[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49632-49634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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: [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

[[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


