[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29717-29719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12512]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Pharmacy Compounding Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 Committee: Pharmacy Compounding Advisory Committee.
General Function of the Committee: To provide advice on scientific,
technical, and medical issues concerning drug compounding under
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), and, as required, any other product for which FDA has
regulatory responsibility, and make appropriate recommendations to the
Commissioner of Food and Drugs.
Date and Time: The meeting will be held on June 17, 2015, from 8:30
a.m. to 5 p.m., and on June 18, 2015, from 8:30 a.m. to 11:30 a.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 including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/
AdvisoryCommittees/
[[Page 29718]]
AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Jayne E. Peterson, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, email: [email protected], or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes
the conditions that must be satisfied for human drug products
compounded by a licensed pharmacist or licensed physician to be exempt
from the following 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); (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)).
The Drug Quality and Security Act adds a new section, 503B, to the
FD&C Act (21 U.S.C. 353b) that creates a new category of ``outsourcing
facilities.'' Outsourcing facilities, as defined in section 503B of the
FD&C Act, are facilities that meet certain conditions described in
section 503B, including registration with FDA as an outsourcing
facility. If these conditions are satisfied, a drug product compounded
for human use by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from three sections of
the FD&C Act: (1) Section 502(f)(1), (2) section 505, and (3) section
582 (21 U.S.C. 360eee-1), but not section 501(a)(2)(B).
One of the conditions that must be satisfied to qualify for the
exemptions under both sections 503A and 503B of the FD&C Act is that
the drug that is compounded does not appear on a list published by the
Secretary of drugs 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 (``withdrawn or removed
list'') (see sections 503A(b)(1)(C) and 503B(a)(4) of the FD&C Act).
Another condition that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that a bulk drug
substance (active pharmaceutical ingredient) used in a compounded drug
must meet one of the following criteria: (1) Complies with the
standards of an applicable United States Pharmacopoeia (USP) or
National Formulary monograph, if a monograph exists, and the USP
chapter on pharmacy compounding; (2) if an applicable monograph does
not exist, is a component of a drug approved by the Secretary of Health
and Human Services (the Secretary); or (3) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, appears on a list (``section 503A bulk drug substances
list'') developed by the Secretary through regulations issued by the
Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act).
Another condition that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that the compounded
drug product is not a drug product identified by the Secretary by
regulation as a drug product that presents demonstrable difficulties
for compounding that reasonably demonstrate an adverse effect on the
safety or effectiveness of that drug product (see section 503A(b)(3)(A)
of the FD&C Act).
Another condition that must be satisfied to qualify for the
exemptions in section 503B of the FD&C Act is that the compounded drug
is not identified (directly or as part of a category of drugs) on a
list published by the Secretary of drugs or categories of drugs that
present demonstrable difficulties for compounding that are reasonably
likely to lead to an adverse effect on the safety or effectiveness of
the drug or category of drugs, taking into account the risks and
benefits to patients, or the drug is compounded in 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 (B) of the FD&C Act).
FDA will discuss with the committee drugs proposed for inclusion on
the withdrawn or removed list pursuant to sections 503A and 503B and on
the section 503A bulk drug substances list. FDA will also discuss with
the committee the criteria FDA proposes to use to evaluate candidates
to be identified as difficult to compound pursuant to sections 503A and
503B.
Agenda: On June 17, 2015, during the morning session, the committee
will receive updates on certain issues to follow up on discussions from
the last meeting including the options for obtaining access to
investigational new drugs and the processes FDA plans to use to add or
remove drugs from the section 503A bulk drug substances list. During
this session, the committee will also discuss revisions FDA is
considering to the list of drug products that may not be compounded
under the exemptions provided by the FD&C Act because the drug products
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. The list of those drug products is currently
codified at 21 CFR 216.24. FDA now is considering whether to amend the
rule to add four more drugs to the list: Aprotinin, ondansetron
hydrochloride, bromocriptine mesylate, and acetaminophen. As previously
explained in the Federal Register of July 2, 2014 (79 FR 37687 at 37689
through 37690), the list may specify that a drug may not be compounded
in any form, or, alternatively, may expressly exclude a particular
formulation, indication, dosage form, or route of administration from
an entry on the list because an approved drug containing the same
active ingredient(s) has not been withdrawn or removed from the market.
Moreover, a drug may be listed only with regard to certain
formulations, indications, routes of administration, or dosage forms
because it has been found to be unsafe or not effective in those
particular formulations, indications, routes of administration, or
dosage forms. FDA plans to seek the committee's advice concerning the
inclusion of these drug products.
On June 17, 2015, during the afternoon session, the committee will
discuss four bulk drug substances nominated for inclusion on the
section 503A bulk drug substances list. FDA intends to discuss the
following nominated bulk drug substances: Brilliant Blue G, tranilast,
N-acetyl-D-glucosamine, and oxitriptan. The nominators of these
substances will be invited to make a short presentation supporting the
nomination. Other nominated substances will be discussed at future
committee meetings.
During the morning session on June 18, 2015, the committee will
discuss the criteria FDA is proposing to use to evaluate drug products
or categories of
[[Page 29719]]
drug products for identification as demonstrably difficult to compound.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://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 committee.
Written submissions may be made to the contact person on or before June
9, 2015. Oral presentations from the public will be scheduled between
approximately 11 a.m. to 11:15 a.m. and 3:45 p.m. to 4 p.m. on June 17,
2015, and between approximately 9:15 a.m. to 9:45 a.m. on June 18,
2015. Those individuals interested in making formal oral presentations
should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before June
4, 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 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 June 8, 2015.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Jayne E. Peterson at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 19, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-12512 Filed 5-21-15; 8:45 am]
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