List of Bulk Drug Substances That May Be Used in Pharmacy Compounding; Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act, 72841-72843 [2013-28979]
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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Proposed Rules
accordance with all applicable
conditions that are necessary to prevent
the drug or category of drugs from
presenting such demonstrable
difficulties (see section 503B(a)(6)(A)
and (a)(6)(B) of the FD&C Act). Section
503B(c)(2) of the FD&C Act requires that
before issuing regulations to implement
section 503B(a)(6) of the FD&C Act, an
advisory committee on compounding be
convened and consulted.
FDA intends to develop and publish
a single list of drug products and
categories of drug products that cannot
be compounded and still qualify for any
of the exemptions set forth in sections
503A and 503B because they present
demonstrable difficulties for
compounding.
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
II. Request for Nominations
To identify candidates for the
difficult-to-compound list, FDA is
seeking public input in the form of
specific drug products or categories of
drug products that are difficult to
compound. Interested groups and
individuals may nominate drug
products or categories of drug products
that are difficult to compound for
inclusion on the list. After evaluating
the nominations and, as required by
Congress, consulting with the Pharmacy
Compounding Advisory Committee (see
sections 503A(d)(1) and 503B(c)(2) of
the FD&C Act), FDA will issue the list
as a regulation under notice-andcomment rulemaking procedures.
Nominations should include the
following for each drug product or drug
product category nominated, and any
other relevant additional information
available:
• Name of drug product or drug
product category;
• Reason why the drug product or
drug product category should be
included on the list, taking into account
the risks and benefits to patients.
Reasons may include but are not
limited to:
Æ The potential effect of
compounding on the potency, purity,
and quality of a drug product, which
could affect the safety and effectiveness
of the drug product. Factors that may be
relevant to this determination include:
1. Drug Delivery System
• Is a sophisticated drug delivery
system required to ensure dosing
accuracy and/or reproducibility?
• Is the safety or efficacy of the
product a concern if there is product-toproduct variability?
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2. Drug Formulation and Consistency
• Is a sophisticated formulation of the
drug product required to ensure dosing
accuracy and/or reproducibility?
• Because of the sophisticated
formulation, is product-to-product
uniformity of the drug product often
difficult to achieve?
• Is the safety or efficacy of the
product a concern if there is product-toproduct variability?
3. Bioavailability
• Is it difficult to achieve and
maintain a uniformly bioavailable
dosage form?
• Is the safety or effectiveness of the
product a concern if the bioavailability
varies?
4. Complexity of Compounding
• Is the compounding of the drug
product complex?
• Are there multiple, complicated, or
interrelated steps?
• Is there a significant potential for
error in one or more of the steps that
could affect drug safety or effectiveness?
72841
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 comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set
comments. Identify comments with the
docket number found in the brackets in
the heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–28980 Filed 12–2–13; 11:15 am]
BILLING CODE 4160–01–P
5. Facilities and Equipment
• Are sophisticated facilities and/or
equipment required to ensure proper
compounding of the drug product?
• Is there a significant potential for
error in the use of the facilities or
equipment that could affect drug safety
or effectiveness?
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
6. Training
List of Bulk Drug Substances That May
Be Used in Pharmacy Compounding;
Bulk Drug Substances That May Be
Used To Compound Drug Products in
Accordance With Section 503A of the
Federal Food, Drug, and Cosmetic Act
• Is specialized, highly technical
training essential to ensure proper
compounding of the drug product?
7. Testing and Quality Assurance
• Is sophisticated, difficult-to-perform
testing of the compounded drug product
required to ensure potency, purity,
performance characteristics, or other
important characteristics prior to
dispensing?
• Is there a significant potential for
harm if the product is compounded
without proper quality assurance
procedures and end-product testing?
Æ Adverse effects that could result
when the drug product or drug product
category is not made according to
appropriate conditions.
FDA cannot guarantee that all drug
products or drug product categories
nominated during the nomination
period will be considered for inclusion
on the next published difficult to
compound list. Nominations received
during the comment 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
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA–2013–N–1525]
AGENCY:
Food and Drug Administration,
HHS.
Withdrawal of proposed rule;
request for nominations.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
withdrawing the proposed rule to list
bulk drug substances used in pharmacy
compounding and preparing to develop
a list of bulk drug substances (bulk
drugs) that may be used to compound
drug products, although they are neither
the subject of a United States
Pharmacopeia (USP) or National
Formulary (NF) monograph nor
components of FDA-approved drugs. 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:
E:\FR\FM\04DEP1.SGM
04DEP1
72842
Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Proposed Rules
FDA is withdrawing the
proposed rule published January 7, 1999
(64 FR 996), as of December 4, 2013.
Submit written or electronic
nominations for the bulk drug
substances list by March 4, 2014.
ADDRESSES: You may submit
nominations, identified by Docket No.
FDA–2013–N–1525, 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.’’
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 number FDA–2013–N–1525 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:
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
I. Background
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.
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13:50 Dec 03, 2013
Jkt 232001
351(a)(2)(B)) (concerning current good
manufacturing practice (CGMP) 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 a drug product may be
compounded if the licensed pharmacist
or licensed physician compounds the
drug product using bulk drug
substances that: ‘‘(I) comply with the
standards of an applicable United States
Pharmacopoeia or National Formulary
monograph, if a monograph exists, and
the United States Pharmacopoeia
chapter on pharmacy compounding; (II)
if such a monograph does not exist, are
drug substances that are components of
drugs approved by the Secretary; or (III)
if such a monograph does not exist and
the drug substance is not a component
of a drug approved by the Secretary, that
appear on a list developed by the
Secretary through regulations issued by
the Secretary under subsection (d) [of
Section 503A]’’ (section 503A(b)(1)(A)(i)
of the FD&C Act).
Section 503A 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
503A(b)(1)(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)(1)(A)(i)(III) 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).
As described in more detail below, in
1998, FDA began to develop a list of
bulk drug substances that may be used
in compounding, but before a final rule
was published, 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.
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
Supreme Court in 2002.1 After the court
decision, FDA suspended its efforts to
develop the list of bulk drug substances
that could be used in compounding.
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 2002.2 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
bulk drug substances that may be used
in compounding under section 503A.
II. Previous Efforts To Develop the List
of Bulk Drug Substances Under Section
503A of the FD&C Act
In the Federal Register of April 7,
1998 (63 FR 17011), FDA invited all
interested persons to nominate bulk
drug substances for inclusion on the list
of bulk drug substances that may be
used in compounding under section
503A. In total, FDA received
nominations for 41 different drug
substances. After evaluating the
nominated drugs and consulting with
the Pharmacy Compounding Advisory
Committee as required by section 503A,
FDA published a proposed rule
proposing to list 20 drugs on the section
503A bulk drugs list in January 1999 (64
FR 996, January 7, 1999). The proposed
rule also discussed 10 nominated drug
substances that were still under
consideration for the bulk drugs list.
The Pharmacy Compounding Advisory
Committee reconvened in May 1999 to
discuss drugs included in the proposed
rule, in addition to other bulk drug
substances (see 64 FR 19791 (April 22,
1999)). However, as explained
previously (see the ‘‘Background’’
section), after the 2002 U.S. Supreme
Court decision, the Agency suspended
its efforts to develop the bulk drugs list
under section 503A.
FDA intends to reconsider the bulk
drug substances that were proposed for
inclusion on the list and that neither
have an applicable USP or NF
monograph nor are components of an
FDA-approved drug due to the time
1 See Thompson v. Western States Med. Ctr., 535
U.S. 357 (2002).
2 The DQSA also adds a new section 503B to the
FD&C Act (21 U.S.C. 353b) that creates a new
category of ‘‘outsourcing facilities.’’ For additional
information concerning bulk drug substances that
may be used to compound drug products in
accordance with section 503B, see the notice, ‘‘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’’ published in this issue of the Federal
Register.
E:\FR\FM\04DEP1.SGM
04DEP1
Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Proposed Rules
lapse since the last proposal. Therefore,
the Agency withdraws the proposed
rule, ‘‘List of Bulk Drug Substances That
May Be Used in Pharmacy
Compounding,’’ published in the
Federal Register of January 7, 1999 (64
FR 996).
III. 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. After
evaluating the nominations and, as
required by section 503A, consulting
with the USP and the Pharmacy
Compounding Advisory Committee,
FDA will issue the list as a regulation
under notice-and-comment rulemaking
procedures.
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.
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
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; and
• A bibliography of available safety
and efficacy data,3 including any
relevant peer-reviewed medical
literature.
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);
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 an NDA.
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13:50 Dec 03, 2013
Jkt 232001
• 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, as
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 the 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
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. 2013–28979 Filed 12–2–13; 11:15 am]
BILLING CODE 4160–01–P
OVERSEAS PRIVATE INVESTMENT
CORPORATION
22 CFR Part 706
[No. FOIA–2013]
RIN 3420–ZA00
Freedom of Information
Overseas Private Investment
Corporation.
ACTION: Notice of Proposed Rulemaking.
AGENCY:
This rule proposes revisions
to the Overseas Private Investment
Corporation’s (‘‘OPIC’’) Freedom of
Information Act (FOIA) regulations by
making substantive and administrative
changes. These revisions are intended to
supersede OPIC’s current FOIA
regulations, located at this Part. The
SUMMARY:
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
72843
proposed rule incorporates the FOIA
revisions contained in the Openness
Promotes Effectiveness in our National
Government Act of 2007 (‘‘OPEN
Government Act’’), makes
administrative changes to reflect OPIC’s
cost, and organizes the regulations to
more closely match those of other
agencies for ease of reference. The
proposed rule also reflects the
disclosure principles established by
President Barack Obama and Attorney
General Eric Holder in their FOIA
Policy Memoranda issued on January
12, 2009 and March 19, 2009,
respectively.
Written comments must be
postmarked and electronic comments
must be submitted on or before January
3, 2014.
ADDRESSES: You may submit comments,
identified by Docket Number FOIA–
2013, by one of the following methods:
• Email: foia@opic.gov. Include
docket number FOIA–2013 in the
subject line of the message.
• Mail: Nichole Cadiente,
Administrative Counsel, Overseas
Private Investment Corporation, 1100
New York Avenue NW., Washington,
DC 20527. Include docket number
FOIA–2013 on both the envelope and
the letter.
FOR FURTHER INFORMATION CONTACT:
Nichole Cadiente, Administrative
Counsel, (202) 336–8400, or foia@
opic.gov.
DATES:
The
revision of Part 706 incorporates
changes to the language and structure of
the regulations and adds new provisions
to implement the OPEN Government
Act. OPIC is already complying with
these changes and this proposed
revision serves as OPIC’s formal
codification of the applicable law and
its practice.
The most significant change in this
proposed rule revision is the treatment
of business submitters. This section will
define confidential commercial
information more concisely and provide
a default expiration date for
confidentiality labels. This will enable
OPIC to more efficiently process
requests for commercial information,
which compose the majority of OPIC’s
FOIA requests. Among other substantive
changes: the search date is now the
responsive record cutoff date, the
information OPIC posts online has been
clarified, there is more detail on how to
request records about an individual, and
illustrative examples have been added.
In general, comments received,
including attachments and other
supporting materials, are part of the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\04DEP1.SGM
04DEP1
]]>Agencies
[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Proposed Rules]
[Pages 72841-72843]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28979]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA-2013-N-1525]
List of Bulk Drug Substances That May Be Used in Pharmacy
Compounding; Bulk Drug Substances That May Be Used To Compound Drug
Products in Accordance With Section 503A of the Federal Food, Drug, and
Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Withdrawal of proposed rule; request for nominations.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing the proposed rule to list bulk drug substances used in
pharmacy compounding and preparing to develop a list of bulk drug
substances (bulk drugs) that may be used to compound drug products,
although they are neither the subject of a United States Pharmacopeia
(USP) or National Formulary (NF) monograph nor components of FDA-
approved drugs. 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.
[[Page 72842]]
DATES: FDA is withdrawing the proposed rule published January 7, 1999
(64 FR 996), as of December 4, 2013.
Submit written or electronic nominations for the bulk drug
substances list by March 4, 2014.
ADDRESSES: You may submit nominations, identified by Docket No. FDA-
2013-N-1525, 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.''
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 number FDA-2013-N-1525 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
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 (CGMP) 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 a drug product
may be compounded if the licensed pharmacist or licensed physician
compounds the drug product using bulk drug substances that: ``(I)
comply with the standards of an applicable United States Pharmacopoeia
or National Formulary monograph, if a monograph exists, and the United
States Pharmacopoeia chapter on pharmacy compounding; (II) if such a
monograph does not exist, are drug substances that are components of
drugs approved by the Secretary; or (III) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, that appear on a list developed by the Secretary through
regulations issued by the Secretary under subsection (d) [of Section
503A]'' (section 503A(b)(1)(A)(i) of the FD&C Act).
Section 503A 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
503A(b)(1)(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)(1)(A)(i)(III) 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).
As described in more detail below, in 1998, FDA began to develop a
list of bulk drug substances that may be used in compounding, but
before a final rule was published, 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 list of bulk drug substances that
could be used in compounding.
---------------------------------------------------------------------------
\1\ See Thompson v. Western States Med. Ctr., 535 U.S. 357
(2002).
---------------------------------------------------------------------------
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.\2\ 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 bulk drug substances that may be used
in compounding under section 503A.
---------------------------------------------------------------------------
\2\ The DQSA also adds a new section 503B to the FD&C Act (21
U.S.C. 353b) that creates a new category of ``outsourcing
facilities.'' For additional information concerning bulk drug
substances that may be used to compound drug products in accordance
with section 503B, see the notice, ``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'' published in this issue of the
Federal Register.
---------------------------------------------------------------------------
II. Previous Efforts To Develop the List of Bulk Drug Substances Under
Section 503A of the FD&C Act
In the Federal Register of April 7, 1998 (63 FR 17011), FDA invited
all interested persons to nominate bulk drug substances for inclusion
on the list of bulk drug substances that may be used in compounding
under section 503A. In total, FDA received nominations for 41 different
drug substances. After evaluating the nominated drugs and consulting
with the Pharmacy Compounding Advisory Committee as required by section
503A, FDA published a proposed rule proposing to list 20 drugs on the
section 503A bulk drugs list in January 1999 (64 FR 996, January 7,
1999). The proposed rule also discussed 10 nominated drug substances
that were still under consideration for the bulk drugs list. The
Pharmacy Compounding Advisory Committee reconvened in May 1999 to
discuss drugs included in the proposed rule, in addition to other bulk
drug substances (see 64 FR 19791 (April 22, 1999)). However, as
explained previously (see the ``Background'' section), after the 2002
U.S. Supreme Court decision, the Agency suspended its efforts to
develop the bulk drugs list under section 503A.
FDA intends to reconsider the bulk drug substances that were
proposed for inclusion on the list and that neither have an applicable
USP or NF monograph nor are components of an FDA-approved drug due to
the time
[[Page 72843]]
lapse since the last proposal. Therefore, the Agency withdraws the
proposed rule, ``List of Bulk Drug Substances That May Be Used in
Pharmacy Compounding,'' published in the Federal Register of January 7,
1999 (64 FR 996).
III. 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. After evaluating the nominations and, as
required by section 503A, consulting with the USP and the Pharmacy
Compounding Advisory Committee, FDA will issue the list as a regulation
under notice-and-comment rulemaking procedures.
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; and
A bibliography of available safety and efficacy data,\3\
including any relevant peer-reviewed medical literature.
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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 an NDA.
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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, as 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 the 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 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. 2013-28979 Filed 12-2-13; 11:15 am]
BILLING CODE 4160-01-P
