
[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Notices]
[Pages 69062-69063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24085]


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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 (PCAC). The general function of the committee is to provide 
advice on scientific, technical, and medical issues concerning drug 
compounding, as well as any other product for which FDA has regulatory 
responsibility, and to make appropriate recommendations to the Agency. 
The meeting will be open to the public.

DATES: The meeting will be held on November 3, 2016, from 8:30 a.m. to 
4:30 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, MD 20993-0002, 301-796-9001, FAX: 
301-847-8533, 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 in a State licensed pharmacy or a 
Federal facility, or licensed physician, to be exempt from the 
following three sections of the Federal Food, Drug, and Cosmetic Act 
(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).
    The Drug Quality and Security Act added a new section 503B to the 
FD&C Act (21 U.S.C. 353b), which created a new category of compounders 
termed ``outsourcing facilities.'' Under section 503B of the FD&C Act, 
outsourcing facilities are defined, in part, as 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 drug supply chain security 
requirements (21 U.S.C. 360eee-1). Outsourcing facilities are not 
exempt from CGMP requirements in section 501(a)(2)(B).
    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

[[Page 69063]]

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 developed by the 
Secretary through regulations issued by the Secretary (the ``503A Bulks 
List'') (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 
PCAC, 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 
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 intends to discuss with the committee bulk drug substances 
nominated for inclusion on the 503A Bulks List and drug products 
nominated for inclusion on the list of drug products that present 
demonstrable difficulties for compounding under sections 503A and 503B 
of the FD&C Act (``Difficult to Compound List'').
    Agenda: The committee intends to discuss five bulk drug substances 
nominated for inclusion on the section 503A Bulks List. FDA will 
discuss the following nominated bulk drug substances: Glycolic acid, 
trichloroacetic acid, kojic acid, diindolylmethane, and vasoactive 
intestinal peptide. The chart in this document describes which use(s) 
FDA reviewed for each of the five bulk drug substances being discussed 
at this advisory committee meeting. The nominators of these substances 
will be invited to make a short presentation supporting the nomination.

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             Drug                           Use(s) reviewed
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Diindolylmethane.............  Treatment of cancer.
Glycolic acid................  Hyperpigmentation (including melasma) and
                                photodamaged skin.
Trichloroacetic acid.........  Common warts and genital warts.
Kojic acid...................  Hyperpigmentation and as a chelating
                                agent to promote wound healing.
Vasoactive intestinal peptide  A condition described as ``chronic
                                inflammatory response syndrome''.
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    The committee also intends to discuss drug products that employ 
transdermal and topical delivery systems, which were nominated for the 
Difficult to Compound List. The nominators will be invited to make a 
short presentation supporting the nomination.
    FDA intends to make background material available to the public on 
its Web site 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 
will be 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 
October 25, 2016. Oral presentations from the public will be scheduled 
between approximately 9:25 a.m. and 9:35 a.m., 10:25 a.m. and 10:35 
a.m., 11:40 a.m. and 11:50 a.m., 1:45 p.m. and 1:55 p.m., 2:50 p.m. and 
3 p.m., and 4:10 p.m. and 4:20 p.m. on November 3, 2016. 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 October 17, 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 October 18, 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: September 30, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-24085 Filed 10-4-16; 8:45 am]
 BILLING CODE 4164-01-P


