[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Notices]
[Pages 27163-27165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09797]


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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) announces a forthcoming 
public advisory committee meeting of the Pharmacy Compounding Advisory 
Committee. The general function of the committee is to provide advice 
and recommendations to FDA on regulatory issues. 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 8, 2022, from 9:30 a.m. to 5:15 
p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this 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 7, 
2022. Submit either electronic or written comments on this public 
meeting by June 7, 2022. Please note that late, untimely filed comments 
will not be considered. Electronic comments must be submitted on or 
before June 7, 2022. The https://www.regulations.gov electronic filing 
system will accept comments until 11:59 p.m. Eastern Time at the end of 
June 7, 2022. 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 24, 2022, 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 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

[[Page 27164]]

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: [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 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 Federal Food, Drug, and Cosmetic 
Act (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 (NDAs) or 
abbreviated new drug applications (ANDAs)).
    Section 503B of the FD&C Act 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: Ammonium tetrathiomolybdate, 
enclomiphene citrate, ferric subsulfate, and glutathione. 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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Ammonium Tetrathiomolybdate..................  Wilson disease, use as
                                                copper (Cu) chelation
                                                therapy for the
                                                treatment of breast
                                                cancer, kidney cancer,
                                                prostate cancer,
                                                colorectal cancer,
                                                esophageal cancer, and
                                                malignant pleural
                                                mesothelioma.
Enclomiphene Citrate.........................  To increase serum
                                                testosterone,
                                                luteinizing hormone
                                                (LH), and follicle-
                                                stimulating hormone
                                                (FSH) to normal levels
                                                in the treatment of
                                                secondary hypogonadism.
Ferric Subsulfate............................  For use as an astringent
                                                and hemostatic agent
                                                during minor surgical
                                                procedures.

[[Page 27165]]

 
Glutathione..................................  Skin lightening, cystic
                                                fibrosis, asthma,
                                                chronic obstructive
                                                pulmonary disease,
                                                chronic lung disease,
                                                oxidative stress,
                                                reduction of the side
                                                effects of chemotherapy,
                                                inhibition of chemical
                                                induced carcinogenesis,
                                                prevention of radiation
                                                injury, treatment of
                                                heavy metal poisoning
                                                (cadmium and mercury),
                                                acetaminophen toxicity,
                                                autism spectrum
                                                disorder, Alzheimer's
                                                disease, Parkinson's
                                                disease, major
                                                depressive disorder,
                                                schizophrenia,
                                                helicobacter pylori
                                                infection, human
                                                immunodeficiency virus
                                                infection, tuberculosis,
                                                otitis media, peripheral
                                                obstructive arterial
                                                disease, anemia,
                                                diabetes, and septic
                                                shock.
------------------------------------------------------------------------

    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: Lorcaserin Hydrochloride: All 
drug products containing lorcaserin hydrochloride. 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 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 24, 2022, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 10:35 a.m. to 10:50 a.m., 12:15 p.m. to 12:30 p.m., 2:25 
p.m. to 2:40 p.m., 3:45 p.m. to 4 p.m., and 4:50 p.m. to 5:05 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 16, 2022. 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 17, 
2022.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] 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, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09797 Filed 5-5-22; 8:45 am]
BILLING CODE 4164-01-P