[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Pages 3967-3969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01267]


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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.

[[Page 3968]]


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 February 23, 2015, from 
8:30 a.m. to 5 p.m., and February 24, 2015, from 8:15 a.m. to 3 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. Information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.
    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: <a href="/cdn-cgi/l/email-protection#aefeedefedeec8cacf80c6c6dd80c9c1d8"><span class="__cf_email__" data-cfemail="471704060407212326692f2f3469202831">[email protected]</span></a>, 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: On November 27, 2013, the Drug Quality and Security Act 
(DQSA) amended section 503A of the FD&C Act to remove certain 
provisions regarding the advertising and promotion of compounded drugs 
and the solicitation of prescriptions for compounded drugs that were 
found to be unconstitutional by the U.S. Supreme Court in 2002. By 
removing the unconstitutional provisions, the law removed uncertainty 
regarding the validity of section 503A of the FD&C Act, which is 
applicable to compounders nationwide.
    Section 503A of the FD&C Act (21 U.S.C. 353a) describes the 
conditions under which a human drug product compounded for an 
identified individual patient based on the receipt of a prescription 
can qualify for exemptions from 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) requirements for drugs); (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 or abbreviated new drug applications).
    The DQSA also created a new section 503B of the FD&C Act, under 
which a compounder can register as an ``outsourcing facility.'' Drug 
products compounded at outsourcing facilities may be able to qualify 
for exemptions from the FDA approval requirements (section 505 of the 
FD&C Act) and the requirement to label products with adequate 
directions for use (section 502(f)(1) of the FD&C Act) but will still 
be subject to CGMP requirements under section 501(a)(2)(B) of the FD&C 
Act.
    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 of drugs 
published by the Secretary 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 (see sections 
503A(b)(1)(C) and 503B(a)(4) of the FD&C Act).
    Another condition in section 503A of the FD&C Act that must be 
satisfied to qualify for the section 503A exemptions is that bulk drug 
substances used in a compounded drug must meet one of the following 
criteria: (I) Comply 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; (II) if such a 
monograph does not exist, are drug substances that are components of 
drugs approved by the Secretary of Health and Human Services (the 
Secretary); or (III) if such a monograph does not exist and the drug 
substance is not a component of a drug approved by the Secretary, that 
appear on a list developed by the Secretary through regulations issued 
by the Secretary (section 503A(b)(1)(A)(i) of the FD&C Act). FDA will 
discuss drugs proposed for inclusion on these two lists with the 
Pharmacy Compounding Advisory Committee (committee).
    Agenda: On February 23, 2015, during the morning session, the 
committee will discuss proposed revisions 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 products is 
currently codified at 216.24 (21 CFR 216.24), and FDA is proposing to 
revise and update the list at Sec.  216.24 for purposes of both 
sections 503A and 503B of the FD&C Act. On July 2, 2014, FDA published 
a proposed rule that would add 25 drug products to this list and modify 
the description of one drug product on this list to add an exception 
(79 FR 37687, July 2, 2014). FDA received two drug-specific comments on 
the proposed rule. One comment requested that FDA clarify whether the 
entry for adenosine phosphate that is currently included on the list 
(all drug products containing adenosine phosphate) is intended to 
include all three forms of adenosine phosphate (mono-, di-, and 
triphosphate). The second comment requested that chloramphenicol 
tablets, 250 milligrams, be excluded from the list. FDA will discuss 
both of these comments with the committee.
    On February 23, 2015, during the afternoon session, and on February 
24, 2015, the committee will discuss proposed criteria for developing 
the list of bulk drug substances that may be used to compound drug 
products in accordance with section 503A of the FD&C Act and will 
discuss six substances nominated for inclusion on the list. On December 
4, 2013, and July 2, 2014, FDA published notices in the Federal 
Register (78 FR 72841 and 79 FR 37747) soliciting nominations for this 
list. At this first meeting of the committee, FDA intends to discuss 
the following nominated bulk drug substances: Cantharidin, 
diphenylcyclopropenone, piracetam, silver protein mild, squaric acid 
dibutyl ester, and thymol iodide. 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.

[[Page 3969]]

    FDA intends to make background material available to the public at 
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 
February 9, 2015. Oral presentations from the public will be scheduled 
between approximately 10:15 a.m. to 10:45 a.m. and 3:35 p.m. to 3:50 
p.m. on February 23, 2015, and between approximately 9:30 a.m. to 9:45 
a.m. and 11:45 a.m. to noon on February 24, 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 February 12, 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 February 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 
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: January 21, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-01267 Filed 1-23-15; 8:45 am]
BILLING CODE 4164-01-P


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