82 FR 49632 - Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 206 (October 26, 2017)

Page Range		49632-49634
FR Document		2017-23223

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 under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), and, as required, 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.

Federal Register, Volume 82 Issue 206 (Thursday, October 26, 2017)

[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49632-49634]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-23223]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5818]

Pharmacy Compounding Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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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 under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), and, as required, 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 20, 2017, from 8:30 a.m. to
5 p.m. and November 21, 2017, from 8:30 a.m. to 11:30 a.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: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-5818. The docket will close on November
17, 2017. Submit either electronic or written comments on this public
meeting by November 17, 2017. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before November 17, 2017. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of November 17, 2017. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
Comments received on or before November 3, 2017, will be provided
to the committee. Comments received after that date will be taken into
consideration by the Agency.
You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-5818 for ``Pharmacy Compounding Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cindy Chee, 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: 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

[[Page 49633]]

cannot always be published quickly enough to provide timely notice.
Therefore, you should always check the Agency's Web site at https://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 (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 a 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)).
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 (21 U.S.C. 360eee-1) (concerning
the drug supply chain security requirements). 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 (NF) 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 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, 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
(``Difficult to Compound List'').
Agenda: The committee intends to discuss six bulk drug substances
nominated for inclusion on the section 503A Bulks List. FDA will
discuss the following nominated bulk drug substances: astragalus, L-
citrulline, pregnenolone, 7-keto dehydroepiandrosterone (DHEA),
epigallocatechin gallate (EGCg), and resveratrol. The chart below
identifies the use(s) FDA reviewed for each of the six 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.

------------------------------------------------------------------------
Drug Uses reviewed
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Astragalus........................ Allergic rhinitis, asthma, diabetes,
herpes simplex keratitis, wound
healing.
L-citrulline...................... Hyperammonaemia due to cycle
disorders.
Pregnenolone...................... Rheumatoid arthritis,
hypercholesterolemia, manic and
depressive symptoms of bipolar
disorder and bipolar disorder with
substance abuse (dual diagnosis),
positive and negative symptoms of
schizophrenia.
7-keto dehydroepiandrosterone..... Weight loss, Raynaud's phenomena.
Epigallocatechin gallate.......... Treatment of obesity, wound healing,
corneal neovascularization, non-
alcoholic fatty liver disease,
cardiac hypertrophy, diabetes (type
1 & 2), Parkinson's disease.
Resveratrol....................... Treatment of older adults with
impaired glucose tolerance, pain.
------------------------------------------------------------------------

The committee also intends to discuss liposome drug products and
drug products produced using hot melt extrusion technology for
inclusion on the Difficult to Compound List. Drug products produced
``by extrusion or nanotechnology'' were nominated for inclusion on 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 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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the

[[Page 49634]]

appropriate advisory committee meeting link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before November 3, 2017, will be provided to
the committee. Oral presentations from the public will be scheduled
between approximately 9:35 a.m. and 9:45 a.m., 10:55 a.m. and 11:05
a.m., 12 noon and 12:10 p.m., 2:05 p.m. and 2:15 p.m., 3:25 p.m. and
3:35 p.m., and 4:30 p.m. and 4:40 p.m. on November 20, 2017, and
between approximately 9:40 a.m. and 9:50 a.m. and 11:10 a.m. and 11:20
a.m. on November 21, 2017. 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 October 26, 2017. 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 27, 2017.
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 Chee 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 https://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: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23223 Filed 10-25-17; 8:45 am]
BILLING CODE 4164-01-P

Document Created: 2018-10-25 10:14:24
Document Modified: 2018-10-25 10:14:24

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; establishment of a public docket; request for comments.
Dates		The meeting will be held on November 20, 2017, from 8:30 a.m. to 5 p.m. and November 21, 2017, from 8:30 a.m. to 11:30 a.m.
Contact		Cindy Chee, 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 https:// 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.
FR Citation		82 FR 49632

82 FR 49632 - Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 206 (October 26, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration