Notice2022-19501
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products; Draft Guidance for Industry; Availability
Primary source
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Published
September 9, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products." This draft guidance is intended to assist industry in providing information in labeling about the quantities at which sodium, potassium, and phosphorus as constituents of active or inactive drug ingredients are present in human over-the-counter (OTC) and prescription drug products.
Full Text
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<title>Federal Register, Volume 87 Issue 174 (Friday, September 9, 2022)</title>
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[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55444-55446]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19501]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0528]
Quantitative Labeling of Sodium, Potassium, and Phosphorus for
Human Over-the-Counter and Prescription Drug Products; Draft Guidance
for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human
Over-the-Counter and Prescription Drug Products.'' This draft guidance
is intended to assist industry in providing information in labeling
about the quantities at which sodium, potassium, and phosphorus as
constituents of active or inactive drug ingredients are present in
human over-the-counter (OTC) and prescription drug products.
DATES: Submit either electronic or written comments on the draft
guidance by November 8, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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 information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-D-0528 for ``Quantitative Labeling of Sodium, Potassium, and
Phosphorus for Human Over-the-Counter and Prescription Drugs.''
Received comments 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
[[Page 55445]]
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.'' The Agency 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 to 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 this 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpo.gov/fdsys/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8926, or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Quantitative Labeling of Sodium, Potassium, and Phosphorus
for Human Over-the-Counter and Prescription Drugs Products.'' This
draft guidance focuses on sodium, potassium, and phosphorus when
present as constituents of active or inactive drug product ingredients
(e.g., sodium as a constituent of the inactive ingredient anhydrous
trisodium citrate, phosphorus as a constituent of the inactive
ingredient dibasic calcium phosphate, or sodium as a constituent of the
active ingredient naproxen sodium).
Sodium, potassium, and phosphorus are often present in drug
products as constituents of active or inactive ingredients. The amounts
of these constituents can vary among drug products, including drugs
with the same active ingredient, depending on factors such as the
manufacturer, formulation, and dosage form. For example, the amount of
sodium, potassium, or phosphorus may differ between a reference listed
drug and a generic version of the drug, or the amount may vary among
different generic versions of the same drug.
This draft guidance restates the legal requirements set forth in
current regulations for the quantitative labeling of sodium and
potassium for OTC products intended for oral ingestion. There is no
current regulation requiring quantitative information specifically for
sodium or potassium in prescription drugs. However, this draft guidance
recommends that manufacturers of OTC and prescription drug products
include quantitative information for sodium, potassium, and phosphorus
(when present above threshold levels described in the draft guidance)
in the product's labeling to assist healthcare providers and patients.
Healthcare providers generally recommend that patients with certain
clinical conditions such as heart failure, hypertension, or chronic
kidney disease, restrict dietary intake of sodium, potassium, or
phosphorus. Including information about the quantities of these
constituents in drug product labeling would allow healthcare providers
and patients to account for the amounts of these constituents present
in a patient's daily drug regimen when determining an individual's
total daily intake. Quantifying these constituents in drug product
labeling as recommended in this draft guidance may allow healthcare
providers and patients to select drug products with lower amounts of
these constituents when necessary if such alternatives are available.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Quantitative
Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-
Counter and Prescription Drug Products.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to proposed collections of information
described in FDA's 60-day notice requesting public comment on the
proposed collection of information entitled, ``Agency Information
Collection Activities; Proposed Collection; Comment Request; General
Drug Labeling Provisions and Over-the-Counter Monograph Drug User Fee
Submissions.'' The proposed collections of information are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). As required by the
PRA, FDA has published an analysis of these information collection
provisions elsewhere in this edition of the Federal Register and will
submit them for OMB approval following the period for public comment.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in certain sections of 21 CFR part 201 have been approved under OMB
control number 0910-0572; the collections of information in 21 CFR part
314 have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, https://www.fda.gov/
[[Page 55446]]
vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19501 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-P
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