
[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18148-18150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07667]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1847]


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 May 8, 2017, from 8:30 a.m. to 4:30 
p.m. and May 9, 2017, from 8:30 a.m. to 12 noon.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2017-N-1847. The docket will close on May 5, 
2017. Comments received on or before April 24, 2017, will be provided 
to the committee. Comments received after that date will be taken into 
consideration by the Agency.

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. 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-1847 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 Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

[[Page 18149]]

     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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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: 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.

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 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 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 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 
(``Difficult to Compound List'').
    Agenda: The committee will receive updates on certain issues to 
follow up on discussions from previous meetings, including quality 
standards and conditions at certain compounding facilities. In 
addition, 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: Nicotinamide 
adenine dinucleotide, nicotinamide adenine dinucleotide disodium 
reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl 
sulfate, and artemisinin. The chart below describes which use(s) FDA 
reviewed for each of the six bulk drug substances being discussed at 
this

[[Page 18150]]

advisory committee meeting. The nominators of these substances will be 
invited to make a short presentation supporting the nomination.

------------------------------------------------------------------------
                  Drug                           Use(s) reviewed
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Nicotinamide adenine dinucleotide......  Reducing fatigue in multiple
                                          sclerosis.
Nicotinamide adenine dinucleotide        Reduce symptoms of fatigue in
 disodium reduced.                        chronic fatigue syndrome.
Nettle (Urtica dioica) whole plant.....  Glycemic control.
Ubiquinol..............................  Glycemic control.
Vanadyl sulfate........................  Diabetes, hypoglycemia,
                                          hyperlipidemia, heart disease,
                                          preventing cancer.
Artemisinin............................  Malaria, protozoal infections
                                          (particularly toxoplasmosis),
                                          helminthic infections, stomach
                                          ulcers, cancer.
------------------------------------------------------------------------

    The committee also intends to discuss oral solid modified release 
drug products that employ coated 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 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. 
All electronic and written submissions submitted to the Docket (see the 
Addresses section) on or before April 24, 2017, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 10:15 a.m. and 10:25 a.m., 11:35 a.m. and 11:45 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 May 8, 2017, and between approximately 10 a.m. and 10:10 a.m. 
and 11:35 a.m. and 11:50 a.m. on May 9, 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 April 14, 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 April 17, 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 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: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07667 Filed 4-14-17; 8:45 am]
 BILLING CODE 4164-01-P


