredient'' is any component that is intended to
furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease, or to
affect the structure or any function of the body of man or other
animals. The term includes those components that may undergo chemical
change in the manufacture of the drug product and be present in the
drug product in a modified form intended to furnish the specified
activity or effect. (See Sec. 210.3(b)(7) (21 CFR 210.3(b)(7)).)
[[Page 65772]]
Any component other than an active ingredient is an ``inactive
ingredient.'' (See Sec. 210.3(b)(8).) Inactive ingredients used in
compounded drug products, which commonly include flavorings, dyes,
diluents, or other excipients, need not appear on the Secretary's list
of bulk drug substances to be eligible for use in compounding drug
products and will not be included on the list.
In a document dated November 27, 2013, published in the Federal
Register of December 4, 2013 (78 FR 72838), FDA invited all interested
persons to nominate bulk drug substances for inclusion on the 503B
bulks list. Over 2,000 substances were nominated. However, many of the
nominations were not for bulk drug substances used in compounding as
active ingredients, or they did not include sufficient information to
allow FDA to evaluate the nominated substances for placement on the
list. To improve the efficiency of the process for developing the 503B
bulks list, FDA reopened the nomination process in July 2014 (79 FR
37747, July 2, 2014), and provided more detailed information on what it
needs to evaluate nominations for the list. FDA stated that bulk drug
substances that were previously nominated would not be further
considered unless they were renominated with adequate support to permit
a meaningful evaluation. Substances that were already eligible for use
in compounding or that were not adequately supported would not be
evaluated for placement on the list.
In response to the July 2, 2014, request for nominations,
approximately 2,590 unique substances were nominated. Of the nominated
substances, approximately 1,750 are not eligible for inclusion on the
list because they are either a finished drug product, a biological
product subject to licensure in a biologics license application (BLA),
a radiopharmaceutical drug product, a substance with no currently
accepted medical use that is included on Schedule I of the Controlled
Substances Act (CSA) (21 U.S.C. 812(c)), or they appear on the list
published by FDA of substances that have been withdrawn or removed from
the market because such drug products or components of such drug
products have been found to be unsafe or not effective. Of the
substances that are not biological products subject to licensure in a
BLA, finished drug products, radiopharmaceuticals, do not appear on
Schedule I in the CSA, and do not appear on the withdrawn or removed
list, approximately 650 substances were nominated with insufficient
supporting evidence for FDA to evaluate them.
II. Establishment of a Docket
As described in section III.B of the draft guidance entitled
``Interim Policy on Compounding Using Bulk Drug Substances Under
Section 503B of the Federal Food, Drug, and Cosmetic Act,'' FDA is
establishing a public docket so that interested parties can comment on
nominated bulk drug substances, nominate bulk drug substances that were
not previously nominated for the 503B bulks list, or renominate with
adequate supporting information bulk drug substances that were
previously nominated but that were not supported by sufficient
information for FDA to evaluate them. Docket No. FDA-2013-N-1524 is
closed for comment. Therefore, this new docket can be used for
commenting on nominations previously submitted to that docket as well
as for submitting new nominations.
In the Federal Register document seeking nominations, FDA stated
that the following information about clinical need is necessary to
provide adequate support for nominations to the 503B bulks list:
A statement describing the medical condition(s) that the
drug product to be compounded with the nominated bulk drug substances
is intended to treat;
A list of FDA-approved drug products, if any, that address
the same medical condition;
If there are any FDA-approved drug products that address
the same medical condition, an explanation of why a compounded drug
product is necessary;
If the approved drug product is not suitable for a
particular patient population, an estimate of the size of the
population that would need a compounded drug product;
A bibliography of safety and efficacy data for the drug
product compounded using the nominated substance, if available,
including any relevant peer-reviewed medical literature; and
If there is an FDA-approved drug product that includes the
bulk drug substance nominated, an explanation of why the drug product
proposed to be compounded must be compounded from bulk rather than with
the FDA-approved drug product.
Therefore, to be considered for placement on the 503B bulks list,
this information should be submitted for each nominated substance.
Interested groups and individuals may nominate specific bulk drug
substances for inclusion on the 503B bulks list, renominate previously
nominated substances with additional information, or comment on
nominated substances. Nominations will only be evaluated if they are
for specific active ingredients that meet the definition of a bulk drug
substance in Sec. 207.3(a)(4). Nominated substances that do not meet
this definition will not be included on the list. To fully evaluate a
bulk drug substance using the criteria identified in this document, FDA
needs the following information about both the nominated bulk drug
substance and the drug product(s) that will be compounded using such
substance:
A. Active Ingredients
1. Confirmation That the Nominated Substance Is a Bulk Drug Substance
A statement that the nominated substance is an active
ingredient that meets the definition of ``bulk drug substance'' in
Sec. 207.3(a)(4), and an explanation of why the substance is
considered an active ingredient when it is used in compounded drug
products, citing specific sources that describe the active properties
of the substance.
2. General Background on the Bulk Drug Substance
Ingredient name;
chemical name;
common name(s); and
identifying codes, as available, from FDA's Unique
Ingredient Identifiers (UNII) used in the FDA/USP Substance
Registration System, available at https://fdasis.nlm.nih.gov/srs/.
Because substance names can vary, this code, where available, will be
used by the Agency to confirm the exact substance nominated and to
identify multiple nominations of the same substance so the information
can be reviewed together.
Chemical grade of the ingredient;
description of the strength, quality, stability, and
purity of the ingredient, and a copy of a certificate of analysis that
is representative of the characteristics of the nominated ingredient;
information about how the ingredient is supplied (e.g.,
powder, liquid); and
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.
B. Clinical Need To Compound
For FDA to be able to meaningfully evaluate a substance, the
information provided regarding the clinical need for compounding with a
bulk drug substance must be specific to the particular substance
nominated and
[[Page 65773]]
drug product to be compounded. A ``boilerplate'' or general explanation
of clinical need for compounding with bulk drug substances will not
enable FDA to conduct an adequate review. Prescribers of the compounded
drug products who may be in the best position to explain why there is a
clinical need for a compounded drug product may provide data in support
of a nomination. The following information about clinical need is
necessary to provide adequate support for nominations to the 503B bulks
list:
A statement describing the medical condition(s) that the
drug product to be compounded with the nominated bulk drug substances
is intended to treat (i.e., what patient need is met by the drug
product compounded with the bulk drug substance);
a list of FDA-approved drug products, if any, that address
the same medical condition;
if there are FDA-approved drug products that address the
same medical condition, an explanation of why a compounded drug product
is necessary (i.e., why the approved drug product is not suitable for a
particular patient population);
if the approved drug product is not suitable for a
particular patient population, an estimate of the size of the
population that would need a compounded drug product (e.g., for a drug
product compounded from bulk because of patient allergies or other
intolerances to excipients in FDA-approved drug products, FDA expects
the supporting information to include a good faith estimate of the
patient population with the specific medical condition that suffers
from the allergy or intolerance, with citations to the literature
regarding the incidence of the condition or a statement that a search
was conducted and no references were found); \2\
---------------------------------------------------------------------------
\2\ For example, if there is a need to compound a drug product
from bulk drug substances due to patient sensitivity to a
preservative or other excipient in the approved drug product, the
supporting data is expected to set forth the number of patients for
whom the drug product is prescribed that are allergic or sensitive
to that particular excipient.
---------------------------------------------------------------------------
a bibliography of safety and efficacy data for the drug
compounded using the nominated substance,\3\ if available, including
any relevant peer-reviewed medical literature; and
---------------------------------------------------------------------------
\3\ 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 a new drug application. Note that data regarding
safety and efficacy, while relevant, is not indicative of a clinical
need for a particular bulk drug substance, and additional
information regarding the clinical need must be provided.
---------------------------------------------------------------------------
if there is an FDA-approved drug product that includes the
bulk drug substance nominated, an explanation of why the drug product
proposed to be compounded must be compounded from bulk rather than with
the FDA-approved drug product.
General or boilerplate statements regarding the need to compound
from the bulk drug substance or the benefits of compounding generally
will not be considered sufficient. Note that the Agency does not
consider supply issues, such as backorders, that do not rise to the
level of a drug shortage listed on FDA's drug shortage Web site as
evidence of a clinical need for compounding with a bulk drug substance,
and section 503B of the FD&C Act already allows compounding from bulk
drug substances if the compounded drug product is on the FDA drug
shortage list. Similarly, considerations of cost and convenience will
not be considered indicators of clinical need.
C. Information on the Drug Product That Will Be Compounded With the
Bulk Drug Substance
Information about the dosage form(s) into which the bulk
drug substance will be compounded;
information about the strength(s) of the compounded drug
product(s);
information about the anticipated route(s) of
administration of the compounded drug product(s); and
information about the previous use(s) of the compounded
drug product(s).
D. Process for Submitting Nominations and Comments
Because the prior deadline for submitting nominations has passed,
FDA is opening this docket so that interested persons can submit
nominations of bulk drug substances and provide adequate support for
FDA to evaluate whether those substances should be placed on the 503B
bulks list. Bulk drug substances that were previously nominated and for
which inadequate information was provided \4\ need to be renominated
with the information identified in this document to be considered for
inclusion on the 503B bulks list. Nominators are encouraged to submit
as much of the information identified in this document as possible.
Unless adequate supporting data is received for a bulk drug substance,
FDA will be unable to consider it further for inclusion on the list.
---------------------------------------------------------------------------
\4\ As referenced in this document, a list of the substances in
this category is available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM467373.pdf.
---------------------------------------------------------------------------
For efficient consolidation and review of nominations, nominators
are encouraged to submit their nominations in an editable Excel file.
Specifically, nominators are encouraged to format their nominations as
follows:
------------------------------------------------------------------------
Column A--What information is Column B--Put data specific to
requested? the nominated substance
------------------------------------------------------------------------
What is the name of the nominated Provide the ingredient name.
ingredient?
Is the ingredient an active ingredient Provide an explanation for why
that meets the definition of ``bulk it is considered an active
drug substance'' in Sec. ingredient when it is used in
207.3(a)(4)? specific compounded drug
products, and provide
citations to specific sources
that describe its active
properties.
What is the chemical name of the Chemical name.
substance?
What is the common name of the Common name.
substance?
Does the substance have a UNII code? UNII code.
What is the chemical grade of the Provide the chemical grade.
substance?
What is the strength, quality, Provide the strength, quality,
stability, and purity of the stability, and purity
ingredient? information and attach a
certificate of analysis.
How is the ingredient supplied? Describe how the ingredient is
supplied (e.g., powder,
liquid).
Is the substance recognized in foreign List the foreign pharmacopeias
pharmacopeias or registered in other or other countries in which it
countries? is registered.
Has information been submitted about Put yes, no, or unknown. If
the substance to the USP for yes, state the status of the
consideration of monograph monograph, if known.
development?
[[Page 65774]]
What medical condition(s) is the drug Describe the medical
product compounded with the bulk drug condition(s) that the drug
substances intended to treat? product compounded with the
bulk drug substances is
intended to treat.
Are there other drug products approved List the other approved
by FDA to treat the same medical treatments.
condition?
If there are FDA-approved drug products Provide a justification for
that address the same medical clinical need, including an
condition, why is there a clinical estimate of the size of the
need for a compounded drug product? population that would need the
compounded drug.
Are there safety and efficacy data on Provide a bibliography of
compounded drugs using the nominated safety and efficacy data for
substance? the drug compounded using the
nominated substance, if
available, including any
relevant peer-reviewed medical
literature.
If there is an FDA-approved drug Provide an explanation of why
product that includes the bulk drug it is necessary to compound
substance nominated, is it necessary from the bulk drug substance.
to compound a drug product from the
bulk drug substance rather than from
the FDA-approved drug product?
What dosage form(s) will be compounded State the dosage form(s).
using the bulk drug substance?
What strength(s) will be compounded List the strength(s) of the
from the nominated substance? drug product(s) that will be
compounded from the nominated
substance, or a range of
strengths, if known.
What are the anticipated route(s) of List the route(s) of
administration of the compounded drug administration of the
product(s)? compounded drug product(s).
Has the bulk drug substance been used Describe previous uses of the
previously to compound drug bulk drug substance in
product(s)? compounding.
Is there any other relevant Provide any other information
information? you would like FDA to consider
in evaluating the nomination.
------------------------------------------------------------------------
In addition to nominating new substances or renominating substances
previously nominated without sufficient supporting information,
individuals and organizations will be able to comment via the docket
established by this notice on substances nominated for the 503B bulks
list that have not yet been addressed in a Federal Register document
proposing substances for the 503B bulks list. Comments may be submitted
regarding nominations submitted to both this docket and nominations
previously submitted to Docket No. FDA-2013-N-1524. Comments may
provide any relevant information about particular bulk drug substances,
including that in support of, or in opposition to, the placement of a
nominated bulk drug substance on the 503B bulks list. However, comments
submitted should not address the 503B bulks list generally or other
matters related to the Agency's regulation of compounding. Comments
about nominated substances that have been addressed by the Agency in a
Federal Register document proposing substances for the 503B bulks list
should be submitted to the docket for the document in which the
substance is addressed.
Please do not submit comments that have already been submitted to
other dockets. Such submissions are duplicative and not helpful to the
Agency. If comments on particular documents or issues are submitted to
this docket rather than the docket specifically opened for the
particular document or issue, the comment might not be considered as
the specific documents are being finalized and issues considered. FDA
will not respond to questions submitted to this docket.
Information in the docket will be publicly available. Therefore, we
remind nominators and commenters not to submit personal or confidential
information.
Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27270 Filed 10-26-15; 8:45 am]
BILLING CODE 4164-01-P
