[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41969-41970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13767]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-0939]
Prohibition on Wholesaling Under Section 503B of the Federal
Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled
``Prohibition on Wholesaling Under Section 503B of the Federal Food,
Drug, and Cosmetic Act.'' This draft guidance describes FDA's
interpretation of, and policies concerning, the statutory prohibition
on wholesaling for certain compounded drugs. This draft guidance also
describes examples of how FDA intends to apply the statutory
wholesaling provision.
DATES: Submit either electronic or written comments on the draft
guidance on or before August 28, 2023 to ensure that the Agency
considers your comment on this draft guidance before it begins work on
the final version of the guidance. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before August 28, 2023. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 28, 2023. 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.
ADDRESSES: You may submit comments on any guidance at any time 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 information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-D-0939 for ``Prohibition on Wholesaling Under Section 503B of
the Federal Food, Drug, and Cosmetic Act.'' Received comments 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.'' The Agency will
review this copy, including the claimed confidential information, in
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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 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: 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.
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. 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: Dominic Markwordt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5104, Silver Spring, MD 20993, 301-796-
3100, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Prohibition on Wholesaling Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.'' This draft guidance describes FDA's
interpretation of, and policies concerning, the prohibition on
wholesaling in section 503B of the FD&C Act (21 U.S.C. 353b). This
draft guidance also describes examples of how FDA intends to apply
section 503B of the FD&C Act's wholesaling provision.
Section 503B of the FD&C Act describes the conditions that must be
satisfied for human drugs compounded by an outsourcing facility to be
exempt from the following three sections of the FD&C Act: section 505
(21 U.S.C. 355) (concerning the approval of drugs under new drug
applications or abbreviated new drug applications); section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning
drug supply chain security requirements).
Pursuant to section 503B(a)(8) of the FD&C Act, one of the
conditions that must be met for a drug compounded by an outsourcing
facility to qualify for the exemptions in section 503B of the FD&C Act
is that the drug will not be sold or transferred by an entity other
than the outsourcing facility that compounded the drug. However, the
wholesaling provision does not prohibit administration of a drug in a
health care setting or dispensing a drug pursuant to a prescription
executed in accordance with section 503(b)(1) of the FD&C Act. The
statutory prohibition on wholesaling in section 503B(a)(8) of the FD&C
Act helps to ensure that compounding is based on individual patient
need, which, in turn, reduces the overall risk of patient harm and
helps to preserve the integrity of the U.S. drug approval process. It
also helps to preserve the integrity of the U.S. drug supply chain.
This prohibition, like other conditions in section 503B of the FD&C
Act, preserves important distinctions between outsourcing facilities,
which are intended to compound drugs for patients whose medical needs
cannot be met by approved drugs, from conventional manufacturers, which
generally engage in mass manufacturing of FDA-approved drug products.
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 the
``Prohibition on Wholesaling Under Section 503B of the Federal Food,
Drug, and Cosmetic Act.'' It does not establish any rights for any
person and is not binding on FDA or the public. An alternative approach
than what is described in the guidance can be used if it satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this draft guidance contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 207 pertaining to registration of
producers of drugs and listing of drugs in commercial distribution have
been approved under OMB control number 0910-0045. The collections of
information in 21 CFR parts 210 and 211 pertaining to current good
manufacturing practice have been approved under OMB control number
0910-0139. The collections of information pertaining to postmarketing
adverse drug experience reporting have been approved under OMB control
number 0910-0230. The collections of information for adverse event
reporting and human drug compounding under section 503B of the FD&C Act
have been approved under OMB control number 0910-0800.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13767 Filed 6-27-23; 8:45 am]
BILLING CODE 4164-01-P