[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Pages 7351-7352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02786]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Pharmacy Compounding Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: 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 (PCAC).
General Function of the Committee: To provide advice on scientific,
technical, and medical issues concerning drug compounding under
sections 503A and 503B (21 U.S.C. 353A and 353B) 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 March 8, 2016, from 8:30
a.m. to 4:30 p.m., and on March 9, 2016, from 8:30 a.m. to 1 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 including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: Cindy Hong, 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.
SUPPLEMENTARY INFORMATION:
Background: Section 503A of the FD&C Act 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) (concerning current
good manufacturing practice (CGMP)); (2) section 502(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 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), concerning the labeling of drugs with adequate directions
for use; (2) section 505, concerning the approval of human drug
products under NDAs or ANDAs; and (3) section 582, concerning the track
and trace requirements in the Drug Supply Chain Security Act (Pub. L.
113-53). Outsourcing facilities are not exempt from CGMP requirements
in section 501(a)(2)(B) of the FD&C Act.
One of the conditions 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
product 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 (the ``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).
A 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, by regulation after consulting with the
Pharmacy Compounding Advisory Committee, of drugs or categories of
drugs that present demonstrable difficulties for compounding that are
reasonably likely
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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 identified on the list as 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 section 503A bulk drug substances list and on the demonstrably
difficult to compound list under sections 503A and 503B of the FD&C
Act.
Agenda: On March 8, 2016, the committee will discuss six bulk drug
substances nominated for inclusion on the section 503A bulk drug
substances list. FDA will discuss the following nominated bulk drug
substances: Quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze
dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The
nominators of these substances will be invited to make a short
presentation supporting the nomination.
On March 9, 2016, the committee will discuss two categories of drug
products nominated for the list of drug products that present
demonstrable difficulties for compounding. These categories of drug
products are metered dose inhalers and dry powder inhalers. The
nominators who nominated the category of drugs or specific drug
products in the category will be invited to make a short presentation
supporting the nomination.
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
March 1, 2016. Oral presentations from the public will be scheduled
between approximately 11 a.m. to 11:15 a.m. and 3:15 p.m. to 3:30 p.m.
on March 8, 2016, and between approximately 11:30 a.m. to 12 noon on
March 9, 2016. 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 February 24, 2016. 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 February
25, 2016.
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
disabilities. If you require accommodations due to a disability, please
contact Cindy Hong 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: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-02786 Filed 2-8-16; 4:15 pm]
BILLING CODE 4164-01-P