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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
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
2021N0357 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, 2404027500.
Confidential SubmissionsTo 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 FDAs 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-201509-18/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, 2404027500.
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 209930002, 240
4022507, Fax: 3018478533, email:
PCAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1800
7418138 3014430572 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 FDAs 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 501a2B 21 U.S.C.
351a2B concerning current good manufacturing practice; 2 section 502f1 21 U.S.C. 352f1
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 502f1, 2 section 505, and 3 section 582 21
U.S.C. 360eee1 concerning drug
Bulk drug substance
Uses evaluated
Choline Chloride

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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 503Ac of the FD&C Act the 503A Bulks List see section 503Ab1Ai 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 503Ab1C and 503Ba4 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 uses 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.

Liver diseases including hepatic steatosis and non-alcoholic fatty liver disease.
Atherosclerosis.
Fetal alcohol spectrum disorder.
Supplementation in long-term total parenteral nutrition.

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