Notice2022-09797
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
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Published
May 6, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 88 (Friday, May 6, 2022)</title>
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[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Notices]
[Pages 27163-27165]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="/cdn-cgi/l/email-protection#29796a686a694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="80d0c3c1c3c0e6e4e1aee8e8f3aee7eff6">[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 FDA's website at
<a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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.
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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.
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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
<a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. 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
<a href="/cdn-cgi/l/email-protection#3a5c5e5b55575b7a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="4c2a282d23212d0c2a282d6224243f622b233a">[email protected]</span></a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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
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