[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Notices]
[Pages 59160-59161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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