[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Pages 7351-7352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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 (PCAC).
    General Function of the Committee: To provide advice on scientific, 
technical, and medical issues concerning drug compounding under 
sections 503A and 503B (21 U.S.C. 353A and 353B) 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 March 8, 2016, from 8:30 
a.m. to 4:30 p.m., and on March 9, 2016, from 8:30 a.m. to 1 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.

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: [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.

SUPPLEMENTARY INFORMATION: 
    Background: Section 503A of the FD&C Act 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) (concerning current 
good manufacturing practice (CGMP)); (2) section 502(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 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), 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, concerning the track 
and trace requirements in the Drug Supply Chain Security Act (Pub. L. 
113-53). 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 (the ``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).
    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 
Pharmacy Compounding Advisory Committee, of drugs or categories of 
drugs that present demonstrable difficulties for compounding that are 
reasonably likely

[[Page 7352]]

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 will discuss with the committee drugs proposed for inclusion on 
the section 503A bulk drug substances list and on the demonstrably 
difficult to compound list under sections 503A and 503B of the FD&C 
Act.
    Agenda: On March 8, 2016, the committee will discuss six bulk drug 
substances nominated for inclusion on the section 503A bulk drug 
substances list. FDA will discuss the following nominated bulk drug 
substances: Quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze 
dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The 
nominators of these substances will be invited to make a short 
presentation supporting the nomination.
    On March 9, 2016, the committee will discuss two categories of drug 
products nominated for the list of drug products that present 
demonstrable difficulties for compounding. These categories of drug 
products are metered dose inhalers and dry powder inhalers. The 
nominators who nominated the category of drugs or specific drug 
products in the category 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. 
Written submissions may be made to the contact person on or before 
March 1, 2016. Oral presentations from the public will be scheduled 
between approximately 11 a.m. to 11:15 a.m. and 3:15 p.m. to 3:30 p.m. 
on March 8, 2016, and between approximately 11:30 a.m. to 12 noon on 
March 9, 2016. 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 24, 2016. 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 
25, 2016.
    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: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-02786 Filed 2-8-16; 4:15 pm]
 BILLING CODE 4164-01-P