
[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35782-35783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13169]


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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: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Pharmacy Compounding Advisory 
Committee. The general function of the committee is 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 Agency. The meeting will be open to the public.

DATES: The meeting will be held on June 23, 2016, from 8:30 a.m. to 5 
p.m.

ADDRESSES: 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,

[[Page 35783]]

MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: 
PCAC@fda.hhs.gov, 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 (CGMP)); (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 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).
    FDA will discuss with the committee drugs proposed for inclusion on 
the section 503A bulk drug substances list.
    Agenda: The committee intends to discuss six bulk drug substances 
nominated for inclusion on the section 503A bulk drug substances list. 
FDA intends to discuss the following nominated bulk drug substances: 
Chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea 
tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS). The 
nominators of these substances will be invited to make a short 
presentation supporting the nomination. During the afternoon session, 
the committee will receive updates on certain issues to follow up on 
discussions from previous meetings, including the option for obtaining 
access to investigational new drugs under expanded access.
    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 
15, 2016. Oral presentations from the public will be scheduled between 
approximately 9:30 a.m. and 9:40 a.m., 10:35 a.m. and 10:45 a.m., 11:40 
a.m. and 11:50 a.m., 2:15 p.m. and 2:25 p.m., 3:20 p.m. and 3:30 p.m., 
and 4:40 p.m. and 4:50 p.m. Those individuals interested in making 
formal oral presentations should notify Cindy Hong 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 10, 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 June 13, 
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: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13169 Filed 6-2-16; 8:45 am]
 BILLING CODE 4164-01-P


