80 FR 59160 - Pharmacy Compounding Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 190 (October 1, 2015)

Page Range		59160-59161
FR Document		2015-24834
Federal Register, Volume 80 Issue 190 (Thursday, October 1, 2015)
[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Notices]
[Pages 59160-59161]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24834]


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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 October 27, 2015, from 8 
a.m. to 5:30 p.m., and on October 28, 2015, from 8:30 a.m. to 4:45 p.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/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: 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: [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 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 Health and Human Services (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; 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).
    FDA will discuss with the committee drugs proposed for inclusion on 
the withdrawn or removed list pursuant to sections 503A and 503B of the 
FD&C Act and on the section 503A bulk drug substances list.
    Agenda: On October 27, 2015, during the morning session, the 
committee will discuss a revision 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 product has been withdrawn or removed 
from the market because such drug product or such components of 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 regulation to add one more drug to the 
list: Quinacrine: All drug products containing quinacrine for 
intrauterine administration. As 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 this drug product.
    On October 27, 2015, during the morning and afternoon sessions, the 
committee will discuss six bulk drug substances nominated for inclusion 
on the section 503A bulk drug substances

[[Page 59161]]

list. FDA intends to discuss the following nominated bulk drug 
substances: Quinacrine hydrochloride, methylsulfonylmethane, curcumin, 
germanium sesquioxide, rubidium chloride, and deoxy-D-glucose. The 
nominators of these substances will be invited to make a short 
presentation supporting the nomination.
    On October 28, 2015, during the morning and afternoon sessions, 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: Alanyl-L-
glutamine, glutaraldehyde, glycyrrhizin, and domperidone. Other 
nominated substances will be discussed at future committee meetings.
    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 
October 13, 2015. Oral presentations from the public will be scheduled 
between approximately 9:45 a.m. to 10 a.m., 1:30 p.m. to 1:45 p.m., and 
4:15 p.m. to 4:30 p.m. on October 27, 2015, and between approximately 
11 a.m. to 11:15 a.m. and 2:45 p.m. to 3:30 p.m. on October 28, 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 
October 9, 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 October 13, 
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 
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 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-24834 Filed 9-30-15; 8:45 am]
BILLING CODE 4164-01-P
59160 Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices

vote in the selection process. Persons Washington, DC area). A notice in the that a bulk drug substance (active
who nominate themselves to serve as Federal Register about last minute pharmaceutical ingredient) used in a
voting or nonvoting consumer modifications that impact a previously compounded drug must meet one of the
representatives will not participate in announced advisory committee meeting following criteria: (1) Complies with the
the selection process. cannot always be published quickly standards of an applicable United States
Dated: September 25, 2015. enough to provide timely notice. Pharmacopoeia (USP) or National
Jill Hartzler Warner,
Therefore, you should always check the Formulary monograph, if a monograph
Agency’s Web site at http:// exists, and the USP chapter on
Associate Commissioner for Special Medical
Programs.
www.fda.gov/AdvisoryCommittees/ pharmacy compounding; (2) if an
default.htm and scroll down to the applicable monograph does not exist, is
[FR Doc. 2015–24835 Filed 9–30–15; 8:45 am]
appropriate advisory committee meeting a component of a drug approved by the
BILLING CODE 4164–01–P
link, or call the advisory committee Secretary; or (3) if such a monograph
information line to learn about possible does not exist and the drug substance is
modifications before coming to the not a component of a drug approved by
DEPARTMENT OF HEALTH AND
meeting. the Secretary, appears on a list (‘‘section
HUMAN SERVICES Background: Section 503A of the 503A bulk drug substances list’’)
Food and Drug Administration FD&C Act (21 U.S.C. 353a) describes the developed by the Secretary through
conditions that must be satisfied for regulations issued by the Secretary (see
[Docket No. FDA–2015–N–0001] human drug products compounded by a section 503A(b)(1)(A)(i) of the FD&C
licensed pharmacist or licensed Act).
Pharmacy Compounding Advisory physician to be exempt from the FDA will discuss with the committee
Committee; Notice of Meeting following three sections of the FD&C drugs proposed for inclusion on the
AGENCY: Food and Drug Administration, Act: (1) Section 501(a)(2)(B) (21 U.S.C. withdrawn or removed list pursuant to
HHS. 351(a)(2)(B)) (concerning current good sections 503A and 503B of the FD&C
ACTION: Notice. manufacturing practice); (2) section Act and on the section 503A bulk drug
502(f)(1) (21 U.S.C. 352(f)(1)) substances list.
This notice announces a forthcoming (concerning the labeling of drugs with Agenda: On October 27, 2015, during
meeting of a public advisory committee adequate directions for use); and (3) the morning session, the committee will
of the Food and Drug Administration section 505 (21 U.S.C. 355) (concerning discuss a revision FDA is considering to
(FDA). The meeting will be open to the the approval of human drug products the list of drug products that may not be
public. under new drug applications (NDAs) or compounded under the exemptions
Name of Committee: Pharmacy abbreviated new drug applications provided by the FD&C Act because the
Compounding Advisory Committee. (ANDAs)). drug product has been withdrawn or
General Function of the Committee: The Drug Quality and Security Act removed from the market because such
To provide advice on scientific, adds a new section, 503B, to the FD&C drug product or such components of
technical, and medical issues Act (21 U.S.C. 353b) that creates a new drug products have been found to be
concerning drug compounding under category of ‘‘outsourcing facilities.’’ unsafe or not effective. The list of those
sections 503A and 503B of the Federal Outsourcing facilities, as defined in drug products is currently codified at 21
Food, Drug, and Cosmetic Act (FD&C section 503B of the FD&C Act, are CFR 216.24. FDA now is considering
Act), and, as required, any other product facilities that meet certain conditions whether to amend the regulation to add
for which FDA has regulatory described in section 503B, including one more drug to the list: Quinacrine:
responsibility, and make appropriate registration with FDA as an outsourcing All drug products containing quinacrine
recommendations to the Commissioner facility. If these conditions are satisfied, for intrauterine administration. As
of Food and Drugs. a drug product compounded for human explained in the Federal Register of July
Date and Time: The meeting will be use by or under the direct supervision 2, 2014, (79 FR 37687 at 37689 through
held on October 27, 2015, from 8 a.m. of a licensed pharmacist in an 37690), the list may specify that a drug
to 5:30 p.m., and on October 28, 2015, outsourcing facility is exempt from may not be compounded in any form,
from 8:30 a.m. to 4:45 p.m. three sections of the FD&C Act: (1) or, alternatively, may expressly exclude
Location: FDA White Oak Campus, Section 502(f)(1), (2) section 505, and (3) a particular formulation, indication,
10903 New Hampshire Ave., Bldg. 31 section 582 (21 U.S.C. 360eee–1), but dosage form, or route of administration
Conference Center, the Great Room (Rm. not section 501(a)(2)(B). from an entry on the list because an
1503), Silver Spring, MD 20993–0002. One of the conditions that must be approved drug containing the same
Answers to commonly asked questions satisfied to qualify for the exemptions active ingredient(s) has not been
including information regarding special under both sections 503A and 503B of withdrawn or removed from the market.
accommodations due to a disability, the FD&C Act is that the drug that is Moreover, a drug may be listed only
visitor parking, and transportation may compounded does not appear on a list with regard to certain formulations,
be accessed at: http://www.fda.gov/ published by the Secretary of Health indications, routes of administration, or
AdvisoryCommittees/ and Human Services (the Secretary) of dosage forms because it has been found
AboutAdvisoryCommittees/ drugs that have been withdrawn or to be unsafe or not effective in those
ucm408555.htm. removed from the market because such particular formulations, indications,
Contact Person: Cindy Hong, Center drug products or components of such routes of administration, or dosage
mstockstill on DSK4VPTVN1PROD with NOTICES6

for Drug Evaluation and Research, Food drug products have been found to be forms. FDA plans to seek the
and Drug Administration, 10903 New unsafe or not effective (‘‘withdrawn or committee’s advice concerning the
Hampshire Ave., Bldg. 31, Rm. 2417, removed list’’) (see sections inclusion of this drug product.
Silver Spring, MD 20993–0002, 301– 503A(b)(1)(C) and 503B(a)(4) of the On October 27, 2015, during the
796–9001, FAX: 301–847–8533, email: FD&C Act). morning and afternoon sessions, the
PCAC@fda.hhs.gov, or FDA Advisory Another condition that must be committee will discuss six bulk drug
Committee Information Line, 1–800– satisfied to qualify for the exemptions substances nominated for inclusion on
741–8138 (301–443–0572 in the under section 503A of the FD&C Act is the section 503A bulk drug substances

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Document Created: 2015-12-15 08:41:16
Document Modified: 2015-12-15 08:41:16
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.
FR Citation		80 FR 59160
80 FR 59160 - Pharmacy Compounding Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 190 (October 1, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
