[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Notices]
[Pages 24631-24633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0357]


Pharmacy Compounding Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) announces 
a forthcoming public advisory committee meeting of the Pharmacy 
Compounding Advisory Committee. The general function of the committee 
is to provide advice on scientific, technical, and medical issues 
concerning drug compounding under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act), and, as required, any other product for which FDA has 
regulatory responsibility, and to make appropriate recommendations to 
the Agency. The meeting will be open to the public. FDA is establishing 
a docket for public comment on this document.

DATES: The meeting will be held on June 9, 2021, from 10 a.m. to 5:05 
p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all meeting participants will be joining this advisory committee 
meeting via an online teleconferencing platform. Answers to commonly 
asked questions about FDA advisory committee meetings may be accessed 
at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2021-N-0357. The docket will close on June 8, 
2021. Submit either electronic or written comments on this public 
meeting by June 8, 2021. Please note that late, untimely filed comments 
will not be considered. Electronic comments must be submitted on or 
before June 8, 2021. The https://www.regulations.gov electronic filing 
system will accept comments until 11:59 p.m. Eastern Time at the end of 
June 8, 2021. Comments received by mail/hand delivery/courier (for 
written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.
    Comments received on or before May 26, 2021, will be provided to 
the committee. Comments received after that date will be taken into 
consideration by FDA. In the event that the meeting is cancelled, FDA 
will continue to evaluate any relevant applications or information, and 
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and

[[Page 24632]]

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-0357 for ``Pharmacy Compounding Advisory Committee; Notice 
of Meeting; Establishment of a Public Docket; Request for Comments.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review 
this copy, including the claimed confidential information, in its 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify the information as ``confidential.'' Any 
information marked as ``confidential'' will not be disclosed except in 
accordance with 21 CFR 10.20 and other applicable disclosure law. For 
more information about FDA's posting of comments to public dockets, see 
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Takyiah Stevenson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, 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 FDA's website at 
https://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 (21 U.S.C. 353a) describes 
the conditions that must be satisfied for human drug products 
compounded by a licensed pharmacist in a State licensed pharmacy or a 
Federal facility, or a 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 or abbreviated new drug applications).
    Section 503B of the FD&C Act (21 U.S.C. 353b) describes the 
conditions that must be satisfied for drug products compounded in an 
outsourcing facility to be exempt from (1) section 502(f)(1), (2) 
section 505, and (3) section 582 (21 U.S.C. 360eee-1) (concerning drug 
supply chain security requirements) of the FD&C Act.
    One of the conditions that must be satisfied for a drug product to 
qualify for the exemptions under section 503A of the FD&C Act is that 
the licensed pharmacist or licensed physician compounds the drug 
product using bulk drug substances (as defined in 21 CFR 207.3) that: 
(1) 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; (2) if an 
applicable monograph does not exist, are drug substances that are 
components of drugs 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, that appear on a list developed by the Secretary through 
regulations issued by the Secretary under section 503A(c) of the FD&C 
Act (the ``503A Bulks List'') (see section 503A(b)(1)(A)(i) of the FD&C 
Act).
    One of the conditions that must be satisfied to qualify for the 
exemptions under section 503A or section 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). 
The Withdrawn or Removed List is codified at 21 CFR 216.24.
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. The committee 
will discuss the following four bulk drug substances nominated for 
inclusion on the 503A Bulks List: Choline chloride, oxitriptan (also 
known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin. 
The chart below identifies the use(s) FDA reviewed for each of the four 
bulk drug substances being discussed at this advisory committee 
meeting. The nominators of these substances or another interested party 
will be invited to make a short presentation supporting the nomination.

------------------------------------------------------------------------
        Bulk drug substance                    Uses evaluated
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Choline Chloride..................  Liver diseases (including hepatic
                                     steatosis and non-alcoholic fatty
                                     liver disease).
                                    Atherosclerosis.
                                    Fetal alcohol spectrum disorder.
                                    Supplementation in long-term total
                                     parenteral nutrition.

[[Page 24633]]

 
Melatonin.........................  Treatment of sleep disorders in
                                     patients with autism spectrum
                                     disorder (specifically children and
                                     adolescents).
Methylcobalamin...................  Amyotrophic lateral sclerosis (also
                                     known as ALS).
                                    Pain management.
                                    Peripheral neuropathy (including
                                     diabetic neuropathy).
                                    Inborn errors of metabolism (also
                                     known as genetic metabolic
                                     disorders) (including
                                     methylenetetrahydrofolate reductase
                                     deficiency (also known as MTHFR)).
                                    Hyperhomocysteinemia (including
                                     conjunctive therapy in hemodialysis
                                     patients).
                                    Vitamin B12 deficiency.
                                    Autism spectrum disorder.
Oxitriptan (5-HTP)................  Treatment for patients with
                                     tetrahydrobiopterin (BH4)
                                     deficiency.
------------------------------------------------------------------------

    The committee will also discuss revisions FDA is considering to the 
Withdrawn or Removed List. FDA now is considering whether to amend the 
rule to add one more entry to the list: Neomycin Sulfate: All 
parenteral drug products containing neomycin sulfate (except for 
ophthalmic or otic use, or when combined with polymyxin B sulfate for 
irrigation of the intact bladder). 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. 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 the list.
    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 website prior to the meeting, the 
background material will be made publicly available on FDA's website at 
the time of the advisory committee meeting. Background material and the 
link to the online teleconference meeting room will be available at 
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll 
down to the appropriate advisory committee meeting link. The meeting 
will include slide presentations with audio components to allow the 
presentation of materials in a manner that most closely resembles an 
in-person advisory committee meeting. Procedure: Interested persons may 
present data, information, or views, orally or in writing, on issues 
pending before the committee. All electronic and written submissions 
submitted to the Docket (see ADDRESSES) on or before May 26, 2021, will 
be provided to the committee. Oral presentations from the public will 
be scheduled between approximately 11 a.m. to 11:15 a.m., 12:25 p.m. to 
12:40 p.m., 2:15 p.m. to 2:30 p.m., 3:35 p.m. to 3:50 p.m., and 4:40 
p.m. to 4:55 p.m. Eastern Time. 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 May 17, 2021. 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 May 18, 2021.
    For press inquiries, please contact the Office of Media Affairs at 
fdaoma@fda.hhs.gov or 301-796-4540.
    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 Takyiah Stevenson (see FOR FURTHER INFORMATION CONTACT) at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://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 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09621 Filed 5-6-21; 8:45 am]
BILLING CODE 4164-01-P


