
[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29717-29719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Pharmacy Compounding Advisory Committee.
    General Function of the Committee: 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 
Commissioner of Food and Drugs.
    Date and Time: The meeting will be held on June 17, 2015, from 8:30 
a.m. to 5 p.m., and on June 18, 2015, from 8:30 a.m. to 11:30 a.m.
    Location: 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/

[[Page 29718]]

AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Jayne E. Peterson, 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.
    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); (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 adds a new section, 503B, to the 
FD&C Act (21 U.S.C. 353b) that creates a new category of ``outsourcing 
facilities.'' Outsourcing facilities, as defined in section 503B of the 
FD&C Act, are 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), (2) section 505, and (3) section 
582 (21 U.S.C. 360eee-1), but not section 501(a)(2)(B).
    One of the conditions that must be satisfied to qualify for the 
exemptions under both sections 503A and 503B of the FD&C Act is that 
the drug that is compounded does not appear on a list published by the 
Secretary of drugs that have been withdrawn or removed from the market 
because such drug products or components of such drug products have 
been found to be unsafe or not effective (``withdrawn or removed 
list'') (see sections 503A(b)(1)(C) and 503B(a)(4) 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 a bulk drug 
substance (active pharmaceutical ingredient) used in a compounded drug 
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 (``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).
    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).
    Another 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 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 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 will discuss with the committee drugs proposed for inclusion on 
the withdrawn or removed list pursuant to sections 503A and 503B and on 
the section 503A bulk drug substances list. FDA will also discuss with 
the committee the criteria FDA proposes to use to evaluate candidates 
to be identified as difficult to compound pursuant to sections 503A and 
503B.
    Agenda: On June 17, 2015, during the morning session, the committee 
will receive updates on certain issues to follow up on discussions from 
the last meeting including the options for obtaining access to 
investigational new drugs and the processes FDA plans to use to add or 
remove drugs from the section 503A bulk drug substances list. During 
this session, the committee will also discuss revisions FDA is 
considering to the list of drug products that may not be compounded 
under the exemptions provided by the FD&C Act because the drug products 
have been withdrawn or removed from the market because such drug 
products or components of such drug products have been found to be 
unsafe or not effective. The list of those drug products is currently 
codified at 21 CFR 216.24. FDA now is considering whether to amend the 
rule to add four more drugs to the list: Aprotinin, ondansetron 
hydrochloride, bromocriptine mesylate, and acetaminophen. As previously 
explained in the Federal Register of July 2, 2014 (79 FR 37687 at 37689 
through 37690), the list may specify that a drug may not be compounded 
in any form, or, alternatively, may expressly exclude a particular 
formulation, indication, dosage form, or route of administration from 
an entry on the list because an approved drug containing the same 
active ingredient(s) has not been withdrawn or removed from the market. 
Moreover, a drug may be listed only with regard to certain 
formulations, indications, routes of administration, or dosage forms 
because it has been found to be unsafe or not effective in those 
particular formulations, indications, routes of administration, or 
dosage forms. FDA plans to seek the committee's advice concerning the 
inclusion of these drug products.
    On June 17, 2015, during the afternoon session, the committee will 
discuss four bulk drug substances nominated for inclusion on the 
section 503A bulk drug substances list. FDA intends to discuss the 
following nominated bulk drug substances: Brilliant Blue G, tranilast, 
N-acetyl-D-glucosamine, and oxitriptan. The nominators of these 
substances will be invited to make a short presentation supporting the 
nomination. Other nominated substances will be discussed at future 
committee meetings.
    During the morning session on June 18, 2015, the committee will 
discuss the criteria FDA is proposing to use to evaluate drug products 
or categories of

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drug products for identification as demonstrably difficult to compound.
    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 
9, 2015. Oral presentations from the public will be scheduled between 
approximately 11 a.m. to 11:15 a.m. and 3:45 p.m. to 4 p.m. on June 17, 
2015, and between approximately 9:15 a.m. to 9:45 a.m. on June 18, 
2015. 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 June 
4, 2015. 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 8, 2015.
    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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Jayne E. Peterson 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 19, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-12512 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P


